PART II AND III

AN OFFERING STATEMENT PURSUANT TO REGULATION A RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. INFORMATION CONTAINED IN THIS PRELIMINARY OFFERING CIRCULAR IS SUBJECT TO COMPLETION OR AMENDMENT. THESE SECURITIES MAY NOT BE SOLD NOR MAY OFFERS TO BUY BE ACCEPTED BEFORE THE OFFERING STATEMENT FILED WITH THE COMMISSION IS QUALIFIED. THIS PRELIMINARY OFFERING CIRCULAR SHALL NOT CONSTITUTE AN OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY NOR MAY THERE BE ANY SALES OF THESE SECURITIES IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL BEFORE REGISTRATION OR QUALIFICATION UNDER THE LAWS OF SUCH STATE. THE COMPANY MAY ELECT TO SATISFY ITS OBLIGATION TO DELIVER A FINAL OFFERING CIRCULAR BY SENDING YOU A NOTICE WITHIN TWO BUSINESS DAYS AFTER THE COMPLETION OF THE COMPANY’S SALE TO YOU THAT CONTAINS THE URL WHERE THE FINAL OFFERING CIRCULAR OR THE OFFERING STATEMENT IN WHICH SUCH FINAL OFFERING CIRCULAR WAS FILED MAY BE OBTAINED.

PRELIMINARY OFFERING CIRCULAR DATED AUGUST 1, 2019

MONOGRAM ORTHOPAEDICS, INC.

53 Bridge Street, Unit 507, Brooklyn, New York, 11251

(718) 576-3205
 

www.monogramorthopedics.com

UP TO 5,000,000 SHARES OF SERIES A PREFERRED STOCK

UP TO 5,000,000 SHARES OF COMMON STOCK INTO WHICH THE SERIES A PREFERRED STOCK MAY CONVERT

PRICE: $4.00 PER SHARE

Holders of our Series A Preferred Stock have limited voting rights compared to holders of our Common Stock. For instance, holders of our Common Stock will have the right to elect two directors as a single class, while holders of our Series A Preferred Stock will only vote for a single director together with the holders of our Common Stock. See “Securities Being Offered” at Page 31 for more information on the rights of our Series A Preferred Stock.

	Price to Public		Underwriting discount and commissions*		Proceeds to issuer**
Per share	$	4.00	$	0.35	$	3.65
Total Minimum	$	2,750,000	$	275,000	$	2,475,000
Total Maximum	$	20,000,000	$	1,750,000	$	18,250,00

*The Series A Preferred Stock is convertible into Common Stock either at the discretion of the investor or automatically upon the occurrence of certain events, like effectiveness of registration of the Common Stock in an initial public offering. The total number of shares of the Common Stock into which the Series A Preferred Stock may be converted will be determined by dividing the original issue price per share by the conversion price per share. See “Securities Being Offered” at page 31 for additional details.

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** The company has engaged SI Securities, LLC to serve as its sole and exclusive placement agent to assist in the placement of its securities. The company will pay SI Securities, LLC in accordance with the terms of the Issuer Agreement between the company and SI Securities, LLC, a copy of which is filed as an exhibit to the Offering Statement of which this Offering Circular is a part. If the placement agent identifies all the investors and the maximum amount of shares is sold, the maximum amount the company would pay SI Securities, LLC is $1,750,000. This does not include transaction fees paid directly to SI Securities, LLC by investors. See “Plan of Distribution and Selling Securityholders” for details of compensation and transaction fees to be paid to the placement agent on page 15.

The company expects that the amount of expenses of the offering that it will pay will be approximately $75,000, not including commissions or state filing fees.

The company is selling shares of Series A Preferred Stock.

The company has engaged The Bryn Mawr Trust Company of Delaware as an escrow agent (the “Escrow Agent”) to hold funds tendered by investors, and assuming we sell a minimum of $2,750,000 in shares, may hold a series of closings at which we receive the funds from the Escrow Agent and issue the shares to investors.  The offering will terminate at the earlier of: (1) the date at which the maximum offering amount has been sold, (2) one year from the date upon which the Securities and Exchange Commission qualifies the Offering Statement of which this Offering Circular forms a part, or (3) the date at which the offering is earlier terminated by the company in its sole discretion. In the event we have not sold the minimum amount of shares by [one year from qualification], or sooner terminated by the company, any money tendered by potential investors will be promptly returned by the Escrow Agent. The company may undertake one or more closings on a rolling basis once the minimum offering amount is sold. After each closing, funds tendered by investors will be available to the company. The offering is being conducted on a best-efforts basis.

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INVESTING IN THE SERIES A PREFERRED STOCK OF MONOGRAM ORTHOPAEDICS, INC. IS SPECULATIVE AND INVOLVES SUBSTANTIAL RISKS. YOU SHOULD PURCHASE THESE SECURITIES ONLY IF YOU CAN AFFORD A COMPLETE LOSS OF YOUR INVESTMENT. SEE “RISK FACTORS” BEGINNING ON PAGE 7 TO READ ABOUT THE MORE SIGNIFICANT RISKS YOU SHOULD CONSIDER BEFORE BUYING THE SERIES A PREFERRED STOCK OF THE COMPANY.

THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION DOES NOT PASS UPON THE MERITS OR GIVE ITS APPROVAL OF ANY SECURITIES OFFERED OR THE TERMS OF THE OFFERING, NOR DOES IT PASS UPON THE ACCURACY OR COMPLETENESS OF ANY OFFERING CIRCULAR OR OTHER SOLICITATION MATERIALS. THESE SECURITIES ARE OFFERED PURSUANT TO AN EXEMPTION FROM REGISTRATION WITH THE COMMISSION; HOWEVER THE COMMISSION HAS NOT MADE AN INDEPENDENT DETERMINATION THAT THE SECURITIES OFFERED ARE EXEMPT FROM REGISTRATION

GENERALLY NO SALE MAY BE MADE TO YOU IN THIS OFFERING IF THE AGGREGATE PURCHASE PRICE YOU PAY IS MORE THAN 10% OF THE GREATER OF YOUR ANNUAL INCOME OR NET WORTH. DIFFERENT RULES APPLY TO ACCREDITED INVESTORS AND NON-NATURAL PERSONS. BEFORE MAKING ANY REPRESENTATION THAT YOUR INVESTMENT DOES NOT EXCEED APPLICABLE THRESHOLDS, WE ENCOURAGE YOU TO REVIEW RULE 251(d)(2)(i)(C) OF REGULATION A. FOR GENERAL INFORMATION ON INVESTING, WE ENCOURAGE YOU TO REFER TO www.investor.gov.

Sales of these securities will commence on approximately August 15, 2019.

The company is following the “Offering Circular” format of disclosure under Regulation A.

In the event that we become a reporting company under the Securities Exchange Act of 1934, we intend to take advantage of the provisions that relate to “Emerging Growth Companies” under the JOBS Act of 2012. See “Implications of Being an Emerging Growth Company.”

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TABLE OF CONTENTS

SUMMARY	5
RISK FACTORS	7
DILUTION	12
PLAN OF DISTRIBUTION AND SELLING SECURITYHOLDERS	15
USE OF PROCEEDS TO ISSUER	17
THE COMPANY’S BUSINESS	18
THE COMPANY’S PROPERTY	22
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	23
DIRECTORS, EXECUTIVE OFFICERS AND SIGNIFICANT EMPLOYEES	27
COMPENSATION OF DIRECTORS AND EXECUTIVE OFFICERS	28
SECURITY OWNERSHIP OF MANAGEMENT AND CERTAIN SECURITYHOLDERS	29
INTEREST OF MANAGEMENT AND OTHERS IN CERTAIN TRANSACTIONS	30
SECURITIES BEING OFFERED	31
FINANCIAL STATEMENTS FOR THE FISCAL YEARS ENDED DECEMBER 31, 2018 AND 2017	34

In this Offering Circular, the term “Monogram Orthopaedics” “Monogram”, “we”, “us”, “our” or “the company” refers to Monogram Orthopaedics, Inc.

THIS OFFERING CIRCULAR MAY CONTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO, AMONG OTHER THINGS, THE COMPANY, ITS BUSINESS PLAN AND STRATEGY, AND ITS INDUSTRY. THESE FORWARD-LOOKING STATEMENTS ARE BASED ON THE BELIEFS OF, ASSUMPTIONS MADE BY, AND INFORMATION CURRENTLY AVAILABLE TO THE COMPANY’S MANAGEMENT. WHEN USED IN THE OFFERING MATERIALS, THE WORDS “ESTIMATE,” “PROJECT,” “BELIEVE,” “ANTICIPATE,” “INTEND,” “EXPECT” AND SIMILAR EXPRESSIONS ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS, WHICH CONSTITUTE FORWARD LOOKING STATEMENTS. THESE STATEMENTS REFLECT MANAGEMENT’S CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND ARE SUBJECT TO RISKS AND UNCERTAINTIES THAT COULD CAUSE THE COMPANY’S ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE CONTAINED IN THE FORWARD-LOOKING STATEMENTS. INVESTORS ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH SPEAK ONLY AS OF THE DATE ON WHICH THEY ARE MADE. THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO REVISE OR UPDATE THESE FORWARD-LOOKING STATEMENTS TO REFLECT EVENTS OR CIRCUMSTANCES AFTER SUCH DATE OR TO REFLECT THE OCCURRENCE OF UNANTICIPATED EVENTS.

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SUMMARY

Overview

"Monogram Orthopaedics, Inc. (“Monogram,” “we,” “our,” or the “company”) is developing a product solution architecture for enabling mass personalization of orthopedic implants by linking 3D printing and robotics via automated digital image analysis algorithms. The company has a robot prototype that is designed to optically track a simulated surgical target and execute auto-generated cut paths for high precision insertion of a custom patient specific implants. These implants and cut-paths are generated with proprietary Monogram software algorithms. Monogram intends to produce and market surgical robotic equipment and related software, orthopaedic implants, tissue ablation tools, navigation consumables (fiducial markers or Apriltags) and other miscellaneous instrumentation necessary for the execution of reconstructive joint replacement procedures.

The Offering

Securities offered:	Maximum of 5,000,000 shares of Series A Preferred Stock
Securities outstanding before the
Offering (as of June 24, 2019)
Common Stock	4,787,704 shares

Securities outstanding after the

Offering:

Series A Preferred Stock	5,000,000 shares (1)
Common Stock	4,787,704 shares (2) (3)

(1) If  all of our holders of convertible notes convert their notes shares of Series A Preferred Stock, there would be 6,836,132 shares of Series A Preferred outstanding after the Offering.

(2) On May 28, 2019, the company effected a 25-for-1 reverse split of its issued and outstanding common stock. This number represents the post-reverse split number of common stock of the company issued and outstanding.

(3) As of the date of this Offering Circular, all shares due to Mount Sinai pursuant to the Exclusive License Agreement (filed herewith as Exhibit 6.17) have been issued, for a total of 604,763 shares as of June 24, 2019. No cash consideration was received by the company in exchange for the shares. In the event the company raises the maximum offering amount of $20,000,000, the company would issue an additional 591,945 shares to Mt Sinai, for a total of 1,196,708 shares issued pursuant to the License Agreement and amendment included as Exhibit 6.17 and Exhibit 6.24, respectively. The additional shares would also be issued without cash consideration being received by the company.

Implications of Being an Emerging Growth Company

As an issuer with less than $1 billion in total annual gross revenues during our last fiscal year, we will qualify as an “emerging growth company” under the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) and this status will be significant if and when we become subject to the ongoing reporting requirements of the Exchange Act upon filing a Form 8-A. An emerging growth company may take advantage of certain reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. In particular, as an emerging growth company we:

· will not be required to obtain an auditor attestation on our internal controls over financial reporting pursuant to the Sarbanes-Oxley Act of 2002;

· will not be required to provide a detailed narrative disclosure discussing our compensation principles, objectives and elements and analyzing how those elements fit with our principles and objectives (commonly referred to as “compensation discussion and analysis”);

· will not be required to obtain a non-binding advisory vote from our shareholders on executive compensation or golden parachute arrangements (commonly referred to as the “say-on-pay,” “say-on-frequency” and “say-on-golden-parachute” votes);

· will be exempt from certain executive compensation disclosure provisions requiring a pay-for-performance graph and CEO pay ratio disclosure;

· may present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations, or MD&A; and

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· will be eligible to claim longer phase-in periods for the adoption of new or revised financial accounting standards.

We intend to take advantage of all of these reduced reporting requirements and exemptions, including the longer phase-in periods for the adoption of new or revised financial accounting standards, and hereby elect to do so. Our election to use the phase-in periods may make it difficult to compare our financial statements to those of non-emerging growth companies and other emerging growth companies that have opted out of the phase-in periods under Section 107 of the JOBS Act.

Under the JOBS Act, we may take advantage of the above-described reduced reporting requirements and exemptions for up to five years after our initial sale of common equity pursuant to a registration statement declared effective under the Securities Act of 1933, as amended, or such earlier time that we no longer meet the definition of an emerging growth company. Note that this offering, while a public offering, is not a sale of common equity pursuant to a registration statement, since the offering is conducted pursuant to an exemption from the registration requirements. In this regard, the JOBS Act provides that we would cease to be an “emerging growth company” if we have more than $1 billion in annual revenues, have more than $700 million in market value of our Common Stock held by non-affiliates, or issue more than $1 billion in principal amount of non-convertible debt over a three-year period.

Certain of these reduced reporting requirements and exemptions are also available to us due to the fact that we may also qualify, once listed, as a “smaller reporting company” under the Commission’s rules. For instance, smaller reporting companies are not required to obtain an auditor attestation on their assessment of internal control over financial reporting; are not required to provide a compensation discussion and analysis; are not required to provide a pay-for-performance graph or CEO pay ratio disclosure; and may present only two years of audited financial statements and related MD&A disclosure.

Selected Risks Associated with Our Business

Our business is subject to a number of risks and uncertainties, including those highlighted in the section titled “Risk Factors” immediately following this summary. These risks include, but are not limited to, the following:

· We are a comparatively early-stage company that has incurred operating losses in the past, expect to incur operating losses in the future, and may never achieve or maintain profitability.

· Monogram does not currently hold any issued patents, and there is no guarantee that the company will ever be issued patents on the applications submitted to the USPTO.

· Monogram depends on a licensing agreement for its intellectual property which, if terminated, would significantly impair its ability to continue its operations. Significant delays in the development of Monogram’s technology may result in default on the terms of this agreement, which increases the risk of this licensing agreement being terminated.

· Our technology is not yet fully developed, and there is no guarantee that we will ever successfully develop the technology that is essential to our business.

· Our business plan is predicated on obtaining market clearance from the Food and Drug Administration (“FDA”) under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, or the FDCA. If we are unable to obtain Section 510(k) clearance, it is unlikely that we will be able to continue to operate as a going concern.

· We could be adversely affected by product liability, product recall, personal injury or other health and safety issues.

· Reductions in third party reimbursement levels, from private or government agency plans, and potential changes in industry pricing benchmarks for joint replacements could materially and adversely affect our results of operations.

· We may be subject to patient data protection requirements.

· We operate in a highly competitive industry that is dominated by several very large, well-capitalized market leaders and the size and resources of some of our competitors may allow them to compete more effectively than we can.

· We rely on third parties to provide services essential to the success of our business.

· We expect to raise additional capital through equity and/or debt offerings to support our working capital requirements and operating losses.

· All of our assets are pledged as collateral to a lender.

· The company is controlled by its officers and directors.

· In certain circumstances investors will not have dissenters' rights

· Investors in this offering must vote their shares to approve of certain future events, including our sale.

· This investment is illiquid.

· The auditor included a “going concern” note in its audit report.

· Investors in this offering may not be entitled to a jury trial with respect to claims arising under the subscription agreement and investors’ rights agreement, which could result in less favorable outcomes to the plaintiff(s) in any action under these agreements.

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RISK FACTORS

The SEC requires the company to identify risks that are specific to its business and its financial condition. The company is still subject to all the same risks that all companies in its business, and all companies in the economy, are exposed to. These include risks relating to economic downturns, political and economic events and technological developments (such as cyber-attacks and the ability to prevent such attacks). Additionally, early-stage companies are inherently more risky than more developed companies, and the risk of business failure and complete loss of your investment capital is present. You should consider general risks as well as specific risks when deciding whether to invest.

Risks Related to Our Company

We have a limited operating history upon which you can evaluate our performance, and have not yet generated profits. Accordingly, our prospects must be considered in light of the risks that any new company encounters. Our company was incorporated under the laws of the State of Delaware on April 21, 2016, and we have not yet generated profits. The likelihood of our creation of a viable business must be considered in light of the problems, expenses, difficulties, complications, and delays frequently encountered in connection with the growth of a business, operation in a competitive industry, and the continued development of our technology and products. We anticipate that our operating expenses will increase for the near future, and there is no assurance that we will be profitable in the near future. You should consider our business, operations and prospects in light of the risks, expenses and challenges faced as an emerging growth company.

The auditor included a “going concern” note in its audit report. We may not have enough funds to sustain the business until it becomes profitable. Even if we raise funds through this offering, we may not accurately anticipate how quickly we may use the funds and whether these funds are sufficient to bring the business to profitability.

Our technology is not yet fully-developed, and there is no guarantee that we will successfully develop our technology. Monogram is developing complex technology that will require significant technical and regulatory expertise to develop and commercialize. If we are unable to successfully develop and commercialize our technology and products, it will significantly affect our viability as a company. 

We are subject to substantial governmental regulation relating to the manufacturing, labeling and marketing of our products, and will continue to be for the lifetime of our company. The FDA and other governmental authorities in the United States regulate the manufacturing, labeling and marketing of our products. The process of obtaining regulatory approvals to market a medical device can be expensive and lengthy and applications may take a long time to be approved, if they are approved at all. Our compliance with the quality system, medical device reporting regulations and other laws and regulations applicable to the manufacturing of products within our facilities and those contracted by third parties is subject to periodic inspections by the FDA and other governmental authorities. Complying with regulations, and, if necessary, remediary actions can be significantly expensive. Failure to comply with applicable regulatory requirements may subject us to a range of sanctions, including substantial fines, warning letters that require corrective action, product seizures, recalls, halting product manufacturing, revocation of approvals, exclusion from future participation in government healthcare programs, substantial fines and criminal prosecution.

We are subject to federal and state healthcare regulations and laws relating to anti-bribery and anti-corruption, and non-compliance with such laws could lead to significant penalties. State and Federal anti-bribery laws, healthcare fraud and abuse laws dictate how we conduct the relationships that we and our distributors and others that market our products have with healthcare professionals, such as physicians and hospitals. We also must comply with a variety of other laws that protect the privacy of individually identifiable healthcare information. These laws and regulations are broad in scope and are subject to evolving interpretation and we could be required to incur substantial costs to monitor compliance or to alter our practices if we are found not to be in compliance. In addition, violations of these laws may be punishable by criminal or civil sanctions, including substantial fines, imprisonment of current or former employees and exclusion from participation in governmental healthcare programs.

Government regulations and other legal requirements affecting our company are subject to change. Such change could have a material adverse effect on our business. We operate in a complex, highly regulated environment. The numerous federal, state and local regulations that our business is subject to include, but are not limited to: federal and state registration and regulation of medical devices; applicable governmental payor regulations including Medicare and Medicaid; data privacy and security laws and regulations including those under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); the Affordable Care Act (“ACA”) or any successor to that act; laws and regulations relating to the protection of the environment and health and safety matters, including those governing exposure to, and the management and disposal of, hazardous substances; regulations regarding food and drug safety including those of the Food and Drug Administration (“FDA”), and consumer protection and safety regulations including those of the Consumer Product Safety Commission, as well as state regulatory authorities, governing the availability, sale, advertisement and promotion of products we sell; federal and state laws governing health care fraud and abuse; anti-kickback laws; false claims laws; and laws against the corporate practice of medicine. The FDA and state regulatory authorities have broad enforcement powers, including the ability to seize or recall products and impose significant criminal, civil and administrative sanctions for violations of these laws and regulations.

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Changes in laws, regulations and policies and the related interpretations and enforcement practices may significantly affect our cost of doing business as we endeavor maintain compliance with such new policies and laws. Changes in laws, regulations and policies and the related interpretations and enforcement practices generally cannot be predicted may require extensive system and operational changes. Noncompliance with applicable laws and regulations could result in civil and criminal penalties that could adversely affect our business, including: suspension of payments from government programs; loss of required government certifications; loss of authorizations to participate in or exclusion from government programs, including the Medicare and Medicaid programs; loss of licenses; and significant fines or monetary penalties. Any failure to comply with applicable regulatory requirements could result in significant legal and financial exposure, damage our reputation, and have a material adverse effect on our business operations, financial condition and results of operations.

We have not yet obtained clearance of our products by the U. S. Food and Drug Administration, or FDA, which is critical to our business plan. In order to sell our products, we must obtain market clearance from the Food and Drug Administration (“FDA”) under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, or the FDCA (see “The Company’s Business – Regulation.”).If Monogram is unable to obtain Section 510(k) clearance, we will not be able to sell our products, and it is unlikely that we will be able to continue to operate as a going concern. In addition, the FDA may request clinical data with our 510(k) submission. The FDA has indicated an increased focus on robotic technologies that perform automated operations and may request clinical data for our robot and/or implants. If the FDA requests such information, it will materially and adversely impact our development timeline and increase the cost to obtain market clearance. These factors combined may impact our ability to continue to operate as a going concern.

We anticipate initially sustaining operating losses. It is anticipated that we will initially sustain operating losses in seeking Section 510(k) clearance. Our ability to become profitable depends on obtaining 510(k) clearance, and subsequent success in licensing and selling of products. There can be no assurance that this will occur. Unanticipated problems and expenses are often encountered in offering new products which may impact whether the company is successful. Furthermore, we may encounter substantial delays and unexpected expenses related to development, technological changes, marketing, regulatory requirements and changes to such requirements or other unforeseen difficulties. There can be no assurance that we will ever become profitable. If the company sustains losses over an extended period of time, it may be unable to continue in business.

Our products may not gain market acceptance among hospitals, surgeons, physicians, patients, healthcare payors and the medical community. A critical element in our commercialization strategy is to persuade the medical community on the efficacy of our products and to educate then on their safe and effective use. Surgeons, physicians and hospitals may not perceive the benefits of our products and may be unwilling to change from the devices they are currently using. A number of factors may limit the market acceptance of our products, including the following:

· rate of adoption by healthcare practitioners;

· rate of a product’s acceptance by the target population;

· timing of market entry relative to competitive products;

· availability of third-party reimbursement;

· government review and approval requirements;

· extent of marketing efforts by us and third-party distributors or agents retained by us; and

· side effects or unfavorable publicity concerning our products or similar products.

Our inability to successfully commercialize our products will have a material adverse effect on the value of your investment.

We could be adversely affected by product liability, personal injury or other health and safety issues. We could be adversely impacted by the supply of defective products. We are also exposed to risks relating to the surgical robotic technology services and products we provide. Defective products or errors in our technology could lead to serious injury or death. Product liability or personal injury claims may be asserted against us with respect to any of the products we supply or services we provide. Monogram is also liable for harms caused by any faults in raw materials or products supplied by third-party manufacturers and suppliers that our company utilizes. It is our responsibility to have a quality management system in place and to audit our suppliers to ensure that products supplied to our company meet proper standards. Should a product or other liability issues arise, the coverage limits under insurance programs and the indemnification amounts available to us may not be adequate to protect us against claims and judgments. We also may not be able to maintain such insurance on acceptable terms in the future. We could suffer significant reputational damage and financial liability if we experience any of the foregoing health and safety issues or incidents, which could have a material adverse effect on our business operations, financial condition and results of operations.

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If third-party payors fail to provide appropriate levels of reimbursement for the use of our products, our revenues could be adversely affected. Sales of our products depend on the availability of adequate reimbursement from third-party payors. In each market in which we do business, our inability to obtain reimbursement approval or the failure of third-party payors to reimburse health care providers at a level which justifies the use of our products instead of cheaper alternatives will hurt our business.

Moreover, we are unable to predict what changes will be made to the reimbursement methodologies used by third-party payors in the future. Changes in political, economic and regulatory influences may significantly affect healthcare financing and reimbursement practices. For example, there have been multiple attempts through legislative action and legal challenges to repeal or amend the ACA. We cannot predict whether current or future efforts to repeal or amend these laws will be successful, nor can we predict the impact that such a repeal or amendment and any subsequent legislation would have on our business and reimbursement levels. There have also been a number of other proposals and enactments by the federal government and various states to reduce Medicaid reimbursement levels in response to budget deficits, and we expect additional proposals in the future. We cannot assure you that recent or future changes reimbursement policies and practices will not materially and adversely affect our results of operations. Efforts to control healthcare costs, including costs of reconstructive joint replacement, are continuous and reductions in third party reimbursement levels could materially and adversely affect our results of operations.

We rely on a licensing agreement with Icahn School of Medicine at Mount Sinai. We are party to a licensing agreement (and related option agreement) with Icahn School of Medicine at Mount Sinai (“Mount Sinai”) pursuant to which Mount Sinai has granted Monogram an exclusive license to patents related to customizable bone implants, surgical planning software, and surgical robots (see “The Company’s Business – Intellectual Property”). The patent, software, technical information, know how, etc. licensed under this agreement is integral to our company’s core products and technology. As such, we are reliant on the licensing agreement with Mount Sinai to operate our business. Under the terms of our licensing agreement, Mount Sinai has the right to terminate our license for the patent if we materially breach any of our obligations under the licensing agreement. Further, the licensing agreement expires upon the later of (i) 12 years from the first commercial sale of such any product that we sell using the intellectual property covered in the licensed patent or (ii) expiration of the licensed patent. If our arrangement with Mount Sinai were to end, we would no longer be able to use the intellectual property covered by the patent, which could significantly affect our business.

We may default on our obligations under the licensing agreement with Icahn School of Medicine at Mount Sinai, which could result in termination of agreement. Pursuant to the terms of Licensing Agreement with Mount Sinai (and Amendment thereto filed as Exhibit 6.24), we must have a first commercial sale our products within seven (7) years of the Effective Date of the agreement, or by October 10, 2024. Failure to meet this deadline would constitute a breach of our agreement, and Mount Sinai would have the right to give us a notice of default, and could ultimately terminate the licensing agreement if we fail to cure this default within sixty (60) days. A termination of this licensing agreement would also terminate our related option agreement with Mount Sinai, as the option agreement is governed by the terms of the licensing agreement. Currently, we expect to achieve a commercial sale within this timeframe. If we are unsuccessful in doing so, however, we would be in default, and would be exposed to the risk of Mount Sinai terminating the agreement, along with our right to license its intellectual property. Such a result would materially impact our ability to operate as a going concern.

We operate in a highly competitive industry that is dominated by several very large, well-capitalized market leaders and is constantly evolving. New entrants to the market, existing competitor actions, or other changes in market dynamics could adversely impact us.  The level of competition in the orthopaedic market is high, with several very large, well-capitalized competitors holding a majority share of the market. Changes in market dynamics or actions of competitors or manufacturers, including industry consolidation and the emergence of new competitors and strategic alliances, could materially and adversely impact our business. Disruptive innovation by existing or new competitors could alter the competitive landscape in the future and require us to accurately identify and assess such changes and make timely and effective changes to our strategies and business model to compete effectively.

Currently, we are not aware of any well-known orthopaedic companies that broadly offer robotic technology in combination with surgical navigation for the insertion of patient specific orthopaedic implants. Nonetheless, many of our competitors in this market have significant financial resources and may seek to extend their robotics and orthopaedic implant technology to accommodate the robotic insertion of patient specific implants. Further, a number of companies offer surgical navigation systems for use in arthroplasty procedures that provide a minimally invasive means of viewing the anatomical site. As such, other companies may create similar technology and/or products that we are producing, which would increase competition in our industry. As competition increases, a significant increase in general pricing pressures could occur, which could require us to reevaluate our pricing structures to remain competitive. For example, if we are not able to anticipate and successfully respond to changes in market conditions, it could result in a loss of customers or renewal of contracts or arrangements on less favorable terms. 

Our company does not currently hold any patents on its products or technology. Monogram Orthopaedics currently licenses 5 provisional patents, which includes a patent application with the USPTO, 2 provisional patent applications with the USPTO, and has submitted 2 additional patent applications to the USPTO (see “The Company’s Business – Intellectual Property”). As of the date of this Offering, the company has not been issued any patents. There is no guarantee that the company will ever be issued patents on the applications it has submitted or has licensed. Our success depends to a significant degree upon the protection of our products and technology. If we are unable to secure patents for our products and technology, other companies with greater resources may copy our technology and/or products, or improve upon them, putting us at a disadvantage to our competitors.

Successful infringement claims against us could result in significant monetary liability or prevent us from selling some of our products. If successfully developed, our products and technology may be highly disruptive to a very large and growing market. Our competitors are well capitalized with significant intellectual property protection and resources, and may initiate infringement lawsuits against our company. Such litigation could be expensive and could also prevent us from selling our products, which would significantly harm our ability to grow our business as planned.

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Our failure to attract and retain highly qualified personnel in the future could harm our business. As the company grows, it will be required to hire and attract additional qualified professionals such as software engineers, robotics engineers, machine vision and machine learning experts, biomechanical engineers, project managers, regulatory professionals, sales and marketing professionals, accounting, legal, and finance experts. The company may not be able to locate or attract qualified individuals for such positions, which will affect the company’s ability to grow and expand its business.

We rely on third party manufacturers and service providers. Our third party partners provide a variety of essential business functions, including distribution, manufacturing, and many others. It is possible that some of these third parties will fail to perform their services or will perform them in an unacceptable manner. If we encounter problems with one or more of these parties and they fail to perform to expectations, it could have a material adverse impact on the company.

Our future success is dependent on the continued service of our small management team. Monogram is managed by three directors and one executive officer. Our success is dependent on their ability to manage all aspects of our business effectively. Because we are relying on our small management team, we lack certain business development resources that may hurt our ability to grow our business. Any loss of key members of our executive team could have a negative impact on our ability to manage and grow our business effectively. We do not maintain a key person life insurance policy on any of the members of our senior management team. As a result, we would have no way to cover the financial loss if we were to lose the services of our directors or officers. 

We expect to raise additional capital through equity and/or debt offerings to support our working capital requirements and operating losses. In order to fund future growth and development, the company will likely need to raise additional funds in the future by offering shares of its Common or Preferred Stock and/or other classes of equity, or debt that convert into shares of common or Preferred Stock, any of which offerings would dilute the ownership percentage of investors in this offering. See “Dilution.” Furthermore, if the company raises capital through debt, the holders of our debt would have priority over holders of common and Preferred Stock and the company may be required to accept terms that restrict its ability to incur more debt. We cannot assure you that the necessary funds will be available on a timely basis, on favorable terms, or at all, or that such funds if raised, would be sufficient. The level and timing of future expenditure will depend on a number of factors, many of which are outside our control. If we are not able to obtain additional capital on acceptable terms, or at all, we may be forced to curtail or abandon our growth plans, which could adversely impact the company, its business, development, financial condition, operating results or prospects.

Any valuation at this stage is difficult to assess. The valuation for this Offering was established by the company. Unlike listed companies that are valued publicly through market-driven stock prices, the valuation of private companies, especially early-stage companies, is difficult to assess and you may risk overpaying for your investment.

If we cannot raise sufficient funds, we will not succeed. We are offering shares of our Series A Preferred Stock in the amount of up to $20,000,000 in this Offering on a best-efforts basis and may not raise the complete amount. Even if the maximum amount is raised, we are likely to need additional funds in the future in order to grow, and if we cannot raise those funds for whatever reason, including reasons relating to the company itself or to the broader economy, the company may not survive. If we raise a substantially lesser amount than the Maximum Raise, we will have to find other sources of funding for some of the plans outlined in “Use of Proceeds To Issuer.”.

All of our assets are pledged as collateral to a lender. We have entered into convertible promissory notes with lenders that contain covenants that limit our ability to engage in specified types of transactions. These covenants limit our ability to, among other things:

· petition for bankruptcy;

· assignment of the notes to other creditors;

· appointment of a receiver of any property of the company; and

· consolidate, merge, sell or otherwise dispose of all or substantially all of our assets.

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A breach of any of these covenants could result in a default under the notes Upon the occurrence of an event of default under these notes, the lender could elect to declare all amounts outstanding thereunder to be immediately due and payable. We have pledged all of our assets as collateral under our credit facility.

Risks Related to the Securities in this Offering

In certain circumstances investors will not have dissenters' rights. The investors’ rights agreement that investors will execute in connection with the offering contains a “drag-along” provision whereby investors agree to vote any shares they own in the same manner as the majority holders of our other classes of stock. Specifically, and without limitation, if the majority holders of our other classes of stock determine to sell the company, depending on the nature of the transaction, investors will be forced to sell their stock in that transaction regardless of whether they believe the transaction is the best or highest value for their shares, and regardless of whether they believe the transaction is in their best interests.

We have previously granted anti-dilution rights in the form of preemptive rights to certain holders of our Common Stock. The effect of those rights is that at any time we intend to issue additional shares of our stock that would dilute those holders, they would first have the right to acquire additional shares to maintain their pro rata ownership. While investors in this offering will be granted certain participation rights in future offerings of securities by the company, investors who are not accredited investors may not be able to participate in all of those offerings if such offering relies upon Rule 506(b) or (c) of Regulation D. As a result, upon future issuances of stock by the company, investors in this offering may experience more substantial dilution than other stockholders. See Exhibit 6.17 for further information about the preemptive rights granted to certain holders of our Common Stock.

We will be required to enter into a stock purchase agreement with Mount Sinai for the shares that have already been issued by the company. Pursuant to the License Agreement with Mount Sinai, the company will provide Mount Sinai with “customary agreements reasonably required by any future institutional equity investors with respect to the voting of its common stock and regarding subjecting the common stock held by [Mount Sinai] to rights of first refusal and co-sale…” for the Common Stock that has already been issued to Mount Sinai. We will be required to finalize such agreements before September 22, 2019. We have not begun negotiations on this terms of these agreements, however, once finalized, investors in this offering may believe such terms to be superior to those receive by investors in this offering.

