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): June 1, 2023

TREACE MEDICAL CONCEPTS, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-40355	47-1052611
(State or other jurisdiction<br><br>of incorporation)	(Commission<br><br>File Number)	(IRS Employer<br><br>Identification Number)

100 Palmetto Park Place

Ponte Vedra, Florida 32081

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (904) 373-5940

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)
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☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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, $0.001 par value per share	TMCI	The Nasdaq Global Select Market

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 June 1, 2023, Treace Medical Concepts, Inc. (the “Company” or “TMCI”) posted an investor presentation on its website at investors.treace.com and issued a press release relating to the Company’s plan to acquire certain assets of MIOS Marketing, LLC d/b/a RedPoint Medical3D (“RPM-3D”) used in providing pre-operative planning and patient-specific guides for the surgical correction of foot and ankle deformities.

A copy of the investor presentation and press release are attached as Exhibit 99.1 and 99.2 to this Current Report on Form 8-K.

The information in Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 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 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 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 8.01	Other Events.

On June 1, 2023, TMCI entered into an asset purchase agreement (the “APA”) with RPM-3D and certain owners of RPM-3D. Under the APA, TMCI will acquire at closing certain intellectual property, including patent applications and proprietary processes, a regulatory clearance, inventory, contracts, licenses, software, hardware, marketing materials and other related assets used in pre-operative planning and providing patient-specific guides for the surgical correction of foot and ankle deformities.

TMCI will pay RPM-3D an aggregate purchase price of up to $30.0 million, payable as follows: $20.0 million upon closing, $3.5 million upon completion of certain transition services milestones at 12 months of the closing date, $3.5 million upon completion of certain technological advancement milestones within 12 months of the closing date, and, subject to prior completion of the transition services and the technological advancement milestones, up to $3.0 million upon the issuance of certain patent claims.

The APA contains closing conditions, representations, warranties and covenants of the parties that are customary for agreements of its type. Each of TMCI and RPM-3D agreed to certain indemnification obligations for damages suffered in connection with the breach of their respective representations, warranties, covenants or agreements contained in the APA; RPM-3D agreed to certain indemnification obligations for taxes attributable to RPM-3D and liabilities not expressly assumed by TMCI; and TMCI agreed to certain indemnification obligations for post-closing liabilities attributable to contracts expressly assumed by TMCI, subject in each case to customary limitations.

Item 9.01	Financial Statements and Exhibits.
Exhibit No.	Description
99.1	TMCI's Investor Presentation dated June 1, 2023
99.2	Press Release of Treace Medical Concepts, Inc. issued on June 1, 2023
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.

	TREACE MEDICAL CONCEPTS, INC.
Date: June 1, 2023	By:	/s/ Mark L. Hair
		Mark L. Hair
		Chief Financial Officer

JUNE 1, 2023

Forward Looking Statements and Other Cautions This presentation may include forward- looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, strategy and plans, industry environment, potential growth opportunities, and our expectations for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” or the negative version of these words and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, strategy, short- and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. These risks and uncertainties, many of which are beyond our control, include risks described in the section entitled Risk Factors in our filings made with the Securities and Exchange Commission (the “SEC”), including our 2022 Form 10-K filed with the SEC on March 8, 2023 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, expected to be filed with the SEC on May 9, 2023. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations. This presentation may also contain estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumption, and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. By receiving this presentation, you acknowledge that you will be solely responsible for your own assessment of the market and our market position and that you will conduct your own analysis and be solely responsible for forming your own view of the potential future performance of our business.

Technology platform designed to customize bunion and midfoot correction procedures via intelligent planning and patient-specific cut guides Transaction Overview Upfront Cash $20 million Potential Milestone Payments $10 million Transaction Asset Purchase Assets Technology for Pre-Operative Planning and PSI Guides Patent Applications 22 FDA Status 510(k) Clearance

Pre-Operative Planning Patient-Specific Cut Guide Customized Intra-Operative Assistance AI-enabled software utilizes the patient’s CT scan data to create a 3D plan for correcting the patient’s deformity A patient-specific, 3D-printed cut guide is produced, customized to fit the patient’s unique foot anatomy The patient-specific guide and associated instrumentation are designed to streamline surgical approach for accurate, corrective cuts Technology Summary – RedPoint Medical 3D

Complements Our Business Strategy Industry’s Only Bunion-Focused Direct Sales Channel Rapid, Focused Innovation Highly Effective  Surgeon Education Compelling Lapiplasty® Clinical Outcomes  Comprehensive Direct-to-Patient Education Technologies complement our rapid, focused innovation approach to advance Lapiplasty® & Adductoplasty® therapies, with opportunity to further enhance surgeon & patient education and optimize clinical outcomes

