8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): June 2, 2021

PAVMED INC.

(Exact Name of Registrant as Specified in Charter)

Delaware	001-37685	47-1214177
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

One Grand Central Place, Suite 4600, New York, New York	10165
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: (212) 949-4319

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

[  ]	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).
[  ]	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12).
[  ]	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)).
[  ]	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)).

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, Par Value $0.001 Per Share	PAVM	The Nasdaq Stock Market LLC
Series Z Warrants to Purchase Common Stock	PAVMZ	The Nasdaq Stock Market LLC
Series W Warrants to Purchase Common Stock	PAVMW	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company [X]

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  [  ]

Item 8.01.Other Events.

On May 28, 2021, PAVmed Inc. (the “Company”), through a newly formed subsidiary, Veris Health Inc. (“Veris”), acquired Oncodisc Inc. (“Oncodisc”), a digital health company with groundbreaking tools to improve personalized cancer care through remote patient monitoring.

The acquisition was completed pursuant to a stock purchase agreement dated May 28, 2021, by and among Veris, the Company, Oncodisc Holdings LLC (“Oncodisc Holdings”), James Mitchell, M.D., and Andrew Thoreson, M.D. Upon the closing of the acquisition, Veris issued approximately 19.6% of its equity interests to Oncodisc Holdings in exchange for all of the issued and outstanding equity interests of Oncodisc. The Company owns the remaining 80.4% of Veris’ equity interests. The Company also provided $155,250 in cash to pay off two Oncodisc convertible notes. The stock purchase agreement contains certain customary representations and warranties and covenants, including indemnification obligations and five-year non-compete provisions to which Drs. Mitchell and Thoreson will be subject.

Oncodisc was founded by Dr. Mitchell, who is joining Veris as its full-time Chief Medical Officer, and Dr. Thoreson, who will serve as a Veris consultant. Oncodisc’s core technologies include an intelligent implantable vascular access port with biologic sensors and wireless communication, combined with an oncologist-designed remote digital healthcare platform that provides patients and physicians with new tools to improve outcomes and optimize the delivery of cost-effective care through remote monitoring and data analytics. PAVmed will manage Veris through a management services agreement (as more fully described below) until such time that the Veris board of directors decides to engage a dedicated management team, and will finance its operations through intercompany advances until Veris decides to raise its own capital.

In connection with the acquisition, Veris, the Company and Oncodisc Holdings entered into a shareholders agreement. The shareholders agreement includes transfer restrictions, rights of co-sale, drag-along rights, voting provisions and other customary rights and obligations of the Company and Oncodisc Holdings with respect to their shares of Veris common stock. The shareholders agreement also provides that:

● The board of directors of Veris will consist of up to four people, including up to three designated by the Company and one designated by Oncodisc Holdings.

● Oncodisc Holdings will have certain anti-dilution rights. Except in the case of certain exempted issuances, if Veris issues any additional shares of Veris common stock, Veris is required to issue additional shares to Oncodisc Holdings as necessary for Oncodisc Holdings to maintain its percentage interest. Exempted issuances include, without limitation, the issuance of up to 2,000,000 shares of Veris capital stock to employees, directors, consultants or advisors of Veris pursuant to an equity plan approved by the Veris board of directors. In addition, issuances of convertible securities will not trigger the anti-dilution rights, unless and until such securities are converted into Veris common stock.

● In the event Veris fails to achieve certain milestones by certain specified deadlines (subject to cure periods), Oncodisc Holdings will have the right, in its sole discretion, to require the Company to transfer to Oncodisc Holdings a percentage of the shares of Veris common stock then held by the Company (such percentage varying, up to 80%, depending on the milestone).

● If Dr. Mitchell or Dr. Thoreson commits an act constituting “cause”, Veris has the right to redeem the shares of Veris common stock held by Oncodisc Holdings for a redemption price equal to 50% of the fair market value of such shares. If the board of directors of Veris determines that it is not in Veris’ best interests to pursue device or software products based on the Oncodisc technology, Veris has the right to redeem the shares of Veris common stock held by Oncodisc Holdings for a redemption price equal to 100% of the fair market value of such shares. In the latter case, the redemption price may be paid by transferring the existing Oncodisc intellectual property to Oncodisc Holdings.

The shareholders agreement, including the anti-dilution rights described above, terminates, subject to the survival of certain provisions, (i) upon the consummation of any transaction whereby any class of securities of Veris, any successor to Veris or any affiliate of the foregoing becomes publicly traded or listed on a securities exchange, market or quotation system (including a direct listing), (ii) upon the sale of all or substantially all the assets, business or capital stock of Veris, or (iii) upon the exercise by Veris of its redemption rights described above.

The Company and Veris also entered into a management services agreement, which provides for Veris to compensate the Company in exchange for the Company providing certain administrative, management and other services to Veris, including management and oversight of research and development and regulatory matters.