Investors in this offering may not be entitled to a jury trial with respect to claims arising under the subscription agreement, the investors’ rights agreement, which could result in less favorable outcomes to the plaintiff(s) in any action under these agreements. Investors in this offering will be bound by the subscription agreement and investors’ rights agreement both of which include a provision under which investors waive the right to a jury trial of any claim they may have against the company arising out of or relating to these agreements. By signing these agreements, the investor warrants that the investor has reviewed this waiver with his or her legal counsel, and knowingly and voluntarily waives the investor’s jury trial rights following consultation with the investor’s legal counsel.

If we opposed a jury trial demand based on the waiver, a court would determine whether the waiver was enforceable based on the facts and circumstances of that case in accordance with the applicable state and federal law. To our knowledge, the enforceability of a contractual pre-dispute jury trial waiver in connection with claims arising under the federal securities laws has not been finally adjudicated by a federal court. However, we believe that a contractual pre-dispute jury trial waiver provision is generally enforceable, including under the laws of the State of New York, which governs the subscription agreement and investors’ rights agreement, and in the Court of Chancery in the State of Delaware. In determining whether to enforce a contractual pre-dispute jury trial waiver provision, courts will generally consider whether the visibility of the jury trial waiver provision within the agreement is sufficiently prominent such that a party knowingly, intelligently and voluntarily waived the right to a jury trial. We believe that this is the case with respect to the subscription agreement and investors’ rights agreement. You should consult legal counsel regarding the jury waiver provision before entering into the subscription agreement and investors’ rights agreement. 

If you bring a claim against the company in connection with matters arising under either the investors’ rights agreement or the subscription agreement, including claims under federal securities laws, you may not be entitled to a jury trial with respect to those claims, which may have the effect of limiting and discouraging lawsuits against the company. If a lawsuit is brought against the company under the either of these agreements, it may be heard only by a judge or justice of the applicable trial court, which would be conducted according to different civil procedures and may result in different outcomes than a trial by jury would have had, including results that could be less favorable to the plaintiff(s) in such an action. 

Nevertheless, if this jury trial waiver provision is not permitted by applicable law, an action could proceed under the terms of the subscription agreement or investors’ rights agreement with a jury trial. No condition, stipulation or provision of the subscription agreement or investors’ rights agreement serves as a waiver by any holder of common shares or by us of compliance with any substantive provision of the federal securities laws and the rules and regulations promulgated under those laws.

In addition, when the shares are transferred, the transferee is required to agree to all the same conditions, obligations and restrictions applicable to the shares or to the transferor with regard to ownership of the shares, that were in effect immediately prior to the transfer of the Shares, including but not limited to the investors’ rights agreement or subscription agreement.

Our Certificate of Incorporation also includes a forum selection provision, which could result in less favorable outcomes to the plaintiff(s) in any action against our company. Our Certificate of Incorporation includes a forum selection provision that requires any claims against the company by stockholders not arising under the federal securities laws to be brought in the Court of Chancery State in the state of Delaware. This forum selection provision may limit investors’ ability to bring claims in judicial forums that they find favorable to such disputes and may discourage lawsuits with respect to such claims.

This investment is illiquid. There is no currently established market for reselling these securities. If you decide that you want to resell these securities in the future, you may not be able to find a buyer. Although the company intends to apply in the future for quotation of its Common Stock on an over-the-counter market, or similar, exchange, there are a number of requirements that the company may or may not be able to satisfy in a timely manner. Even if we obtain that quotation, we do not know the extent to which investor interest will lead to the development and maintenance of a liquid trading market. You should assume that you may not be able to liquidate your investment for some time, or be able to pledge these shares as collateral.

You will need to keep records of your investment for tax purposes. As with all investments in securities, if you sell our Series A Preferred Stock at a profit or loss, you will probably need to pay tax on the long- or short-term capital gains that you realize, or apply the loss to other taxable income. If you do not have a regular brokerage account, or your regular broker will not hold our Series A Preferred Stock for you (and many brokers refuse to hold securities issued under Regulation A) there will be nobody keeping records for you for tax purposes and you will have to keep your own records, and calculate the gain or loss on any sales of the Series A Preferred Stock. 

The value of your investment may be diluted if the company issues additional options. A pool of unallocated options is typically reserved for future employees, which affects the fully-diluted pre-money valuation for this offering. The price per share of the Series A Preferred Stock has been calculated assuming a 2% post-money unallocated option pool, which may not account for all additional options the company will issue after the offering and may not provide adequate protection against the dilution investors may face due to such additional issuances. Any option issuances by the company over the 2% pool will lower the value of your shares.

Investors in this offering will receive our Series A Preferred Stock, which has limited voting rights compared our Common Stock. Investors in this offering that purchase our Series A Preferred Stock will have limited voting rights compared to those of the holders of our Common Stock. Our Certificate of Incorporation states that the holders of our Common Stock are entitled to elect two (2) directors of the corporation to our Board of Directors alone as a class. Our Preferred Stockholders therefore will have no choice as to the election of two members of the Board of Directors of the company. The Preferred Stockholders also do not have the right to vote for any directors of the corporation as a standalone class, which is a right granted to our Common Stockholders. The holders of our Preferred Stock are entitled to vote together with the holders of the Common Stock for the election of one (1) independent director, and may vote together with the holders of the Common Stock on any additional directors to be elected to our Board of Directors after the initial (3) directors are elected. Therefore, investors in this offering will very likely not be able to exert the same amount of control over the management of the company as the holders of the Common Stock. See “Securities Being Offered” for more information on the voting rights of our Series A Preferred Stock.

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DILUTION

Dilution means a reduction in value, control or earnings of the shares the investor owns.

Immediate dilution  

An early-stage company typically sells its shares (or grants options over its shares) to its founders and early employees at a very low cash cost, because they are, in effect, putting their “sweat equity” into the company. When the company seeks cash investments from outside investors, like you, the new investors typically pay a much larger sum for their shares than the founders or earlier investors, which means that the cash value of your stake is diluted because all the shares are worth the same amount, and you paid more than earlier investors for your shares.

The following table compares the price that new investors are paying for their shares with the effective cash price paid by existing shareholders, giving effect to full conversion of all outstanding convertible notes and assuming that the shares are sold at $4.00 per share. The schedule presents shares and pricing as issued and reflects all transactions since inception, which gives investors a better picture of what they will pay for their investment compared to the company’s insiders than just including such transactions for the last 12 months, which is what the SEC requires.

The following table presents the approximate effective cash price paid for all share and potential shares issuable by the company as of June 24, 2019. On May 28, 2019, the company effected a 25-for-1 reverse split of its issued and outstanding common stock.

	Date Issued	Issued Shares			Potential Shares			Total Issued and Potential Shares			Effective Cash Price per Share at Issuance or Potential Conversion
Common Shares:
Common Shares	2019		4,231,284	(2)		—			4,231,284		$	0.0001156
Common Shares	2017 - 2018		85,819			—			85,819		$	0.0025000
Convertible Notes:
Convertible Notes:	2019		—			41,433			41,433	(1)	$	1.1905499
Convertible Notes:	2018		—			936,345			936,345		$	1.2899225
Convertible Notes:	2017		—			949,305			949,305		$	1.1905499
Options:
2019 Stock Option and Grant Plan	2019		470,600			—			470,600		$	0.6121014
Warrants:
Warrants	2019		—			251,984	(3)		251,984		$	4.9606244
Total Common Share Equivalents	2019		4,787,704			2,179,067			6,966,771		$	0.5645749
Investors in this offering, assuming $20 Million raised	2019		5,000,000			—			4,992,880		$	4.00
Total After Inclusion of this Offering	2019		12,306,732			935,678			13,242,410		$	1.8917007

(1) Assumes conversion of all issued and outstanding convertible notes.

(2) The shares of Common Stock issued in 2019 were issued to Benjamin Sexson and Douglas Unis in consideration for past and future services to the company and under the terms of the Exclusive License Agreement included as Exhibit 6.17, respectively.

(3) We have entered into a warrant to purchase capital stock with ZB Capital Partners LLC (the “Warrant Holder”) (filed herewith as Exhibit 6.23), Under the terms of the warrant, the Warrant Holder has the right to acquire $1,000,000 worth of shares of the company’s stock upon the occurrence of the company raising $5,000,000 in an equity financing. The Warrant Holder would acquire the shares being sold in the equity financing at the same per share price paid by other investors in this offering, but reduced by the 8.75% fee to the Placement Agent. The Warrant Holder has represented to the company that they do not intend to exercise their warrant in this offering. As such, we have excluded the potential shares of the Warrant Holder from the dilution calculation as we are not able to make a reasonable determination of the effective cash price to be paid. For reference, were the Warrant Holder were to exercise its warrant as part of this offering, it would be able to acquire up to 273,582 shares of our Series A Preferred Stock in exchange for cash consideration of $1,000,000

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The following table illustrates the dilution that new investors will experience upon investment in the company relative to existing holders of our securities. Because this calculation is based on the net tangible assets of the company, we are calculating based our net tangible book value of $(1,391,026) as of December 31, 2018, as included in our audited financial statements. As such, this table does not include shares or convertible notes issued in 2019. However, the values have been adjusted to reflect the reverse split effected on May 28, 2019, as noted above.

The offering costs assumed in the following table includes up to $1,750,000 in commissions to SI Securities, LLC, as well as legal and accounting fees incurred for this Offering.

The table presents three scenarios for the convenience of the reader: a $2,750,000 raise from this offering (the minimum offering), a $12,000,000 raise from this offering, and a fully subscribed $20,000,000 raise from this offering (the maximum offering).

On Basis of Full Conversion of Issued Instruments	$2.75 Million Raise			$12 Million Raise			$20 Million Raise
Price per Share	$	4.00		$	4.00		$	4.00
Shares Issued		687,500			3,000,000			5,000,000
Capital Raised	$	2,750,000		$	12,000,000		$	20,000,000
Less: Offering Costs	$	315,625		$	1,125,000		$	1,825,000
Net Offering Proceeds	$	2,434,375		$	10,875,000		$	18,175,000
Net Tangible Book Value Pre-financing as of December 31, 2018	$	(1,391,026	)	$	(1,391,026	)	$	(1,391,026	)
Net Tangible Book Value Post-financing	$	1,043,349		$	9,483,974		$	16,783,974
Shares issued and outstanding pre-financing as of December 31, 2018		1,971,469	(1)		1,971,469	(1)		1,971,469	(1)
Post-Financing Shares Issued and Outstanding		2,658,969			4,971,469			6,971,469
Net tangible book value per share prior to offering	$	(0.71	)	$	(0.71	)	$	(0.71	)
Increase/(Decrease) per share attributable to new investors	$	1.10		$	2.61		$	3.11
Net tangible book value per share after offering	$	0.39		$	1.91		$	2.41
Dilution per share to new investors ($)	$	(3.61	)	$	(2.09	)	$	(1.59	)
Dilution per share to new investors (%)		(90.2	)%		(52.3	)%		(39.8	)%

(1) Assumes conversion of all issued Convertible Notes issued as of December 31, 2018, resulting in the issuance of an additional 1,885,650 shares.

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Future dilution

Another important way of looking at dilution is the dilution that happens due to future actions by the company. The investor’s stake in a company could be diluted due to the company issuing additional shares. In other words, when the company issues more shares, the percentage of the company that you own will go down, even though the value of the company may go up. You will own a smaller piece of a larger company. This increase in number of shares outstanding could result from a stock offering (such as an initial public offering, another crowdfunding round, a venture capital round, angel investment), employees exercising stock options, or by conversion of certain instruments (e.g. convertible bonds, preferred shares or warrants) into stock.

If the company decides to issue more shares, an investor could experience value dilution, with each share being worth less than before, and control dilution, with the total percentage an investor owns being less than before. There may also be earnings dilution, with a reduction in the amount earned per share (though this typically occurs only if the company offers dividends, and most early stage companies are unlikely to offer dividends, preferring to invest any earnings into the company).

The type of dilution that hurts early-stage investors most occurs when the company sells more shares in a “down round,” meaning at a lower valuation than in earlier offerings. An example of how this might occur is as follows (numbers are for illustrative purposes only):

· In June 2017 Jane invests $20,000 for shares that represent 2% of a company valued at $1 million.

· In December the company is doing very well and sells $5 million in shares to venture capitalists on a valuation (before the new investment) of $10 million. Jane now owns only 1.3% of the company but her stake is worth $200,000.

· In June 2018 the company has run into serious problems and in order to stay afloat it raises $1 million at a valuation of only $2 million (the “down round”). Jane now owns only 0.89% of the company and her stake is worth only $26,660.

This type of dilution might also happen upon conversion of convertible notes into shares. Typically, the terms of convertible notes issued by early-stage companies provide that in the event of another round of financing, the holders of the convertible notes get to convert their notes into equity at a “discount” to the price paid by the new investors, i.e., they get more shares than the new investors would for the same price. Additionally, convertible notes may have a “price cap” on the conversion price, which effectively acts as a share price ceiling. Either way, the holders of the convertible notes get more shares for their money than new investors. In the event that the financing is a “down round” the holders of the convertible notes will dilute existing equity holders, and even more than the new investors do, because they get more shares for their money. Investors should pay careful attention to the amount of convertible notes that the company has issued (and may issue in the future, and the terms of those notes.

If you are making an investment expecting to own a certain percentage of the company or expecting each share to hold a certain amount of value, it’s important to realize how the value of those shares can decrease by actions taken by the company. Dilution can make drastic changes to the value of each share, ownership percentage, voting control, and earnings per share.

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PLAN OF DISTRIBUTION AND SELLING SECURITYHOLDERS

Plan of Distribution

The company is offering a minimum of 687,500 and up to 5,000,000 shares of Series A Preferred Stock (the “Shares”) on a “best efforts” basis at a price of $4.00 per share. The minimum subscription is $1,000. SeedInvest Auto Invest participants have a lower investment minimum of $200.

The company has engaged SI Securities, LLC as its sole and exclusive placement agent to assist in the placement of its securities. SI Securities, LLC is under no obligation to purchase any securities or arrange for the sale of any specific number or dollar amount of securities.

Commissions and Discounts

The following table shows the total discounts and commissions payable to the placement agents in connection with this offering assuming we raise the maximum amount of offering proceeds:

	Per Share
Public offering price	$	4.00
Placement Agent commissions	$	1,750,000	(1)
Proceeds, before expenses, to us	$	18,250,000

(1) SI Securities, LLC will receive commissions of 8.75% of the offering proceeds.

Other Terms

Except as set forth above, the company is not under any contractual obligation to engage SI Securities, LLC to provide any services to the company after this offering, and has no present intent to do so. However, SI Securities, LLC may, among other things, introduce the company to potential target businesses or assist the company in raising additional capital, as needs may arise in the future. If SI Securities, LLC provides services to the company after this offering, the company may pay SI Securities, LLC fair and reasonable fees that would be determined at that time in an arm’s length negotiation.

SI Securities, LLC intends to use an online platform provided by SeedInvest Technology, LLC, an affiliate of SI Securities, LLC, at the domain name www.seedinvest.com (the “Online Platform”) to provide technology tools to allow for the sales of securities in this offering. SI Securities, LLC will charge you a non-refundable transaction fee equal to 2% of the amount you invest (up to $300) at the time you subscribe for our shares. This fee will be refunded in the event the company does not reach its minimum fundraising goal. In addition, SI Securities, LLC may engage selling agents in connection with the offering to assist with the placement of securities.

Selling Security holders

No securities are being sold for the account of security holders; all net proceeds of this offering will go to the company.

Transfer Agent and Registrar 

Capshare, Inc. will serve as transfer agent to maintain shareholder information on a book-entry basis. We will not issue shares in physical or paper form. Instead, our shares will be recorded and maintained on our shareholder register.

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Investors’ Tender of Funds and Return of Funds

After the Commission has qualified the Offering Statement, the company will accept tenders of funds to purchase the Series A Preferred Stock. The company may close on investments on a “rolling” basis (so not all investors will receive their shares on the same date), provided that the minimum offering amount has been met. Tendered funds will remain in escrow until both the minimum offering amount has been reached and a closing has occurred. However, in the event we have not sold the minimum amount of shares by May 31, 2020, or sooner terminated by the company, any money tendered by potential investors will be promptly returned by the Escrow Agent. Upon closing, funds tendered by investors will be made available to the company for its use.

In order to invest you will be required to subscribe to the offering via the company’s website and agree to the terms of the offering, investors’ rights agreement and the subscription agreement.

In the event that it takes some time for the company to raise funds in this offering, the company may rely on cash on hand, or may seek to raise funds by conducting a new offering of equity or debt securities.

In order to invest you will be required to subscribe to the offering via the Online Platform and agree to the terms of the offering, the subscription agreement, investors’ rights agreement, and any other relevant exhibits attached thereto.

Provisions of Note in Our Subscription Agreement and Investors’ Rights Agreement

Our subscription agreement and investors’ rights agreement include forum selection provisions that require any claims against the company based on the subscription agreement and/or investors’ rights agreement not arising under the federal securities laws to be brought in a court of competent jurisdiction in the State of New York. These forum selection provisions may limit investors’ ability to bring claims in judicial forums that they find favorable to such disputes and may discourage lawsuits with respect to such claims. The company has adopted these provisions to limit the time and expense incurred by its management to challenge any such claims. As a company with a small management team, this provision allows its officers to not lose a significant amount of time travelling to any particular forum so they may continue to focus on operations of the company.

Jury Trial Waiver 

The subscription agreement and investors’ rights agreement provides that subscribers waive the right to a jury trial of any claim they may have against us arising out of or relating to the subscription agreement. By signing the subscription agreement and investors’ rights agreement, the investor warrants that the investor has reviewed this waiver with the investor’s legal counsel, and knowingly and voluntarily waives his or her jury trial rights following consultation with the investor’s legal counsel. If we opposed a jury trial demand based on the waiver, a court would determine whether the waiver was enforceable given the facts and circumstances of that case in accordance with applicable case law.

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USE OF PROCEEDS TO ISSUER

Assuming a maximum raise of $20,000,000, the net proceeds of this offering would be approximately $18,175,000 after subtracting estimated offering costs of $1,750,000 to SI Securities, LLC in commissions, $12,000 in audit fees, $13,000 in Edgarization fees and $50,000 in legal fees. If Monogram successfully raises the maximum amount under this raise the company intends to try and fund the development of the robotic system, knee and hip implant.

Assuming a raise of $12,000,000, representing 60% of the maximum offering amount, the net proceeds would be approximately $10,875,000 after subtracting estimated offering costs of $1,050,000 to SI Securities, LLC in commissions, $12,000 in audit fees, $13,000 in Edgarization fees, and $50,000 in legal fees. In such an event, Monogram would adjust its use of proceeds by limiting the number of implants we intend to try to develop to our knee implant and robotic system. The company would also limit its speed of growth and limit the amount of additional recruiting of new employees.

Assuming a raise of the minimum of $2,750,000, representing 13.8% of the maximum offering amount, net proceeds would be approximately $2,434,375 after subtracting estimated offering costs of $240,625 to SI Securities, LLC in commissions, $12,000 in audit fees, $13,000 in Edgarization fees, and $50,000 in legal fees. In such an event, Monogram would adjust its use of proceeds by limiting the scope of development considerably to the navigated surgical robot and would focus on developing a cheaper and improved robot for the insertion of generic implants. The company would also limit its speed of growth and limit the amount of additional recruiting of new employees.

Please see the table below for a summary our intended use of proceeds from this offering:

Percent	Minimum Offering $2,750,000 Raise		$12,000,000 Raise		Maximum Offering $20,000,000 Raise
Allocation	Use Category	%	Use Category	%	Use Category
55.82%	Product Development	49.50%	Product Development	40.70%	Product Development
16.00%	Payroll (1)	18.00%	Payroll (1)	18.50%	Payroll (1)
3.77%	General Administrative	6.33%	General Administrative	11.50%	Working Capital
10.00%	Marketing	10.00%	Marketing	10.00%	Marketing
8.75%	Commissions	8.75%	Commissions	8.75%	Commissions
0.00%	Working Capital	4.75%	Working Capital	8.40%	General Administrative
2.75%	Offering Expenses	2.00%	Offering Expenses	1.75%	Offering Expenses
2.91%	Pre-payment of Notes (2)	0.67%	Pre-payment of Notes (2)	0.40%	Pre-payment of Notes (2)

(1) The company’s CEO, Benjamin Sexson, has contracted with the company for an annual salary of $120,000. Mr. Sexson has opted to defer 62.5% of his monthly salary, or $6,250 per month out of the $10,000 monthly salary he is owed. As of June 30, 2019, Mr. Sexson’s total deferred salary in 2019 is $37,500. Mr. Sexson also deferred salary in 2018, $48,000 of which was loaned to the company on February 11, 2019 in the form of a promissory note, and of which approximately $877 is still deferred and outstanding. (Note: As of December 31, 2018, the Company owed Mr. Sexson a total of $48,877 in salary accrual). A portion of the proceeds from this offering will go towards paying Mr. Sexson’s current salary payments, as well as his deferred salary, which is approximately $38,377. as of June 30, 2019. No proceeds will go towards the payment of the $48,000 promissory note payable.. As provided in the Employment Agreement included as Exhibit 6.2, Mr. Sexson’s salary is subject to increase upon the occurrence of certain events. If the company closes a round of equity financing of at least $5,000,0000 on or prior to December 31, 2019, Mr. Sexson’s annual base salary shall be increased to $250,000. In addition, Mr. Sexson is eligible to earn an annual bonus in an amount of 50% of his aggregate base salary earned in such year, subject to the achievement of certain performance goals, milestones and objectives, as established from time to time by an appropriate committee of the company’s Board. Any increase to Mr. Sexson’s salary or any bonus payments to Mr. Sexson will be made out of the proceeds of this offering. Additionally, Mr. Sexson is entitled to severance payments by the company equal to six months' of his base salary at the time of his termination if he is terminated without cause. The company could use the proceeds of this offering to pay Mr. Sexson’s severance payments in the event of such a termination. As of December 31, 2018, the Company owed Mr. Sexson $53,488, comprised of $48,877 in salary accrual, $3,641 in unreimbursed expenses, and $970 that was not paid out upon the repurchase of common shares by the Company. Doug Unis, a director of the company, also receives a consulting fee of $35,000 for consulting services unrelated to his position as director. This agreement is included as Exhibit 6.1. A portion of the proceeds of this offering will go towards paying Mr. Unis’s consulting fee.

(2) The company intends to use a portion of the proceeds to discharge indebtedness owed to Ron Lennox pursuant to convertible notes held by Mr. Lennox, which are included as exhibits to this offering circular. The principal amount due on these notes is $76,000, and $4,098 in interest payable has accrued as of December 31, 2018. Investors should note that Doug Unis has also provided debt financing to the company, for which those notes are included as exhibits to this offering circular. The company does not intend to use any proceeds from the offering to discharge any indebtedness owed to Mr. Unis or to Mr. Sexson, other than to repay Mr. Sexson’s deferred salary as outlined in (1) above. (Note: As of December 31, 2018, the Company owed (i) Mr. Sexson a total of $53,488 comprised of $48,877 in salary accrual, $3,641 in unreimbursed expenses, and $970 that was not paid out upon the repurchase of common shares by the Company; and (ii) Mr. Unis a total of $26,517 comprised of $4,000 in accrued expenses and $22,517 of unreimbursed expenses. See “Related Party Transactions” on F-17 of the company’s audited financial statements filed with this offering circular.)

Because the offering is a “best efforts”, we may close the offering without sufficient funds for all the intended purposes set out above, or even to cover the costs of this offering. The above use of proceeds assumes a 510(k) submission without a request for clinical data from the FDA. Please see our “Risk Factors” for additional disclosures related a clinical data request from the FDA.

The company reserves the right to change the above use of proceeds if management believes it is in the best interests of the company

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THE COMPANY’S BUSINESS

Overview

Monogram Orthopaedics, Inc was incorporated under the laws of the State of Delaware on April 21, 2016 as “Monogram Arthroplasty Inc.” On March 27, 2017, the company changed its name to “Monogram Orthopaedics, Inc.” Monogram Orthopaedics is developing a product solution architecture for enabling mass personalization of orthopedic implants by linking 3D printing and robotics via automated digital image analysis algorithms. The company has a robot prototype that can execute auto-generated cut paths for high precision insertion of a custom patient specific implants in synthetic bone specimens. These implants and cut-paths are generated with proprietary Monogram software algorithms. Monogram intends to produce and market surgical robotic equipment and related software, orthopaedic implants, tissue ablation tools, navigation consumables (fiducial markers or Apriltags) and other miscellaneous instrumentation necessary for the execution of reconstructive joint replacement procedures.

Our Background

Our company’s business is based on ideas formulated by Dr. Douglas Unis, an Associate Professor of Orthopaedic Surgery, and technology developed by Dr. Unis, Professor Anthony Costa, the head of the Neurosurgery Simulation Core, and Sulaiman Somani, a medical student at the Mount Sinai School of Medicine (“MSSM”).

Our founding philosophy is that advances in robotics, computer vision technologies and advanced manufacturing methods (such as additive manufacturing) will usher in a whole new way of thinking about reconstructive joint procedures and orthopedic implants. We believe that the future of orthopedic joint replacements lies in build-to-order, customized and fully patient specific implants that are inserted into bone cavities prepared by high precision robotic tools. We believe that to facilitate the cost-efficient delivery of anatomy restoring patient specific implants it is necessary to develop a highly efficient process for not only designing and fabricating fully customized implants, but also for developing the surgical plans and robotic inputs that allow for the accurate preparation of bone to accommodate them. High-precision patient specific implants require a comparable degree of high-precision patient specific bone preparation that moves beyond two dimensional planar cuts or alignment, for example. It is our assessment that for these processes to be truly scalable they require a high degree of automation and a high functioning navigated surgical robot that can execute complex cutpaths; i.e. a product solution architecture with image processing, scalable customized implant design, pre-operative planning, and robotic execution.

It is our view that patient specific implants will prove to be clinically superior over the long term while also alleviating the tremendous inventory burden and capital inefficiencies of generic implant distribution. We believe that implants should be designed and optimized to fit and restore a patient anatomy and that the ability of a robot to execute irregular cuts will exceed the capabilities of even the most skilled surgeons. Monogram believes that the use of patient specific implants and robotic surgery will, over time, reduce complication, failure rates and reduce costs considerably.

Principal Products and Services

Monogram’s primary business will be to design and manufacture customized hip, knee and shoulder implants that are made specifically for each patient as well as the equipment required for insertion, including:

· Navigated surgical robots with optical tracking equipment and an end-effector,

· Pre-operative and intra-operative software,

· Consumable Tissue ablation tools, and

· Navigation consumables (fiducial markers, tracked retractors, etc.).

The Monogram robotic system and related hardware (optical tracking equipment, end-effector, etc.) are multi-use capital equipment. To properly use the robotic system, Monogram’s pre-operative planning software, robotic controls and intra-operative software are needed. This software will be subject to an annual license, fees for which will be based on the scope of use (total hip arthroplasty, total knee arthroplasty, or multiple applications, for example). Each clinical application will be billed separately. During the procedure, a mix of re-usable and single use instrumentation is needed. The elements of our system are sold separately but generally must be used with the system to properly perform its intended clinical function.

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A significant percentage of orthopaedic medical devices are outsourced to original equipment manufacturers (OEMs). Monogram intends to outsource the manufacture of its products (including implants and instrumentation needed to execute reconstructive joint replacements) to large, established suppliers that may already be approved suppliers for the largest market participants and may have decades of product specific manufacturing expertise. Monogram intends to work with FDA registered ISO 13485 approved suppliers with the proper Quality Management Systems and product specific expertise.

According to analysis conducted on orthopaedic procedures, as of 2017 the average cost of implant components for total hip procedures was approximately $5,136 and for primary total knee procedures $4,547. Monogram expects to price our products consistent with the market.  

Market

According to sources and analysis trusted by management, the orthopaedic devices market is considered to be highly concentrated, with the top five market participants accounting for almost 60% of total sales as of 2017. The joint reconstruction devices market, which will be Monogram’s primary target market, reconstructive joint replacements, is even more concentrated with the top four market participants accounting for approximately 78% of sales for the total market. The total joint replacement devices market as of 2017 was approximately $18.1 billion globally. In the United States, the number of hip replacement procedures was estimated to be to 625,600 and the number of knee replacements was estimated to be 966,900 in 2017.

Most patients who undergo reconstructive joint replacement surgeries are aged between 50 and 80 years old with the average patient age for hip and knee replacements around approximately 65 years of age. Many of these patients rely on third-party payors, principally federal Medicare, state Medicaid and private health insurance plans, to pay for all or a portion of the costs and fees associated with joint replacement surgeries.

According to the orthopaedic industry statistical analysis and research, the reconstructive joint replacement market is expected to grow at an annual rate of approximately 3.6% with growth driven primarily by an aging population, the obesity epidemic and developments in advanced materials that have improved the longevity of implants and their efficacy for younger patients which grows the patient candidate pool. The fastest growing patient demographic are patients aged 45 to 54 years of age.

Management believes that the market for robotics and surgically prepared press-fit implants will outpace market growth primarily because of the limited market penetration and observed growth of the Stryker Corporation. In particular, we have paid close attention to its performance in the robotically prepared press-fit knee market. According to publicly available information provided by the Stryker Corporation (Stryker Corporation, Q4 2018 Earnings Call, Jan 29, 2019), there were roughly 24,800 robotic procedures performed in the U.S. during the quarter, with full year MAKO procedures topping 76,900. Mako Total Knee procedures increased over 35% sequentially to approximately 15,500, with knees representing roughly 60% of all MAKO procedures performed in the U.S. in 2018. MAKO is a robotic-arm assisted technology that helps surgeons provide patients with a personalized surgical experience. Monogram believes this indicates low penetration of press-fit knees as a percentage of Total Knee Replacements. The Stryker Corporation has indicated in a Company Conference Presentation on February 27, 2019 at the SVB Leerink Global Healthcare Conference, that there are 5,000 orthopaedic hospitals in the US, the majority of which they think would be a candidate for at least one robot. As of Q4 2018, the Stryker Corporation had 523 installed in the US. Monogram management believes that robot penetration and the use of surgical robots for bone preparation of press-fit implants is low. Management believes that customized, and specifically customized press-fit implants and the use of navigated robotic insertion will grow, driven by an industry focus on normalizing patient outcomes and efforts to mitigate clinical risk and improve productivity and the benefits of not using bone cement. At the same conference, the Stryker Corporation described the limitations of cement; handling time, set-up time, odor related to it and most significantly, leaving behind another foreign body that can degrade over time and cause implant loosening. Monogram’s implants will not utilize bone cement, which we believe provides an opportunity for us to disrupt this market. With the technology and product infrastructure we are developing, we believe we will be in prime position to capitalize on this growing market.

Competition

We face competition from large, well-known companies in the medical device industry as a whole, as well as specifically in the orthopaedic medical device industry. Currently the top five market participants in the joint replacement devices market are Zimmer Biomet Holdings, Inc., DePuy Orthopaedics, Inc., a Johnson & Johnson company, Stryker Corporation, and Smith & Nephew, Inc. These companies dominate the market for orthopaedic products. These companies, as well as other companies like ConforMIS, Inc., offer implant solutions, including (depending on the competitor) a combination of conventional instruments and generic implants, robotics and generic implants, or patient-specific instruments and patient-specific implants for use in conventional total and partial orthopaedic replacement surgeries.

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Currently, we are not aware of any well-known orthopaedic companies that broadly offer robotic technology in combination with surgical navigation for the insertion of patient-specific orthopaedic implants. To our knowledge the only use of robotic technology in combination with surgical navigation is for the insertion of generic orthopaedic implants. These competitors and other medical device companies have significant financial resources and may seek to extend their robotics and orthopaedic implant technology to accommodate the robotic insertion of patient specific implants. A number of these and other companies also offer surgical navigation systems for use in arthroplasty procedures that provide a minimally invasive means of viewing the anatomical site.

Our Innovative Approach

Monogram’s principal innovation over our competition will be our ability to produce customized, robotically inserted orthopaedic implants rapidly and at scale. The product solution architecture that we are developing enables rapid fabrication and mass personalization of robotically inserted patient specific orthopaedic implants.

The Monogram technology platform – a series of algorithms that auto-segment images and auto-generate implants that can be integrated into a navigated robotic system for surgery – automates the design and insertion of high conforming implants from raw CT images using automated digital image analysis algorithms. The navigated robot can then execute optimized auto-generated cut paths that surgically prepare the corresponding cavities to facilitate high-precision insertion of the implant.

We believe that Monogram’s navigated robot features several enhancements that will improve the user experience as compared to the current robots in use. Specifically, we intend for the Monogram robot to feature tracking cameras that are mounted directly to the robot to mitigate line-of-site issues. The robot also features seven degrees-of-freedom with control algorithms that leverage the kinematic redundancy to avoid interoperative boundaries and optimize the surgical execution. Additionally, the robot will utilize complex tracking capabilities for soft-tissue avoidance.

For the patient specific implants, it is generally understood that a tight fit and insertability can be conflicting requirements for a viable implant. The Monogram implants are designed such that cortical contact, and therefore stability, are maximized while remaining insertable. The Monogram implants are designed to reconstruct the native patient anatomy as closely as possible.

With generic implants in hips for example, manual bone preparation can contribute to periprosthetic fracture, dislocation, leg length inequality, subsidence and early loosening, and suboptimal function outcomes. With generic knee implants aseptic loosening of the tibial component and malalignment can be reasons for failure. Current hip stems have very limited options to restore anatomy. For example, most implants are available in only two widths despite wide human anatomic variations. They are geometric as opposed to organic in shape, which limits the amount of direct bone contact required for initial stability and long-term biological fixation. There is currently no commercially viable way to produce implants matching both the internal bone cavity and external biomechanics of the joint. The software required to efficiently create 3D models and implants from patient imaging is highly sophisticated. Additionally, there are limited methods for precisely sculpting an implant’s exact complement in bone.

