トリースメディカルコンセプツの適時開示・決算・その他

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 13, 2026

TREACE MEDICAL CONCEPTS, INC.

(Exact name of registrant as specified in its charter)



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


	☐	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, $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 2.02. Results of Operations and Financial Condition.

On January 13, 2026, Treace Medical Concepts, Inc. (the "Company") issued a press release regarding certain preliminary unaudited financial results for the quarter and the year-ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

This information furnished under this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 7.01. Regulation FD Disclosure.

On January 13, 2026, the Company posted an investor presentation, which may be accessed through its investor relations website. A copy of the presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein. The Company intends to use this presentation in meetings with analysts, investors and others from time to time, including at the J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026 at 7:30 am Pacific Time / 10:30 am Eastern Time. A live webcast of this event, as well as an archived recording and presentation, will be available in the Investors section of the Company's website.

The information furnished under this Item 7.01, including Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.


Item 9.01 (d) Exhibits	Financial Statements and Exhibits.
Exhibit No.		Description
99.1		Press Release of Treace Medical Concepts, Inc. issued on January 13, 2026
99.2		Investor Presentation, dated January 13, 2026 (furnished pursuant to Item 7.01)
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: January 13, 2026	By:	/s/ Mark L. Hair
		Mark L. Hair
		Chief Financial Officer

EX-99.1 2 tmci-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

Treace Announces Preliminary, Unaudited Fourth Quarter and Full-Year 2025 Revenue

PONTE VEDRA, Florida, January 13, 2026 -- Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities, today announced its preliminary, unaudited fourth quarter and full-year 2025 revenue results.

Highlights:

•

Preliminary revenue of $62.1 million to $62.5 million in the fourth quarter of 2025, an approximate 9% decrease at the midpoint over the same period in 2024.

•

Preliminary revenue of $212.3 million to $212.7 million for the full-year 2025, an approximate 2% increase at the midpoint compared to the prior year and in-line with the previously provided revenue guidance range of $211 million to $213 million.

•

New active surgeon additions of approximately 202 for full-year 2025; ended the year with approximately 3,337 active surgeons, a 6% increase compared to the prior year and approximately 33% of the estimated 10,000 U.S. surgeons performing bunion surgery.

“Despite top-line headwinds, we are encouraged by our fourth-quarter progress. Surgeon adoption of our expanded suite of 3D bunion technologies again drove mid–single-digit case volume growth in the quarter,” said John T. Treace, CEO and Chairman of Treace. “Supported by our dedicated, bunion-focused sales force, these technologies position us to further penetrate the bunion market and expand our surgeon customer base. We maintain a leading position in the bunion market and remain focused on expanding our share of the bunion procedure market, improving profitability, and delivering long-term value to shareholders.”

2026 Outlook:

Treace is not issuing full-year 2026 guidance at this time, however, the Company anticipates continued positive procedure volume growth as well as the impact of previously disclosed dynamics, including headwinds related to broader economic conditions and softer consumer sentiment, as well as a product mix shift.

The Company plans to provide 2026 financial guidance during its fourth quarter 2025 earnings conference call, which is currently scheduled for Thursday, February 26, 2026, at 4:30 p.m. Eastern Time.

The preliminary unaudited financial information in this press release has not been subject to the more rigorous standards of review for Treace’s filed financial statements, may be adjusted, including as a result of its internal closing processes and the external auditing procedures of its independent registered public accounting firm, and remains subject to change until the Company files its full financial statements for 2025.

Treace to Present at J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026

John T. Treace, Chief Executive Officer, Chairman and Founder of Treace, will present at the J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, beginning at 7:30 am Pacific Time / 10:30 am Eastern Time.

Following this presentation, Mr. Treace will be joined by Mark L. Hair, Chief Financial Officer of Treace, for a question-and-answer session. A live webcast and replay of the presentation will be available on the Company’s investor relations website at https://investors.treace.com/.