Synergies for Future Growth “We believe there are excellent synergies with RedPoint’s FDA cleared technologies and our Lapiplasty® and Adductoplasty® procedures that strengthen our market leadership and accelerate our competitive differentiation, as we advance our mission to improve surgical outcomes for patients suffering from bunion and related midfoot deformities,” said John T. Treace. Development of automation for efficiency and scalability Technology platform supporting future innovation Opportunity for incremental growth of blended ASP Potential to expand active surgeon user base Designed to improve surgical efficiency and patient outcomes Opportunity for differentiated supportive clinical evidence Research &Development Expansion Expanded Revenue Opportunities Continued Focus on Patient Outcomes

EX-99.2

Exhibit 99.2

Treace Medical Concepts to Acquire Technology

Enabling Patient Specific Instrumentation for Foot and Ankle Surgeries

PONTE VEDRA, Fla. – June 1, 2023—Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of hallux valgus (commonly known as bunions), today announced that it has signed an asset purchase agreement to acquire certain assets of MIOS Marketing, LLC d/b/a RedPoint Medical3D (“RPM-3D”), a medical technology company offering pre-operative planning and patient-specific guides designed to deliver accurate surgical correction of deformities customized to the patient’s unique foot anatomy, for a purchase price of $20 million in an upfront cash payment, with up to $10 million in potential milestone payments.

Using patient CT scan data, RPM-3D applies innovative software technologies to develop a three-dimensional (3D) pre-operative plan for correcting the patient’s deformity and produce a 3D-printed, patient-specific cut guide designed to efficiently make accurate, corrective cuts. RPM-3D software and systems will be integrated with the Company’s instrumentation and implant systems in 2023, with commercial introduction of patient-specific products expected in the second half of 2024.

“We believe there are excellent synergies with RPM-3D’s FDA cleared technologies and our Lapiplasty® and Adductoplasty® procedures that strengthen our market leadership and accelerate our competitive differentiation, as we advance our mission to improve surgical outcomes for patients suffering from bunion and related midfoot deformities,” said John T. Treace, CEO, Founder and Board Member of Treace. “RPM-3D’s 22 patent applications further expand and reinforce our market leading global IP portfolio covering technologies for the correction of bunion and related deformities. In addition, the RPM-3D purchase builds upon our acceleration in R&D initiatives that we announced in early 2022. These targeted R&D efforts are delivering an expanding portfolio of unique, problem-solving technologies for our customers and marketed through our direct, bunion-focused sales force,” Mr. Treace concluded.

This announcement follows the Company’s recently launched Adductoplasty® Midfoot Correction System, SpeedRelease™ and TriTome™ Release Instruments, and S4A Anatomic Plating Kit; and its Micro-Lapiplasty™ Minimally Invasive System and SpeedPlate™ Rapid Compression Implant System, which are expected for full commercial release in late 2023.

For additional information on RPM-3D and this transaction, a presentation is available on the Events and Presentation section of the Company’s investor relations website at https://investors.treace.com/news-events/events-presentations.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements, including, but not limited to the Company’s expectations of synergies with RPM-3D’s technologies, the acceleration of its market leadership and differentiation in the years ahead, and plans for the development of technologies and introduction of products. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results or other events to differ materially from those contemplated in this press release can be found in the Risk Factors section of Treace’s public filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 8, 2023 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 9,

2023. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of their date and, except to the extent required by law, the Company undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.

About Treace Medical Concepts

Treace Medical Concepts, Inc. is a medical technology company with the goal of advancing the standard of care for the surgical management of bunion and related midfoot deformities. Bunions are complex 3-dimensional deformities that originate from an unstable joint in the middle of the foot and affect approximately 65 million Americans, of which Treace estimates 1.1 million are annual surgical candidates. Treace has pioneered and patented the Lapiplasty® 3D Bunion Correction™ System – a combination of instruments, implants, and surgical methods designed to surgically correct all 3 planes of the bunion deformity and secure the unstable joint, addressing the root cause of the bunion and helping patients get back to their active lifestyles. Treace expanded its offering with the Adductoplasty® Midfoot Correction System, designed for reproducible surgical correction of the midfoot to provide further support to hallux valgus patients. For more information, please visit www.treace.com.

Contacts:

Treace Medical Concepts

Mark L. Hair

Chief Financial Officer

mhair@treace.net

(904) 373-5940

Investors:

Gilmartin Group

Lynn Lewis or Vivian Cervantes

IR@treace.net