Our surgical approach will attempt to use uniquely designed and additively manufactured (AM) patient matched titanium hip stems and tibial knee implants that will require robotically milled complementary cavities for insertion. Monogram is a pre-commercialization company that has not yet validated our manufacturing method or the clinical efficacy of our products. To date the goal of our development efforts has been to determine if our hypothesis that patient specific implants inserted into robotically prepared surgical cavities warrants further research and development. The goal of our implants is to more accurately restore patient anatomy and mitigate some of the potential causes of failure described above. We have conducted preliminary testing that we interpret to be supportive of our hypothesis that more accurate restoration of patient anatomy and robotic insertion of patient specific implants improves initial stability and we believe to warrant further research. We will continue to focus our development efforts with a focus on pre-operative planning, robotic execution and implant design. Our testing will likely include comparisons with implants that may represent the existing standard of care as a benchmark to try and demonstrate that the initial stability of our implants shows less micromotion than their generic counterparts. Furthermore, validation of the viability of our manufacturing method is critically important to our success. Our R&D efforts will consist primarily of simulating mechanical strength tests mandated by the FDA. Considerable work remains to validate our manufacturing method. Furthermore, robotically preparing the simulated bone specimens for insertion of our implants for our evaluation proved extremely challenging and was more time consuming than the manual insertion method. The added time to register the bone and to robotically execute the cuts is a disadvantage of our system. It should be noted that while our system has performed well in synthetic bone specimens in the past, we need to prove commercial feasibility in a range of human bones to test our ability to produce corresponding implants and cavities.

Through our innovative approach, we believe Monogram equipment will be significantly cheaper and more capital efficient than traditional knee and hip replacement systems. For example, the Mako robot produced by Stryker Corporation (Ticker: SYK) is the dominant leader in navigated surgical robotics with 642 robots installed globally, based on public information from a Q4 2018 Stryker Corp Earnings Call. Further, public information from a Q3 2018 Stryker Corp Earnings Call, Stryker established that it was selling its Mako robots for $1,000,000, while reporting gross profit margins on its robot sales of 62%. Our management believes this implies a production cost of approximately $380,000 per robot. We estimate the cost to produce one of our own robots will be below this cost. Investors should note, our assumptions about the production costs of Stryker may be inaccurate, or may not be current.

Sales & Orders

The specific sales process for each of our product categories is as follows:

Surgical Robot with End-Effector

Generally, the company must identify a surgeon within the organization willing to advocate for the purchase of the capital equipment to the hospital. Orders are placed by hospital finance and buying departments in advance of any surgical procedures. Cost is often a major objection to purchase. Monogram intends to address this objection by offering high performing equipment at a price that is below other market participants. Some of Monogram’s competitors offer hospitals financing options for large equipment purchases. Monogram will explore offering financing options.

Cutting Tools and Navigation Consumables

Consumable equipment is generally billed per use and associated with the specific surgical case for which it was used. The hospital takes stock of consumed materials which are billed by Monogram.

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Technology Platform

Monogram will license its technology platform to hospitals, which will provide those hospitals with access to Monogram’s pre-operative surgeon planning portal, where surgeons can access via a web-based interface. The motion control and intra-operative control algorithms are embedded in the surgical robotic system.

Implants

Monogram will receive orders for implants through the Monogram technology platform. The hospital will generally aggregate the materials used in a given surgical case which are billed by Monogram.

Design

The Monogram technology platform automates the design of high conforming implants from raw CT images using automated digital image analysis algorithms. These algorithms auto-segment images and auto-generate implant designs that are sent to a manufacturer to produce the patient-specific implants. Monogram will be producing a patient specific hip stem, but the other components of the total hip implant system (head, liner, acetabular cup) are standard. Monogram will be producing a patient specific tibia but the other components of the total knee replacement (femoral implant and plastic insert) are standard. Monogram is focusing on patient specific design only where there is a clear clinical benefit from personalization.

Monogram’s other products are pre-designed, and therefore will only require manufacture and distribution in order to reach the end-customer.

Manufacturing

The implant designs generated on the Monogram technology platform will be used to create 3D printed titanium implants manufactured by an established ISO13485 contract manufacturer. The company is in discussions with development and manufacturing companies for these services.

Manufacturing of our surgical robots, navigation consumables and cutting tools will be outsourced to well-established FDA registered ISO13485 approved manufacturers with proven quality management systems.

Quality Control and Dispatch

Our proposed distribution model contemplates using a distribution facility to ship our products to customers. Such facilities will receive final products from our suppliers that have been approved by their respective quality management systems. Our distribution facility will then conduct a final inspection of the products, and, once approved, ship them to our customers.

Our Market

We intend to market our products to orthopaedic surgeons, hospitals (or other medical facilities), and patients. Our ideal customers are hospitals in high population metropolitan regions that tend to employ high-volume technology focused surgeons.

Through the use of direct sales representatives, independent sales representatives and distributors, we intend to market and sell our products in the United States and over time in other markets if we are able to successfully scale operations in the United States.

Research and Development

The company currently has several Research and development (“R&D”) initiatives underway including mechanical testing of a patient specific hip, micromotion studies of a patient specific press-fit knee implant, and performance testing of a robot mounted navigation system. R&D amounted to $31,700 and $48,317 for the years ended December 31, 2018 and 2017, respectively. In 2017, the majority of our R&D expenses were related to costs incurred developing and testing our patient specific hip implant for initial stability with the UCLA Orthopaedic Biomechanics Laboratory. In 2018, the majority of our R&D related expenses were related to the continuation of these studies. To date, we have spent approximately $80,000 on R&D. We estimate we will use the proceeds of this offering to fund future R&D initiatives, such as cadaveric studies of our robotically inserted knee and hip implants, development of our surgical navigation systems, development of our computer vision algorithms and continued mechanical testing of our implants.

Employees

The company currently has 2 full-time employees that work out of our headquarters at 53 Bridge Street, Unit 507, Brooklyn, New York, 11251.

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Regulation

Medical products and devices are regulated by the Food and Drug Administration (the “FDA”) in the United States and can be regulated by foreign governments for devices sold internationally. The Federal Food, Drug and Cosmetic Act and regulations issued by the FDA regulate testing, manufacturing, packaging, and marketing of medical devices. Under the current regulations and standards, we believe that our products and devices are subject to general controls, including compliance with labeling and record-keeping rules. In addition, our medical devices require pre-market clearance, which for our products and devices will require a 510(k) premarket notification submission.

Further, our manufacturing processes and facilities are also subject to regulations, including the FDA’s QSR requirements (formerly Good Manufacturing Practices). These regulations govern the way we manufacture our products and maintain documentation for our manufacturing, testing and control activities. In addition, to the extent we manufacture and sell products abroad, those products are subject to the relevant laws and regulations of those countries.

Finally, the labeling of our products and devices, our promotional activities and marketing materials are regulated by the FDA and various state agencies. Violations of regulations promulgated by these agencies may result in administrative, civil or criminal actions against us or our manufacturers by the FDA or governing state agencies.

Today, Monogram has not yet received clearance to market its products in the United States (FDA) or internationally, and as such is not currently selling and distributing any products. Monogram has engaged a regulatory consulting group, “Musculoskeletal Clinical Regulatory Advisers, LLC” to assist with its 510(k) premarket notification submission for our system of products and technology. We hope to submit to the FDA our 510(k) premarket notification submission within three years of the closing of this offering, and expect approval by the FDA within 12 months of submission. As such, the company expects FDA approval of its 510(k) premarket notification within 4 years of the closing of the offering. Notably this timeline assumes no request for clinical data from the FDA. Please see our “Risk Factors” regarding risks related to our company if such a clinical data request occurs. 

Intellectual Property

Monogram Orthopaedics does not currently hold any issued patents or trademarks. We have licensed from Mount Sinai the following patent applications, which is currently under review:

ID Type	Number	Title	Filing Date
International Publication Number	WO 2017/177182 Al	APPARATUS, METHOD AND SYSTEM FOR PROVIDING CUSTOMIZABLE BONE IMPLANTS	October 6, 2015
U.S. Provisional Patent Application Number	62/811,811,855	CUSTOMIZED TIBIAL TRAYS CONTACTABLE WITH AN UNDERLYING CORTICAL BONE, METHODS, AND SYSTEMS FOR KNEE REPLACEMENT”	February 28, 2019
U.S. Provisional Patent Application Number	62/834,692	CUSTOM HIP DESIGN AND INSERTABILITY ANALYSIS	April 16, 2019

In addition to the above, we have submitted the following 2 provisional patent applications:

· 5247.005P– ROBOT MOUNTED CAMERA REGISTRATION AND TRACKING SYSTEM FOR ORTHOPEDIC AND NEUROLOGICAL SURGERY

· 5247.003P- A SYSTEM AND METHOD FOR INTERACTION AND DEFINITION OF TOOL PATHWAYS FOR A ROBOTIC CUTTING TOOL

Litigation

From time to time, the company may be involved in a variety of legal matters that arise in the normal course of business. The company is not currently involved in any litigation, and its management is not aware of any pending or threatened legal actions relating to its intellectual property, conduct of its business activities, or otherwise. See “Risk Factors” for a summary of risks our company may face in relation to litigation against our company. 

THE COMPANY’S PROPERTY

 The company leases office space at 53 Bridge Street, Unit 507, Brooklyn, NY 11201 which serves as its headquarters. Monogram intends to lease distribution facilities in the future.

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion of our financial condition and results of operations for the fiscal years ended December 31, 2017 and December 31, 2018 should be read in conjunction with our financial statements and the related notes included in this Offering Circular. The following discussion contains forward-looking statements that reflect our plans, estimates, and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements.

Overview

Monogram Orthopaedics, Inc. is developing a product solution architecture for enabling mass personalization of orthopedic implants by linking 3D printing and robotics via automated digital image analysis algorithms. The company has a working navigated robot prototype that can optically track a simulated surgical target and execute auto-generated cut paths for high precision insertion of patient specific implants in synthetic bone specimens. These implants and cut-paths are generated with proprietary Monogram software algorithms.

Results of Operations

Year ended December 31, 2018 Compared to Year ended December 31, 2017

The company is in an early stage of development.  The company did not generate revenues for the years ended December 31, 2018 and 2017.

Our costs and expenses currently consist of general and administrative expenses consisting primarily of salaries, travel and office expenses of administrative employees and contractors, software license fees, and other overhead expenses. It should be noted that the first recorded transactions in the 2017 fiscal year on April 19, 2017, so for the purposes of comparison 2017 shows approximately 8 months, 15 days of recorded transactions and 2018 shows 12 full months of recorded transactions. Despite this the company was still able to decrease costs and expenses in full year-over-year comparisons. Costs and expenses totaled $619,170 for the year ended December 31, 2018 compared to $622,090 for the year ended December 31, 2017, a decrease of 0.5%, primarily due to:

· General and administrative expenses decreased to $101,679 for the year ended December 31, 2018 from $124,704 for the year ended December 31, 2017, an 18.4% decrease, due primarily to reductions in salaries and payroll taxes, reductions in insurance premiums, small medical equipment purchases, advertising and marketing;

· Wages and payroll related expenses decreased to $378,523 for the year ended December 31, 2018 from $400,541 for the year ended December 31, 2017, a 5.5% decrease primarily due to reductions in company personnel in 2018;

· Legal and professional services expenses increased to $104,114 for 2018 from $44,757 for 2017, an increase of 132.6% due to fees incurred in connection with the issuances of convertible notes, intellectual property filings and contract negotiations as well as in connection with retaining the services of a regulatory consulting firm;

· Research and development costs decreased to $31,700 for 2018 from $48,317 for 2017, a 34.4% decrease, due to the completion of the “Mechanical Testing of a Novel 3D-Printed Femoral Stem Under Dynamic Loading” study conducted by the UCLA Orthopaedic Biomechanics Laboratory (also known as the Orthopaedic Institute for Children); and

Other expenses increased to $93,098 for 2018 from $36,905 for 2017, an increase of 152.3%. This increase was primarily due to:

· Interest expenses increasing to $62,184 for 2018 from $23,612 for the year ended December 31, 2017, an increase of 163.4% primarily due to the issuance of additional convertible notes see “—Liquidity and Capital Resources” below; and

· Depreciation expense increasing to$30,957 for 2018 from $13,345 for 2017, an increase of 8.1%, due to depreciation related to the purchase of a second robot in late 2017 and other equipment purchased in 2017 and 2018 that were not subject to a full year of depreciation in 2017.

As a result of the foregoing, the company generated a net loss of $712,268 for 2018 compared to a net loss of $658,995 for 2017, an 8.1% increase in net loss.

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Since the end of the period covered by our financial statements, our legal and professional, research and development, payments to contractors, and marketing and advertising expenses are expected to increase in connection with this Offering. Our expenses related to wages and payroll taxes have temporarily decreased due to employees voluntarily deferring wages and temporary reductions in headcount. We expect wages and payroll tax expenses to increase following this Offering. We expect rent to decrease following a move to a less expensive facility.

Liquidity and Capital Resources

At December 31, 2018 the company’s cash on hand was $922,108. The company is not generating revenues and requires the continued infusion of new capital to continue business operations. The company has recorded losses since inception, and as of December 31, 2018, had negative working capital of $1,430,172 and a stockholders’ deficit of $1,391,026. The company has historically been capitalized by contributions from related parties and its officers and directors. The company plans to continue to try to raise additional capital through crowdfunding offerings, equity issuances, or any other method available to the company. Absent additional capital, the company may be forced to significantly reduce expenses and could become insolvent.

The company estimates that if it raised the maximum amount sought in this Offering, it could continue its current rate of operations through October 2019 without raising additional capital.

Issuances of Equity and Convertible Notes

Since inception, the company has funded operations through the issuance of equity securities and convertible notes. Between 2017 and 2018, the company issued convertible promissory notes for total proceeds of $2,152,000. The accrued interest on these notes was $85,795 as of December 31, 2018.

The company received total proceeds of $2,803 from issuances of Common Stock in 2017. The company did not receive any proceeds from issuances of Common Stock in 2018. 

Indebtedness

The company has entered into convertible notes in the combined principal amount of $2,152,000. Convertible notes comprising $1,830,000 of the $2,152,000 bear interest at 6% per year. Convertible notes comprising $322,000 of $2,152,000 bear interest at 4% per year.

The notes mature at various times from October 16, 2019 through December 24, 2020. Certain of these notes are secured by all of the company’s assets. If Monogram were to default on any of these notes, the noteholders have the option to convert the note into shares of Common Stock of Monogram, or cause the principal and interest of the notes to become immediately due and payable. The secured interest of these notes is solely for repayment of notes upon liquidation of the company, and therefore the company would not be compelled to allow the lender to take possession of its assets if the lender elects to convert the note into shares of the company’s Common Stock.

The combined principal amount and the accrued interest of these notes was $2,152,000 and $85,795 as of December 31, 2018, respectively.

The company currently has no material commitments for capital expenditures.

Plan of Operations and Milestones

We are not yet operational, and have yet to generate any revenues. We have established the following milestones in our plan of operations for the next 12 months:

· If we raise the minimum amount set out in “Use of Proceeds,” we will formally engage our development partners to begin the development of the Monogram technologies with the intent to file for Section 510(k) clearance with the FDA. The scope of technologies we intend to file will depend on the level of funding. At a minimum we intend to submit our robotic system, and depending on capital we will submit applications for our knee and/or hip implants. We anticipate that we will file the respective technologies to the FDA within three (3) years of the closing of the minimum offering amount (i.e. 510(k) premarket notification submission). The company does not believe it would be able to obtain full FDA approval of its products and technology if only the minimum of $2,750,000 is raised in this offering. The company believes that the minimum raise would maintain viability of the company and position it to advance farther towards FDA approval. We would seek additional capital through private offerings to accredited or institutional investors to secure the additional capital necessary to reach FDA approval, which we estimate would be $7 million.

· Following the closing of the minimum offering, we intend to search for and hire a Director of Engineering (for which we have already engaged a recruiter) and anticipate hiring such a position within one month of the closing of this offering. Management will work closely with the Director of Engineering to resource product development with the intent of filing the respective technologies with the FDA within three years. The Director of Engineering would be responsible for supporting the implementation of a Quality Management System within 12 months of being hired.

· Within twelve months of submitting our 510(k) application with the FDA we anticipate we would (pending favorable reception and $7 million in total financing secured) be able to legally market our products and technology within seven (7) years of the close of this offering.

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· Within 6 months of receiving FDA approval, we anticipate will be able to begin building out our distribution and sales channels.

· Assuming we raise $2.75 million in this offering, we do not anticipate we will have adequate funding to obtain an FDA approval for the robot without additional capital. We estimate that a minimum of $7 million will be needed to obtain an FDA approval for the robot assuming no clinical data requests. If we raise $7 million, we anticipate being able to start delivering our surgical robots for insertion of generic implants within four years of the close of this offering, assuming no clinical data requests from the FDA. Assuming we raise $12 million in this offering, we anticipate we will commercialize our surgical robot and custom patient specific tibia implant in a similar timeframe. Assuming we raise $20 million in this offering, we anticipate we will commercialize our surgical robot and custom patient specific tibia implant and custom patient specific hip implant in a similar timeframe, assuming no clinical data requests from the FDA We expect to generate revenues within six months of an FDA approval.   Image: Timeline to FDA Approval Assuming No Clinical Data Requests (in Years)      

We believe the minimum offering amount of proceeds from this offering will satisfy our cash requirements to implement our plan of operations.

Trend Information

Our primary addressable market is for reconstructive hip and knee procedures, specifically primary Total Hip Arthroplasty (“THA”) and primary Total Knee Arthroplasty (“TKA”) procedures. Reconstructive joint replacement procedures are intended to replace diseased or damaged bone with fabricated implants designed to restore patient function. Management of the company has reviewed third party reports which identify According to iData Research, Inc. of Vancouver, British Columbia, it is estimated that approximately 448,700 THA and 805,500 TKA procedures where were conducted in the United states in 2017, compared to 441,100 THA procedures and 770,100 TKA procedures in 2016. The represents a year-over-year increase in surgical volume from 2016 to 2017 of 4.0% for THA procedures and 4.6% for TKA procedures. Generally, the fabricated implants are surgically inserted and fixation is achieved via cement or osseointegration (“press-fit”, “cementless”, “uncemented”). Monogram is focusing its developments on cementless knee fixation.

Joint reconstruction and musculoskeletal care are widely recognized as highly effective treatments as measured by the rates of long-term survivability. As such we expect the procedure volumes to continue to grow with strong demographic tailwinds. Industry publications identify the global market for Knee Joint Reconstruction Sales in 2017 was estimated to be $8.7bn and the global market for Hip Joint Reconstruction Sales was estimated to be $7.2bn in the same period. Those same publications projected the market for Knee Joint Reconstruction Sales to increase to $10.4bn by 2022 and projected the market for Hip Joint Reconstruction Sales to increase to $8.1bn by 2022. While insurers and other healthcare providers such as Centers for Medicare & Medicaid Services ("CMS") seem to recognize that these procedures are generally effective at returning patients to productivity, pressures persist to improve quality and reduce cost. We believe these pressures are a potential tailwind for technologies that help surgeons achieve reproducible, total “episode of care” positive outcomes (reducing length of stay, reducing revision surgeries, supporting better patient outcomes, etc.).

The push for reproducible positive outcomes has been positive for the adoption of computer assisted surgical robotics. Despite this robot adoption is still early. We believe that robotic adoption and the penetration of computer assistive tools remains in the earlier stages of adoption. For instance, in public information available from its Q4 2018 earnings call, Stryker Corporation indicated that it had performed 15,500 Total Knee procedures in the quarter. Also, at the Evercore HEALTHCONx Healthcare Conference on November 28, 2018, Styker executives indicated that there were approximately 600 robots installed globally but 5,000 hospitals in the US alone that are a target for a least one robot.

It should be noted that the emergence of 3D printing technologies allow manufacturers to print porous structures directly into implants. As identified in the above industry studies, it is our view that the growth and demand for press-fit uncemented implants is increasing. Further, we believe that the combination of robotics and 3D printing appears to be highly synergistic because of the benefits of precision bone preparation for press-fit implants. Moreover, we believe that advances in 3D printing will continue to improve the mechanical properties and viability of 3D printed implants in a range of applications.

In conclusion, it is our view that computer assisted robotic procedures will continue to increase market penetration and improve. Advances in image processing, navigation, robotics, and advanced manufacturing are favorable developments.

Relaxed Ongoing Reporting Requirements

If we become a public reporting company in the future, we will be required to publicly report on an ongoing basis as an “emerging growth company” (as defined in the Jumpstart Our Business Startups Act of 2012, which we refer to as the JOBS Act) under the reporting rules set forth under the Exchange Act. For so long as we remain an “emerging growth company”, we may take advantage of certain exemptions from various reporting requirements that are applicable to other Exchange Act reporting companies that are not “emerging growth companies”, including but not limited to:

· not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act;

· taking advantage of extensions of time to comply with certain new or revised financial accounting standards;

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· being permitted to comply with reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements; and

· being exempt from the requirement to hold a non-binding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved.

If we become a public reporting company in the future, we expect to take advantage of these reporting exemptions until we are no longer an emerging growth company. We would remain an “emerging growth company” for up to five years, although if the market value of our Common Stock that is held by non-affiliates exceeds $700 million as of any June 30 before that time, we would cease to be an “emerging growth company” as of the following December 31.

If we do not become a public reporting company under the Exchange Act for any reason, we will be required to publicly report on an ongoing basis under the reporting rules set forth in Regulation A for Tier 2 issuers. The ongoing reporting requirements under Regulation A are more relaxed than for “emerging growth companies” under the Exchange Act. The differences include, but are not limited to, being required to file only annual and semiannual reports, rather than annual and quarterly reports. Annual reports are due within 120 calendar days after the end of the issuer’s fiscal year, and semiannual reports are due within 90 calendar days after the end of the first six months of the issuer’s fiscal year.

In either case, we will be subject to ongoing public reporting requirements that are less rigorous than Exchange Act rules for companies that are not “emerging growth companies”, and our shareholders could receive less information than they might expect to receive from more mature public companies.

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DIRECTORS, EXECUTIVE OFFICERS AND SIGNIFICANT EMPLOYEES

Name	Position	Age	Date Appointed to Current Position	Approximate hours per week for part-time employees
Executive Officers
Benjamin Sexson	Chief Executive Officer, President	34	April 2018	N/A
Directors
Benjamin Sexson	Director	34	April 2018	N/A
Dr. Douglas Unis	Director	44	April 2016	4
Rick Van Kirk (1)	Director	36	April 2016	0 (Approximately 8 hours per year)

(1) Mr. Van Kirk was elected by Pro-Dex, Inc. pursuant to rights granted to Pro-Dex. Inc. via the secured promissory note agreement filed as Exhibit 6.9 to this Offering Circular. The agreement provides that Pro-Dex, Inc. shall have the right to appoint one director of the company so long as Pro-Dex, Inc. holds the note or any of the securities issuable upon conversion of the note.

Benjamin Sexson, CFA – CEO and Director

Benjamin Sexson is the Chief Executive Officer and a Director of Monogram Orthopedics, and has served in such capacities since he joined the company in April 2018. and has Prior to joining Monogram, Mr. Sexson served as the Director of Business Development at Pro-Dex, Inc., one of the largest OEM manufacturer of Orthopedic Robotic End-Effectors in the world from October 2015 to April 2018. In his tenure at Pro-Dex, Mr. Sexson was responsible for helping support the development, management and launch of the company’s first ever custom proprietary product solution and successfully negotiating the highest margin distribution agreements with a major strategic partner. In addition, Mr. Sexson helped secure and negotiate two additional major development agreements and has helped expand the company’s addressable markets from powered surgical tools in CMF to Thoracic, Trauma, Spine and Extremities as well as other product applications. Mr. Sexson is a named inventor on multiple patent applications at Pro-Dex. Prior to joining Pro-Dex, Mr. Sexson started Brides & Hairpins, a successful B2B retail brand that currently supplies Nordstrom, Bloomingdales, Urban Outfitters. Prior to that, Mr. Sexson worked in various finance positions and is a CFA Charterholder. Mr. Sexson graduated with honors from Caltech with a Bachelor’s Degree in Mechanical Engineering in 2006.

Dr. Douglas Unis – Founder and Director

Dr. Douglas Unis is a board certified orthopedic surgeon specializing in adult reconstructive surgery and is the founder and Chief Medical Officer of Monogram Orthopedics, Inc. Dr. Unis founded Monogram Orthopedics in 2015, and has served as a Director of the company since its inception. Dr. Unis has served as an Associate Professor at the Icahn School of Medicine since November 2015 and has been a practicing surgeon since 2004. He began serving as an Assistant Professor at Icahn School of Medicine at Mount Sinai in March 2014, until becoming an Associate Professor in November 2015. Dr. Unis has consulted with many leading orthopedic companies including Zimmer Biomet and Think Surgical. Prior to founding Monogram Orthopaedics, Dr. Unis was a consultant with Think Surgical, working with them for over 4 years to help with the development of their robotic total hip and knee arthroplasty system. Dr. Unis is widely recognized as a leader and innovator in the NYC area having performed the regions’ first muscle sparing anterior total hip replacement in 2005. Dr. Unis earned his BA from Duke University and Doctor of Medicine from Case Western Reserve University and later completing his residency at Northwestern University and a fellowship from Rush University in Adult Reconstruction. 

Rick Van Kirk – Director

Mr. Richard L. Van Kirk is a Director of Monogram, and has served in this capacity since our inception. He is the Chief Executive Officer of Pro-Dex, Inc. (“Pro-Dex”), the largest OEM manufacturer of Orthopedic Robotic End-Effectors on the market. Mr. Van Kirk also serves on Pro-Dex’s Board of Directors. Mr. Van Kirk was appointed to the Board of Directors of Pro-Dex concurrent with his appointment as it’s CEO in January 2015. He joined Pro-Dex in January 2006 and was named Pro-Dex’s Vice President of Manufacturing in December 2006. In April 2013 he was appointed as the Chief Operating Officer of Pro-Dex. Mr. Van Kirk’s career includes over 13 years of management experience in manufacturing. Mr. Van Kirk previously served as Manufacturing Manager and Manager of Product Development at Comarco Wireless Technologies, ChargeSource Division, which provides power and charging functionality for popular electronic devices and wireless accessories. Prior to Comarco, Mr. Van Kirk was General Manager at Dynacast, a leader in precision die casting. Mr. Van Kirk earned a BA in Business Administration at California State University, Fullerton and an MBA from Claremont Graduate School. 

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COMPENSATION OF DIRECTORS AND EXECUTIVE OFFICERS

For the fiscal year ended December 31, 2018, we compensated our three highest-paid directors and executive officers as follows:

Name and Position	Capacities in which compensation was received	Cash compensation ($)			Other compensation ($)		Total compensation ($)
Benjamin Sexson, CEO, Director	-		-	(1)		-		-
Dr. Douglas Unis, Director	Consultant		35,000	(2)		-		35,000
Rick Van Kirk, Director	-		-	(3)		-		-

(1)

The company has entered into an Employment Agreement with its CEO, Benjamin Sexson, which is included as Exhibit 6.2. The agreement provides for an annual base salary of $70,000, which is subject to increase upon the occurrence of two events. The first of these events is the receipt by the company of $500,000 in financing from Mount Sinai. As of the date of this offering circular, this event has already occurred, and Mr. Sexson’s annual base salary increased to $120,000. The second of these events is the company’s close of a round of equity financing of at least $5,000,0000 on or prior to December 31, 2019, which would increase Mr. Sexson’s base salary to $250,000 per year. In addition, Mr. Sexson is eligible to earn an annual bonus in an amount of 50% of his aggregate base salary earned in such year, subject to the achievement of certain performance goals, milestones and objectives, as established from time to time by an appropriate committee of the company’s Board. Additionally, Mr. Sexson is entitled to severance payments by the company equal to six months' of his base salary at the time of his termination if he is terminated without cause. Mr. Sexson earned an annual salary of $70,000 from April 29, 2018 – December 20, 2018, totaling $45,260.27 and an annual salary of $120,000 from December 21, 2018 – December 31, 2018, totaling $3,616.44. However, Mr. Sexson opted to defer payment of his salary, and on February 11, 2019 loaned to the company the amount owed to him in the form of a promissory note for $48,000 (See Exhibit 6.14). The remaining $876.71 is still deferred. Mr. Sexson’s salary increased to $120,000 on December 21, 2018 as a result of the company raising $500,000 of new financing as defined in the terms of his employment agreement. (See Exhibit 6.2). Mr. Sexson has opted to defer 62.5% of his current monthly salary, or $6,250 per month out of the $10,000 monthly salary he is owed. As of June 30, 2019, Mr. Sexson’s total deferred salary in 2019 is $37,500.

(2)

Mr. Unis earned consulting fee of $35,000 in 2018 in consideration for his services as a consultant to the company, pursuant to the Consulting Agreement between Mr. Unis and the company (See Exhibit 6.1). Mr. Unis receives no compensation for his services as a director.

(3) Mr. Van Kirk was elected by Pro-Dex, Inc. pursuant to rights granted to Pro-Dex. Inc. via the secured promissory note agreement filed as Exhibit 6.9 to this Offering Circular. The agreement provides that Pro-Dex, Inc. shall have the right to appoint one director of the company so long as Pro-Dex, Inc. holds the note or any of the securities issuable upon conversion of the note.

For the fiscal year ended December 31, 2018, we paid our directors as a group (3) $0. There are three directors as of the date of this offering circular.

Other than cash compensation, no other compensation was provided to the executive officers or directors in their capacities as officers and directors of the company.

On May 7, 2019, the company adopted an incentive plan (the “2019 Stock Option and Grant Plan” or “Plan”), which reserves 50,000,000 shares of common stock for issuance under the Plan and 15,000,000 shares allowed for issuance pursuant to Incentive Stock Options. As of the date of this offering circular, the company has granted 48,927,010 shares to Benjamin Sexson under the Plan, 18,347,628 of which have been issued. As a result of the 25-for-1 reverse split effected May 28, 2019, the 18,347,628 shares issued to Mr. Sexson under the Plan were reduced to 733,905, and the 48,927,010 grant of shares to Benjamin Sexson was reduced to 1,957,080. In addition, the shares reserved under the Plan and the shares allowed for issuance pursuant to Incentive Stock Options were proportionally reduced to 2,000,000 and 600,000, respectively.

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SECURITY OWNERSHIP OF MANAGEMENT AND CERTAIN SECURITYHOLDERS

The following table sets out, as of May 31, 2019, the voting securities of the company that are owned by executive officers and directors, and other persons holding more than 10% of any class of the company’s voting securities, or having the right to acquire those securities. The table assumes that all options and warrants have vested. The company’s voting securities include all shares of the company’s Common Stock.

Name and Address of Beneficial Owner	Title of class	Amount and nature of beneficial ownership			Amount and nature of beneficial ownership acquirable			Percent of class
Benjamin Sexson, 53 Bridge Street, Unit 507, Brooklyn, NY 11201 (3)	Common Stock		1,957,080	(1)		160,000	(2)		44.22	%
Dr. Douglas Unis, 53 Bridge Street, Unit 507, Brooklyn, NY 11201	Common Stock		1,853,752	(1)		189,676	(2)		42.48	%
The Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY 10029 (4)	Common Stock		604,763			0	(4)		12.00	%

(1)	Includes unvested shares of Common Stock granted pursuant to Restricted Stock Purchase Agreements between the company and Mr. Sexson and Dr. Unis.
(2)	The acquirable shares for Mr. Sexson are comprised of stock options granted pursuant to the company’s Plan. The acquirable shares for Dr. Unis are comprised of stock options granted pursuant to the company’s Plan and a portion of shares that are to be issued to Dr. Unis from Mount Sinai pursuant to the terms of the Licensing Agreement. (See (4) below).
(3)	Pursuant to Mr. Sexson’s employment agreement, Mr. Sexson is entitled to pre-emptive rights permitting him preserve his vested equity position in the company in the event of any additional issuances of company common stock (or securities convertible into common stock), at a per-share price equal to the then current fair market value, as reasonably determined by the Board. Mr. Sexson does not intend to exercise this pre-emptive right.
(4)	Pursuant to the Licensing Agreement between the company and Mount Sinai, Mount Sinai has the right to maintain 12% of the fully-diluted outstanding Common Stock of the company until the company receives an aggregate of $10,000,000 in cash in exchange for its equity securities. Dr. Unis, Mr. Costa, Mr. Somani and the Icahn School of Medicine at Mount Sinai have each agreed, pursuant to a separate agreement to which the company is not a party, to split that 12% as follows: 7.4% to Mount Sinai, 1.6% to Dr. Unis, 1%, to Mr. Somani, and 0.4% to Mr. Costa, with the remaining 0.6% going to the laboratory in which the intellectual property that is the subject of the Licensing Agreement was generated. However, as of the date of this Offering Circular, all of the shares issued pursuant to the Licensing Agreement are held by Mount Sinai. In addition, Mount Sinai’s holdings currently equal 12% of the company’s outstanding common stock, and therefore has been issued all shares due to it under the terms of the Licensing Agreement. See “Interest of Management in Certain Transactions” for further information on this Licensing Agreement.

