8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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): January 12, 2022

Paragon 28, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-40902	27-3170186
(State or other jurisdiction of	(Commission File Number)	(I.R.S. Employer
incorporation or organization)		Identification No.)

14445 Grasslands Drive	80112
Englewood, CO	(Zip Code)
(Address of principal executive offices)

Registrant’s telephone number, including area code:   (730) 399-3400

(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:

☐ 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 $0.01 per share	FNA	The New York Stock Exchange

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 ☒

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 7.01 Regulation FD Disclosure.

On January 12, 2022, Paragon 28, Inc. (the “Company”) posted an investor presentation to its website at IR.Paragon28.com relating to the Company’s acquisition of Disior Oy. (“Disior”), a three-dimensional analytics pre-operative planning software company based in Helsinki, Finland, focused on the complex foot and ankle anatomy. A copy of the investor presentation is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.

Item 8.01 Other Events.

On January 12, 2022, the Company issued a press release announcing its acquisition of Disior. A copy of the Company’s press release titled “Paragon 28 Announces Acquisition of Disior” is furnished pursuant to Item 8.01 as Exhibit 99.2 hereto.

The information in Item 8.01 of this Current Report on Form 8-K, including Exhibit 99.2, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in Item 8.01 of this Current Report on Form 8-K, including Exhibit 99.2, shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.

Item 9.01 Financial Statements and Exhibits.

Exhibit Number	Description of Exhibit
99.1	Paragon 28’s Investor Presentation dated January 12, 2022
99.2	Press Release, dated January 12, 2022, titled “Paragon 28 Announces Acquisition of Disior”
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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

	PARAGON 28, INC.
Date: January 12, 2022	By:	/s/ Jonathan Friedman
		Jonathan Friedman
		General Counsel

EX-99.1

Exhibit 99.1

+ 2016 Year Incorporated 20 Employees Helsinki Headquarters $18 Million Leading International Pre - Operative Planning Software Upfront Cash Payment $8 Million Potential Technology & Commercial Milestone Earnouts

Preoperative Planning Software AI Technology Patient Specific Algorithms Patient Specific Implants + Instruments Laser Alignment 3d Printing & Modeling Navigation & Guidance Technology Robotics Tools to Validate Outcomes Data Collection & Aggregation AI Technology Intra - operative Support Post - operative Evaluation Pre - operative Planning Continuously feed post - operative data to inform future cases Improved and reproducible outcomes Increased patient access to therapies Smart28 Mission Our initiative to modernize and improve all aspects of Foot + Ankle treatments by utilizing advanced technologies What is Smart28? 1 2 3 Smart28 Ecosystem Will Improve Patient Outcomes and Further P28 Leadership Position

Disior - The Perfect Partner for our Smart 28 Ecosystem Intra - operative Support Post - operative Evaluation Pre - operative Planning 1 2 3 Auto - segmentation and surgical planning tool 3D modeling to better address complex cases Accelerates research and development efforts to improve Foot & Ankle outcomes Complements Additive Orthopaedics FDA cleared and CE marked

Phase 1 – Research & Development • Accelerate groundbreaking research projects Phase 2 – Commercial Launch Phase 3 – Outcome Optimization • Expand surgical planning capabilities of Disior • Patient Specific Implant / Instrument integration • Offer Disior platform to broad surgeon audience • Utilize platform in medical education • Build community to share cases and spread knowledge • Continuously refine pre - operative plans through A.I. • Supported by years of research and real - world data • Analyze planned - to - actual outcomes Disior Integration into Smart 28

Disior Provides Foundation for Smart28 Synergies Research & Development • Accelerate R&D projects • Scalability of patient specific surgical support Revenue Opportunities • Improve surgical outcomes • Optimized solutions, proven results, more customers Strategic Surgeon Network • Global research leaders • Platform to showcase work

EX-99.2

Exhibit 99.2

Paragon 28 Announces Acquisition of Disior

Disior advances Paragon 28’s SMART 28^TM strategy, providing a comprehensive 3D analytics and pre-operative planning platform, and will immediately accelerate internal research programs

ENGLEWOOD, Colo. – January 12, 2022 (BUSINESS WIRE) – Paragon 28, Inc. (NYSE: FNA) (“Paragon 28” or “P28”), a leading medical device company exclusively focused on the foot and ankle orthopedic market, today announced the acquisition of Disior Oy., a leading three-dimensional analytics pre-operative planning software company based in Helsinki, Finland, focused on the complex foot and ankle anatomy.