Dr. Mitchell entered into an employment agreement with the Company to serve as Vice President, Digital Health of the Company and the Chief Medical Officer of Veris, and Dr. Thoreson entered into a consulting agreement with Veris to continue to support the development of the Oncodisc technology. As compensation for their future services, subject to approval of the Company’s compensation committee, Drs. Mitchell and Thoreson will receive options to purchase 100,000 shares and 50,000 shares, respectively, of the Company’s common stock, to be granted under the Company’s Fourth Amended and Restated 2014 Long-Term Incentive Equity Plan. The agreements include intellectual property assignment and confidentiality provisions. The employment agreement also includes non-compete provisions.

On June 2, 2021, the Company issued a press release announcing the launch of Veris and the acquisition of Oncodisc. A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated by reference herein.

Item 9.01.Financial Statements and Exhibits.

(d)	Exhibits:
Exhibit No.	Description
99.1	Press release.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated: June 2, 2021

PAVMED INC.
By:	/s/ Dennis M. McGrath
	Dennis M. McGrath
	President and Chief Financial Officer

EX-99.1

Exhibit 99.1

PAVmed Launches Digital Health Company Veris Health Inc.

New subsidiary Veris acquires privately held oncology digital health company Oncodisc Inc.

Technologies include first intelligent implantable vascular access port with biologic sensors and wireless communication combined with remote oncology digital healthcare platform

NEW YORK, June 2, 2021 (GLOBE NEWSWIRE) — PAVmed Inc. (Nasdaq: PAVM, PAVMZ) (the “Company” or “PAVmed”), a highly differentiated, multi-product, commercial-stage medical technology company, today announced the launch of a new subsidiary, digital health company Veris Health Inc. (“Veris”), which acquired Oncodisc Inc. (“Oncodisc”), a digital health company with groundbreaking tools to improve personalized cancer care through remote patient monitoring.

Oncodisc was founded by experienced physician entrepreneurs, James Mitchell, M.D., who joins Veris as its full-time Chief Medical Officer, and Andrew Thoreson, M.D., who will serve as a Veris consultant. Oncodisc’s core technologies include the first intelligent implantable vascular access port with biologic sensors and wireless communication, combined with an oncologist-designed remote digital healthcare platform that provides patients and physicians with new tools to improve outcomes and optimize the delivery of cost-effective care through remote monitoring and data analytics.

“PAVmed is entering the rapidly expanding digital health sector at an exciting time, characterized by high-multiple IPO’s and M&A activity driven by dramatically increased utilization of telemedicine, remote patient monitoring and artificial intelligence, which collectively seek to establish new standards for data-driven optimized care,” said Lishan Aklog, M.D., PAVmed’s Chairman and Chief Executive Officer. “This acquisition is consistent with our commitment to identify and seize upon unique and timely opportunities to create value in any sector, as we did three years ago with Lucid in the diagnostics sector. We expect Veris to leverage strong synergies with the robust expanded infrastructure we built to support Lucid during this period.”

“I warmly welcome Drs. Mitchell and Thoreson to the PAVmed family,” Dr. Aklog added. “They have developed all the necessary elements to create the premier integrated digital healthcare platform for millions of cancer patients and their oncologists, representing an estimated $2 to 3 billion U.S. addressable market opportunity, based on established reimbursement codes and an attractive recurring revenue subscription model. The technology is also applicable to potentially even larger market opportunities in other conditions such as renal failure and heart failure. As with many digital health platforms, we have additional prospects for substantial value-creation through data monetization and biotherapeutic clinical trial support.”

“Over 80% of U.S. cancer care, including immunotherapy and chemotherapy, takes place in outpatient clinics, leaving patients unmonitored while at high risk of complications and hospitalizations, up to 50% of which can be avoided,” said James Mitchell, M.D., co-founder and Chief Executive Officer of Oncodisc, and now Chief Medical Officer of Veris. “Although we have solid published data demonstrating that remote monitoring of cancer patients reduces hospital utilization, improves outcomes including survival, and is well-reimbursed, current consumer-oriented tools have not succeeded due to limited data points and poor patient adherence. We are excited to join this impressive team and believe we have found in PAVmed the ideal partner, with a proven track record of success, to bring our technologies into the market for the benefit of patients.”

Oncodisc was founded in 2018 by Mitchell, a radiation-oncologist, and Thoreson, an interventional radiologist, who previously co-founded Redsmith, Inc., an interventional catheter company whose technology was acquired by C.R. Bard Inc., now BD Inc. (NYSE: BDX), in 2017. Oncodisc received a National Science Foundation (“NSF”) Small Business Innovation Research (“SBIR”) grant award to support its early work and completed both the MedTech Innovator Accelerator and UCSF Rosenman Institute Accelerator programs.

Its groundbreaking vascular access port contains biologic sensors capable of generating continuous data on key physiologic parameters known to predict adverse outcomes in cancer patients undergoing treatment. Wireless communication to the patient’s smartphone and its cloud-based digital healthcare platform efficiently and effectively delivers actionable real time data to patients and physicians. The technologies are the subject of multiple patent applications and one allowed patent awaiting final issuance. Veris is targeting FDA 510(k) clearance of the intelligent implantable vascular access port and launch of the remote digital healthcare platform for H2-2022.