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INTEREST OF MANAGEMENT AND OTHERS IN CERTAIN TRANSACTIONS

On October 10, 2017, the company entered into an Exclusive Licensing Agreement (the “Licensing Agreement”) with Icahn School of Medicine at Mount Sinai (“Mount Sinai”), an entity which is affiliated with one of our Directors, Doug Unis, who is employed as an associate professor at Mount Sinai. The Licensing Agreement grants Monogram a revenue-bearing, world-wide right and (a) exclusive license, with the right to grant sublicenses (on certain conditions) to certain intellectual property relating to customizable bone implants and surgical planning software and (b) non-exclusive license, with the right to grant sublicenses on certain conditions, to certain technical information for the exploitation of the intellectual property in its field of use and (c) royalty-free, irrevocable license for certain derivative works to be used either commercially outside the field of use or teaching, patient care or non-commercial academic research purposes. Mount Sinai was granted equity in the company pursuant to the Licensing Agreement, along with the right to maintain 12% of the fully-diluted outstanding Common Stock of the company until the company receives an aggregate of $10,000,000 in cash in exchange for its equity securities. As stated above under “Security Ownership of Management and Certain Securities Holders”, Dr. Unis, Mr. Costa, Mr. Somani and the Icahn School of Medicine at Mount Sinai have each agreed, pursuant to a separate agreement to which the company is not a party, to split that 12% as follows: 7.4% to Mount Sinai, 1.6% to Dr. Unis, 1%, to Mr. Somani, and 0.4% to Mr. Costa, with the remaining 0.6% going to the laboratory in which the intellectual property that is the subject of the Licensing Agreement was generated. As of the date of this offering circular, all shares issuable to Mount Sinai pursuant to the terms of the Licensing Agreement have been issued. Pursuant to the terms the Licensing Agreement (and the Amendment thereto filed as Exhibit 6.24), we must have a first commercial sale our products within seven (7) years of the Effective Date of the agreement, or by October 10, 2024. Failure to meet this deadline would constitute a breach of our agreement, and Mount Sinai would have the right to give us a notice of default, and could ultimately terminate the licensing agreement if we fail to cure this default within sixty (60) days.

In addition, as part of the Licensing Agreement, we are obligated to enter into a stock purchase agreement with Mount Sinai for the shares of Common Stock already issued to Mount Sinai. We have not begun negotiating that stock purchase agreement with Mount Sinai, but are required to enter into such an agreement before September 22, 2019. The stock purchase agreement will include “reasonable or customary agreements reasonably required by any future institutional equity investors with respect to the voting of its common stock, and regarding subjecting the common stock held by [Mount Sinai] to rights of first refusal and co-sale…”.

On March 18, 2019, the company entered into an option agreement (the “Option Agreement”) with Mount Sinai pursuant to which the company was granted an option to license additional intellectual property rights under the terms and conditions as set forth in the aforementioned Licensing Agreement. The company exercised this option on March 26^th, 2019 for an exercise fee of $1,000. (See Exhibit 6.18 for further information.) The intellectual property licensed pursuant to this Option Agreement is detailed under “Description of Business – Intellectual Property”. Since this Option Agreement is governed by the terms of the Licensing Agreement, any termination of the Licensing Agreement would automatically terminate this Option Agreement.

Payments under the agreement include: annual license maintenance fees, milestone payments (upon completion of certain events, such as FDA Clearance of Monogram’s custom implants), running royalties (subject to certain adjustments) and sublicense fees.

On December 20, 2018, the company entered into a development and supply agreement with Pro-Dex, Inc., whereby Pro-Dex, Inc. and the company agreed, subject to certain conditions, to negotiate and endeavor to enter into a future agreements through which Pro-Dex, Inc. would develop and supply end-effectors, gearing, and saws, and other surgical products to Monogram. Richard L. Van Kirk is the Chief Executive Officer of Pro-Dex, Inc. and is a Director of Monogram. The conditions to enter into the future development and supply agreements are (i) the raise of at least $5,000,000 in equity capital through the issuance of Common Stock or Preferred Stock by Monogram on or before October 19, 2019, and (ii) the entry into a separate modification agreement regarding the terms of the convertible note issued by Monogram to Pro-Dex, Inc. Monogram and Pro-Dex, Inc. have entered into that modification agreement, dated December 20, 2018, as detailed further below. Richard L. Van Kirk is the Chief Executive Officer of Pro-Dex, Inc. and is a Director of Monogram.

On May 8, 2017, the company issued a convertible promissory note to Ronald Lennox, former CEO and President of Monogram, in the principal amount of $56,000. The note bears interest at 4% per year with balance due and payable on December 31, 2019. On November 9, 2017, the company issued another convertible promissory note to Ronald Lennox in the principal amount of $20,000. The note bears interest at 4% per year with balance due and payable on December 31, 2019.

On June 23, 2017, the company issued a convertible promissory note to Doug Unis, a Director of Monogram, in the principal amount of $50,000. The note consisted of two proposed tranches, one for $28,000 and a second tranche for $22,000, the release of which was subject to the achievement of certain milestones. The second $22,000 tranche was never contributed under this note. The note bears interest at 4% per year with balance due and payable on June 23, 2019.

On January 19, 2018, the company issued a convertible promissory note to American IRA, LLC FBO Julia Jordan IRA, of which Doug Unis is an assign, in the principal amount of $28,000. The note bears interest at 4% per year with balance due and payable on January 19, 2020. Julia Jordan is Doug Unis’s wife.

On May 30, 2018, the company issued a convertible promissory note to Doug Unis, a Director of Monogram, in the principal amount of $15,000. The note bears interest at 4% per year with balance due and payable on May 30, 2020.

On April 19, 2017, the company issued a convertible promissory note to Pro-Dex, Inc., in the principal amount of $800,000. Richard L. Van Kirk is the Chief Executive Officer of Pro-Dex, Inc. and is a Director of Monogram. The company and Pro-Dex, Inc. subsequently amended the terms of the note via an agreement dated December 20, 2018. The note currently bears interest at 6% per year with balance due and payable on October 19, 2019. Pursuant to the amendment agreement between Pro-Dex, Inc. and the company dated December 20, 2018, the company also granted Pro-Dex, Inc. a right of first refusal to purchase an amount equal to 10% of any capital stock offered for sale by the company, subject to certain limitations and exclusions. This right shall continue until a closing of a firm commitment underwritten public offering pursuant to a registration statement under the Securities Act of 1933 in which gross proceeds raised by Monogram equal or exceed $30,000,000. The company also granted Pro-Dex, Inc. the right to appoint one (1) director to the Board of Monogram so long as the note is outstanding. That director is Rick Van Kirk, who currently serves as a director of our company

On December 20, 2018, the company issued warrants to Pro-Dex, Inc. to purchase up to 5% of the outstanding Common Stock and Preferred Stock of the company as of the date of the exercise, calculated on a post-exercise basis. The warrants have an exercise price of $1,250,000, and may be exercised at any time prior to (i) December 20, 2025, (ii) the closing of an initial public offering of the company’s securities, or (iii) a liquidation event by the company. Richard L. Van Kirk is the Chief Executive Officer of Pro-Dex, Inc. and is a Director of Monogram.

On February 11, 2019, the company issued a convertible promissory note to Ben Sexson, Director and CEO of Monogram, in the principal amount of $48,000. The note bears interest at 4% per year with balance due and payable on February 11, 2020.

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SECURITIES BEING OFFERED

General

The company is offering shares of Series A Preferred Stock in this offering. The Series A Preferred Stock may be converted into shares of the Common Stock of the company at the discretion of each investor, or automatically upon the occurrence of certain events, like an initial public offering. The company is therefore qualifying up to 5,000,000 shares of Series A Preferred Stock, convertible into 5,000,000 shares of Common Stock, under the Offering Statement of which this Offering Circular is a part.

The following description summarizes the most important terms of the company’s capital stock. This summary does not purport to be complete and is qualified in its entirety by the provisions of Monogram’s amended certificate of incorporation and bylaws, copies of which have been filed as exhibits to the Offering Statement of which this Offering Circular is a part. For a complete description of Monogram’s capital stock, you should refer to the amended and restated certificate of incorporation and bylaws of the company and to the applicable provisions of Delaware law.

The authorized capital stock of the company consists of Common Stock, par value $0.001 per share, and Preferred Stock, par value $0.001 per share. The total number of authorized shares of Common Stock of Monogram is 13,025,000 and the total number of authorized shares of Preferred Stock is 7,250,000, all of which is designated as Series A Preferred Stock. 

As of June 24, 2019, the outstanding shares of the company included:

Class	Authorized		Issued and Outstanding
Series A Preferred Stock		7,250,000		0
Common Stock		13,025,000		4,787,704

On May 7, 2019, the company adopted an incentive plan (the “2019 Stock Option and Grant Plan” or “Plan”), which reserves 50,000,000 shares of common stock for issuance under the Plan and 15,000,000 shares allowed for issuance pursuant to Incentive Stock Options. As of the date of this offering circular, the company has granted 48,927,010 shares to Benjamin Sexson under the Plan, 18,347,628 of which have been issued. As a result of the 25-for-1 reverse split effected May 28, 2019, the 18,347,628 shares issued to Mr. Sexson under the Plan were reduced to 733,905, and the 48,927,010 grant of shares to Benjamin Sexson was reduced to 1,957,080. In addition, the shares reserved under the Plan and the shares allowed for issuance pursuant to Incentive Stock Options were proportionally reduced to 2,000,000 and 600,000, respectively.

Provisions of Note in Our Certificate of Incorporation

Our Certificate of Incorporation includes a forum selection provision that requires any claims against the company by stockholders not arising under the federal securities laws to be brought in the Court of Chancery State in the state of Delaware. This forum selection provision may limit investors’ ability to bring claims in judicial forums that they find favorable to such disputes and may discourage lawsuits with respect to such claims. The company has adopted this provision to limit the time and expense incurred by its management to challenge any such claims. As a company with a small management team, this provision allows its officers to not lose a significant amount of time travelling to any particular forum so they may continue to focus on operations of the company.

Common Stock

Voting Rights

Each holder of the company’s Common Stock is entitled to one vote for each share on all matters submitted to a vote of the shareholders, including the election of directors. In addition, holders of our Common Stock are entitled to vote as a separate class for the election of two (2) directors of the company’s Board of Directors. Holders of our Preferred Stock may not vote on the election of these directors.

Dividend Rights

Holders of Common Stock are entitled to receive dividends, as may be declared from time to time by the Board of Directors out of legally available funds as detailed in the company’s Restated Articles. The company has never declared or paid cash dividends on any of its capital stock and currently does not anticipate paying any cash dividends after this offering or in the foreseeable future.

Liquidation Rights

In the event of a voluntary or involuntary liquidation, dissolution, or winding up of the company, the holders of the Common Stock are entitled to share ratably in the net assets legally available for distribution to shareholders after the payment of all debts and other liabilities of the company. Holders of the Series A Preferred Stock are entitled to a liquidation preference that is senior to holders of the Common Stock, and therefore would receive dividends and liquidation assets prior to the holders of the Common Stock.

Series A Preferred Stock

Voting Rights

Each holder of the company’s Series A Preferred Stock is entitled to one vote for each share on all matters submitted to a vote of the shareholders, including the election of directors, subject to the following restrictions:

· The holders of our Common Stock are entitled to elect two (2) directors to the company’s Board of Directors as a standalone class. The Preferred Stockholders may not exercise any voting rights in the election of these directors.

Holders of our Preferred Stock specifically have the right to vote with the holders of the Common Stock to elect:

· one (1) independent director to the company’s Board of Directors; and

· any additional directors to the company’s Board of Directors after the elections outlined above.

Each holder of Series A Preferred Stock will be entitled to one vote for each share of Common Stock into which such share of Preferred Stock could be converted. Fractional votes will not be permitted and if the conversion results in a fractional share, it will be disregarded.

Additionally, the holders of the Series A Preferred Stock are entitled to certain protective provisions that require the company to obtain the written consent or affirmative vote of a majority of the outstanding shares of Preferred Stock prior to effecting certain corporate actions, comprised of the following:

(a) alter the rights, powers or privileges of the Preferred Stock in a way that adversely affects the Preferred Stock;

(b) increase or decrease the authorized number of shares of any class or series of capital stock;

(c) authorize or create (by reclassification or otherwise) any new class or series of capital stock having rights, powers, or privileges set forth in the Certificate of Incorporation of the company, as then in effect, that are senior to or on a parity with any series of Preferred Stock;

(d) redeem or repurchase any shares of Common Stock or Preferred Stock (other than pursuant to employee or consultant agreements giving the company the right to repurchase shares upon the termination of services pursuant to the terms of the applicable agreement);

(e) declare or pay any dividend or otherwise make a distribution to holders of Preferred Stock or Common Stock;

(f) increase or decrease the number of directors of the company;

(g) liquidate, dissolve, or wind-up the business and affairs of the company

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Dividend Rights

Holders of Series A Preferred Stock will be entitled to receive dividends as may be declared from time to time by the Board of Directors out of legally available funds and on a pari passu basis with holders of the Common Stock. The company has never declared or paid cash dividends on any of its capital stock and currently does not anticipate paying any cash dividends after this offering or in the foreseeable future.

Conversion Rights

Shares of Series A Preferred Stock will be convertible, at the option of the holder, at any time, into fully paid and nonassessable shares of the company’s Common Stock at the then-applicable conversion rate. Initially, the conversion rate will be one share of Common Stock per share of Series A Preferred Stock. The conversion rate is subject to adjustment in the event of stock splits, reverse stock splits or the issuance of a dividend or other distribution payable in additional shares of Common Stock.

Additionally, each share of Series A Preferred Stock will automatically convert into Common Stock:

i) immediately prior to the closing of a firm commitment underwritten public offering of the company’s Common Stock on Form S-1, registered under the Securities Act, at a per share price not less than the Original Issue Price (as defined below) adjusted for any stock dividends, combinations, splits, recapitalizations and the like, for a total offering proceeds $5,000,000 or more (before deduction of underwriters commissions and expenses); or

ii) upon the affirmative election of the holders of a majority of the outstanding shares of Preferred Stock, voting as a single class and on an as-converted basis.

In either of these events, the shares will convert in the same manner as a voluntary conversion.

Right to Receive Liquidation Distributions

In the event of a liquidation, dissolution or winding up of the company, whether voluntary or involuntary, or certain other events (each a “Deemed Liquidation Event”) such as the sale or merger of the company, all holders of Series A Preferred Stock will be entitled to a liquidation preference that is senior to holders of the Common Stock. Holders of Series A Preferred Stock will receive a liquidation preference equal to the greater of (a) an amount for each share equal to the Original Issue Price for such share, adjusted for any stock dividends, combinations, splits, recapitalizations and the like (the “liquidation preference”) plus any declared but unpaid dividends with respect to such shares or (b)  such amount per share as would have been payable had all shares of Series A Preferred Stock been converted into Common Stock immediately prior to such liquidation, dissolution or winding up or Deemed Liquidation Event. Initially, the liquidation preferences for the shares of Series A Preferred Stock will be $4.00 per share (the “Original Issue Price”).

If, upon such liquidation, dissolution, or winding up or Deemed Liquidation Event, the assets (or the consideration received in a transaction) that are distributable to the holders of Preferred Stock are insufficient to permit the payment to such holders of the full amount of their respective liquidation preference, then all of such funds will be distributed ratably among the holders of the Preferred Stock in proportion to the full amounts to which they would otherwise be entitled to receive.

After the payment of the full liquidation preference of the Series A Preferred Stock, the remaining assets of the company legally available for distribution (or the consideration received in a transaction), if any, will be distributed ratably to the holders of the Common Stock in proportion to the number of shares of Common Stock held by each such holder.

Drag Along Right

The investors’ rights agreement that investors will execute in connection with the offering contains a “drag-along provision” related to the certain events, such as the sale, merger or dissolution of the company (a “Liquidating Event”). Investors who purchase Series A Preferred Stock agree that, if the board of directors, the majority of the holders of the company’s Common Stock, and the majority of the holders of the company’s Series A Preferred Stock vote in favor of such a Liquidating Event, then such holders of Series A Preferred Stock will vote in favor of the transaction if such vote is solicited, refrain from exercising dissenters’ rights with respect to Liquidating Event, and deliver any documentation or take other actions reasonably requested by the company or the other holders in connection with the Liquidating Event.

32

Information Rights

The company also agrees in the investors’ rights agreement to grant certain information rights to investors in this offering that invest $50,000 or more in this offering (“Major Purchasers”). The information rights provided to Major Purchasers include: (1) annual unaudited financial statements for each fiscal year of the company, including an unaudited balance sheet as of the end of such fiscal year, an unaudited income statement, and an unaudited statement of cash flows, all prepared in accordance with generally accepted accounting principles and practices; and (2) quarterly unaudited financial statements for each fiscal quarter of the company (except the last quarter of the company’s fiscal year), including an unaudited balance sheet as of the end of such fiscal quarter, an unaudited income statement, and an unaudited statement of cash flows, all prepared in accordance with generally accepted accounting principles and practices, subject to changes resulting from normal year-end audit adjustments. If the company has audited records of any of the foregoing, it will provide those in lieu of the unaudited versions.

Additional Rights and Participation Rights

The investors’ rights agreement that investors will execute in connection with the offering grants investors and their transferees certain rights in connection with the company’s next equity offering. If in its next equity offering after the date that an investor executes the investors’ rights agreement (the “Next Financing”) the company issues securities that (a) have rights, preferences or privileges that are more favorable than the terms of the Series A Preferred Stock or (b) provide all such future investors in the Next Financing contractual terms such as registration rights, the company agrees to provide substantially equivalent rights to the investor with respect to the Series A Preferred Stock (with appropriate adjustment for economic terms or other contractual rights), including the amount of the Series A preferred stock liquidating distributions, through the investor’s proxy, if applicable, subject to the investor’s execution of any documents, including, if applicable, investor rights, co-sale, voting, and other agreements, executed by the investors purchasing securities in the Next Financing (the “Next Financing Documents”), provided that certain rights may be reserved for investors with a minimum amount of investment in the Next Financing. Upon the execution and delivery of the Next Financing Documents, the investors’ rights agreement (excluding any then-existing and outstanding obligations) will be automatically amended and restated by and into the Next Financing Documents and will be terminated and of no further force or effect. As a result, the rights of investors who participate in any Next Financing will instead be governed by the Next Financing Documents.

In the investors’ rights agreement, the company also grants investors in this offering participation rights. Investors will have the right of first refusal to purchase the investor’s Pro Rata Share of any New Securities (each as defined below) that the company may issue in the Next Financing. The investor will have no right to purchase any New Securities if the investor cannot demonstrate to the company’s reasonable satisfaction that the investor is at the time of the proposed issuance of New Securities eligible to purchase such New Securities under applicable securities laws. An investor’s “Pro Rata Share” means the ratio of (i) the number of shares of the company’s Common Stock issued or issuable upon conversion of the Series A Preferred Stock owned by the investor, to (ii) that number of shares of the company’s capital stock equal to the sum of (A) all shares of the company’s capital stock (on an as-converted basis) issued and outstanding, assuming exercise or conversion of all options, warrants and other convertible securities and promissory notes, and (B) all shares of the company’s capital stock reserved and available for future grant under any equity incentive or similar plan.

“New Securities” means any shares of the company’s capital stock to be issued in the Next Financing, including Common Stock or Preferred Stock, whether now authorized or not, and rights, options or warrants to purchase Common Stock or Preferred Stock, and securities of any type whatsoever that are, or may become, convertible or exchangeable into Common Stock or Preferred Stock “New Securities” does not include: (i) shares of Common Stock issued or issuable upon conversion of any outstanding shares of Preferred Stock; (ii) Common Stock or Series A Preferred Stock issued upon conversion of any outstanding convertible notes; a(iii) shares of Common Stock or Preferred Stock issuable upon exercise of any options, warrants, or rights to purchase any securities of the company outstanding as of the date the Offering Statement is qualified by the Commission and any securities issuable upon the conversion thereof; (iv) shares of Common Stock or Preferred Stock issued in connection with any stock split or stock dividend or recapitalization; (v) shares of Common Stock (or options, warrants or rights therefor) granted or issued after the date the Offering Statement is qualified by the Commission to employees, officers, directors, contractors, consultants or advisers to, the company or any subsidiary of the company pursuant to incentive agreements, stock purchase or stock option plans, stock bonuses or awards, warrants, contracts or other arrangements that are approved by the board of directors; (vi) shares of the company’s Series A Preferred Stock issued in this offering; (vii) any other shares of Common Stock or Preferred Stock (and/or options or warrants therefor) issued or issuable primarily for other than equity financing purposes and approved by the board of directors; (vii) shares of Common Stock issued or issuable by the company to the public pursuant to a registration statement filed under the Securities Act; and (ix) any other shares of the company’s capital stock, the issuance of which is specifically excluded by approval of the board of directors.

The company will send investors, or investors’ proxies, if applicable, a notice describing the type of New Securities and the price and the general terms upon which the it proposes to issue the New Securities. An investor will have fourteen (14) days from the date of notice, to agree to purchase a quantity of New Securities, up to their Pro Rata Share. If an investor fails to exercise in full the right of first refusal within the 14-day period, then the company will have one hundred twenty (120) days after that to sell the New Securities with respect to which the investor’s right of first refusal was not exercised. If the company has not issued and sold the minimum amount of New Securities to be sold in the Next Financing within the 120-day period, then the company will not issue or sell any New Securities without again first offering those New Securities to investors in accordance with the terms of the investors’ rights agreement.

Benjamin Sexson, our CEO, is entitled to pre-emptive rights permitting him preserve his vested equity position in the company in the event of any additional issuances of company common stock (or securities convertible into common stock), at a per-share price equal to the then current fair market value, as reasonably determined by the Board. Mr. Sexson does not intend to exercise this pre-emptive right.

Investor Perks

To encourage participation in the Offering, the company is providing specific perks for investors. The company is of the opinion that these perks do not alter the sales price or cost basis of the securities in this offering. Instead, the perks are promotional items or a “thank you” to investors that help the company achieve its mission. However, it is recommended that investors consult a tax professional to fully understand any tax implications of receiving any perks before investing. The company anticipates that the perks for this offering are as follows:

Tier 1 – Available for all investors that have invested at least $1,000

· Quarterly investor updates

Tier 2 – Available for all investors that have invested at least $25,000

In addition to the Tier 1 perks:

· Free newly designed Monogram t-shirt (estimated cash value $25).

Tier 3 – Available for all investors that have invested at least $100,000

In addition to the Tier 1 and Tier 2 perks:

· participation in regularly scheduled quarterly call with Monogram senior management.

Tier 4 – Available for all investors that have invested at least $250,000

In addition to the Tier 1, Tier 2 and Tier 3 perks:

· Travel and accommodations to Monogram location for an in-person investor tour and a one-time dinner with our management team. Also includes invitation to annual updates (dinners, calls, etc.) with the Monogram senior management team. (Estimated cash value $2,250).

33

MONOGRAM ORTHOPAEDICS, INC.

TABLE OF CONTENTS

	Page
Independent Auditor’s Report	F-1
Financial Statements as of December 31, 2018 and 2017 and for the years then ended:
Balance Sheets	F-2
Statements of Operations	F-3
Statements of Changes in Stockholders’ Equity	F-4
Statements of Cash Flows	F-5
Notes to Financial Statements	F-6–F-18

34

INDEPENDENT AUDITOR’S REPORT

Members of:

WSCPA

AICPA

PCPS

802 N. Washington

PO Box 2163

Spokane, Washington

99210-2163

P 509-624-9223

TF 1-877-264-0485

mail@fruci.com

www.fruci.com

To the Board of Directors and Stockholders
of Monogram Orthopaedics, Inc.

We have audited the accompanying financial statements of Monogram Orthopaedics, Inc., which comprise the balance sheets as of December 31, 2018 and 2017, and the related statements of operations, stockholders’ deficit, and cash flows for the years then ended, and the related notes to the financial statements.

Management’s Responsibility for the Financial Statements

Management is responsible for the preparation and fair presentation of these financial statements in accordance with accounting principles generally accepted in the United States of America; this includes the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of financial statements that are free from material misstatement, whether due to fraud or error.

Auditor’s Responsibility

Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free from material misstatement.

An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements. The procedures selected depend on the auditor’s judgment, including the assessment of the risks of material misstatement of the financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the entity’s preparation and fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entity’s internal control. Accordingly, we express no such opinion. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluating the overall presentation of the financial statements.

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.

Going Concern

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has sustained recurring losses from operations and has significant accumulated and working capital deficits. These factors raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Opinion

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Monogram Orthopaedics, Inc. as of December 31, 2018 and 2017, and the results of its operations and its cash flows for the years then ended in accordance with accounting principles generally accepted in the United States of America.

Emphasis of Matter

As discussed in Note 11, the financial statements have been revised to retrospectively reflect the effects of a reverse stock split that occurred subsequent to the issuance of our initial audit report. Our opinion is not modified with respect to this matter.

 

Spokane, Washington

February 22, 2019, except as to the first paragraph of Note 8, Note 9, Note 11, and the third paragraph of Note 12, for which the date is July 3, 2019

F-1

MONOGRAM ORTHOPAEDICS INC.

Balance Sheets

	December 31, 2018			December 31, 2017
Assets
Current assets:
Cash and cash equivalents	$	922,108		$	235,888
Total current assets		922,108			235,888
Equipment, net of accumulated depreciation		262,146			138,188
Total assets	$	1,184,254		$	374,076
Liabilities and Stockholders’ Deficit
Current liabilities:
Accounts payable
Trade	$	257,480		$	24,273
Related party		80,005			-
Accrued interest payable		78,568			21,964
Accrued interest payable – related parties		7,227			1,647
Current portion of long-term debt		1,825,000			-
Current portion of long-term debt – related parties		104,000			-
Total current liabilities		2,352,280			47,884
Long-term debt		180,000			900,000
Long-term debt – related parties		43,000			104,000
Total liabilities		2,575,280			1,051,884
Commitments and Contingencies		-			-
Stockholders’ deficit:
Common stock, $.001 par value; 13,025,000 shares authorized, 89,382 and 127,382 shares issued and outstanding in 2018 and 2017, respectively		89			127
Capital in excess of par value		2,146			3,058
Accumulated deficit		(1,393,261	)		(680,993	)
Total stockholders’ deficit		(1,391,026	)		(677,808	)
Total liabilities and stockholders’ deficit	$	1,184,254		$	374,076

Accompanying notes are an integral part of these financial statements

F-2

MONOGRAM ORTHOPAEDICS INC.

Statements of Operations

	Years Ended December 31,
	2018			2017
Revenues	$	-		$	-
Cost and expenses:
Wages and payroll related expenses		378,523			400,541
General and administrative		101,679			124,704
Marketing and advertising		3,154			3,771
Legal and professional services		104,114			44,757
Research and development		31,700			48,317
Total costs and expenses		619,170			622,090
Loss from operations		(619,170	)		(622,090	)
Other income (expense)
Interest expense		(62,184	)		(23,612	)
Depreciation		(30,957	)		(13,354	)
Interest income		43			61
Total other income (expense)		(93,098	)		(36,905	)
Net income (loss) before taxes		(712,268	)		(658,995	)
Income tax		-			-
Net income (loss)	$	(712,268	)	$	(658,995	)
Basic and diluted earnings (loss) per share	$	(6.89	)	$	(7.51	)
Weighted average number of basic and diluted shares outstanding		103,333			87,778

Accompanying notes are an integral part of these financial statements

F-3

MONOGRAM ORTHOPAEDICS INC.

Statements of Stockholders' Deficit

For the years ended December 31, 2018 and 2017

							Capital in Excess of			Accumulated			Total
	Shares			Amount			Par Value			Deficit			Deficit
Balance, December 31, 2016		—		$	—		$			$	(21,998	)	$	(21,998	)
Net loss, December 31, 2017		—			—						(658,995	)		(658,995	)
Sale of common stock		112,096			112			2,691			—			2,803
Stock issued for services		15,286			15			367			—			382
Balance, December 31, 2017		127,382			127			3,058			(680,993	)		(677,808	)
Net loss, December 31, 2018		—			—			—			(712,268	)		(712,268	)
Stock repurchase		(38,000	)		(38	)		(912	)		—			(950	)
Balance, December 31, 2018		89,382		$	89		$	2,146		$	(1,393,261	)	$	(1,391,026	)

Accompanying notes are an integral part of these financial statements

F-4

MONOGRAM ORTHOPAEDICS INC.

Statements of Cash Flows

	Year			Year
	Ended			Ended
	December 31,			December 31,
	2018			2017
Operating activities
Net loss	$	(712,268	)	$	(658,995	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		—			382
Depreciation		30,957			13,354
Changes in non-cash working capital balances:
Accounts payable		233,207			2,275
Accrued payable – related parties		79,055			—
Accrued interest payable		62,184			23,611
Cash used in operating activities		(306,865	)		(619,373	)
Investing activities
Purchase of equipment		(154,915	)		(151,542	)
Cash used in investing activities		(154,915	)		(151,542, )
Financing activities
Proceeds from notes payable		1,105,000			900,000
Proceeds from note payable – related parties		43,000			104,000
Proceeds from sale of common stock		—			2,803
Cash provided by financing activities		1,148,000			1,006,803
Increase in cash and cash equivalents during the period		686,220			235,888
Cash and cash equivalents, beginning of the period		235,888			-
Cash and cash equivalents, end of the period	$	922,108		$	235,888
Cash paid for:
Interest	$	—		$	—
Income taxes	$	—		$	—
Non-cash financing activities
Repurchase of common stock by related party	$	950		$	—

Accompanying notes are an integral part of these financial statements

F-5

MONOGRAM ORTHOPAEDICS INC.

NOTES TO FINANCIAL STATEMENTS

AS OF AND FOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017

1. Description of Business and Summary of Accounting Principles

Description of the Organization

Monogram Orthopaedics Inc. (“Monogram,” “we,” “our,” or the “Company”), incorporated in the state of Delaware on April 21, 2016, is developing a product solution architecture for enabling mass personalization of orthopedic implants by linking 3D printing and robotics via automated digital image analysis algorithms. 

The company has a working navigated robot prototype that can optically track a simulated surgical target and execute optimized auto-generated cut paths for high precision insertion of patient specific implants in synthetic bone specimens. These implants and cut-paths are generated with proprietary Monogram software algorithms.

The financial statements are presented in United States dollars and have been prepared in accordance with generally accepted accounting principles in the United States of America.  The Company’s fiscal year end is December 31. The Company operates from its headquarters in Brooklyn, New York.

Income Taxes

The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income and the reversal of deferred tax liabilities during the period in which related temporary differences become deductible. A valuation allowance has been established to eliminate the Company’s deferred tax assets as it is more likely than not that none of the deferred tax assets will be realized.

The Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such a position are measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon settlement with the tax authorities. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. The Company records interest related to unrecognized tax benefits in interest expense and penalties in income tax expense. The Company has determined that it had no significant uncertain tax positions requiring recognition or disclosure.

F-6

The Company records uncertain tax positions in accordance with ASC 740 on the basis of a two-step process whereby (1) we determine whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, we recognize the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority.    

Revenue Recognition

In May 2014, the FASB issued ASU 2014-09, "Revenue from Contracts with Customers (Topic 606)." The Company adopted the new standard as of January 1, 2018, utilizing a full retrospective transition method. Adoption of the new standard resulted in no changes for revenue recognition related as the Company has not yet generated revenue.

Earnings (Loss) Per Share

Earnings (loss) per share is computed by dividing net income or loss by the weighted-average number of shares outstanding. To the extent that stock options and convertible debt are anti-dilutive, they are excluded from the calculation of diluted earnings (loss) per share. See Note 9 for details of potentially dilutive securities.

Cash and Cash Equivalents

The Company considers all highly liquid investments purchased with original maturities of three months or less to be cash equivalents. The Company did not have any cash equivalents during fiscal 2018 and 2017.

Equipment

Equipment expenditures are recorded at cost. Costs which extend the useful lives or increase the productivity of the assets are capitalized, while normal repairs and maintenance that do not extend the useful life or increase the productivity of the asset are expensed as incurred. Equipment, including the Company’s robot, are depreciated on the straight-line method over the estimated useful lives of the assets. Equipment will be depreciated over a five-year useful life. Any construction in progress is stated at cost and depreciation will commence once the project is constructed and placed in service.

Asset Impairment

Long-lived assets, such as property, plant, and equipment are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require a long-lived asset or asset group be tested for possible impairment, the Company first compares undiscounted cash flows expected to be generated by that asset or asset group to its carrying amount. If the carrying amount of the long-lived asset or asset group is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying amount exceeds its fair value. Fair value is determined through various valuation techniques including discounted cash flow models, quoted market values and third-party independent appraisals, as considered necessary. The Company recorded no asset impairment in 2018 or 2017.

F-7

General and Administrative Expenses

General and administrative expenses include salaries, travel and office expenses of administrative employees and contractors; software license fees; and other overhead expenses.

Research and Development Costs

Research and development (“R&D”) costs are expensed as incurred and amounted to $31,700 and $48,317 for the years ended December 31, 2018 and 2017, respectively. In 2017, the majority of our R&D expenses were related to costs incurred developing and testing our patient specific hip implant with the UCLA Orthopaedic Biomechanics Laboratory.  The company currently has several R&D initiatives underway including mechanical testing of a patient specific hip, micromotion studies of a patient specific press-fit knee implant, and performance testing of a robot mounted navigation system.

Advertising Costs

Advertising and marketing costs are expensed as incurred and amounted to $3,154 and $3,771 for the years ended December 31, 2018 and 2017, respectively.

Use of Estimates

In preparing financial statements in conformity with generally accepted accounting principles, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. The most significant estimate relates to the accruals for income tax valuation allowance. On a continual basis, management reviews its estimates, utilizing currently available information, changes in facts and circumstances, historical experience and reasonable assumptions. After such reviews, and if deemed appropriate, those estimates are adjusted accordingly. Actual results could differ from those estimates.

Recent Accounting Pronouncements

In January 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-01 – “Financial Instruments – Overall (Subtopic 825-10) – Recognition and Measurement of Financial Assets and Financial Liabilities.”  ASU 2016-01, among other changes, requires equity investments (except those accounted for under the equity method of accounting or those that result in consolidation of the investee) to be measured at fair value with changes in fair value recognized in net income.  This Update also simplifies the impairment assessment of equity investments without readily determinable fair values by requiring a qualitative assessment to identify impairment.  The amendments in ASU 2016-01 will become effective for public business entities for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years.  We are currently evaluating the effect of the adoption of ASU 2016-01 will have on our consolidated results of operations, financial position or cash flows.