Forward-Looking Statements

This press release and statements made during the Company’s presentation and question-and-answer session at the J.P. Morgan Healthcare Conference contain 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, anticipated fourth quarter and full-year 2025 revenue; expected increase in product adoptions and procedure volumes; expected improvements in profitability and liquidity; anticipated 2026 dynamics and headwinds; ability to effectively respond to and mitigate the impact of challenges in the current market environment, including in response to increased competition, evolving surgeon and patient preferences for minimally invasive bunion solutions, changes in tariff and trade policies, economic uncertainty or soft consumer sentiment; anticipated future product launches and the timing of such product launches; ability to increase case volumes, expand surgeon customer base and utilization rate, and increase procedure penetration and market share; expected seasonality; and anticipated pace of growth in the foot and ankle market. 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, 2024, which was filed with the SEC on February 27, 2025 and any subsequent Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. 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. The Company’s preliminary, unaudited results for the fourth quarter and full year ended December 31, 2025, reflect the Company’s current estimates based on information available as of the date of this press release and are subject to change, including as a result of the completion of the Company’s financial and operating closing procedures, customary audit procedures, and other developments that may occur before the completion of these procedures. Accordingly, you should not place undue reliance on these preliminary, unaudited results, which may differ materially from actual results and are not necessarily indicative of its operating results for any future periods.

Internet Posting of Information

Treace routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.treace.com. The Company encourages investors and potential investors to consult the Treace website regularly for important information about Treace.

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 67 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 three 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. To further support the needs of surgeons and bunion patients, Treace offers its Adductoplasty® Midfoot Correction System, designed for reproducible surgical correction of midfoot deformities, two systems for minimally invasive osteotomy procedures, namely the Nanoplasty® 3D Minimally Invasive Bunion Correction System and the Percuplasty™ Percutaneous 3D Bunion Correction System, and the SpeedMTP® MTP Fusion System. Treace continues to expand its footprint in the marketplace by extending its SpeedPlate® rapid compression implant platform to new applications, as well as providing surgeons with advanced digital solutions with its IntelliGuide® patient specific, pre-op planning and cut guide technology. For more information, please visit www.treace.com.

To learn more about Treace, connect with us on LinkedIn, X, Facebook and Instagram.

Contacts:

Treace Medical Concepts
Mark L. Hair
Chief Financial Officer
mhair@treace.net
(904) 373-5940

Investors:

Gilmartin Group
Philip Trip Taylor

IR@treace.net

EX-99.2 3 tmci-ex99_2.htm EX-99.2

1 44th Annual J.P. Morgan Healthcare Conference John T. Treace, CEO, Founder, Chairman January 14, 2026

Forward-looking Statements: This presentation and our Q&A session may include forward-looking statements subject to substantial risks and uncertainties that may cause actual results to differ materially from those anticipated or implied by such forward-looking statements. We include forward-looking statements about, among other topics, our future results of operations and financial position, strategy and plans, industry environment, potential growth opportunities, and future product launches and operations. These forward-looking statements are based on our current assumptions, expectations and projections about future events and trends and are subject to risks and uncertainties, many of which are beyond our control. Information about these risks and uncertainties can be found in the section entitled Risk Factors in our filings with the SEC, including our 2024 Form 10-K as well as in our subsequent Form 10-Qs available at www.sec.gov and investors.treace.com. Also, since 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 or their impact on our business. The forward-looking events and circumstances discussed in this presentation and Q&A session 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. The forward-looking statements in this presentation or during our Q&A session speak only as of their date, and we undertake no obligation to update or revise any of these statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Market Data: This presentation contains estimates and statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves assumptions and limitations. You are cautioned not to give undue weight to such estimates. Also, projections, assumptions, and estimates of our future performance and the future performance of the markets in which we operate are subject to substantial uncertainty and risk. Investor’s Analysis: By attending or receiving this presentation, you acknowledge that you are solely responsible for your own assessment of the market and our market position, for conducting your own analysis, and for forming your own view of the potential future performance of our business. Non-GAAP Financial Measures: To supplement the financial results presented in accordance with GAAP, this presentation presents Adjusted EBITDA. Non-GAAP financial measures such as Adjusted EBITDA are presented in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. Reconciliations between GAAP and non‐GAAP results are included at the end of this presentation, and additional information about how management calculates and uses Adjusted EBITDA can be found in our press release issued on November 6, 2025. There are limitations related to the use of non-GAAP financial measures such as Adjusted EBITDA because they are not prepared in accordance with GAAP, may exclude significant income and expenses required by GAAP to be recognized in our financial statements, and may not be comparable to non-GAAP financial measures used by other companies. We encourage investors to carefully consider our results under GAAP, as well as our supplemental non‐GAAP information and the reconciliation between these presentations, to more fully understand our business. Forward-Looking Statements & Non-GAAP Financial Measures 2