Disior will be an integral component to SMART 28^TM, the company’s ecosystem of enabling technologies for pre-operative planning, intra-operative support, and post-operative evaluation.

Disior’s anatomy-specific surgical modules will provide foot and ankle surgeons the objective data needed for the diagnosis and creation of patient-specific surgical plans, and assessment of patient outcomes. Disior is also highly complementary to the assets of Additive Orthopaedics, which P28 acquired in May of 2021.

“Disior advances our previously communicated growth strategy to target unique technologies and will immediately accelerate our internal research and development efforts, plus provide surgeons unique pre-operative planning capabilities. Disior’s software combined with our broad product portfolio further differentiates us from the competition,” said Albert DaCosta, Chairman and CEO of P28. “P28’s ultimate mission is to improve patient outcomes, and we believe our SMART 28^TM ecosystem will modernize all aspects of foot and ankle surgery.”

“The entire Disior team is very excited to join the Paragon 28 family,” said Anna-Maria Henell, CEO of Disior. “With this partnership, we have combined our talented teams and will bring a new standard of care to foot and ankle patients.”

For additional information on SMART 28^TM and Disior, a presentation is available on the Events and Presentation section of the Company’s investor relations website.

Transaction Details
Pursuant to the terms of the acquisition agreement, Paragon 28 paid $18 million at closing and agreed to potential future payments of up to $8 million contingent upon achieving specific technological advancements and commercial milestones. Paragon 28 funded the closing payment by drawing down on its existing term loan facility.

About Paragon 28, Inc.

Based in Englewood, Colo., Paragon 28, is a leading medical device company exclusively focused on the foot and ankle orthopedic market and is dedicated to improving patient lives. From the onset, Paragon 28® has provided innovative orthopedic solutions, procedural approaches and instrumentation that cover a wide range of foot and ankle ailments including fracture fixation, hallux valgus (bunions), hammertoe, ankle, progressive collapsing foot deformity (PCFD) or flatfoot, charcot foot and orthobiologics. The company designs products with both the patient and surgeon in mind, with the goal of improving outcomes, reducing ailment recurrence and complication rates, and making the procedures simpler, consistent, and reproducible.

Forward Looking Statements

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: Paragon 28’s potential to shape a better future for foot and ankle patients and Disior becoming an integral component to SMART 28^TM. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware. Forward-looking statements should not be read as a guarantee of future performance or results and may not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. These forward-looking statements are based on Paragon 28’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These risks and uncertainties are described more fully in the section titled “Risk Factors” in Paragon 28’s filings with the Securities and Exchange Commission (the “SEC”), including Paragon 28’s final prospectus filed with the SEC pursuant to Rule 424(b)(4) on October 19, 2021. Paragon 28 does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. These forward-looking statements should not be relied upon as representing Paragon 28’s views as of any date subsequent to the date of this press release.

Investor Contact:

Gilmartin Group

Matt Bacso, CFA

investors@neuropace.com

XML

Cover	Jan. 12, 2022
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Jan. 12, 2022
Entity File Number	001-40902
Entity Registrant Name	Paragon 28, Inc.
Entity Central Index Key	0001531978
Entity Tax Identification Number	27-3170186
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	14445 Grasslands Drive
Entity Address, City or Town	Englewood
Entity Address, State or Province	CO
Entity Address, Postal Zip Code	80112
City Area Code	(730)
Local Phone Number	399-3400
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Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.01 per share
Trading Symbol	FNA
Security Exchange Name	NYSE
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false