F-8

In February 2016, the FASB issued ASU 2016-02 – “Leases (Topic 842).” Under ASU 2016-02, entities will be required to recognize lease asset and lease liabilities by lessees for those leases classified as operating leases.  Among other changes in accounting for leases, a lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term.  When measuring assets and liabilities arising from a lease, a lessee (and a lessor) should include payments to be made in optional periods only if the lessee is reasonably certain to exercise an option to extend the lease or not to exercise an option to terminate the lease.  Similarly, optional payments to purchase the underlying asset should be included in the measurement of lease assets and lease liabilities only if the lessee is reasonably certain to exercise that purchase option.  The amendments in ASU 2016-02 will become effective for fiscal years beginning after December 15, 2018, including interim periods with those fiscal years, for public business entities.  We are currently evaluating the effect of the adoption of ASU 2016-02 will have on our consolidated results of operations, financial position or cash flows.

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipt and Cash Payments. The new guidance addresses certain classification issues related to the statement of cash flows which will eliminate the diversity of practice in how certain cash receipts and cash payments are presented and classified in the statement of cash flows. The guidance is effective for fiscal years beginning after December 2017. Early adoption is permitted. We are currently evaluating the possible impact of ASU 2016-15, but do not anticipate that it will have a material impact on the Company's consolidated results of operations, financial position or cash flows.

In January 2017, the FASB issued ASU No. 2017-01, clarifying the Definition of a Business, which narrows the definition of a business. This ASU provides a screen to determine whether a group of assets constitutes a business. The screen requires that when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is not a business. This screen reduces the number of transactions that need to be further evaluated as acquisitions. If the screen is not met, this ASU (1) requires that to be considered a business, a set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create an output and (2) removes the evaluation of whether a market participant could replace missing elements. Although outputs are not required for a set to be a business, outputs generally are a key element of a business; therefore, the FASB has developed more stringent criteria for sets without outputs. The ASU is effective for annual periods beginning after December 15, 2018. Management determined that the adoption of this guidance will not have a material impact on the financial statements.

F-9

In March 2017 the FASB issued ASU 2017-04 Intangibles—Goodwill and Other (Topic 350) Simplifying the Test for Goodwill Impairment. This amendment simplifies the measurement of goodwill by eliminating Step 2 from the goodwill impairment test. This update is effective for fiscal years beginning after December 15, 2021. The adoption of ASU No. 2017-04 is not expected to have a material impact on the Company’s financial statements.

In May 2017, the FASB issued ASU 2017-09 which clarifies the guidance on the modification accounting criteria for share-based payment awards. The new guidance requires registrants to apply modification accounting unless three specific criteria are met. The three criteria are 1) the fair value of the award is the same before and after the modification, 2) the vesting conditions are the same before and after the modification and 3) the classification as a debt or equity award is the same before and after the modification. This update is effective for fiscal years beginning after December 15, 2017 and are to be applied prospectively to new awards granted after adoption. Management determined that the adoption of this guidance will not have a material impact on the financial statements.

Management does not believe that any other recently issued, but not yet effective, accounting standards could have a material effect on the accompanying financial statements. As new accounting pronouncements are issued, we will adopt those that are applicable under the circumstances.

2. Going Concern Matters and Realization of Assets

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the ordinary course of business. However, the Company has sustained recurring losses from its continuing operations and as of December 31, 2018, had negative working capital of $1,430,172 and a stockholders’ deficit of $1,391,026. In addition, the Company is unable to meet its obligations as they become due and sustain its operations. The Company believes that its existing cash resources are not sufficient to fund its continuing operating losses, capital expenditures, lease and debt payments and working capital requirements.

The Company may not be able to raise sufficient additional debt, equity or other cash on acceptable terms, if at all. Failure to generate sufficient revenues, achieve certain other business plan objectives or raise additional funds could have a material adverse effect on the Company’s results of operations, cash flows and financial position, including its ability to continue as a going concern, and may require it to significantly reduce, reorganize, discontinue or shut down its operations.

In view of the matters described above, recoverability of a major portion of the recorded asset amounts shown in the accompanying balance sheet is dependent upon continued operations of the Company which, in turn, is dependent upon the Company’s ability to meet its financing requirements on a continuing basis, and to succeed in its future operations. The financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might be necessary should the Company be unable to continue in its existence. Management’s plans include:

F-10

1. Seek to raise equity for working capital purposes and to force conversion of or pre-pay existing debt balances as they become due. With sufficient additional cash available to the Company, it can make the additional development expenditures necessary to develop a commercially viable product and generate revenues, and consequently cut monthly operating losses.

2. Continue to develop its technology and intellectual property and look for industry partners to use or sell its product.

Management has determined, based on its recent history and its liquidity issues that it is not probable that management’s plan will sufficiently alleviate or mitigate, to a sufficient level, the relevant conditions or events noted above. Accordingly, the management of the Company has concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year after the issuance date of these financial statements.

There can be no assurance that the Company will be able to achieve or maintain cash-flow-positive operating results. If the Company is unable to generate adequate funds from operations or raise sufficient additional funds, the Company may not be able to repay its existing debt, continue to develop its product, respond to competitive pressures or fund its operations. As a result, the Company may be required to significantly reduce, reorganize, discontinue or shut down its operations. The financial statements do not include any adjustments that might result from this uncertainty.

3. Equipment

Equipment, net consists of the following as of December 31, 2018 and 2017

	2018			2017
Computer equipment	$	27,065		$	24,030
Medical equipment		6,142			4,262
Robot		123,250			123,250
Work-in-process equipment		150,000			-
		306,457			151,542
Accumulated depreciation		(44,311	)		(13,354	)
Equipment, net	$	262,146		$	138,188

For the years ended December 31, 2018 and 2017, depreciation expense amounted to $30,957 and $13,354, respectively.

4. Debt

The following table summarizes components debt as of December 31, 2018 and 2017: 

	2018		2017
Convertible term notes	$	1,925,000	$	900,000
Secured convertible term notes		80,000		-
Convertible term notes – related parties		147,000		104,000
Total Debt	$	2,152,000	$	1,004,000

F-11

All of the notes are convertible and they mature at various times from October 19, 2019 through December 24, 2020, as noted in the table below:

Description	Principal		Maturity Date	Interest Rate			Valuation Cap
Secured term note	$	450,000	10/19/2019		6	%	$	6,000,000
Secured term note		350,000	10/19/2019		6	%	$	6,000,000
Related party note		28,000	12/31/2019		4	%	$	6,000,000
Related party note		28,000	12/31/2019		4	%	$	6,000,000
Related party note		20,000	12/31/2019		4	%	$	6,000,000
Related party note		28,000	12/31/2019		4	%	$	6,000,000
Related party note		28,000	1/19/2020		4	%	$	6,000,000
Secured term note		50,000	12/31/2019		4	%	$	6,000,000
Secured term note		50,000	12/31/2019		4	%	$	6,000,000
Related party note		15,000	5/30/2020		4	%	$	6,000,000
Secured term note		40,000	7/12/2020		6	%	$	6,000,000
Secured term note		40,000	7/13/2020		6	%	$	6,000,000
Unsecured term note		25,000	9/18/2020		6	%	$	10,000,000
Unsecured term note		50,000	11/9/2020		4	%	$	8,000,000
ZB Capital Partners		700,000	12/31/2019		6	%	$	6,000,000
ZB Capital Partners		225,000	12/31/2019		6	%	$	8,000,000
Unsecured term note		25,000	12/24/2020		4	%	$	10,000,000
Total	$	2,152,000

The notes payable are convertible into equity upon the closing of a Financing (as hereinafter defined). The term "Equity Securities" means the class of the Company's preferred stock issued in the Financing. The Equity Securities issued upon conversion of the notes shall be of the same class of Equity Securities purchased by investors in the Financing but shall be designated as a separate series of Equity Securities that shall have the same rights and preferences of the Equity Securities purchased by new purchasers in the Financing, except that the "Original Issue Price" of the series Equity Securities issued to holders of notes, as set forth in the Company's then-current Certificate of Incorporation for the purposes of calculating liquidation preferences, conversion ratios, anti-dilution adjustments, dividends and the like, will be the Conversion Price (as hereinafter defined). Additionally, the note holders shall receive pro rata participation rights with respect to all future equity issuances, subject to customary exceptions, such that each note holder shall have the right to participate in future equity issuances in an amount that permits it to maintain its fully-diluted ownership in the Company after each equity issuance. At that time, all of the principal amount outstanding under the notes and any accrued and unpaid interest thereon shall be converted automatically at the Conversion Price without further action of the note holders into shares of equity securities issued at such Financing. The term "Conversion Price" means an amount equal to the lesser of (i) eighty percent (80%) of the per share price paid in the Financing or (ii) the price equal to the quotient of the amount in the “Valuation Cap” column in the table above, divided by the aggregate number of fully diluted outstanding shares of the Company's common stock, as defined, immediately prior to the initial closing of the Financing. The term "Financing" means any equity financing for the account of the Company involving the issuance and sale of shares of Equity Securities which occurs on or before the notes mature and at which time the aggregate gross proceeds received by the Company (excluding any amounts from the conversion of any of the notes and any other convertible notes previously issued by the Company) equals or exceeds $5,000,000.

F-12

Until the payment or conversion of the entire principal amount of the notes and the payment or conversion of the entire accrued interest thereon, the Company shall not take any of the following actions without the prior written consent of the note holders (which may be granted or withheld in the note holders' discretion):

(a)        consummate any sale of the Company or consent to the consummation of any sale of the Company;

(b)        increase or decrease the total number of authorized shares of common stock of the Company, except in connection with any capital raising securities issuance (including, without limitation, any Financing);

(c)        pay compensation to any employee of the Company in excess of $180,000 per year;

(d)        declare or pay any dividends or make any other distributions to the holders of common stock of the Company;

(e)        change the authorized number of directors of the Company to more than five or less than three;

(f)        incur any future indebtedness in excess of $20,000 in the aggregate other than deferred expenses that the Company and payee thereof agree can be converted into convertible debt, however any additional indebtedness of any kind shall be expressly made subordinate to this Note; or

(g)        change the principal business of the Company or enter into a new line of business.

The secured convertible term notes grant a security interest in and to all of the Company’s right, title and interest the Company’s assets, tangible and intangible, wherever located, whether now existing or acquired in the future, including, but not limited to (i) all fixtures and personal property of every kind; and (ii) all proceeds and products derived from the Company’s assets; and all books and records.

5. Fair Value Measurements

The Company uses fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures of financial instruments on a recurring basis.

F-13

Fair Value Hierarchy

The Fair Value Measurements Topic of FASB’s ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are as follows:

Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.

Level 3 inputs are unobservable inputs for the asset or liability.

Determination of Fair Value

Under the Fair Value Measurements Topic of the FASB Accounting Standards Codification, the Company bases its fair value on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. It is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data and, therefore, are based primarily upon management’s own estimates, are often calculated based on current pricing policy, the economic and competitive environment, the characteristics of the asset or liability and other such factors. Therefore, the results cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique, and changes in the underlying assumptions used, including discount rates and estimates of future cash flows, that could significantly affect the results of current or future value.

Valuation methodologies used for assets and liabilities recorded at fair value and for estimating fair value where it is practicable to do so for financial instruments not recorded at fair value are as follows: 

Cash and cash equivalents, accounts receivable, and accounts payable

The Company considers all highly liquid investments with maturities of three months or less to be cash equivalents. In general, carrying amounts approximate fair value because of the short maturity of these instruments.

Long-lived Assets

Long-lived assets are measured at fair value on a non-recurring basis and are classified in Level 3 of the fair value hierarchy. The fair value is estimated utilizing unobservable inputs, including appraisals on real estate as well as evaluations of the marketability and potential relocation of other assets in similar condition and similar market areas.

F-14

Debt

At December 31, 2018 and 2017, the Company’s convertible debt was carried at its face value plus accrued interest. Based on the financial condition of the Company, it is impracticable for the Company to estimate the fair value of its short and long-term debt.

The Company has no instruments with significant off-balance sheet risk.

6. Income Taxes

At December 31, 2018, the Company had net operating loss carryforwards for Federal income tax purposes of approximately $1,400,000 expiring in the years of 2019 through 2034. Utilization of the net operating losses may be subject to annual limitations provided by Section 382 of the Internal Revenue Code and similar State provisions.

On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (the “Act”) was signed into law. The Act makes broad and significantly complex changes to the U.S. corporate income tax system by, among other things; reducing the U.S. federal corporate income tax rate from 35% to 21%, and potentially impacting our net operating loss carryforwards. Given the significant changes resulting from and complexities associated with the Act, the estimated financial impacts for fiscal 2018 are provisional. The ultimate outcome may differ from these provisional amounts, due to, among other things, additional analysis, changes in interpretations and assumptions the Company has made, additional regulatory guidance that may be issued and actions the Company may take as a result of the Act. Actual impacts on the Company’s net operating loss carryforwards are expected to be finalized after the Company's 2018 U.S. corporate income tax return is filed.

Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities as of December 31, 2018 and 2017 were as follows:

	2018		2017
Deferred tax assets, net:
Net operating loss carryforwards	$	300,000	$	240,000
Valuation allowance		300,000		240,000
Net deferred assets	$	—	$	—

The valuation allowance increased to approximately $300,000 at December 31, 2018, from $240,000 at December 31, 2017.

F-15

The following is a reconciliation of the tax provisions for the years ended December 31, 2018 and 2017 with the statutory Federal income tax rates:

	Percentage of Pre-Tax Income
	2018			2017
Statutory Federal income tax rate		21.0	%		34.0	%
Loss generating no tax benefit		(21.0	)		(34.0	)
Effective tax rate		—			—

The Company did not have any material unrecognized tax benefits as of December 31, 2018 and 2017. The Company does not expect the unrecognized tax benefits to significantly increase or decrease within the next twelve months.  The Company recorded no interest and penalties relating to unrecognized tax benefits as of and during the years ended December 31, 2018 and 2017. The Company is subject to U.S. federal income tax, as well as taxes by various state jurisdictions. The Company is currently open to audit under the statute of limitations by the federal and state jurisdictions for the years ending December 31, 2016 through 2018.

7. Commitments and Contingencies

Litigation

The Company accrues for loss contingencies associated with outstanding litigation, claims and assessments for which management has determined it is probable that a loss contingency exists and the amount of loss can be reasonably estimated. Costs for professional services associated with litigation claims are expensed as incurred. As of December 31, 2018, the Company has not accrued or incurred any amounts for litigation matters.

Leases

The Company leases its headquarters under a non-cancelable lease which expires August 31, 2019. For the years ended December 31, 2018 and 2017, rent expense amounted to $35,674 and $51,294, respectively. Future minimum lease payments, which end on August 31, 2019, total $16,800.

8. Stockholders’ Deficit

The Company is authorized to issue 13,025,000 shares of its common stock, par value $0.001, and 7,250,000 shares of its preferred stock, par value $0.001. 112,096 shares were issued at par value to the founding shareholders in in year ended December 31, 2017. In May 2018, the company purchased all of the 38,000 shares issued to one of the founding shareholders for a payment of $970, which were immediately retired and recorded as unissued stock. The payment was made by the Company’s Chief Executive Officer, and is included in the related parties payable account. As a result of this transaction, the common stock account decreased by $38 and capital in excess of par value decreased by $912. In the year ended December 31, 2017, the Company recorded $382 in stock-based compensation expense for 15,286 shares issued in conjunction with a license agreement.

F-16

On December 20, 2018 the Company issued a 7-year non-dilutive cashless warrant to purchase (i) shares of common stock equal to five percent (5%), calculated on a post-exercise basis, of the fully diluted capitalization of the Company, as of the date or dates of exercise, plus (ii) shares of preferred stock of each class or series of preferred stock of the Company equal to five percent (5%), calculated on a post-exercise basis, of the total issued and outstanding number of preferred shares of the Company, as of the date or dates of exercise. Based upon the Black-Scholes valuation model, with assumptions including: (1) a term of 7 years; (2) a volatility rate of 100% (3) a discount rate of 1.00% and (4) zero dividends, the warrant had a nominal value.

9. Loss Per Common Share

Loss per common share data was computed as follows:

	2018			2017
Net loss	$	(712,268	)	$	(658,995	)
Weighted average common shares outstanding		103,333			87,778
Effect of dilutive securities		—			—
Weighted average dilutive common shares outstanding		103,333			87,778
Earnings (loss) per common share – basic	$	(6.89	)	$	(7.51	)
Earnings (loss) per common share – diluted	$	(6.89	)	$	(7.51	)

For the year ended December 31, 2018, the Company excluded 4,469 shares of common stock issuable upon the exercise of outstanding warrants to purchase common stock from the calculation of net loss per share because the effect would be anti-dilutive. All of the Company’s debt is convertible into shares of common stock, however, the debt cannot be converted until certain contingencies are met. Consequently, any potentially issuable shares of common stock resulting from a debt conversion have not been considered.

10. Related Party Transactions

The Company has transactions with stockholders or entities related to the stockholders for transactions related to initial start-up activities. Such transactions and balances as of and for the years ended December 31, 2018 and 2017 are as follows:

	2018		2017
Accounts payable	$	80,005	$	-
Accrued interest payable	$	7,227	$	1,647
Current portion of long-term debt	$	104,000	$	-
Long-term debt	$	43,000	$	104,000

F-17

The Company owes a board member $71,000 and $28,000 in notes payable at December 31, 2018 and 2017, respectively. The same board member is also owed $3,129 and $589 in accrued interest payable, and $26,488 and $0 in accounts payable at December 31, 2018 and 2017, respectively.

The Company owes its Chief Executive Officer $53,488 and $0 in accounts payable at December 31, 2018 and 2017, respectively.

The Company owes its former Chief Executive Officer $76,000 and $76,000 in notes payable at December 31, 2018 and 2017, respectively. The same person is also owed $4,098 and $1,058 in accrued interest payable at December 31, 2018 and 2017, respectively.

11. Reverse Split

On May 29, 2019, the Company issued to each of its stockholders one share of common stock for every 25 shares of common stock held by such stockholder. The financial statements as of and for the years ended December 31, 2018 and 2017 have been adjusted to give effect to the reverse split.

The table below presents the details of the accounts and disclosures that were impacted by applying the effect of the reverse split to the financial results for the years ended December 31, 2018 and 2017.

	As Originally						Post-Reverse
Year ended December 31, 2018	Reported			Adjustments			Split Amounts
Common stock, $.001 par value	$	2,235		$	(2,146	)	$	89
Capital in excess of par value	$	—		$	2,146		$	2,146
Basic and diluted earnings (loss) per share	$	(0.28	)	$	(6.61	)	$	(6.89	)
Weighted average number of basic and diluted shares outstanding		2,583,317			(2,479,984	)		103,333
Year ended December 31, 2017
Common stock, $.001 par value	$	3,185		$	(3,058	)	$	127
Capital in excess of par value	$	—		$	3,058		$	3,058
Basic and diluted earnings (loss) per share	$	(0.30	)	$	(7.12	)	$	(7.51	)
Weighted average number of basic and diluted shares outstanding		2,194,458			(2,106,680	)		87,778

The originally reported number of authorized shares was 4,000,000 shares of common stock. As a result of the restated certificate of incorporation, the Company has authority to issue to 20,275,000 shares, consisting of (a) 13,025,000 shares of common stock, par value of $0.001 per share and (b) 7,250,000 shares of preferred stock, par value $0.001 per share.

12. Subsequent Events

On February 7, 2019 the Company issued a five-year cashless warrant to purchase $1,000,000 of the Company’s common stock or preferred stock at an exercise price equal to the per-share price, reduced by any fee charged by a third party, of a future financing of $5,000,000 or greater.

On February 11, 2019, the Company issued a $48,000 convertible promissory note to its Chief Executive Officer, in exchange for monies owed to him. The note is issued as part of a series of similar convertible promissory notes referred to above in Note 3, with a valuation cap of $6,000,000, annual interest rate of 4.0% and a maturity date of February 11, 2021.

Subsequent to December 31, 2018, the board of directors authorized a reverse split of the common stock on a 1-for-25 basis, whereby the Company issued to each of its stockholders one share of common stock for every 25 shares of common stock held by such stockholder. The reverse split was effective on May 29, 2019. The financial statements as of and for the years ended December 31, 2018 and 2017 have been adjusted to give effect to the reverse split. In conjunction with the reverse split, the Company filed a restated certificate of incorporation with the state of Delaware increasing the total number of shares of all classes of stock that the Company has authority to issue to 20,275,000 shares, consisting of (a) 13,025,000 shares of common stock, par value of $0.001 per share and (b) 7,250,000 shares of preferred stock, par value $0.001 per share. Notes 8, 9 and 11 above, and the financial statements, have been modified to retrospectively reflect the reverse split.

The Company evaluated subsequent events through February 22, 2019, the date these financial statements were available to be issued. There were no other material subsequent events that required recognition or additional disclosure in these financial statements

F-18

PART III

INDEX TO EXHIBITS

1.1	Issuer Agreement with SI Securities, LLC*
1.2	Form of Amendment to Issuer Agreement with SI Securities, LLC.*
2.1	Fourth Amended and Restated Certificate of Incorporation, as amended
2.2	Bylaws*
3.1	Investors’ Rights Agreement*
3.2	Form of Promissory Note Bearing 4% Interest and $6,000,000 Valuation Cap, Maturing on December 31, 2019*
3.3	Form of Promissory Note Bearing 6% Interest and $6,000,000 Valuation Cap, Maturing on July 12, 2020*
3.4	Form of Promissory Note Bearing 6% Interest and $10,000,000 Valuation Cap, Maturing on September 18, 2020*
3.5	Form of Promissory Note Bearing 4% Interest and $8,000,000 Valuation Cap, Maturing on November 9, 2020*
3.6	Form of Promissory Note Bearing 6% Interest and $6,000,000 Valuation Cap, Maturing on December 31, 2019*
3.7	Form of Promissory Note Bearing 6% Interest and $8,000,000 Valuation Cap, Maturing on December 31, 2019*
3.8	Form of Promissory Note Bearing 4% Interest and $10,000,000 Valuation Cap, Maturing on December 24, 2020*
4	Form of Subscription Agreement*
6.1	Consulting Agreement dated March 27, 2017 between Monogram Orthopaedics, Inc. and Doug Unis*
6.2	Amended Employment Agreement dated April 29, 2018 between Monogram Orthopaedics, Inc. and Benjamin Sexson*
6.3	Lease between 53 Bridge LLC and Monogram Orthopaedics, Inc. dated September 1, 2018*
6.4	Promissory Note dated May 8, 2017, of Monogram Orthopaedics Inc. as Borrower, to Ronald Lennox, as Lender.*
6.5	Promissory Note dated June 23, 2017, of Monogram Orthopaedics Inc. as Borrower, to American IRA, LLC FBO Douglas B. Unis, as Lender.*
6.6	Promissory Note Amendment, dated October 24, 2017 of Monogram Orthopaedics Inc. as Borrower, to Ronald Lennox, as Lender.*
6.7	Promissory Note dated January 14, 2018 of Monogram Orthopaedics Inc. as Borrower, to American IRA, LLC FBO Julia Jordan IRA, as Lender.*
6.8	Promissory Note dated May 30, 2018, of Monogram Orthopaedics Inc. as Borrower, Douglas B. Unis, as Lender.*
6.9	Promissory Note dated April 19, 2017, of Monogram Orthopaedics Inc. as Borrower, to Pro-Dex, Inc. as Lender.*
6.10	Extension of Promissory Note dated November 14, 2018 between Monogram Orthopaedics Inc. as Borrower, and American IRA, LLC FBO Douglas B. Unis, as Lender.*
6.11	Extension of Promissory Note dated November 15, 2018 between Monogram Orthopaedics Inc. as Borrower, and Ronald Lennox, as Lender.*
6.12	Promissory Note Amendment dated December 20, 2018 of Monogram Orthopaedics Inc. as Borrower, to Pro-Dex, Inc. as Lender.*
6.13	Promissory Note dated February 11, 2019, of Monogram Orthopaedics Inc. as Borrower, to Benjamin Sexson as Lender.*
6.14	April 30, 2019 Amendment to Employment Agreement dated April 29, 2018 between Monogram Orthopaedics, Inc. and Benjamin Sexson*
6.15	Restricted Stock Award dated March 27, 2017 between Monogram Orthopaedics, Inc. and Douglas Unis.*
6.16	Restricted Stock Award dated April 30, 2019 between Monogram Orthopaedics, Inc. and Benjamin Sexson.*
6.17	Licensing Agreement dated October 3, 2017 between Monogram Orthopaedics, Inc. as Licensee and Icahn School of Medicine at Mount Sinai as Licensor.*
6.18	Option Agreement dated March 18, 2019 between Monogram Orthopaedics, Inc. and Icahn School of Medicine at Mount Sinai.*
6.19	Development and Supply Agreement dated December 20, 2018 between Monogram Orthopaedics Inc. and Pro-Dex, Inc.*
6.20	Warrant Agreement dated December 20, 2018 between Monogram Orthopaedics Inc. and Pro-Dex, Inc.*
6.21	2019 Stock Option and Grant Plan*
6.22	Promissory Note, dated November 9, 2017 of Monogram Orthopaedics Inc. as Borrower, to Ronald Lennox, as Lender.*
6.23	Warrant to Purchase Capital Stock dated February 7, 2019 between Monogram Orthopaedics, Inc. and ZB Capital Partners, LLC as Holder.*
6.24	Amendment to Licensing Agreement dated July 5, 2019 between Monogram Orthopaedics, Inc. as Licensee and Icahn School of Medicine at Mount Sinai.*
8.1	Form of Escrow Agreement*
11	Auditor’s Consent
12	Opinion of CrowdCheck Law LLP
13.1	Offering Page on SeedInvest
13.2	SeedInvest solicitation emails
13.3	Company Updates on SeedInvest
13.4	SeedInvest Webinar Invitations and Transcripts
13.5	Discussion Board on SeedInvest Offering Page
13.6	Transcripts of Videos on SeedInvest Offering Page
13.7	Company Pitch Deck on SeedInvest Offering Page
13.8	Event Invitations

* Previously Filed

35

SIGNATURES

Pursuant to the requirements of Regulation A, the issuer certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form 1-A and has duly caused this Offering Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in New York City, State of New York, on, August 1, 2019.

MONOGRAM ORTHOPAEDICS, INC.
By	/s/ Benjamin Sexson
Benjamin Sexson, Chief Executive Officer
Monogram Orthopaedics, Inc.
The following persons in the capacities and on the dates indicated have signed this Offering Statement.
/s/ Benjamin Sexson
Benjamin Sexson, Chief Executive Officer, Principal Financial Officer, Principal Accounting Officer, Director
Date: August 1, 2019
/s/ Doug Unis
Doug Unis, Director
Date: August 1, 2019

36

EX1A-2A CHARTER

Exhibit 2.1

MONOGRAM ORTHOPAEDICS INC.

RESTATED CERTIFICATE OF INCORPORATION

(Pursuant to Sections 242 and 245 of the
General Corporation Law of the State of Delaware)

Monogram Orthopaedics Inc., a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware (the “General Corporation Law”), does hereby certify as follows.

1.          The name of this corporation is Monogram Orthopaedics Inc. and that this corporation was originally incorporated pursuant to the General Corporation Law on April 21, 2016 under the name Monogram Arthroplasty Inc.

2.          The Board of Directors of this corporation duly adopted resolutions proposing to amend and restate the Certificate of Incorporation of this corporation, declaring said amendment and restatement to be advisable and in the best interests of this corporation and its stockholders, and authorizing the appropriate officers of this corporation to solicit the consent of the stockholders therefor, which resolution setting forth the proposed amendment and restatement is as follows.

RESOLVED, that the Certificate of Incorporation of this corporation be amended and restated in its entirety to read as set forth on Exhibit A attached hereto and incorporated herein by this reference.

3.          Exhibit A referred to above is attached hereto as Exhibit A and is hereby incorporated herein by this reference. This Restated Certificate of Incorporation was approved by the holders of the requisite number of shares of this corporation in accordance with Section 228 of the General Corporation Law.

4.          This Restated Certificate of Incorporation, which restates and integrates and further amends the provisions of this corporation’s Certificate of Incorporation, has been duly adopted in accordance with Sections 242 and 245 of the General Corporation Law.

IN WITNESS WHEREOF, this Restated Certificate of Incorporation has been executed by a duly authorized officer of this corporation on this ____ day of ________, 2019.

By:

Name:  Benjamin Sexson

Title: Chief Executive Officer

EXHIBIT A

MONOGRAM ORTHOPAEDICS INC.

RESTATED CERTIFICATE OF INCORPORATION

ARTICLE I: NAME.

The name of this corporation is Monogram Orthopaedics Inc. (the “Corporation”).

ARTICLE II: REGISTERED OFFICE.

The address of the registered office of the Corporation in the State of Delaware is 251 Little Falls Drive, in the City of Wilmington, County of New Castle. The name of its registered agent at such address is Corporation Service Company.

ARTICLE III: DEFINITIONS.

As used in this Restated Certificate (the “Restated Certificate”), the following terms have the meanings set forth below:

"Board" means the Board of Directors of the Corporation.

“Board Composition” means that:  

(a)          the holders of record of the shares of Common Stock, exclusively and as a separate class, shall be entitled to elect two (2) directors of the Corporation;

(b)          the stockholders shall elect, by the affirmative vote of a majority of the Preferred Stock and Common Stock, voting together as a single class on an as-converted basis, one independent director (i.e., an individual who at the time of his first election as a director is not (i) an employee or a holder of Common Stock of the Company, (ii) a Family Member or Personal Friend of an employee or a holder of Common Stock of the Company, or (iii) an employee of a Person Controlled by an employee or a holder of Common Stock of the Company); and

(c)          any additional directors shall be elected by the affirmative vote of a majority of the Preferred Stock and Common Stock, voting together as a single class on an as-converted basis.  

"Family Member" means, with respect to any individual, such individual's parents, spouse, and descendants (whether natural or adopted) and any trust or other vehicle formed for the benefit of, and controlled by, such individual and/or any one or more of them.

"Personal Friend" means, with respect to any individual, an individual with whom such individual has a pre-existing relationship extending beyond a relationship related to that individual’s business or professional activities.

“Control” (including with correlative meaning, "Controlled by") means (i) with respect to a Person that is a company or corporation, the ownership, directly or indirectly through one or more intermediaries, of more than 50% of the voting rights attributable to the shares of capital stock of that company or corporation and more than 50% of all capital stock of that company or corporation; (ii) with respect to a Person that is not a company or corporation, the ownership, directly or indirectly through one or more intermediaries, of more than 50% of the equity capital of that Person and the power to direct or cause the direction of its management and policies.

“Person” means any individual, corporation, partnership, limited liability company, trust or other entity.

“Original Issue Price” means $4.00 per share for the Series A Preferred Stock.

“Requisite Holders” means the holders of at least a majority of the outstanding shares of Preferred Stock (voting as a single class on an as-converted basis).

ARTICLE IV: PURPOSE.

The nature of the business or purposes to be conducted or promoted is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law.

ARTICLE V: AUTHORIZED SHARES.

The total number of shares of all classes of stock that the Corporation has authority to issue is 20,275,000 shares, consisting of (a) 13,025,000 shares of Common Stock, $0.001 per share and (b) 7,250,000 shares of Preferred Stock, $0.001 per share. The Preferred Stock may be issued from time to time in one or more series, each of such series to consist of such number of shares and to have such terms, rights, powers and preferences, and the qualifications and limitations with respect thereto, as stated or expressed herein. As of the effective date of this Restated Certificate, all shares of the Preferred Stock of the Corporation are hereby designated “Series A Preferred Stock”.

A. COMMON STOCK

The following rights, powers privileges and restrictions, qualifications, and limitations apply to the Common Stock.

1.          General. The voting, dividend and liquidation rights of the holders of the Common Stock are subject to and qualified by the rights, powers and privileges of the holders of the Preferred Stock set forth in this Restated Certificate.

2.          Voting. The holders of the Common Stock are entitled to one vote for each share of Common Stock held at all meetings of stockholders (and written actions in lieu of meetings). Unless required by law, there shall be no cumulative voting. The number of authorized shares of Common Stock may be increased or decreased (but not below the number of shares thereof then outstanding) by (in addition to any vote of the holders of one or more series of Preferred Stock that may be required by the terms of the Restated Certificate) the affirmative vote of the holders of shares of capital stock of the Corporation representing a majority of the votes represented by all outstanding shares of capital stock of the Corporation entitled to vote, irrespective of the provisions of Section 242(b)(2) of the General Corporation Law.

3.          Dividends. Subject to and without limiting the rights of the holders of Preferred Stock to receive concurrent dividends as set forth in this Restated Certificate (other than dividends on shares of Common Stock payable in shares of Common Stock), the holders of Common Stock shall be entitled to receive, when, as and if declared by the Board, out of any assets of the Corporation legally available therefor, such dividends as may be declared from time to time by the Board. Such dividends shall not be cumulative.

B. PREFERRED STOCK

The following rights, powers and privileges, and restrictions, qualifications and limitations, shall apply to the Preferred Stock. Unless otherwise indicated, references to “Sections” in this Part B of this Article V refer to sections of this Part B.

1. Liquidation, Dissolution, or Winding Up; Certain Mergers, Consolidations and Asset Sales.

1.1          Payments to Holders of Preferred Stock. In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Corporation or any Deemed Liquidation Event (as defined below), before any payment shall be made to the holders of Common Stock by reason of their ownership thereof, the holders of shares of Preferred Stock then outstanding must be paid out of the funds and assets available for distribution to its stockholders, an amount per share equal to the greater of (a) the Original Issue Price for such share of Preferred Stock, plus any dividends declared but unpaid thereon, or (b)  such amount per share as would have been payable had all shares of Preferred Stock been converted into Common Stock pursuant to Section 3 immediately prior to such liquidation, dissolution or winding up or Deemed Liquidation Event. If upon any such liquidation, dissolution, or winding up or Deemed Liquidation Event of the Corporation, the funds and assets available for distribution to the stockholders of the Corporation are insufficient to pay the holders of shares of Preferred Stock the full amount to which they are entitled under this Section 1.1, the holders of shares of Preferred Stock will share ratably in any distribution of the funds and assets available for distribution in proportion to the respective amounts that would otherwise be payable in respect of the shares of Preferred Stock held by them upon such distribution if all amounts payable on or with respect to such shares were paid in full.