Treace Medical Concepts, Inc. Medical Device Company Focused on the surgical treatment of bunions and related deformities Industry’s Only Bunion Focused Direct Sales Team Market Leading Technology protected by 96 US Patents and 84 US Pending Patents Driving Penetration FY 2025 preliminary revenue of $212.3M to $212.7M (+2% YOY growth at midpoint)* Expanded Bunion Portfolio featuring best-in-class 3D MIS Osteotomy solutions ~ 1/3 of US Foot & Ankle Surgeons used Treace bunion systems in 2025 Extending Our Leadership Accelerating bunion case volume growth in 2025 and 2026 Expanding Sales Force with additional experienced sales reps Strong R&D Pipeline of technologies for 2026 and beyond The Leader in 3D Bunion Correction® Focused Experts * Preliminary Q4 and full-year revenue remains subject to completion of year-end accounting procedures and adjustments and is subject to change. Pioneering the Future of 3D Bunion Correction®

Largest & Most Underpenetrated Segment in Foot & Ankle 4.4M 1.1M 450K Bunion Patient Opportunity ~10,000 Surgeons ~1 in 4 adults in the US affected1 67M Surgical Procedures3 $2.3B Current US Market Surgical Candidates $5B+ US Market Opportunity Seek MedicalTreatment Annually2 Americans Affected (1) Nix S, et al. 2010. (2) Treace customer surveys (3) iData Research, Inc 4

Transverse Plane Sagittal Plane Frontal Plane Bunions: 3-Plane Deformities 5 An unstable joint in the middle of the foot allows the metatarsal bone to shift outward… creating the painful “bump” on the side of the big toe Bunion (bump) presents here Unstable joint is here In nearly 90% of bunions, the metatarsal bone is rotated in the frontal plane1 Kim Y, et al. Foot Ankle Int 2015 Okuda R, et al. JBJS 2009; Okuda R, et al. JBJS 2007 5 Failure to correct the frontal plane component can lead to a 10-12x greater risk of recurrence2

Lapiplasty®: The Gold Standard for 3-Plane Correction 6 Treace has democratized a 3D Lapidus bunion procedure, making it accessible to more surgeons and their patients Correct. Fixate. Cut. Compress. The Patented Lapiplasty® Procedure

Patient Reported Outcomes (Mean) Visit MOxFQ and VAS Pain Scores Over Time ALIGN3D™ Multicenter Prospective Study1 7 centers, 13 surgeons, 173 patients treated (139 at 48-month follow up) Compelling Outcomes Supported by Differentiated Clinical Data The only commercial surgical bunion system supported by 4-year multicenter, prospective data EARLY WEIGHT BEARING at 7.7 days (avg) in a walking boot 81% pain reduction with 89% improvement in MOxFQ walking/standing scores at 48 months Low recurrence rates 0.8% (HVA >20°) & 8.4% (HVA >15°) at 48 months 4-Year Published Prospective, Multicenter Lapiplasty® Results1 Hatch DJ, et al., JFAS 2025

Driving penetration of our comprehensive 3D bunion portfolio Accelerating our bunion procedure volume growth Expanding our offerings to build wallet share Micro-Lapiplasty® Mini-Adductoplasty™ SpeedMTP® Percuplasty™ IntelliGuide® PSI Nanoplasty® Lapiplasty® Lightning™ 2026 Pioneering the Future of 3D Bunion Correction® 8

Mild to Moderate Moderate to Severe w/ Midfoot Deformity w/ Arthritic Great Toe Joint Comprehensively Addressing All Bunion Classes 9 Extending our leadership through targeted best-in-class 3D instrumented systems 70% of Bunion Surgeries1 30% of Bunion Surgeries1 Present2 in ~ 30% Present3 in ~20% (1) Treace surgeon survey, July 2022; (2) Aiyer et al., 2014; (3) Wilder et al., 2005.

Mild to Moderate Moderate to Severe w/ Midfoot Deformity w/ Arthritic Great Toe Joint Comprehensively Addressing All Bunion Classes 10 Extending our leadership through targeted best-in-class 3D instrumented systems 70% of Bunion Surgeries1 30% of Bunion Surgeries1 Present2 in ~ 30% Present3 in ~20% Adductoplasty® Midfoot Correction System SpeedMTP Midfoot Correction System ® Lapiplasty® 3D Bunion Correction® Nanoplasty® 3D MIS Bunion Correction TM Percuplasty™ Percutaneous 3D Bunion Correction® (1) Treace surgeon survey, July 2022; (2) Aiyer et al., 2014; (3) Wilder et al., 2005.