The planned Veris business model seeks to generate 100% recurring revenue through oncology practice and hospital-based subscriptions. These entities would purchase seats on the platform and pay a monthly remote monitoring charge to drive revenues from remote patient monitoring and device implantation under existing CPT codes, as well as established CMS Oncology Care Model (OCM) bonuses and CMS Quality Reporting Program incentives. Veris also anticipates strong demand for its intelligent implantable vascular access port and remote monitoring platform from oncology biotherapeutic companies to support clinical trials of their novel immunotherapy and chemotherapy agents with continuous physiologic data and transformative analytics.

Veris inherits a world-class medical advisory board including oncologists from leading academic centers such as Harvard’s Dana Farber Cancer Institute, Stanford Medicine, University of California San Francisco, Cedars-Sinai Medical Center and Northwell Health.

PAVmed formed Veris Health Inc., a Delaware Corporation, as a wholly owned subsidiary, which in turn entered into a Stock Purchase Agreement to acquire 100% of the outstanding shares of Oncodisc Inc. from Oncodisc Holdings LLC, including all of Oncodisc’s intellectual property, hardware, and software assets. In exchange, PAVmed granted Oncodisc Holdings LLC a 19.6% equity interest in Veris and provided $155,250 in cash to pay off two Oncodisc convertible notes. No additional cash consideration or PAVmed stock consideration was provided. A Shareholder Agreement between the parties provides additional terms and conditions concerning certain regulatory and commercial milestones, anti-dilution protection and other customary provisions. PAVmed will manage Veris through a Management Services Agreement until such time that the Veris Board of Directors decides to engage a dedicated management team and will finance its operations through intercompany advances until Veris decides to raise its own capital. Mitchell and Thoreson have entered into employment and consulting agreements, respectively, which include stringent intellectual property assignment and non-compete provisions.

About PAVmed and Lucid

PAVmed Inc. is a highly differentiated, multi-product, commercial-stage medical technology company with a diversified product pipeline addressing unmet clinical needs encompassing a broad spectrum of clinical areas with attractive regulatory pathways and market opportunities. Its major subsidiary, Lucid Diagnostics Inc., markets the first and only commercial tools for widespread early detection of esophageal precancer and cancer – the EsoGuard^® Esophageal DNA Test and EsoCheck^® Esophageal Cell Collection Device. Its GI Health division also includes the complementary EsoCure™ Esophageal Ablation Device with Caldus™ Technology. Its Minimally Invasive Interventions markets its CarpX^® Minimally Invasive Device for Carpal Tunnel Syndrome. Other divisions include Infusion Therapy (PortIO™ Implantable Intraosseous Vascular Access Device and NextFlo™ Intravenous Infusion Set), and Emerging Innovations (non-invasive laser-based glucose monitoring, pediatric ear tubes, and mechanical circulatory support). For more information, please visit www.pavmed.com, follow us on Twitter, connect with us on LinkedIn, and watch our videos on YouTube. For more information on our majority owned subsidiary, Lucid Diagnostics Inc., please visit www.luciddx.com, follow Lucid on Twitter, and connect with Lucid on LinkedIn. For detailed information on EsoGuard, please visit www.EsoGuard.com and follow us on Twitter, Facebook and Instagram.

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements, based upon the current beliefs and expectations of PAVmed’s management, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. Risks and uncertainties that may cause such differences include, among other things, volatility in the price of PAVmed’s common stock, Series W Warrants and Series Z Warrants; general economic and market conditions; the uncertainties inherent in research and development, including the cost and time required advance PAVmed’s products to regulatory submission; whether regulatory authorities will be satisfied with the design of and results from PAVmed’s preclinical studies; whether and when PAVmed’s products are cleared by regulatory authorities; market acceptance of PAVmed’s products once cleared and commercialized; our ability to raise additional funding and other competitive developments. PAVmed has not yet received clearance from the FDA or other regulatory body to market many of its products. The Company has been monitoring the COVID-19 pandemic and its impact on our business. The Company expects the significance of the COVID-19 pandemic, including the extent of its effect on the Company’s financial and operational results, to be dictated by, among other things, the success of efforts to contain it and the impact of actions taken in response. New risks and uncertainties may arise from time to time and are difficult to predict. All of these factors are difficult or impossible to predict accurately and many of them are beyond PAVmed’s control. For a further list and description of these and other important risks and uncertainties that may affect PAVmed’s future operations, see Part I, Item IA, “Risk Factors,” in PAVmed’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as the same may be updated in Part II, Item 1A, “Risk Factors” in any Quarterly Report on Form 10-Q filed by PAVmed after its most recent Annual Report. PAVmed disclaims any intention or obligation to publicly update or revise any forward-looking statement to reflect any change in its expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements.

Contacts:

Investors

Mike Havrilla

Director of Investor Relations

(814) 241-4138

JMH@PAVmed.com

Media

Shaun O’Neil

Chief Commercial Officer

(518) 812-3087

SMO@PAVmed.com

Jim Heins / Katie Gallagher

LaVoieHealthScience

(646) 491-7042 / (617) 792-3937

PAVmed@lavoiehealthscience.com