1.2          Payments to Holders of Common Stock. In the event of any voluntary or involuntary liquidation, dissolution, or winding up or Deemed Liquidation Event of the Corporation, after the payment of all preferential amounts required to be paid to the holders of shares of Preferred Stock as provided in Section 1.1, the remaining funds and assets available for distribution to the stockholders of the Corporation will be distributed among the holders of shares of Common Stock, pro rata based on the number of shares of Common Stock held by each such holder.

1.3         Deemed Liquidation Events.

1.3.1       Definition. Each of the following events is a “Deemed Liquidation Event” unless the Requisite Holders elect otherwise by written notice received by the Corporation at least five (5) days prior to the effective date of any such event:

(a)          a merger or consolidation in which (i) the Corporation is a constituent party or (ii) a subsidiary of the Corporation is a constituent party and the Corporation issues shares of its capital stock pursuant to such merger or consolidation, except any such merger or consolidation involving the Corporation or a subsidiary in which the shares of capital stock of the Corporation outstanding immediately prior to such merger or consolidation continue to represent, or are converted into or exchanged for equity securities that represent, immediately following such merger or consolidation, at least a majority, by voting power, of the equity securities of (1) the surviving or resulting party or (2) if the surviving or resulting party is a wholly owned subsidiary of another party immediately following such merger or consolidation, the parent of such surviving or resulting party; provided that, for the purpose of this Section 1.3.1, all shares of Common Stock issuable upon exercise of options outstanding immediately prior to such merger or consolidation or upon conversion of Convertible Securities (as defined below) outstanding immediately prior to such merger or consolidation shall be deemed to be outstanding immediately prior to such merger or consolidation and, if applicable, deemed to be converted or exchanged in such merger or consolidation on the same terms as the actual outstanding shares of Common Stock are converted or exchanged; or

(b)          the sale, lease, transfer, exclusive license or other disposition, in a single transaction or series of related transactions, by the Corporation or any subsidiary of the Corporation of all or substantially all the assets of the Corporation and its subsidiaries taken as a whole, or, if substantially all of the assets of the Corporation and its subsidiaries taken as a whole are held by such subsidiary or subsidiaries, the sale or disposition (whether by merger or otherwise) of one or more subsidiaries of the Corporation, except where such sale, lease, transfer or other disposition is to the Corporation or one or more wholly owned subsidiaries of the Corporation.

1.3.2       Amount Deemed Paid or Distributed. The funds and assets deemed paid or distributed to the holders of capital stock of the Corporation upon any such merger, consolidation, sale, transfer or other disposition described in this Section 1.3 will be the cash or the value of the property, rights or securities paid or distributed to such holders by the Corporation or the acquiring Person, firm or other entity. The value of such property, rights or securities shall be determined in good faith by the Board.

2. Voting.

2.1          General. On any matter presented to the stockholders of the Corporation for their action or consideration at any meeting of stockholders of the Corporation (or by written consent of stockholders in lieu of meeting), each holder of outstanding shares of Preferred Stock may cast the number of votes equal to the number of whole shares of Common Stock into which the shares of Preferred Stock held by such holder are convertible as of the record date for determining stockholders entitled to vote on such matter. Fractional votes shall not be permitted and any fractional voting rights available on an as-converted basis (after aggregating all shares into which shares of Preferred stock held by each holder could be converted) will be rounded to the nearest whole number (with one-half being rounded upward). Except as provided by law or by the other provisions of this Restated Certificate, holders of Preferred Stock shall vote together with the holders of Common Stock as a single class on an as-converted basis, shall have full voting rights and powers equal to the voting rights and powers of the holders of Common Stock, and shall be entitled, notwithstanding any provision of this Restated Certificate, to notice of any stockholder meeting in accordance with the Bylaws of the Corporation.

2.2          Election of Directors. The holders of record of the Company’s capital stock are entitled to elect directors as described in the Board Composition. Any director elected as provided in the preceding sentence may be removed without cause by the affirmative vote of the holders of the shares of the class, classes, or series of capital stock entitled to elect the director or directors, given either at a special meeting of the stockholders duly called for that purpose or pursuant to a written consent of stockholders. At any meeting held for the purpose of electing a director, the presence in person or by proxy of the holders of a majority of the outstanding shares of the class, classes, or series entitled to elect the director constitutes a quorum for the purpose of electing the director.

2.3          Preferred Stock Protective Provisions. The Corporation shall not, either directly or indirectly by amendment, merger, consolidation or otherwise, do any of the following without (in addition to any other vote required by law or the Restated Certificate) the written consent or affirmative vote of the Requisite Holders, given in writing or by vote at a meeting, consenting, or voting (as the case may be) separately as a single class:

(a)          alter the rights, powers or privileges of the Preferred Stock set forth in the Restated Certificate or Bylaws, as then in effect, in a way that adversely affects the Preferred Stock;

(b)          increase or decrease the authorized number of shares of any class or series of capital stock;

(c)          authorize or create (by reclassification or otherwise) any new class or series of capital stock having rights, powers, or privileges set forth in the Certificate of Incorporation of the Corporation, as then in effect, that are senior to or on a parity with any series of Preferred Stock;

(d)          redeem or repurchase any shares of Common Stock or Preferred Stock (other than pursuant to employee or consultant agreements giving the Corporation the right to repurchase shares upon the termination of services pursuant to the terms of the applicable agreement);

(e)          declare or pay any dividend or otherwise make a distribution to holders of Preferred Stock or Common Stock;

(f)          increase or decrease the number of directors of the Corporation;

(g)          liquidate, dissolve, or wind-up the business and affairs of the Corporation, effect any Deemed Liquidation Event, or consent, agree or commit to do any of the foregoing without conditioning such consent, agreement or commitment upon obtaining the approval required by this Section 2.3.

3.             Conversion. The holders of the Preferred Stock have the following conversion rights (the “Conversion Rights”):

3.1         Right to Convert.

3.1.1       Conversion Ratio. Each share of Preferred Stock is convertible, at the option of the holder thereof, at any time, and without the payment of additional consideration by the holder thereof, into such number of fully paid and nonassessable shares of Common Stock as is determined by dividing the Original Issue Price for the series of Preferred Stock by the Conversion Price for that series of Preferred Stock in effect at the time of conversion. The “Conversion Price” for each series of Preferred Stock means the Original Issue Price for such series of Preferred Stock, which initial Conversion Price, and the rate at which shares of Preferred Stock may be converted into shares of Common Stock, is subject to adjustment as provided in this Restated Certificate.

3.1.2       Termination of Conversion Rights. Subject to Section 3.3.1 in the case of a Contingency Event herein, in the event of a liquidation, dissolution, or winding up of the Corporation or a Deemed Liquidation Event, the Conversion Rights will terminate at the close of business on the last full day preceding the date fixed for the first payment of any funds and assets distributable on such event to the holders of Preferred Stock.

3.2          Fractional Shares. No fractional shares of Common Stock will be issued upon conversion of the Preferred Stock. In lieu of any fractional shares to which the holder would otherwise be entitled, the Corporation shall pay cash equal to such fraction multiplied by the fair market value of a share of Common Stock as determined in good faith by the Board. Whether or not fractional shares would be issuable upon such conversion will be determined on the basis of the total number of shares of Preferred Stock the holder is at the time converting into Common Stock and the aggregate number of shares of Common Stock issuable upon such conversion.

3.3         Mechanics of Conversion.

3.3.1       Notice of Conversion. To voluntarily convert shares of Preferred Stock into shares of Common Stock, a holder of Preferred Stock shall surrender the certificate or certificates for the shares of Preferred Stock (or, if such registered holder alleges that any such certificate has been lost, stolen or destroyed, a lost certificate affidavit and agreement reasonably acceptable to the Corporation to indemnify the Corporation against any claim that may be made against the Corporation on account of the alleged loss, theft or destruction of such certificate), at the office of the transfer agent for the Preferred Stock (or at the principal office of the Corporation if the Corporation serves as its own transfer agent), together with written notice that the holder elects to convert all or any number of the shares of the Preferred Stock represented by the certificate or certificates and, if applicable, any event on which the conversion is contingent (a “Contingency Event”); provided, that any such Contingency Event must (A) be of a nature that can be conclusively determined by the Corporation and (B) occur no later than 180 calendar days following delivery of such notice. The conversion notice must state the holder’s name or the names of the nominees in which such holder wishes the certificate or certificates for shares of Common Stock to be issued and, if applicable, a description of the Contingency Event upon which such conversion is contingent. If required by the Corporation, certificates surrendered for conversion shall be endorsed or accompanied by a written instrument or instruments of transfer, in form reasonably satisfactory to the Corporation, duly executed by the registered holder or such holder’s attorney duly authorized in writing. The close of business on the date of receipt by the transfer agent (or by the Corporation if the Corporation serves as its own transfer agent) of the certificates (or lost certificate affidavit and agreement) and notice (or, if later, the date on which all Contingency Events have occurred) will be the time of conversion (the “Conversion Time”), and the shares of Common Stock issuable upon conversion of the shares represented by such certificate shall be deemed to be outstanding of record as of such time. The Corporation shall, as soon as practicable after the Conversion Time, (a) issue and deliver to the holder, or to the holder’s nominees, a certificate or certificates for the number of full shares of Common Stock issuable upon the conversion in accordance with the provisions of this Restated Certificate and a certificate for the number (if any) of the shares of Preferred Stock represented by the surrendered certificate that were not converted into Common Stock, (b) pay in cash such amount as provided in Section 3.2 in lieu of any fraction of a share of Common Stock otherwise issuable upon such conversion and (c) pay all declared but unpaid dividends on the shares of Preferred Stock converted.

3.3.2       Reservation of Shares. For the purpose of effecting the conversion of the Preferred Stock, the Corporation shall at all times while any share of Preferred Stock is outstanding, reserve and keep available out of its authorized but unissued capital stock, that number of its duly authorized shares of Common Stock as may from time to time be sufficient to effect the conversion of all outstanding Preferred Stock; and if at any time the number of authorized but unissued shares of Common Stock is not be sufficient to effect the conversion of all then-outstanding shares of the Preferred Stock, the Corporation shall use its best efforts to cause such corporate action to be taken as may be necessary to increase its authorized but unissued shares of Common Stock to such number of shares as shall be sufficient for such purposes, including, without limitation, engaging in best efforts to obtain the requisite stockholder approval of any necessary amendment to this Restated Certificate. Before taking any action that would cause an adjustment reducing the Conversion Price of a series of Preferred Stock below the then-par value of the shares of Common Stock issuable upon conversion of such series of Preferred Stock, the Corporation shall take any corporate action that may be necessary so that the Corporation may validly and legally issue fully paid and nonassessable shares of Common Stock at such adjusted Conversion Price.

3.3.3       Effect of Conversion. All shares of Preferred Stock that shall have been surrendered for conversion as provided in this Restated Certificate shall no longer be deemed to be outstanding and all rights with respect to such shares will immediately cease and terminate at the Conversion Time, except only the right of the holders thereof to receive shares of Common Stock in exchange therefor, to receive payment in lieu of any fraction of a share otherwise issuable upon such conversion as provided in Section 3.2, and to receive payment of any dividends declared but unpaid thereon. Any shares of Preferred Stock so converted shall be retired and cancelled and may not be reissued, and the Corporation may thereafter take such appropriate action (without the need for stockholder action) as may be necessary to reduce the authorized number of shares of Preferred Stock accordingly.

3.3.4       No Further Adjustment. Upon any conversion of shares of Preferred Stock, no adjustment to the Conversion Price of the applicable series of Preferred Stock will be made with respect to the converted shares for any declared but unpaid dividends on such series of Preferred Stock or on the Common Stock delivered upon conversion.

3.4          Adjustment for Stock Splits and Combinations. If the Corporation at any time or from time to time after the date on which the first share of a series of Preferred Stock is issued by the Corporation (such date referred to herein as the “Original Issue Date” for such series of Preferred Stock) effects a subdivision of the outstanding Common Stock, the Conversion Price for each series of Preferred Stock in effect immediately before that subdivision shall be proportionately decreased so that the number of shares of Common Stock issuable on conversion of each share of that series will be increased in proportion to the increase in the aggregate number of shares of Common Stock outstanding. If the Corporation at any time or from time to time after the Original Issue Date for a series of Preferred Stock combines the outstanding shares of Common Stock, the Conversion Price for each series of Preferred Stock in effect immediately before the combination will be proportionately increased so that the number of shares of Common Stock issuable on conversion of each share of such series shall be decreased in proportion to such decrease in the aggregate number of shares of Common Stock outstanding. Any adjustment under this Section 3.4 becomes effective at the close of business on the date the subdivision or combination becomes effective.

3.5          Adjustment for Certain Dividends and Distributions. If the Corporation at any time or from time to time after the Original Issue Date for a series of Preferred Stock makes or issues, or fixes a record date for the determination of holders of Common Stock entitled to receive, a dividend or other distribution payable on the Common Stock in additional shares of Common Stock, then and in each such event the Conversion Price for such series of Preferred Stock in effect immediately before the event will be decreased as of the time of such issuance or, in the event a record date has been fixed, as of the close of business on such record date, by multiplying such Conversion Price then in effect by a fraction:

(a)          the numerator of which is the total number of shares of Common Stock issued and outstanding immediately prior to the time of the issuance or the close of business on the record date, and

(b)          the denominator of which is the total number of shares of Common Stock issued and outstanding immediately before the time of such issuance or the close of business on the record date plus the number of shares of Common Stock issuable in payment of such dividend or distribution.

Notwithstanding the foregoing, (i) if such record date has have been fixed and the dividend is not fully paid or if such distribution is not fully made on the date fixed therefor, such Conversion Price shall be recomputed accordingly as of the close of business on such record date and thereafter such Conversion Price shall be adjusted pursuant to this Section 3.5 as of the time of actual payment of such dividends or distributions; and (ii) no such adjustment shall be made if the holders of such series of Preferred Stock simultaneously receive a dividend or other distribution of shares of Common Stock in a number equal to the number of shares of Common Stock that they would have received if all outstanding shares of such series of Preferred Stock had been converted into Common Stock on the date of the event.

3.6          Adjustments for Other Dividends and Distributions. If the Corporation at any time or from time to time after the Original Issue Date for a series of Preferred Stock makes or issues, or fixes a record date for the determination of holders of Common Stock entitled to receive, a dividend or other distribution payable in securities of the Corporation (other than a distribution of shares of Common Stock in respect of outstanding shares of Common Stock), then and in each such event the Corporation shall make, simultaneously with the distribution to the holders of Common Stock, a dividend or other distribution to the holders of the series of Preferred Stock in an amount equal to the amount of securities as the holders would have received if all outstanding shares of such series of Preferred Stock had been converted into Common Stock on the date of such event.

3.7          Adjustment for Reclassification, Exchange and Substitution. If at any time or from time to time after the Original Issue Date for a series of Preferred Stock the Common Stock issuable upon the conversion of such series of Preferred Stock is changed into the same or a different number of shares of any class or classes of stock of the Corporation, whether by recapitalization, reclassification, or otherwise (other than by a stock split or combination, dividend, distribution, merger or consolidation covered by Sections 3.4, 3.5, 3.6 or 3.8 or by Section 1.3 regarding a Deemed Liquidation Event), then in any such event each holder of such series of Preferred Stock may thereafter convert such stock into the kind and amount of stock and other securities and property receivable upon such recapitalization, reclassification or other change by holders of the number of shares of Common Stock into which such shares of Preferred Stock could have been converted immediately prior to such recapitalization, reclassification or change.

3.8          Adjustment for Merger or Consolidation. Subject to the provisions of Section 1.3, if any consolidation or merger occurs involving the Corporation in which the Common Stock (but not a series of Preferred Stock) is converted into or exchanged for securities, cash, or other property (other than a transaction covered by Sections 3.5, 3.6 or 3.7), then, following any such consolidation or merger, the Corporation shall provide that each share of such series of Preferred Stock will thereafter be convertible, in lieu of the Common Stock into which it was convertible prior to the event, into the kind and amount of securities, cash, or other property which a holder of the number of shares of Common Stock of the Corporation issuable upon conversion of one share of such series of Preferred Stock immediately prior to the consolidation or merger would have been entitled to receive pursuant to the transaction; and, in such case, the Corporation shall make appropriate adjustment (as determined in good faith by the Board) in the application of the provisions in this Section 3 with respect to the rights and interests thereafter of the holders of such series of Preferred Stock, to the end that the provisions set forth in this Section 3 (including provisions with respect to changes in and other adjustments of the Conversion Price of such series of Preferred Stock) shall thereafter be applicable, as nearly as reasonably may be, in relation to any securities or other property thereafter deliverable upon the conversion of such series of Preferred Stock.

3.9          Certificate as to Adjustments. Upon the occurrence of each adjustment or readjustment of the Conversion Price of a series of Preferred Stock pursuant to this Section 3, the Corporation at its expense shall, as promptly as reasonably practicable but in any event not later than 15 days thereafter, compute such adjustment or readjustment in accordance with the terms of this Restated Certificate and furnish to each holder of such series of Preferred Stock a certificate setting forth the adjustment or readjustment (including the kind and amount of securities, cash, or other property into which such series of Preferred Stock is convertible) and showing in detail the facts upon which such adjustment or readjustment is based. The Corporation shall, as promptly as reasonably practicable after the written request at any time of any holder of any series of Preferred Stock (but in any event not later than 10 days thereafter), furnish or cause to be furnished to such holder a certificate setting forth (a) the Conversion Price of such series of Preferred Stock then in effect and (b) the number of shares of Common Stock and the amount, if any, of other securities, cash, or property which then would be received upon the conversion of such series of Preferred Stock.

3.10        Mandatory Conversion. Upon either (a) the closing of the sale of shares of Common Stock to the public in a firm-commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended, at a per share price not less than the Original Issue Price (as adjusted for stock splits, dividends and the like) per share and for a total offering of not less than $5,000,000 (before deduction of underwriters commissions and expenses) or (b) the date and time, or the occurrence of an event, specified by vote or written consent of the Requisite Holders at the time of such vote or consent, voting as a single class on an as-converted basis (the time of such closing or the date and time specified or the time of the event specified in such vote or written consent, the “Mandatory Conversion Time”), (i) all outstanding shares of Preferred Stock will automatically convert into shares of Common Stock, at the applicable ratio described in Section 3.1.1 as the same may be adjusted from time to time in accordance with Section 3 and (ii) such shares may not be reissued by the Corporation.

3.11        Procedural Requirements. The Corporation shall notify in writing all holders of record of shares of Preferred Stock of the Mandatory Conversion Time and the place designated for mandatory conversion of all such shares of Preferred Stock pursuant to Section 3.10. Unless otherwise provided in this Restated Certificate, the notice need not be sent in advance of the occurrence of the Mandatory Conversion Time. Upon receipt of the notice, each holder of shares of Preferred Stock shall surrender such holder’s certificate or certificates for all such shares (or, if such holder alleges that such certificate has been lost, stolen or destroyed, a lost certificate affidavit and agreement reasonably acceptable to the Corporation to indemnify the Corporation against any claim that may be made against the Corporation on account of the alleged loss, theft or destruction of such certificate) to the Corporation at the place designated in such notice, and shall thereafter receive certificates for the number of shares of Common Stock to which such holder is entitled pursuant to this Section 3. If so required by the Corporation, certificates surrendered for conversion shall be endorsed or accompanied by written instrument or instruments of transfer, in form reasonably satisfactory to the Corporation, duly executed by the registered holder or such holder’s attorney duly authorized in writing. All rights with respect to the Preferred Stock converted pursuant to Section 3.10, including the rights, if any, to receive notices and vote (other than as a holder of Common Stock), will terminate at the Mandatory Conversion Time (notwithstanding the failure of the holder or holders thereof to surrender the certificates at or prior to such time), except only the rights of the holders thereof, upon surrender of their certificate or certificates (or lost certificate affidavit and agreement) therefor, to receive the items provided for in the next sentence of this Section 3.11. As soon as practicable after the Mandatory Conversion Time and the surrender of the certificate or certificates (or lost certificate affidavit and agreement) for Preferred Stock, the Corporation shall issue and deliver to such holder, or to such holder’s nominee(s), a certificate or certificates for the number of full shares of Common Stock issuable on such conversion in accordance with the provisions hereof, together with cash as provided in Section 3.2 in lieu of any fraction of a share of Common Stock otherwise issuable upon such conversion and the payment of any declared but unpaid dividends on the shares of Preferred Stock converted. Such converted Preferred Stock shall be retired and cancelled and may not be reissued as shares of such series, and the Corporation may thereafter take such appropriate action (without the need for stockholder action) as may be necessary to reduce the authorized number of shares of Preferred Stock (and the applicable series thereof) accordingly.

4.            Dividends. Each holder of Preferred Stock shall be entitled to receive, when, as and if declared by the Board, out of any assets of the Corporation legally available therefor, such dividends as may be declared on Common Stock from time to time by the Board (other than dividends on Common Stock payable in shares of Common Stock), on a pro rata basis with the holders of Common Stock. Such dividends shall be payable to the holders of Preferred Stock based on the number of whole shares of Common Stock that would be held by each of them assuming conversion of all the Preferred Stock into Common Stock pursuant to Section 3 as of the record date for determination of holders entitled to such dividend.

5.           Redeemed or Otherwise Acquired Shares. Any shares of Preferred Stock that are redeemed or otherwise acquired by the Corporation or any of its subsidiaries will be automatically and immediately cancelled and retired and shall not be reissued, sold or transferred. Neither the Corporation nor any of its subsidiaries may exercise any voting or other rights granted to the holders of Preferred Stock following any such redemption.

6.            Waiver. Any of the rights, powers, privileges and other terms of the Preferred Stock set forth herein may be waived prospectively or retrospectively on behalf of all holders of Preferred Stock by the affirmative written consent or vote of the holders of the Requisite Holders.

7.            Notice of Record Date. In the event:

(a)          the Corporation takes a record of the holders of its Common Stock (or other capital stock or securities at the time issuable upon conversion of the Preferred Stock) for the purpose of entitling or enabling them to receive any dividend or other distribution, or to receive any right to subscribe for or purchase any shares of capital stock of any class or any other securities, or to receive any other security; or

(b)          of any capital reorganization of the Corporation, any reclassification of the Common Stock of the Corporation, or any Deemed Liquidation Event; or

(c)          of the voluntary or involuntary dissolution, liquidation or winding-up of the Corporation,

then, and in each such case, the Corporation shall send or cause to be sent to the holders of the Preferred Stock a written notice specifying, as the case may be, (i) the record date for such dividend, distribution, or right, and the amount and character of such dividend, distribution or right, or (ii) the effective date on which such reorganization, reclassification, consolidation, merger, transfer, dissolution, liquidation or winding-up is proposed to take place, and the time, if any is to be fixed, as of which the holders of record of Common Stock (or such other capital stock or securities at the time issuable upon the conversion of the Preferred Stock) will be entitled to exchange their shares of Common Stock (or such other capital stock or securities) for securities or other property deliverable upon such reorganization, reclassification, consolidation, merger, transfer, dissolution, liquidation or winding-up, and the amount per share and character of such exchange applicable to the Preferred Stock and the Common Stock. The Corporation shall send the notice at least 20 days before the earlier of the record date or effective date for the event specified in the notice.

8.             Notices. Except as otherwise provided herein, any notice required or permitted by the provisions of this Article V to be given to a holder of shares of Preferred Stock must be mailed, postage prepaid, to the post office address last shown on the records of the Corporation, or given by electronic communication in compliance with the provisions of the General Corporation Law, and will be deemed sent upon such mailing or electronic transmission.

ARTICLE VI: PREEMPTIVE RIGHTS.

No stockholder of the Corporation has a right to purchase shares of capital stock of the Corporation sold or issued by the Corporation except to the extent that such a right may from time to time be set forth in a written agreement between the Corporation and the stockholder.

ARTICLE VII: BYLAW PROVISIONS.

A.           AMENDMENT OF BYLAWS. Subject to any additional vote required by this Restated Certificate or bylaws of the Corporation (the “Bylaws”), in furtherance and not in limitation of the powers conferred by statute, the Board is expressly authorized to make, repeal, alter, amend and rescind any or all of the Bylaws.

B.           NUMBER OF DIRECTORS. Subject to any additional vote required by this Restated Certificate, the number of directors of the Corporation will be determined in the manner set forth in the Bylaws.

C.           BALLOT. Elections of directors need not be by written ballot unless the Bylaws so provide.

D.           MEETINGS AND BOOKS. Meetings of stockholders may be held within or without the State of Delaware, as the Bylaws may provide. The books of the Corporation may be kept outside the State of Delaware at such place or places as may be designated from time to time by the Board or in the Bylaws.

ARTICLE VIII: DIRECTOR LIABILITY.

A.           LIMITATION. To the fullest extent permitted by law, a director of the Corporation shall not be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary duty as a director. If the General Corporation Law or any other law of the State of Delaware is amended after approval by the stockholders of this Article IX to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of a director of the Corporation shall be eliminated or limited to the fullest extent permitted by the General Corporation Law as so amended. Any amendment, repeal or modification of the foregoing provisions of this Article VIII.A by the stockholders will not adversely affect any right or protection of a director of the Corporation existing at the time of such amendment, repeal or modification or increase the liability of any director of the Corporation with respect to any acts or omissions of such director occurring prior to, such repeal or modification.

B.           INDEMNIFICATION. The following indemnification provisions shall apply to the Persons enumerated below.

1.          Right to Indemnification of Directors and Officers. The Corporation shall indemnify and hold harmless, to the fullest extent permitted by applicable law as it presently exists or may hereafter be amended, any Person (an "Indemnified Person") who was or is made or is threatened to be made a party or is otherwise involved in any action, suit or proceeding, whether civil, criminal, administrative or investigative (a "Proceeding"), by reason of the fact that such Person, or a Person for whom such Person is the legal representative, is or was a director or officer of the Corporation or, while a director or officer of the Corporation, is or was serving at the request of the Corporation as a director, officer, employee or agent of another Person, including service with respect to employee benefit plans, against all liability and loss suffered and expenses (including attorneys” fees) reasonably incurred by such Indemnified Person in such Proceeding. Notwithstanding the preceding sentence, except as otherwise provided in Section 3 of this Article VIII.B, the Corporation shall be required to indemnify an Indemnified Person in connection with a Proceeding (or part thereof) commenced by such Indemnified Person only if the commencement of such Proceeding (or part thereof) by the Indemnified Person was authorized in advance by the Board.

2.          Prepayment of Expenses of Directors and Officers. The Corporation shall pay the expenses (including attorneys’ fees) incurred by an Indemnified Person in defending any Proceeding in advance of its final disposition, provided, that, to the extent required by law, such payment of expenses in advance of the final disposition of the Proceeding shall be made only upon receipt of an undertaking by the Indemnified Person to repay all amounts advanced if it should be ultimately determined that the Indemnified Person is not entitled to be indemnified under this Article VIII.B or otherwise.

3.          Claims by Directors and Officers. If a claim for indemnification or advancement of expenses under this Article VIII.B is not paid in full within 30 days after a written claim therefor by the Indemnified Person has been received by the Corporation, the Indemnified Person may file suit to recover the unpaid amount of such claim and, if successful in whole or in part, shall be entitled to be paid the expense of prosecuting such claim. In any such action the Corporation shall have the burden of proving that the Indemnified Person is not entitled to the requested indemnification or advancement of expenses under applicable law.

4.          Indemnification of Employees and Agents. Without limiting the mandatory provisions of Section 1 of this Article VIII.B, the Corporation may indemnify and advance expenses to any Person who was or is made or is threatened to be made or is otherwise involved in any Proceeding by reason of the fact that such Person, or a Person for whom such Person is the legal representative, is or was an employee or agent of the Corporation or, while an employee or agent of the Corporation, is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation or of a partnership, joint venture, limited liability company, trust, enterprise or nonprofit entity, including service with respect to employee benefit plans, against all liability and loss suffered and expenses (including attorneys’ fees) reasonably incurred by such Person in connection with such Proceeding. The ultimate determination of entitlement to indemnification of any employee or agent (other than any director or officer of the Corporation) shall be made in such manner as is determined by the Board in its sole discretion. In no event shall the Corporation be required to indemnify a Person in connection with a Proceeding initiated by such person if the Proceeding was not authorized in advance by the Board.

5.          Advancement of Expenses of Employees and Agents. The Corporation may pay the expenses (including attorneys’ fees) incurred by an employee or agent in defending any Proceeding in advance of its final disposition on such terms and conditions as may be determined by the Board of Directors.

6.          Non-Exclusivity of Rights. The rights conferred on any person by this Article VIII.B shall not be exclusive of any other rights which such person may have or hereafter acquire under any statute, provision of this Restated Certificate, the Bylaws, any agreement or pursuant to any vote of stockholders or disinterested directors or otherwise.

7.          Other Indemnification. The Corporation’s obligation, if any, to indemnify any Person who was or is serving at its request as a director, officer or employee of another Person shall be reduced by any amount the indemnified Person may collect as indemnification from such other Person.

8.          Insurance. The Board may, to the full extent permitted by applicable law as it presently exists, or may hereafter be amended from time to time, authorize an appropriate officer or officers to purchase and maintain at the Corporation’s expense insurance: (i) to indemnify the Corporation for any obligation which it incurs as a result of the indemnification of directors, officers and employees under the provisions of this Article VIII.B; and (ii) to indemnify or insure directors, officers and employees against liability in instances in which they may not otherwise be indemnified by the Corporation under the provisions of this Article VIII.B.

9.          Amendment or Repeal. Any amendment, repeal or modification of the foregoing provisions of this Article VIII.B shall not adversely affect any right or protection hereunder of any Person in respect of any act or omission occurring prior to the time of such amendment, repeal or modification. The rights provided hereunder shall inure to the benefit of any Indemnified Person and such Indemnified Person’s heirs, executors and administrators.

ARTICLE IX: CORPORATE OPPORTUNITIES.

The Corporation renounces any interest or expectancy of the Corporation in, or in being offered an opportunity to participate in, or in being informed about, an Excluded Opportunity. “Excluded Opportunity” means any matter, transaction or interest that is presented to, or acquired, created or developed by, or which otherwise comes into the possession of, (i) any director of the Corporation who is not an employee of the Corporation or any of its subsidiaries, or (ii) any holder of Preferred Stock or any affiliate, partner, member, director, stockholder, employee, agent or other related Person of any such holder, other than someone who is an employee of the Corporation or any of its subsidiaries (a “Covered Person”), unless such matter, transaction or interest is presented to, or acquired, created or developed by, or otherwise comes into the possession of, a Covered Person expressly and solely in such Covered Person’s capacity as a director of the Corporation.

ARTICLE X: EXCLUSIVE FORUM.

Unless the Corporation consents in writing to the selection of an alternative forum, the Court of Chancery in the State of Delaware shall be the sole and exclusive forum for any stockholder (including a beneficial owner) to bring (i) any derivative action or proceeding brought on behalf of the Corporation, (ii) any action asserting a claim of breach of fiduciary duty owed by any director, officer or other employee of the Corporation to the Corporation or the Corporation’s stockholders, (iii) any action asserting a claim against the Corporation, its directors, officers or employees arising pursuant to any provision of the Delaware General Corporation Law or the Corporation’s certificate of incorporation or bylaws or (iv) any action asserting a claim against the Corporation, its directors, officers or employees governed by the internal affairs doctrine, except for, as to each of (i) through (iv) above, any claim as to which the Court of Chancery determines that there is an indispensable party not subject to the jurisdiction of the Court of Chancery (and the indispensable party does not consent to the personal jurisdiction of the Court of Chancery within ten days following such determination), which is vested in the exclusive jurisdiction of a court or forum other than the Court of Chancery, or for which the Court of Chancery does not have subject matter jurisdiction. If any provision or provisions of this Article X shall be held to be invalid, illegal or unenforceable as applied to any Person or circumstance for any reason whatsoever, then, to the fullest extent permitted by law, the validity, legality and enforceability of such provisions in any other circumstance and of the remaining provisions of this Article X (including, without limitation, each portion of any sentence of this Article X containing any such provision held to be invalid, illegal or unenforceable that is not itself held to be invalid, illegal or unenforceable) and the application of such provision to other Persons and circumstances shall not in any way be affected or impaired thereby. Notwithstanding the above, nothing in this Article X shall be construed to be applicable to any action arising under the Federal Securities Laws.

* * * * *

EX1A-11 CONSENT

Exhibit 11

CONSENT OF INDEPENDENT AUDITOR’S

We consent to the inclusion in this Offering Statement on Form 1-A/A of our audit report dated February 22, 2019 (dual-dated as of July 3, 2019), with respect to the balance sheets of Monogram Orthopaedics, Inc. as of December 31, 2018 and December 31, 2017, and the related statements of operations, stockholders’ deficit, and cash flows for the years then ended, Our report relating to those financial statements includes an emphasis of matter paragraph regarding an uncertainty about Monogram Orthopaedics, Inc.’s ability to continue as a going concern.

Fruci & Associates II, PLLC

July 30, 2019

EX1A-12 OPN CNSL

Exhibit 12

July 30, 2019

Board of Directors

Monogram Orthopaedics Inc.

53 Bridge Street, Unit 507

Brooklyn, New York, 11251

To the Board of Directors:

We are acting as counsel to Monogram Orthopaedics Inc. (the “Company”) with respect to the preparation and filing of an offering statement on Form 1-A. The offering statement, and pre-qualification amendments, cover the contemplated sale of up to 5,000,000 shares of the Company’s Series A Preferred Stock, convertible into the Common Stock of the Company.

In connection with the opinion contained herein, we have examined the offering statement, as well as pre-qualification amendments, the certificate of incorporation (as amended) and bylaws, the resolutions of the Company’s board of directors and stockholders, as well as all other documents necessary to render an opinion. In our examination, we have assumed the legal capacity of all natural persons, the genuineness of all signatures, the authenticity of all documents submitted to us as originals, the conformity to original documents of all documents submitted to us as certified or photostatic copies and the authenticity of the originals of such copies.

Based upon the foregoing, we are of the opinion that the shares of Series A Preferred Stock, and Common Stock into which the Series A Preferred Stock may convert, being sold pursuant to the offering statement are duly authorized and will be, when issued in the manner described in the offering statement, legally and validly issued, fully paid and non-assessable.

No opinion is being rendered hereby with respect to the truth and accuracy, or completeness of the offering statement or any portion thereof.

We further consent to the use of this opinion as an exhibit to the offering statement.

Yours truly,

/s/ CrowdCheck Law, LLP

By Andrew Stephenson, Partner

CrowdCheck Law, LLP (f/k/a KHLK LLP)

EX1A-13 TST WTRS

Exhibit 13.1

EX1A-13 TST WTRS

Exhibit 13.2

 

seedihvest Hi James, Seedlnvest is proud to work with companies across all verticals, but we wanted to highlight one vertical in which we have seen a lot of activity in recently, healthtech. We recently closed two of our larger campaigns in this vertical, 20/20 Genesystems which focuses on early-stage cancer detection (raised $5.1 mm) and NowRx which is rethinking traditional pharmacies (raised $6.79mm). Building off the momentum of these successfully funded healthtech deals, we are excited to introduce you to San Francisco-based Gali Health, an Al-powered mobile health assistant for people with chronic conditions. The company is backed by top investors such as Felicis Ventures (investor in Dollar Shave Club, FitBit, Bonobos, Warby Parker, FundersClub) and has collaborations with researchers at Stanford Hospital and UCSF. In addition to Gali Health, Monogram Orthopaedics is currently accepting reservations as it awaits qualification from the SEC for its upcoming Reg A+ campaign. Monogram is combining 3D printing, machine learning, and robotics for high-precision medical implants. If you are interested in either company, feel free to click on the links above to learn more or reply to this email. All the Best, The Seedlnvest Team You are receiving this update because you are part of the Seedlnvest community. If you would like to stop receiving company updates, unsubscribe here. If you would like to stop receiving all Seedlnvest marketing emails, including deal introductions, newsletters, event invitations, and new product announcements, please unsubscribe here. Please note you will still receive investment confirmation emails and all other transactional emails related to activities on your account. Gali Health is offering securities under Regulation CF and Rule 506(c) of Regulation D through SI Securities, LLC ("SI Securities"). The Company has filed a Form C with the Securities and Exchange Commission in connection with its offering, a copy of which may be obtained at: Gali Health: https://www.seedinvest.com/qali.health Monogram Orthopaedics Inc is accepting reservations for an Offering under Tier II of Regulation A. No money or other consideration is being solicited, and if sent in response, it will not be accepted. No sales of securities will be made or commitment to purchase accepted until qualification of the offering statement by the Securities and Exchange Commission (the "Commission”) and approval of any other required government or regulatory agency. A reservation is non-binding and involves no obligation or commitment of any kind. No offer to buy securities can be accepted and no part of the purchase price can be received without an Offering Statement that has been qualified by the Commission. A Preliminary Offering Circular that forms a part of the Offering Statement has been filed with the Commission, a copy of which may be obtained from Monogram Orthopaedics Inc: https://www.seedinvest.com/monoqram Copyright © 2019 Circle Internet Financial Limited (“Circle”), All rights reserved. This communication is intended solely for the use of the individual(s) to whom it was intended to be addressed. If you are not the intended recipient of this message you are hereby notified that any review, dissemination, distribution or copying of this message is strictly prohibited. This communication is for information purposes only and should not be regarded as a recommendation of, or an offer to sell or as a solicitation of an offer to buy, any financial product. Investments are offered only via definitive transaction documents and any potential investor should read such documents carefully, including all risks, before investing. Startup investments involve a high degree of risk and those investors who cannot hold an investment for the long term (at least 5-7 years) or afford to lose their entire investment should not invest in startups. All securities-related activity is conducted by SI Securities, LLC dba Seedlnvest, an affiliate of Circle, and a registered broker- dealer, and member FINRA/SIPC, located at 116 W Houston Street, 6th Floor, New York, NY 10012. To learn more about investing in startups and its risks visit www.seedinvest.com/academy.

EX1A-13 TST WTRS

Exhibit 13.3

 

seedinvest Monogram I Company Update Monogram files two additional patents Monogram recently filed two new patents that cover certain implementations of custom robotic controls. These controls seek to include: • The execution of complex tasks such as high accuracy tracking, obstacle avoidance, and execution of tracked cuts • Fixed point tracking of robot mounted camera systems • A dynamic visualization of the work space Monogram believes that robotic hardware will become increasingly commoditized over time, with superior performance for less cost. CEO Ben Sexson's goal is to be "hardware agnostic," i.e. develop a software architecture that will be deployable to any capable robotic system. By confirming a reservation in Monogram, you have the opportunity to purchase shares ahead of the company's public launch once Monogram receives SEC qualification. A reservation is non-binding; you may cancel at any time. LEARN MORE Interested in learning more? Join next week's Q&A Webinar where CEO Ben Sexson will be answering any questions you have about the deal. Email us if you'd like to ensure your question is addressed. Register Questions? Email us. We're happy to help. You are receiving this email because you are part of the Seedinvest community. If you would like to stop receiving company updates, unsubscribe here. If you would like to stop receiving all Seedinvest marketing emails, including deal introductions, newsletters, event invitations, and new product announcements, please unsubscribe here. Please note you will still receive investment confirmation emails and all other transactional emails related to activities on your account. Monogram Orthopaedics Inc is accepting reservations for an Offering under Tier II of Regulation A. No money or other consideration is being solicited, and if sent in response, it will not be accepted. No sales of securities will be made or commitment to purchase accepted until qualification of the offering statement by the Securities and Exchange Commission (the “Commission”) and approval of any other required government or regulatory agency. A reservation is non-binding and Involves no obligation or commitment of any kind, no offer to buy securities can be accepted and no part of the purchase price can be received without an Offering Statement that has been qualified by the Commission. A Preliminary Offering Circular that forms a part of the Offering Statement has been filed with the Commission, a copy of which may be obtained from Monogram Orthopaedics Inc: https://www.seedinvest.com/monogram Copyright©2019 Circle Internet Financial Limited (“Circle”), All rights reserved. This communication is intended solely for the use of the individual(s) to whom it was intended to be addressed. If you are not the intended recipient of this message you are hereby notified that any review, dissemination, distribution or copying of this message is strictly prohibited. This communication is Tor information purposes only and should not be regarded as a recommendation of. or an offer to sell or as a solicitation of an offer to buy, any financial product. Investments are offered only via definitive transaction documents and any potential investor should read such documents carefully, including all risks, before investing. Startup investments involve a high degree of risk and those investors who cannot hold an investment for the long term (at least 5-7 years) or afford to lose their entire investment should not invest in startups. All securities-related activity is conducted by SI Securities, LLC dba Seedinvest, an affiliate of Circle, and a registered broker-dealer and member FINRA/SIPC, located at 116 W Houston Street, 6th Floor, New York, NY 10012. To learn more about investing in startups and its risks visit www.seedinvest.com/academy.

  

seedinvest Monogram I Company Update A new video has been added to Monogram Orthopaedics' gallery. Click on the link below to watch the video and see Monogram's product at work. In application, the controls demonstrated are designed to allow the surgeon to interact with the surgical robot in real-time. WATCH VIDEO Interested in learning more? Join next week's Q&A Webinar where CEO Ben Sexson will be answering any questions you have about the deal. Email us if you'd like to ensure your question is addressed. Register Questions? Email us. We're happy to help. You are receiving this email because you are interested in Monogram Orthopaedics. If you would like to stop receiving company updates, unsubscribe here. If you would like to stop receiving all Seedlnvest marketing emails, including deal introductions, newsletters, event invitations, and new product announcements, please unsubscribe here. Please note you will still receive investment confirmation emails and all other transactional emails related to activities on your account. Monogram Orthopaedics Inc is accepting reservations for an Offering under Tier II of Regulation A. No money or other consideration is being solicited, and if sent in response, it will not be accepted. No sales of securities will be made or commitment to purchase accepted until qualification of the offering statement by the Securities and Exchange Commission (the “Commission”) and approval of any other required government or regulatory agency. A reservation is non-binding and involves no obligation or commitment of any kind. No offer to buy securities can be accepted and no part of the purchase price can be received without an Offering Statement that has been qualified by the Commission. A Preliminary Offering Circular that forms a part of the Offering Statement has been filed with the Commission, a copy of which may be obtained from Monogram Orthopaedics Inc: https://www.seedinvest.com/monoqram Copyright © 2019 Circle Internet Financial Limited (“Circle”), All rights reserved. This communication is intended solely for the use of the individual(s) to whom it was intended to be addressed. If you are not the intended recipient of this message you are hereby notified that any review, dissemination, distribution or copying of this message is strictly prohibited. This communication is for information purposes only and should not be regarded as a recommendation of, or an offer to sell or as a solicitation of an offer to buy, any financial product. Investments are offered only via definitive transaction documents and any potential investor should read such documents carefully, including all risks, before investing. Startup investments involve a high degree of risk and those investors who cannot hold an investment for the long term (at least 5-7 years) or afford to lose their entire investment should not invest in startups. All securities-related activity is conducted by SI Securities, LLC dba Seedlnvest, an affiliate of Circle, and a registered broker- dealer, and member FINRA/SIPC, located at 116 W Houston Street, 6th Floor, New York, NY 10012. To learn more about investing in startups and its risks visit www.seedinvest.com/academy.

EX1A-13 TST WTRS

Exhibit 13.4

Video 1 Transcript (21:15 – 44:17)

Ben we can see you, can you share your–

(inaudible)

Yeah that's great.

(inaudible) see my screen?

Yes, we can see you and we can see your screen. So thanks again Ben, just want to let everyone know, Ben, so you know, Monogram Orthopedics which is our latest ready plus campaign. The company is actually in reservation mode as it awaits SEC qualifications. So I will let Ben speak more to the company right now.

---

Great, well, thanks everyone for your time today. I'm the CEO of Monogram Orthopedics. Monogram is a technology that is going to completely disrupt the way orthopedic medicine is delivered.

So really what we're doing, Monogram is really dependent on certain foundational technologies that didn't exist until really very recently. We're combining robotics, artificial intelligence, and 3d printing to create just in time inventory solutions for the delivery of orthopedic care.

This has never been done, there's no competition in this market. There are companies that do robotics, there are companies that do some – I'm going to put it in air quotes, because we don't really believe that it's full patient specific solutions, we can get into that – but there's really nobody who's pulling all of these pieces together in an integrated, vertically optimized way.

The market that we're addressing is huge. So one of the landmarks of a good investment is a massive opportunity market with a lot of pay. The hip market is about 7 billion dollars going to 8 over the next 5 years, and the knee market is 8.5 billion going to over 10 billion dollars over the next five years. So very large markets with significant growth.

One of the key things that I will point out is there's well over a million hip and knee replacements a year, but what's remarkable is that the top 4 players account for 76% of the market opportunity. This is just crazy, the market is incredibly unhealthy, and it's just ripe for disruption.

So let's describe why there is a monopoly in the first place.

It really comes down to a simple fact that these companies don't know exactly what size is needed. So they have to have everything available preoperative. What that results in is massive amounts of inventory. When you look at the inventory turns for the industry, they're incredibly low. We're talking about 1 times versus 6, 7 times for the average S&P company. So this is a tremendously inefficient business model, and because it's so inefficient, it creates a monopoly.

We think that we can disrupt that.

Let's just take a specific case. So this is the pricing of a DePuy Synthes corail stem. So ASP list price is about 20,000 dollars, the ASP is about 5. It takes a – and this is based on a case performed by one of our surgeons, surgeon founders – we estimated that it took about 77 thousand dollars for the delivery of 5000 dollars of revenue. So we're talking about a tremendously inefficient business model.

In addition to that, not even accounted for, it takes approximately 7 trays of underutilized instrumentation that needs to be re-sterilized each case, so it's just a tremendously inefficient model.

The second thing that's really interesting is that from a clinical perspective, generic implants aren't that good. When you look at some studies that we've run, so we actually simulated insertion with a surgeon who had, a blind surgeon that had no idea what the purpose of the study was, we just gave him x-rays and implants and had him size and insert the implants. He was, on average, 14 mm off the center from the generic implants. So we're talking about in some cases, it's not only not good at restoring patient anatomy with generics, but it's literally impossible. In simulations we've run, it wasn't even possible to insert the implants.

The other thing that's really interesting is that these implants often aren't inserted in a very efficient way. In fact, these generic implants are inserted with crude manual instruments that actually introduce a lot of clinical challenges. For example, fracture in the case of the insertion of a hip.

So lets get into the Monogram solution. Monogram has developed a fully automated architecture that takes a CT scan and auto generates a segmented CAT file from that CT scan, so we can identify and map the inner cortical wall, the outer cortical wall, the center of rotation, the axis of rotation, all of the key anatomical landmarks. And then what we do with that data is we're auto-generating a perfect, patient specific implant that maximizes conformity with the inner cortical wall. We're doing this for hips and we're doing this for knees.

What's very interesting is once we have the hip, the patient specific hip, what we do is we run it through an algorithm that auto-generates a patient specific cut path, so the cavity and the implant are both going to fit together like a perfect puzzle piece. What's interesting about this is that the end result is an implant that fits perfectly in a cavity that was created perfectly, zero complications, zero risk of fracture, high precision insertion, high precision delivery. Everything in a fully automated workflow with the click of a mouse.

So this is kind of the end result, you'll see this is simulation of our knee, the green is showing all of those regions of cortical contact. So we have literally an implant that fits perfectly within the cavity that was generated by the implant.

Let's get a little bit into what we've developed from an IP perspective. So there's multiple prongs to the Monogram system. Let's start with the consumable, what you see on the top right is proprietary design for our knee. We have proprietary patents on our knee, on our hip, so these are not issued patents, they're applications. We have technical patents that describe how to protect the process itself, auto-generating the implants, simulating the insertion, simulating the robotic execution, and we also have patents on the robotic enhancements that we're doing, so we can get a little bit into those, and I can show you some video of the robot and get into that. But essentially we're taking a very state-of-the-art robot with 7 degrees of freedom, we're running the cut paths through optimization algorithms, we're able to leverage the kinematic redundancy of the robot to worry not only about getting from point A to point B, but how the robot gets there. We're able to introduce dynamic boundaries, I'll show you all of this in the video shortly.

The Monogram team is, Monogram was founded by a surgeon based out of Mt. Sinai, Dr. Doug Unis. We're basically a bunch of, my background is in commercializing medical technologies, and I'm an engineer in my background with a finance background CFA, and have helped commercialize several companies. We have a bunch of robotics, medtech folks, lot of software support, kind of the full gambit of engineering nerds.

In terms of just the market opportunity, it's really incredible, but it's totally wide open. So the top 4 players on the market that I mentioned earlier are Stryker, Zimmer, Smith & Nephew, DePuy Synthes. None of these companies have a robotic solution in combination with patient specific implants. Some of them have robotic solutions, some of those robotic solutions would be more or less capable of actually even inserting a patient specific implant. For example, Stryker has a 4 degree of freedom robot that actually could not actually know the cavities that were milling from the hip. So they would literally need to put their robot into obsolescence and rebuild their whole robotic platform to even execute some of the surgical plans that we have. So it's really, even though the market is huge, there's nobody doing it. So it's really a race to capture this opportunity.

In terms of our raise, we're raising 20 million dollars. The majority, lion's share of that is just going into product development and generating a product as quickly as we can, almost nothing is going into property funded equipment. The model is going to be very lean, very scalable, variable costs. We're working with the largest manufacturer of orthopedic implants in the world to help us manufacture and commercialize those. Early on, we're really focused on market penetration and we'll worry about optimization of pricing down the road. But really, it's about getting this product to the market as quickly as possible.

Let me show you some video of our robot to give you a sense of what we're doing. So, and some of the features that we're able to actually execute.

So to start with, the basic fundamental framework of thinking behind our robot is to give the surgeon as much control as possible, but have everything highly optimized. So what you're seeing here is a demonstration of our controls which actually allow, it's linked to a foot petal that allows the surgeon to control the speed of execution and movement of the arm.

What you're seeing here is really sophisticated target tracking, and you can see how the robot is perfectly following very large movements.

And then finally what you're seeing here is something that's completely proprietary to Monogram, so we are actually mounting the cameras to the robot arm to mitigate the issues of occlusion.

What you're seeing here demonstrated is obstacle avoidance. So if you imagine the ring to be the surgical incision, our robot is able to real time execute a gut pass within a constrained boundary. What you're seeing, the surgeon gooey on the right, is the ability to visualize those boundaries, we're giving the surgeon control over where those boundaries are, and we can tie those boundaries in real time to objects in the surgical theater.

So what we're showing here is that we can actually track retractors, and now all of a sudden the soft tissue that was never, that other robots have no clue and can't visualize, all of a sudden we can see it and create real time boundaries around those soft tissues which is, it adds an incredible level of safety and control to the user, but also allows us to speed things up.

So that's pretty much the summary, and I can get into more nuts and bolts, but I really want to close with this, and this is a quote from 2011 from the CEO of Smith & Nephew, David Illingworth. And Smith & Nephew is one of the top 4 implant companies in the world. And really what he describes is what we're doing.

So he said, "If we can get to the point where we can take an image for a joint replacement and send out an instrument set and an implant that is going to fit perfectly, that's a real need and will drive adoption in the future." That's really the future that Monogram is delivering, so we are bringing to market the future of orthopedics, and it's going to completely disrupt the way business is done today.

I'm happy to take any questions.

-----

Great, thanks so much Ben. Let's get started with the Q&A. First question here, can you go into more detail about your current stage of production?

Sure, so in order to validate that this is possible, there's really 4 things that we needed to prove.

One is we needed to prove the viability of 3d printing for the application, specifically for the hip. There are no mass produced, 3D hip stems on the market. So rather than develop, rather than rely on just our own expertise, we put in place a R&D collaboration agreement with – and all it is is a data sharing agreement – with one of the largest 3D printing companies in the world. And they have a new proprietary powder that was used to test the mechanical strength of simulated hips that we made. We ran those simulated hips through ISO7206 dash 4 and dash 6, for neck and stem fatigue tests, with a group called Empirical Testing and we passed. So we passed 10 million cycles in the neck and 5 million cycles in the stem. So we validated that the viability of the manufacturing process. That's the first thing we validated.

The second thing that we needed to validate was the clinical superiority of our hip and our knee. So with the hip we ran a, what we did was we took generic implants, and compared those as the base case and compared those against the Monogram implants in collaboration with UCLA. And what we showed was that our stem has 700% more cortical contact and 7 times less micro-motion. So we really knocked it out of the park in terms of demonstrating the viability of our implant and its clinical superiority. We also restored the head within microns versus, on average, the generic was about 14 mm off center from the center of the patient.

For the knee, we actually just got data back on our knee from the University of Nebraska, so specifically we're focusing on the tibia, 20 to 30% of tibial failures are related to aseptic loosening of the tibial component. So we have a completely proprietary design, I can show you that design in a slide presentation here, let's pull it up… in our longer form presentation we get into all of this.

So our knee looks a little different, and I can describe a little bit about what it's doing, but what you'll see is we have patient matched limbs at the periphery of the implant that essentially mirror the inner cortical wall and allow us to get right up against that healthy solid bone, the cortical bone. You'll also see that there's 2 medial and lateral humps, and what those humps do is they mitigate the sheer forces across the reception plane. One of the big limitations of generic implants, and you'll see on this slide, is that it's really based on a flat reception plane. So everything's about taking a sagittal saw, recepting the tibia, and placing a flat implant on a flat surface. And that's really not a, it's just a fundamentally flawed design. So what we've done is we've really thought outside of the box and we're driving initial stability at the periphery of the implant where it's most needed. What we've been able to show with the University of Nebraska, and I can share that data, we're probably publishing that next week, is we had remarkable improvement over the leading press-fit tibia which is the Stryker Triathlon. So we literally blew that implant out of the water. We'll be sharing that data shortly.

So I guess in summary, that's the second thing.

The third thing is demonstrating the efficacy of our product. The third thing is the robotic execution. So we're executing high precision tracked cuts with our robotic system. So really now it's about productizing all of these really high functioning prototypes and building them out through the FDA process which we can get into how our strategy on that.

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Great, thank you Ben. Next question here, who would you say are your closest competitors, and can you talk about if there are any overlaps with the company Intuitive Surgical?

Sure, so our closest competitor is Mako, which is a subsidiary of Stryker, they were bought for 1.6 billion dollars. So Mako was a robot that was developed in the late 80s, early 90s, it's a 4 degree of freedom cable driven Barrett arm that was licensed by predecessor companies to Mako.

Mako is used to insert generic implants and it's a completely different robotic platform, so it's based on haptic technology. And the way haptic works is there's a preoperative plan that's developed, and the robot essentially doesn't allow the user to go outside of the boundaries of that preoperative plan. We think that that model is tremendously deficient, we don't think that haptics is the future, we think that there's significant limitations to a 4 degree of freedom arm.

So we think there's just a lot of low hanging fruits to optimize the robotics phase. In addition their navigation is cart mounted, so they're using a MBI Polaris cart-mounted system that has occlusion issues, so if anybody walks in front of the cameras, the procedure basically stops.

So there's just a lot of low hanging fruits to optimize the procedure, and biggest objection from users, outside of it costing over a million dollars, it has an ASP of about a million dollars, it's slow. And it's really only being used in the same old generic implants.

So we believe that the future is better robotics with real time user control, things that, like, soft tissue tracking, the ability to execute cuts within real-time defined boundaries and really hyper optimized cut paths with patient-specific implants. At the end of the day, we think that robots should not be doing what manual instruments can do. So you can insert a Stryker Triathlon knee with manual instruments, and a lot of surgeons do. It's not a 100% utilization of the robot for the total knee. So we really think that the future of robotics is not a nice-to-have, it's a must-have. And we're able to actually insert patient-specific implants, and they cannot be inserted with manual instrumentation. So we really are rethinking things.

Intuitive Surgical is a completely different type of robot. So to start with, if you look at the clinical indications of surgical, of Intuitive Surgical robot, it's really, it is not clinically indicated for orthopedics. And the demands of orthopedics are completely different.

So when you look at an Intuitive Surgical robot, it's really built on a premise of master-slave. So essentially the user is actuating the robot with something like a joystick, and the whole point is really to make very fine, very accurate movements of an end effector. So there's a video of the Intuitive Surgical robot sewing together the skin of a grape for example. The fundamental framework is totally different. There's no optimized cutting tools, the robot really isn't designed for executing high precision tracked cuts in a very efficient way. So just a really, completely different market.

And then on top of it, it's really not an attractive market in our opinion to robot companies, we think that the reason you should be a robot company is because you have a proprietary implant that actually makes a clinical difference. So the Monogram implants are actually fundamentally better. And we have demonstrated that. And so the idea is, really, the 18 billion dollar market is the implant, it's not the robot. So just to come into an orthopedic space with another robot isn't really solving any clinical problems. You need another robot that has a reason for existing. And the reason Monogram exists is to insert better implants and completely disrupt the orthopedic paradigm. The current paradigm is generic implants that are off the shelf, incredibly expensive, incredibly inefficient. We think the market is ready for a just-in-time, inventory solution that is clinically superior. So that's really what Monogram is about.

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Great, thank you. We have time for a couple more questions. Next question is are there any plans for shoulder implants?

Yes, so actually we're putting together a promo video, and one of the surgeons that is on the video is an actively practicing orthopedic surgeon. We think that there's opportunities in ankle, we think that there's opportunities in shoulder, we really think that the whole portfolio of orthopedic implants is ripe for disruption.

So our plan is to capitalize on the low hanging fruit with respect to IP and cover ankle and shoulder and extremities with IP, but we're focusing on our initial commercialization on hips and knees, which are the 18 billion dollar market, and just really, kind of the massive elephant in the room. But those are certainly areas we're going to be focusing on as well. But our plan if we do get acquired in the short term would be to let the larger company commercialize those, someone who already has the infrastructure in place for those channels.

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Thanks Ben, the last question here is kind of about what you just talked about. Can you talk a little bit more about your exit strategy?

Yes. So we believe that it's really important to, so we call it something called brand attraction. So our plan is not to go to companies and say 'buy us', but our plan is to go to surgeons that are early adopters, get scaled, and disrupt. And the more pain that we introduce, the higher our evaluation will go. So our plan is to proceed and access the capital markets and continue to grow, but I will say that we are meeting in June with one of the top 4 orthopedic companies for a demo that has gone all the way up to their CEO in the terms of socializations in their company, so for the right price we will sell the company, but we think we have a very compelling solution, we don't think it takes that much capital to deploy, at least to get to 10 to 20 million dollars, I think we can do it very cost efficiently. So our plan is to continue to grow and disrupt, but we are available if somebody finds us, wants to write a big enough check.

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That's all the time we have for questions, thank you to everyone that watched and who has questions. Again each company will be receiving the questions that we didn't have time for afterwards so please look out for responses on the discussion board.

Video 2 Transcript (full)

Good afternoon everyone, thanks very much for joining in today's webinar, my name is [Nick Pinto], I'm on the venture growth team here at SeedInvest. Excited to be joined by founder and Chief Medical Officer Doug Unis as well as Ben [Sexon], CEO of Monogram Orthopedics, which is linking 3D printing, machine learning, and robotics for high precision, patient matched implants. Ben and Doug will be taking us through a quick pitch presentation and answering questions from the audience. If you have any questions you can ask them in the question section of your gotowebinar control panel. With that, Doug and Ben, please take it away.

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Welcome everyone, we really appreciate your time on today's call. I want to start out by introducing our founder, Doug Unis. Dr. Unis is a practicing orthopedic surgeon out of Mt. Sinai in Manhattan. He is the inventor of Monogram and the core technologies that drive the innovation that we're moving. I want to give Doug an opportunity to introduce the genesis for Monogram, why it's so clinically relevant, and why it's going to be so disruptive, and then circle back to the plan for commercializing these technologies and monetizing this incredible technology.

So Doug, with that I'm going to hand it over to you.

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Good afternoon everybody, thanks for inviting us on the call. So I'm going to start by saying that I truly believe that custom, patient specific implants for joint-replacement surgery is inevitable, it is going to happen and there are 3 reasons for that.

The first is that there is emerging technology in the fields of artificial intelligence, robotics, and [additive] manufacturing where 3D printing, that are making it not only possible but practical and cost efficient.

The second thing is that the companies that sell most of the implants are burdened with massive inventories, that is one of their biggest burdens, and so having on demand, just in time implants is a way to mitigate some of that huge inventory that these companies are carrying.

And the last thing is that we are targeting real clinical issues, we're solving major failure modes in joint replacement surgery with custom implants. We're making a better mouse trap that's better for the patient and if we can show clinical benefit, we get buy in from surgeons, from patients, and from the hospitals alike.

So with that, this is certainly something that is in the industry. This is a quote from the CEO of one of the big joint companies who essentially was describing what I just said, which is that the industry is ready for just in time, custom implants.

So this is our technology in a nutshell. Essentially, we start with a CT scan, and then our proprietary software takes the images from the scan and creates a three-dimensional map that outlines all of the relevant bone anatomy and creates a very detailed internal and external map of the bone. We then auto-generate a CAD file of a custom implant that's designed to fit just that patient's bone, both inside and outside. These are not cemented implants, so the tighter we can get them to fit inside the bone, the better they will work short and long term. And we also can match the patient's anatomy very precisely. The second ingredient is a robot which is the delivery system for creating a perfect bone cavity that accommodates that implant and gives us that perfect fit that is really not possible with the manual instruments that I use today. Ben's heard me say many times that the instruments used are like caveman, bronze-age instruments, metal hammers and chisels and that kind of thing, so this is a big leap forward in terms of how we physically do the surgery.

Orthopedic robotics has not gone anywhere because the generation 1, which is Mako, some of you may know is a big competitor on the market, has shown good results over the last 10 years since they've been on the market. The x-rays look great after the surgery which makes the surgeons happy, the patients get better clinical results, and we're now starting to see data showing improved survivorship of the implants because they're just put in more accurately.

But these 1^st generation robots have had significant issues as well, in terms of their expense, they're slow in the operating room, disruptive in the operating room, and they're very big. So they really kind of blow up your normal OR flow, and have been a barrier to surgeons adopting them.

One of the big reasons is that there's a navigation system involved, which in any kind of surgical robotics, which allows us to track the patient's bone, current navigation systems are very cumbersome and primitive, they rely on cameras that are off the patient, they are off the table by about 10 feet. So you can't get in the way of the camera, we have to put these bulky arrays on the patient, which get in the way, and they're generally just a nuisance.

The other problem with generation 1 robots is we have to register the patient's anatomy, and we need 50 to 60 points per case, which takes a lot of time in the operating room, and it's a hassle. This is what a generation 1 robot looks like in practice. And what you can see is you've got all these guys in the background there with their arms folded because they've all been kicked out of the surgery by this robot which is occupying a huge amount of space, and by this navigation system that nobody can get in the way of, so the surgeon is left with one assistant turned sideways trying to hold the retractor, it's very, very disruptive to the normal workflow.

So the big players, Ben and I actually just met with Johnson & Johnson, who's very interested in this technology, their orthopedic branch is called DePuy, they're the largest player in the joint replacement market. They are very interested in a second generation of robots which is smaller, lighter, less disruptive than the 1^st generation, quicker to do in the operating room, and significantly less expensive. Mako costs about a million too, so there's new technology that's quite a bit cheaper out there. But these gen 2 robots that should be coming online within the next year to 2 years are still only being used to drive sales of the same old off the shelf implants that we've always used. And so what we're suggesting is, and what we're developing is a 3^rd generation robot that continues to make gains in speed in the operating room, and safety and disruption and all of those things, but most importantly is designed to put in custom implants, and it's designed to really completely shift the way that we make and design implants.

And this a view of our robot, this is showing how we can live track a bone, so you see the robot following a bone, live in real time, and it's pretty quick, this is our operating system working on this robotic arm that's a very, very complicated math equation.

We've also mounted robots on the camera, so instead of having that off table navigation system, we now have, we've given the robot a set of eyes so all it has to do is see what's directly in front of it, which eliminates the line of sight issues that we mentioned with traditional navigation.

We also have created what we call obstacle avoidance, or smart retractors, so the surgeon can, so that the robot can essentially track any object that we tell it to, so we put bar codes on the normal retractors that we use, creating kind of a safe space that is represented by that donut there, the robot will do whatever it can to avoid getting into that safe space which in a patient would be potentially a blood vessel or a nerve or a ligament that you don't want to cut, so this is a huge safety feature and allows us to run the robot much faster, improving the OR time.

We also have a gas petal on the robot to change the speed as the surgeon dictates the clinical situation.

The next innovation that we're really excited about is, rather than needing 50 to 60 points, we can 3D print a special guide that will allow us to do three quick points, allowing for very rapid registration of the patient's bone. In other words, what we're doing here is we're telling the robot where the patient's bone is in 3 dimensional space and then it allows the robot to track that bone.

So using this robot and this platform, we are now able to reimagine actual implants and create a totally new generation of orthopedic implants, so this is, I hope you guys can see this, this is our tibial implant for a knee replacement. The biggest reason that knee replacements fail is that the tibial part is loose, it's by far the most common source of failure. What we've done is created the best tibial implant that is available on the market, and our data shows that.

We are able to create irregular, undulating custom surfaces, as you see the robot doing here, rather than the typical flat cut that we do with a regular saw in the operating room. So because we have this tool that can do things that can't be done with manual instruments, we can totally rethink the actual implants and make them work the best that they possibly can. And again, we have data showing that this works, we know that traditional knee implants are kind of like a seesaw, you're putting a flat implant on a flat bone surface, and it's just going to rock back and forth and get loose over time, so we've actually rethought that. And we have data that we've generated with the University of Nebraska showing that our implant is almost twice as stable as the best performing Stryker implant that's on the market. This is a big deal for the industry and really exciting to the DePuy people, the J&J people that we just met with.

On the hip side, we are able to develop a very bone conserving, ultra short stem, the silver stem or grey stem is our custom stem, see how short it is, compared to a typical J&J DePuy stem which looks like kind of a five iron. So we're able to save bone and be much more stable in the bone as well while restoring the patients anatomy.

This is kind of what our implant looks like going in. And again, when we had data that we generated with UCLA, it showed far superiority, 6 plus fold improvement in stability and near perfect restoration of patient anatomy. All this stuff translates into game changing, clinical benefit, and is really exciting to the industry.

This is a look at our data schematic from UCLA. I'm going to turn it over to Ben at this point.

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Sure. So the key things that we really want to do are to de-risk the opportunity and validate the hypothesis, that our knee is clinically superior and then secondly that it's possible to make these implants.

So what you're looking at here are the mechanical testing results for our hip. And you can see we've passed ISO7206-4 and -6 testing, which is extremely rigorous testing. The neck fatigue test is 10 million cycles at 1200 pounds, which is very difficult for 3D printing technologies. We through a collaboration with EOS, which is one of the largest 3D printing companies in the world, have developed a solution that has passed this testing, so we're quite confident that not only is 3D printing a superior candidate clinically, but it's viable from a manufacturing perspective.

This is just a quick overview of some of our intellectual property assets, we have covered a whole range of ideas from the specific implant designs to non-trivial solutions for insertion and insertability testing, the hip cavity is non-trivial, making sure the hip is insertable is non-trivial, making sure that the implant is insertable, various features of the implant, various features of the robot system that Doug described, various features of the implant generation process, and all of those algorithms as well, so we really have, the registration process that Doug described, so we have a full gamut of IP assets that we're continuing to build.

This really just illustrates with numbers the inventory problem that Doug was talking about, Doug alluded to this but 4 companies account for 76% of the total market opportunity. The primary reason for that is the tremendous cost of actually servicing customers.

So we actually pulled this from a case that Doug recently did. We calculated that there were 77 thousand dollars based on the ASP that the hospital was paying for a procedure that generates about 5 thousand dollars of revenue. Obviously tremendously inefficient. On average, Doug uses for a typical hip 7 trays, for a typical knee 5 trays, we think that we can get all of that underutilized tray space down to 1 tray for the hip, 1 tray for the knee, so we can introduce tremendous efficiency.

And again going back to the earlier comment, this is well recognized for the industry, this is where the industry is moving, we're just ahead of the curve.

In terms of margin analysis, we've done quite a bit of work making sure this is economically viable, we are working with numerous manufacturers to make sure we can make our implants in an economic way. Right now as it is today, we're about at a 10% delta on the cost to manufacture, but we expect with continuing efficiencies to be somewhat in line with standard manufacturing methods.

This is a quick look at the Monogram team. Right now, a lot of our focus has been on robotic development, that's probably the most nontrivial piece of what we're doing. All of the algorithms that we're developing are custom, so non-stock, so there's really just a lot of brainpower going into making sure this robot works well and efficiently, and demonstrating that.

We also have pretty solid coverage from a scientific advisory perspective. So my background is in mechanical engineering from CalTech, so we had some pretty sharp minds from CalTech helping us on the robotics side. We also have on the biomechanics side both Hani Haider and Sophia Sangiorgio who run the biomechanics labs at the University of Nebraska and UCLA respectively, as well as EOS, who we alluded to, who are the largest 3D printing company in the world in terms of 3D printers themselves.

These are the terms of the raise. So Monogram is raising 20 million dollars, we're planning on commercializing our technology through the 5-10K pathway. The 5-10K pathway describes a pathway where we will claim substantial equivalence to a product in the field and we will prove that our device has improved or superior safety features. So for the robotics side of things [product name] is our predicate device, we have a couple of stems on the hip side and we're working with our regulatory consultants on the knee side as well. So there's two press fit tibias on the market, one which is 3D printed, the Stryker Triathlon, so we're optimistic that we will be able to commercialize it as efficiently as possible.

And with that, I think we should open up to questions Nick.

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Right, thanks very much for that Ben and Doug. As a quick reminder, if you have any questions you can ask them in the questions section of your gotowebinar control panel. First question, you mentioned on the SeedInvest message section that the 5-10K approval is your single biggest obstacle to commercialization? Do you even need your own robot for the procedure? How valuable is the IP around the robot versus around the rest of the ecosystem of custom implants?

…Nick you there?

Hi, sorry, did you hear me? Alright, Ben can you hear me? Can you hear me now?

Sorry about that, we can hear you guys now.

I think everybody else could probably hear me, but you guys couldn't hear me because you had the computer on mute. Yeah, I didn't just leave you hanging there. Alright we'll try that again.

So you mentioned on the SeedInvest message section that the 5-10K approval is your single biggest obstacle to commercialization? Do you even need your own robot for the procedure? How valuable is the IP around the robot versus around the rest of the ecosystem of custom implants?

Sure, so the basic philosophy of Monogram is we really want to be a software company facilitating the insertion of the next generation of implants. The largest acquisition this phase was a company called Mako, which was bought by Stryker for 1.65 billion dollars. So really the idea for Monogram is to be as platform agnostic as possible and to be able to plug in our very highly complex control algorithms into any piece of hardware on the market. So right now for example, Stryker has 650 robots installed globally. We don't want to take anybody out of the market in terms of being able to acquire Monogram and put it to work.

One of the challenges is, we should say this, our robot is a 7 degree of freedom robot, that we are buying from a supplier called [Kooka], we have a perpetual supply agreement that says as long as they make the robot, they'll supply at a fair market price. So we, we're not reinventing the wheel from a hardware perspective, but we are reinventing the wheel from a software perspective. So all of those fancy bells and whistles that are driving the robotics system are custom and developed for Monogram use.

In terms of do we need, where the value lies, the value really lies in Doug's realization that you could use patient images and 3D printing and robotics to really fundamentally reimagine implant design in a way that solves clinical problems. And the beauty is that it doesn't only solves clinical problems, it solves business problems, real business problems. So Monogram is planning on disrupting the business model fundamentally. It's a business model that's reliant on generic, off the shelf implants, you have to have massive amounts of inventory, it's a one size fits none model. We think that that can be totally reimagined, and the core benefit is that these are actually clinically superior as we've demonstrated with our data.

So I'd say that we're an implant company, we need robots to insert these implants but we, as Doug kind of talked about, robots aren't going anywhere. In fact if you look at the number 1 growing orthopedic company, it's Stryker, and you look at the number 1 product that's growing, it's the Stryker Triathlon, and that's the only robotically inserted total knee on the market, it's the only FDA approved total knee on the market, and it's robotically inserted.

So the fastest growing product and the most adoption is being driven by the product that uses robots and press fit implants. So it's not going anywhere, this is the future, it's beyond debate at this point. What really matters now is can we get to market in a way that is efficient, cost efficient, can we scale, and the biggest hurdle really is putting all of the pieces together and commercializing this technology.

Does that answer it Nick?

Yeah that's a great answer, we actually got a response that said great answer, thank you.

Okay, great.

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Next question, can you expound a little bit on your revenue model?

Sure, so we can share, I guess Nick, I'm trying to think about what's on the presentation on SeedInvest, we have a presentation slide that breaks that out, but really it's a two step process.

So the way that the sales process works, and if you go and look at Stryker conference calls they really confirm this, is you have to find a surgeon advocate within an institution. That surgeon makes a pitch to the buying group that kind of has the hospital budget, or the purse strings to the hospital, and they have to make the case for two things.

One, that whatever they want to buy has some clinical benefit that is quantifiable.

And then two, that it's actually cost efficient and will either generate revenue or generate savings for the hospital.

So we have already started discussions, Doug has pretty solid connections in terms of surgeons that are interested in the technology, so that's been the focus of our efforts, finding and identifying key surgeons who will be the champions of various organizations to drive this. Per robot we expect to generate 600 per placed robot, 600 and 1.5 million dollars, there's a huge gamut in the terms of how much volume a typical hospital moves. We might even be able to get it as high as 3 million dollars per placed robot.

So we've identified 6 institutions right now today that are interested in the robotic system. We expect that to grow considerably. Our plan is to get to 10-20 million dollars of sales and then have a second fundraise, either an exit through an IPO, through an acquisition, or through financing with a major private equity group with growth capital, and we would at that point grow through a mix of internal and external. So our plan is to try to take this raise as far as we can, our target is 10-20 million organically, with a very lean team, and then scale dramatically from there with a second fundraise. That would be the exit opportunity for investors in this round.

But just to put it into perspective, the total market is 18 billion dollars. There's well over a million hips and knees done a year, it's a huge market opportunity and we think we're well positioned to capture it.

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Have you thought about also addressing shoulders?

Yes. Doug, why don't you talk about that. We're in the process of filing IP on shoulder.

Yeah, so we, it's actually, it's really exciting for me, I'm a hip and knee surgeon, I've been in practice for 16 years, that's my world. But it's been really gratifying and kind of exciting to talk to my colleagues that are in shoulder surgery and in foot and ankle surgery because when we present the platform to them, their juices just get flowing, they immediately start seeing the opportunity to redesign implants that they use. So it almost doesn't matter what joint you're talking about, or the spine for that matter, our platform can improve the current implants.

So that's the long answer. The short answer is yes, we're about to file IP on the shoulder as well as the ankle, and one of my colleagues in spine thinks that there's a huge opportunity in the cervical disk replacement market, so really a lot of ways that we can and will go with this.

I would add to that we're looking at ankles as well–

I said that.

Oh okay. And we, for the campaign when we go live, we're putting together a promo video and one of the surgeons featured is a shoulder surgeon.

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Great. Next question, why have you not yet filed for non-provisional patents? When do you intend to file nonprovisionally?

Sure, so we, Monogram is moving very quickly, so we have two, one actually just got filed today, I expect to have the second filed within the next few days. Part of it is these are very complex technologies, and some of the ideas, it takes a little bit of explaining for the lawyers to really fully understand exactly what we're trying to protect. Some of these ideas are not simple, and so it's really just a matter of lawyers drafting and taking what we've written and making it really defensible. That's the biggest challenge in terms of just filing things very quickly, is the level of complexity of what we're filing.

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Got it. Can you please expand more on the FDA approval timeline and major concerns around it?

Sure, so this is the biggest risk of Monogram. So surgical robotics and orthopedic implants are class two devices, so that means that we will not need what's called a PMA, which is kind of a process that class three devices have to go through. So the question is, we're going to be a 5-10K, the question is whether we need to provide clinical data with our submission or not.

So that's something that's really unknowable with 100% certainty until you submit to the FDA. Now what we do have in our corner so to speak is, there are institutions that are staffed by people who used to work at the FDA and now work as consultants that have relationships with the FDA, understand how the FDA thinks, that we are working with to help advise us in terms of how to submit the 5-10K, the strategy for that and so on.

The benefit that we have is that there's a device in the field called Think Surgical, which is an actively milling robot that mills cavities for implants, and we've also talked to our consultants about this predicate, that we think is, we have a pretty good case for substantial equivalence. And they are in the process of doing a clinical trial on a total knee application. So we're in a pretty good spot, but it's impossible for anybody to say with certainty until you actually submit the paperwork. So that is something that investors should be aware of, is that whether of not we have to do clinical data trials is impossible to say with 100% certainty.

With that said, we think that we can, we don't think that it would be in the scope of the typical cancer drug or that sort of product. Generally speaking the orthopedics– to put it in perspective, Think Surgical, the total knee, their clinical trial started in 2017, they're actually expecting their results in June 2019, if you go on the FDA's website you can see their clinical trial. It was a 115 patient trial, so that is not a massive expense, but it will certainly impact the timeline.

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Got it. Next question, why raise funds via crowd funding versus tradition means, and are there any institutional investors you see coming aboard in this round?

Sure, so the first thing I have to do is I have to speak very highly of SeedInvest, they've been a tremendous partner. They understand the opportunity, they did a lot of work doing due diligence to make sure they understood the opportunity, they've been to our facility, they've gone through our IP, it's really been a thorough due diligence process, so I have to speak very highly of them to start.

The second thing is they were very fair in terms of really striking the right balance between supporting founders and supporting investors. So in terms of just those discussions they've been tremendously supportive.

Part of why we are raising through SeedInvest versus tradition means is because of the size of the round. So, the, medical device venture capital funds are really in one of two buckets. They're either extremely large or they're extremely small. So the typical VC has about 25-50 million dollars, and just in terms of safe allocation of capital, if you think about a 5 to 10% allocation of capital we're talking about maybe 500 thousand, a million dollars, maybe 2 million dollars, to lead a 20 million dollar round is just really difficult.

And the large companies, one of the challenges is they just, to do a deal this size it's very difficult in terms of competing with capital for biotech, biotech is very hot right now, and they just want to see companies that are a little more mature in terms of how far along they are, they really want to see companies, really, I would say venture capital and medtech has moved more towards growth capital than true venture capital. So that confluence of factors, and then Doug and I have a lot of relationships with people that are interested in the story, institutional investors and so on that we expect to participate in this round, and having a platform like SeedInvest to help syndicate the round is great.

So that's really the primary reasons for it.

We also like the idea of our investors having liquidity. So I know that there's no secondary market in place now, but for employees of Monogram down the road, and being able to do an IPO down the road, having all these pieces in place are very attractive.

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Thanks Ben. Next question, do you see any other applications of your robotic technology in the future?

Sure, Doug's going to jump into that one.

Yeah, I could probably take that. So in addition to all of the different joints that I mentioned, we actually just had this conversation with one of the heads of sports medicine at J&J, there are applications in sports as well. For example, placing tunnels for an ACL graft, the precision of the placement of those tunnels is always a challenge. That's something that the robot could do really easily with preoperative bone mapping, and that kind of thing. As I said, spine is another area of orthopedics. Probably could do some trauma applications in terms of complex screw placement for big pelvic fractures and that kind of thing, where often placing those screws can be somewhat dangerous because all of the blood vessels and critical structures in that area.

So I guess at the end of the day, there's a lot that can be done, and part of the reason that it's so elastic and versatile is that the robot itself is really capable, it's got a lot of degrees of freedom so it can be maneuvered in all kinds of different positions, and the software that we've created just allows us to map out virtually any part of the skeleton.

So, it's really kind of, sky's the limit.

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Right, thanks Doug. Next question, who are the competitors that you are the most worried about? Is it just Stryker? How long would it take Stryker to emulate your technology?

Sure, so yes, it is just Stryker today. Stryker is the only company on this base with an FDA approved robot, surgical robot for knees and hips. Think Surgical is FDA approved, but they are no longer active in the hip space and Stryker– their business is very small, they're only reaming the acetabular cup, they're doing nothing on the stem side.

Maybe you can talk a little bit, Doug, about what's in biomed, DePuy Synthes, Doug's a consultant with many of these companies, so he knows exactly what's they're working on.

Yeah, so I try to get to it in the slides, just covering a lot of ground as fast as we can, but you know, if Mako, which is Stryker, is generation 1, as Ben said before, Stryker's really shellacking the other big players, particularly Zimmer and DePuy. I mean, they're both in negative growth right now, and Stryker has about 7.5% growth in the last year, so Stryker's just crushing the other two. So they're playing catch up by acquiring robotics companies that really constitute the second generation of robots. The problem is, I think and Ben agrees, it's probably going to be too little too late, because at the end of the day, Stryker's just so far out in front, and the robots that Zimmer and DePuy have purchased are still only able to put in traditional implants.

So the reason that DePuy J&J invited us up to Boston today is because they see the need to leapfrog Stryker and really get out in front in developing the next generation of implant, and to do that you need the next generation platform, which is what we offer.

So the next question was could Stryker do this… I never want to be in a position of saying somebody can't do it. As investors, you should assume that it's going to be cutthroat. What I will say is that it's going to be extremely challenging given that they've penetrated about 10% of the market with a robot that is simply unable to do what we are doing. So there are about 5,000 hospitals in the United States, and Mako has penetrated about 10% of those hospitals with a surgical robot. They're charging their customers a million dollars per robot. So we think that it's a two-edged sword, they're trying to, their logic, as has been stated on several conference calls, is because they're the only game in town, they want to make the business as sticky as possible. So if they're able to get a hospital to fork over a million dollars for a robot, that kind of makes them beholden to Stryker and that investment decision.

We think that's going to put them in a position where it's going to be tricky for them to just transition to a different robot and essentially obsolete their entire product and tell hospitals hey, that million dollars you spent is really worthless. Not to say they couldn't, we just think it's a challenging pivot, but the reason that the Mako robot is unable to do this is really twofold.

One is it only has 4 degrees of freedom. So for the hip cavity, it's actually impossible for, if you're familiar with C&C machining, the Millar cavity is actually impossible with their robot, it cannot be done. You need more degrees of freedom.

And furthermore, with the fundamental controls of the robot, they rely on something called haptics. So the user is actually driving the motion of the arm. The thing is that this is unoptimized motion, and the primary objection from surgeons is the time it takes to prepare the bone for insertion of an implant. And so it's really unoptimized.

Monogram is using a fully automated approach that leverages some of the same technologies that are used in industrial automation. We have a robot, basically from, their robot was invented basically before the optical mouse. We're talking about a state of the art robot, the control algorithms that we're using are completely different. I hope that answers it Nick.

You know, the second thing too, we've started to do a really good job as the first movers in the space of protecting the IP, specifically around the implants. These are specific designs that would be at this point very hard to reproduce without infringing on our IP.

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Got it. Question here, is Intuitive Surgical in the same space?

No. So Intuitive is the Da Vinci, so soft tissue type robots are totally different animals. They're essentially what we call master-slave configurations. A surgeon is kind of sitting in a work station off the operating table and has joysticks to control the robot, which is working on the patient. And it's just a way to kind of study the surgeon's hand, and take the tremor out of the surgeon's hand, etcetera.

What we're doing is really kind of very, very sophisticated CAD cam, you know, kind of CNC milling of a hard substance, it's just a different task.

What we will say is Intuitive Surgical has shown the potential of robotics. Like when robotics actually solved clinical benefits, what's possible.

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Got it. Shifting gears a bit, what are your key milestones in the next 12 to 24 months?

Sure, so step one, the next step for us after this funding will be to develop the surgical robot and the implants to what's called a FDA pre-submission. So we're going to be putting together with our regulatory consultants the pre-submission package for the FDA to review. And then once that's approved, we're going to be submitting that to the FDA and we expect, if there's no clinical trial request from the FDA, we'll be at that point within the next 18 months, and then from there we would be submitting that and we would expect to be live within the next 6 to 12 months.

So our hope is to be in the market, assuming there's no clinical trial request, within the next 2 to 3 years.

But fundamentally in the terms of, I guess I would say de-risking the technology, we've really shown, demonstrated our ability to execute what we're executing, now it's a matter of productizing what we've developed for FDA approval.

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Got it. Thanks Ben. Last question here. What is your ideal exit strategy? Would it be the IPO, or be acquired by one of the larger players like J&J?

In terms of just returns on invested capital, the most accretive thing would be to get an acquisition as quickly as possible. But obviously, we're not going to sell the company for less than it's worth. We, from what we've seen, the large companies in this space have been highly inquisitive and the multiples have been very attractive. So generally, we're seeing multiples of around 20 times sales, we think for technology like this, there really has been no comparable acquisition.

So every robot company that's been purchased in this space has been a pure play robot company that has either been inserting as Doug said the same old generic implants, or partnering as in the case for example of Blue Belt with co-marketing agreements with another distributor. So the analogy that I like to use is razors and razorblades. Everybody that's come before us has been a razor handle company. Nobody has fundamentally reinvented the razor blade, so there really isn't a good comp for what we're worth.

What I will say is that this is an 18 billion dollar market, and if we're successful, it will be the future of this market. So we think that the upside is tremendous, and the discussions we're having, we think there's going to be an appetite for an acquisition from somebody.

I just wanted to add, just to put it in some perspective, I'm a consultant with DePuy J&J, they just acquired a company that makes essentially a jackhammer that's used to insert the femoral component, and it has a forced feedback sensor so that it helps prevent fracturing when you are preparing the femur. But it's relatively unsophisticated and it was designed and developed in a surgeon's garage. They just spend 200 million dollars on that company, so they're willing to spend money if they think it's going to help them sell implants.

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Awesome. Makes sense. Well thanks very much Doug and Ben, and thank you to everyone that joined and asked questions. As a reminder, Monogram is currently accepting reservations on SeedInvest as it awaits SEC qualification. You can learn more and make a reservation or ask any outstanding questions to Doug and Ben at seedinvest.com/monogram.

Thanks again guys.

Video 3 Transcript (18:19 – 38:48)

[before 19:10 is all just setting up the screen.]

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So my name is Ben Sexon, and I'm here joined with Dr. Unis who is a practicing orthopedic surgeon of Mt. Sinai here in Manhattan. I'm the CEO of Monogram Orthopedics. Monogram is reimagining orthopedics. So we're developing patient specific implants that are being robotically inserted with a robot that's being driven by our custom controls. And we have a system, a whole ecosystem of software architecture that allows us to take patient scans, process those scans, and auto-generate implants and cut paths for high precision insertion. We're marrying artificial intelligence, robotics, and 3D printing in a way that we believe will completely transform how orthopedic care is being delivered today.

So with that, excited to open it up to questions and learn what folks are interested in learning about.

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Great, thanks Ben. First question, why just the focus on hips and knees?

Sure, so I'll start with that and Doug, why don't you chime in if you have anything to add. So hips and knees, first of all it's the lion's share of the orthopedic joint replacement market, so combined hips and knees account for about 18 billion dollars, so it's obviously the largest market opportunity.

As amazing as this is, hips are a 7 billion dollar market, and there are actually no robotics companies that are providing a full hip solution today. So there were two companies that were in this base. Think Surgical used to be milling cavities, they're no longer doing that, they've completely exited the hip business. And then Mako Surgical, which is only reaming the acetabular cup and doing nothing on the stem side. So in hips we literally are not exaggerating by saying we have no competition.

Knees, one in five patients are not satisfied with the outcome of their knee procedure. It's a huge market, it's going to be within the next five years over 10 billion dollars. It's a growing market, it's a huge pain point, all of the major strategics are excited about getting into knees. We also have proprietary solutions that we think address major pain points for both hip and knee, so there's the primary areas of focus.

That's not to say that we're ignoring ankles or extremities and other markets, but that's where we're diving into first. Doug, anything you want to say?

Yeah, I would just say we are a platform and when we have shown this platform to some of my colleagues in other areas of orthopedics like spine, foot and ankle, shoulder, it's really exciting to see their wheels start turning and start to imagine how they could use this platform of ours to completely reinvent whatever implant they use.

I think the future is, there are lots and lots of applications for this platform, and we have been talking actively with a number of my colleagues to start filing IP on ankle, shoulder, even cervical disk replacement in the spine world. So application is really wide, but bandwidth is somewhat limited at this point.

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Can you talk about the FDA approval process required and timeframe?

Sure, so there are three clinical pathways for an FDA approval. There's a 5-10K without a clinical trial, a 5-10K with a clinical trial, and then there's something called a PMA which is a whole other ball of wax.

So Monogram is commercializing what's known as a class 2 device, so the question comes down to whether this is going to be a 5-10K with no clinical trial, or with a clinical trial. That's an answer that we can't provide at this time. We're in discussions with multiple regulatory experts to determine whether or not a clinical trial will be needed. Those regulatory experts have talked to the FDA, we're still working on getting more detail on whether or not a clinical trial will be required.

One thing that I would say that's very encouraging, is Think Surgical is very far into a clinical trial, the results of which are due in June for a total knee application. We believe our system to be clinically equivalent to the Think Surgical robot in many respects, we believe that the safety features we're adding to our robot are significant, and significant improvements over the Think Surgical robot, but in terms of excavating cavities and creating cavities with a burr, it's quite similar.

So we're encouraged by the substantial equivalent arguments, but that, in our view, is the biggest risk in terms of time to commercialization and cost to commercialization.

So in terms of time to development, assuming the 5-10K pathway, our goal is to be in the market within the next 3 years, 2 to 3 years, aggressively on the 2, more realistic on the 3, if a clinical trial is required it might take a little bit longer than that.

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Are the control algorithms currently used to direct the robot open or closed loop?

So what we're doing right now is open loop, but we are working to closed loop. The company, we are working with a mix of third party consultants who are robotic experts, and we're also vertically integrated with our own engineers. So in terms of our demo right now, it's open loop, but there's a clear pathway to create a closed loop solution.

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How does the recovery time from surgery change with your procedure?

Doug?

Yeah, so it probably won't change the recovery time as much as, for example, like the surgical approach does. What it will change is the early, medium, and long term functional outcomes. Because what we know is that the more accurately we restore patient anatomy, the more high functioning they'll be in the lifetime of their joint replacement. So, the limitation to manual, standard off the shelf implants is that they don't do a great job of accurately restoring anatomy. So focus more on the ultimate, long term outcome with regard to our technology which I think will be superior to the way we do it now. Certainly more reproducible.

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This next question is actually addressed for Doug specifically. What has been the response from fellow orthopedists thus far? I'm sure it has been positive on the whole, but has there been clinical/operative issues that have come up that you are recognizing and working on?

Yeah, orthopedics is like anything else. It's a bell shaped curve as far as adoption of technology. So starting from one side of the curve where you have innovators and early adopters, and going all the way to the other side of the curve where you have laggards and late adopters who really are skeptics. And so that's kind of what it's like talking to my colleagues.

I would say overall, I just gave a keynote talk at an orthopedic industry conference in Chicago, I'm actually at O'Hara airport right now, and the industry response was really positive, I spoke to probably 1000 people this morning who were industry insiders, and the overwhelming sentiment was this is happening. This is inevitable, the inevitable future of orthopedics is mass customization and robotic precision, so it was well received.

As far as with my surgeon colleagues, I would say most people my age, like mid-career are pretty open to this technology and also believe it to be inevitable and see it as a way that they can illuminate some pain points in their life, like complications such as fracture, dislocation, loosening, revisions, and that type of thing. So I think, we're not going to get all of the surgeons right off of the bat, but I think we have a good shot of getting to the left of that adoption curve fairly early on.

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Will this model be applicable to secondary replacement?

Yeah, I got that question this morning. I would say absolutely, in the future, particularly 3D printing of large implants that lend themselves to revision surgeries is a really perfect application for 3D printing and medical image modeling. There are a lot of different challenges to revision, and so I think right off that bat that's not going to be on the menu, but I think absolutely down the road we will have revision surgery. It's also a much smaller market.

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It seems like the robotic element could takes years to implement in hospitals. Why not just focus on the custom implants?

So I would disagree with that assertion. I think robotic technology has come a long way, the robotic arm that we're using is really state of the art, and the robots that are in use in orthopedic operating rooms around the world are kind of like commodore 64 level technology by comparison. So I think that the sophistication and the capabilities of newer technology are much more advanced. And it's done. The robot arm that we're using was made by a giant industrial robotics company, so a lot of the development work on the arm itself is already done. What we've done is integrate our own software operating system and end effector hardware to make it work for our application. So I think that the timeline to getting a robot to market is way faster in 2019 than it was 15 years ago when this was more in its infancy.

So one thing I would just add onto that is the question of why we need a robot. So if you look at our biggest competitor Mako, the Stryker Triathlon, which is their knee system, was invented in 2003, and they made the acquisition of Mako in 2013, so they're using their robot to insert generic knees, and many of the knees continue to be inserted by manual methods, so their knee can be inserted either manually or with a robot.

It would literally be impossible to put our knee in without a robot. What we're doing is we're actually creating organic surfaces that cannot be mimicked with the human hand or surgical instrumentation, so we actually require the robot as a piece of our ecosystem. And that's one of the things that we think is pretty compelling about our story, the robot isn't just a gimmick, it's actually enhancing and doing something beyond what's humanly possible.

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Have hospital administrators given any feedback on transitioning to this new system?

Yeah, I've talked to some of our people. So one of the big things, it's kind of like Moore's law for computer chips, the technology keeps getting exponentially better as the price point continues to fall, and it's the same with robotic technology. So our biggest competitor in the market is Mako, which is owned by Stryker, which is one of the big joint replacement companies, they retail that unit for 1.2 million dollars.

The arm that we're using, which again is far more advanced, retails for somewhere between 50 and 60 thousand dollars. So the price point is coming down precipitously, and so we have modeled it out where we can actually give these robots away, or lend them to hospitals depending on the volume because of the margins that we're making on the actual joint replacement implants themselves. So as far as the capital expense that is the main concern of hospital administrators, it's going to be much more manageable that it has been with previous robotics units in the past.

And if you look at what Medicare has said about the joint replacement market, they have identified one of the biggest issues in the market is the variance in cost between different hospitals. And they've attributed that variance to quality and outcomes, so when they look at the cost of a procedure, let's say in a low volume hospital versus a high volume hospital, and they see a tremendous difference in terms of the cost of care, you know on average, it might be 30 thousand dollars at a high volume hospital and closer to 50 thousand at a low volume hospital, and so they really are interested in normalizing outcomes, and supportive of technologies that they feel support that mission.

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What makes your robot better than a Stryker or Zimmer Platform? How do you defend against them from simply attaching a [burring] tool on the end of their robots?

Sure. So that's a loaded question… do you want to start Doug, or do you want me to start?

Why don’t you take that one.

Sure, so before even diving into the root of this question, I think it's important to emphasize that we believe that the robotic piece of this, the hardware itself, is commoditized. So that's why we're focused on developing custom software that is modular, and that we could theoretically deploy to any robotic system. What we are is an implant company with a proprietary method for delivering implants in an ecosystem for delivering implants that's never been done. But really when you look at our IP and where the gold mine is, it's in Doug's ideas for the hip and knee, which are designs that we've been testing which show extremely promising results, and that are getting implant companies pretty excited.

So I want to start by saying that there's nothing prohibiting us from going to one of those companies and trying to integrate our solutions, or control algorithms into their hardware.

With that said, the Mako robot was developed in the late 1980's, it's a technology that was licensed from Barrett, it's a cable driven, 4 degree of freedom arm that literally could not mill our hip cavity because it just doesn't have enough degrees of freedom.

The Zimmer robot is a Rosa System that is actually a [Stogly] industrial automation robot that they have repurposed for their application. That robot similarly does not have as many degrees of freedom as our arm, and furthermore it doesn't have sophisticated torque sensing that our robot has, so there would be a lot of modifications required for that arm to actually execute the cavities that we're producing.

So the hardware itself is inferior to our hardware, but the golden solution, what Monogram is, is an implant company with a completely proprietary implant and method for delivering our implants.

Doug anything else you want to say about some of the enhancements, robot mounted cameras, that kind of stuff?

Yeah so we have IP surrounding, essentially making the whole system much more user friendly to the surgeon.

So I use a Mako robot, I've used multiple other robots, I was a consultant at Think Surgical for about 5 years, so I'm pretty familiar with the 1^st generation orthopedic robots. So one of my big goals with Monogram is to dissect out the pain points that we find in the 1^st generation robots and try to innovate to eliminate them.

So we have sped up the process of registering the patient's anatomy with a specific mold that we 3D print to fit on the patient's bone.

We have created obstacle avoidance with the robot, so we have special retractors with bar codes printed on them that the robot avoids, so it allows the surgeon to kind of protect the soft tissue while allowing the robot to very quickly and efficiently mill the bone, so speeding the whole process up while also making it safer.

We've also eliminated line of sight issues, so traditional 1^st generation robots use an off the table camera to track the patient's movement. What we've done is eliminated the line of sight issues where we can't get in the way of that camera. We have mounted a robot, we've mounted cameras onto the end of the robot, so that all it has to do is see what's just a few inches in front of it, rather than see across the operating room. So that has really made the whole system a lot more seamless and less disruptive to the OR flow.

So we're really, I think as a surgeon, those are the kinds of things that if I got that in my hands, I would be more likely to adopt a system like that than some of the earlier, 1^st gen robotic systems.

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Great. Thanks very much, Ben and Doug, that's all the time that we have for you guys today, but nicely done. Appreciate it.

EX1A-13 TST WTRS

Exhibit 13.5

 

 

EX1A-13 TST WTRS

Exhibit 13.6

Monogram SeedInvest Promo Video

https://vimeo.com/349088198

My name is Ben Sexson, and I'm the CEO of Monogram Orthopaedics. Monogram is the future of orthopedic medicine. We looked at Monogram and we see an opportunity for something that's really not been done, that we know of, in the field today. That is our mission as a company, to make it as good as it can get right now. And when monogram gets that full FDA approval, it will be very disruptive to orthopedics. If Monogram can successfully commercialize low-cost, patient specific implants, with high technology, robotic instrumentation, I think that it will disrupt the orthopedic market. And it's going to change things forever. We're doing joint replacements, in an analogue way, still, you know everybody gets an off-the-shelf, one-size-fits-all kind of implant. The way it was done was by picking implants, generic implants, that sort of fit and inserting them with crude manual instrumentation that sort of worked. The future of orthopedic medicine is highly personal, it's about delivering patient specific solutions that are perfectly fit, and perfectly inserted. Utilizing technology like Monogram’s system, will help decrease the risk to the patient, to the surgeon, and to the healthcare payer. So, we're talking about technology that is just becoming viable for the application we're discussing. Patient specific implants that are 3dDprinted is the future. What's really interesting about patient specific implants using 3D printing is you can take CT or MRI data and use that to directly create an implant that would match a patient's anatomy perfectly. Surgeons will demand it; patients will demand it. I think robot adoption will continue to accelerate. So, this is a generic press-fit implant and you can see that it's essentially flat. We’re all of a sudden asking ourselves, so wait a minute why are we using flat implants, like why do we put a flat seesaw type implant on a tibia, that's not the best thing. We have a solution that nobody else in the market is doing, that's completely proprietary, and will be completely disruptive. We're creating rounded surfaces, because we can do it. We're doing because we can, because we have a robot that can, that can mill any shape that we want. Where before, the technology wasn't quite there. Today we can use these materials, they come off the machines fully dense, need very little post-processing, and can almost go straight into a patient. Every patient’s bone is different, and we don't actually know what the cavities are going to look like. What you're seeing here is the robot demonstrating its ability to maneuver in very unique ways and twist and reach cavities that can be difficult to reach. Using robotic technology for hip replacements has decreased dislocation rate, has improved patient satisfaction rate, has decreased leg length discrepancies. Having the robot contort itself in a variety of positions, facilitates obstacle avoidance, so it allows us to speed up the milling time, because the robot is so capable of positioning itself in such a way that it can avoid obstacles while still completing the task at hand. A technology like this could not only upset the surgical realm, by having a better value stream there, but it could also upset the manufacturing realm, because it has the potential to replace existing technologies. I work with Monogram really for two reasons. They are the only company that is utilizing robotics and custom fit implants together. The second reason I'm working with them is because I get to work with some of the most innovative minds in orthopedics today. New femoral stems are required to undergo the test methods ISO 7206- 4 and 7206- 6, if seeking FDA approval. We have simulated ISO 7206 - 4 and - 6 tests of our stem and passed successfully. Monogram has engaged some of the leading regulatory experts in the field, to help assist us with our FDA submission. We plan on submitting via the FDA's 510 K pathway. The goal of a 510 K is to demonstrate substantial equivalence, a comparison of a new device to illegally marketed device. And the legally marketed device is referred to by FDA as predicate. The market is ready for a just-in-time, patient-specific delivery of this care and Monogram is going to do it. Not only is the market ready for it from a business standpoint, but patients deserve better. Monogram’ competition, those OEMS that are out there now selling, these types of products. Manufactured with traditional means and implanted with traditional means, will have to look at a whole new way of doing business. On a personal note, you know, we focus on patients a lot and, as we should, this is all about taking care of patients. We can mitigate a lot of these complications and eliminate some of them. And to solve them with technology, and to look a patient in the eye and say this is as good as it gets now.

Monogram Robotic Controls

https://www.youtube.com/watch?time_continue=5&v=oWb-n3iMmx4

***No Voiceover***

***Text***

Target Tracking

Robot Mounted Cameras

Obstacle Avoidance

Variable Speed

EX1A-13 TST WTRS

Exhibit 13.7

 

EX1A-13 TST WTRS

Exhibit 13.8