Expanding Patient Access to Bunion Surgery Intelliguide™ PSI Micro-Lapiplasty® Lapiplasty® Of surgeons expect MIS osteotomies to be their fastest growing bunion procedure in the next year* 58% Traditional Open Osteotomy Percuplasty™ Percutaneous 3D Correction 4.4MSeeking Medical Treatment1 1.1MSurgical Candidates Procedures2 450k of bunion patients would “greatly increase interest” in surgery with an MIS option4 (1) Treace customer surveys; (2) iData Research, Inc.; (3) Treace surgeon survey, June 2025; (4) Treace patient survey, March 2025. Bunion Patient Opportunity of surgeons expect MIS osteotomies to be their fastest growing bunion procedure in the next year3 56% 11

12 Percuplasty™ Percutaneous 3D Bunion Correction Percuplasty™ MIS Power System* Plug & Play MIS Burr Pre-Settings Nanoplasty® 3D MIS Bunion Correction Accelerating Surgeon Access to 3D MIS Bunion Surgery Expanding the Bunion Market Through Minimally Invasive Approaches *Third-party manufactured and distrubuted by Treace. NEW 2025 NEW 2025 NEW 2025

13 Advancing Our Leadership in Lapiplasty® Technology Lapiplasty® Lightning™ Next-Generation Instrumentation IntelliGuide® PSI Patient-Specific 3D Bunion Correction SpeedTMT™ Rapid Compression Implant 5th generation instrumentation Less steps, faster procedure Enhanced control of 3D correction Fast insertion Dynamic compression Locking screw fixation Intelligent pre-op planning Patient-specific 3D correction Streamlined workflow COMING 2026 NEW 2025 COMING 2026

Expanding Offerings for Our Growing Customer Base 14 Cortifuse™ Demineralized Cortical Fibers SpeedMTP® SpeedAkin™ MicroQuad™ Allograft Wedges SpeedPlate® Implants Complementary Biologics1 Sterile Instruments Percuplasty™ SuperBite™ 1Third party manufactured and distributed by Treace. COMING 2026 NEW 2025 NEW 2025 NEW 2025 NEW 2025 NEW 2025 NEW 2025

Go-to-Market Strategy (1) Sales reps and field fleet includes W2 employees and FTE 1099 sales agents, as of December 31, 2025 Comprehensive introductory and advanced events with experienced surgeon faculty Hands-on training events Focused Surgeon Education Bunion-focused sales force helps drive deeper market penetration Direct Sales Channel ~74% Direct revenue mix ~215 Sales reps1 ~297 Field fleet1 Best-in-Class 3D Bunion Systems Bunion Focused. We Never Stop Innovating. Lapiplasty® Micro-Lapiplasty® Mini-Adductoplasty™ Percuplasty™ Nanoplasty® SpeedMTP® IntelliGuide® PSI 15

Market-Capturing Momentum A Step Ahead™ 16 Tom Lapiplasty® patient All Bunion Cases (~450k annual U.S. cases) Total Penetration3 2.5% 5.5% 7.8% 6.6% 3.9% 2025 2023 2021 21% 5-year CAGR¹ in Active Surgeons2 33% Treace bunion procedures of U.S. bunion surgeons using Active Surgeons2 (~10,000 U.S. Surgeons) 1,783 2,855 3,337 Attacking multiple bunion segments to speed market penetration (1) 5-year CAGR reflects fiscal years 2020 through 2025 Active Surgeons perform at least one Treace Medical case in the trailing twelve months Penetration figures based on an estimated 450,000 annual US surgical procedures (iData Research, Inc., 2022) 2025 2021 2023

Meaningful leverage opportunities to drive profitability Continued focus on operating expense leverage & management Scalability of business Technology-enabled efficiencies 17 Focus on Improved Profitability 4Q’25E 2 We again expect to deliver positive Adj. EBITDA in Q4 The Company defines Non-GAAP adjusted EBITDA as net loss before depreciation and amortization expense, interest income, interest expense, taxes, share-based compensation expense, restructuring costs and litigation related costs. See our GAAP to Non-GAAP reconciliation for more details. Preliminary 2025 Adj EBITDA remains subject to completion of year-end accounting and audit procedures and is subject to change. Jen Lapiplasty® patient

Now a comprehensive bunion solutions company with multiple new technologies Positioned to deliver continued procedure volume growth in 2026 and beyond Strong R&D pipeline of technologies for 2026 and beyond The Leader in the largest and most underpenetrated segment of the foot and ankle market¹ Multiple growth drivers: + Expanded product portfolio + More new products in 2026 + New surgeons + Sales force growth + Reimbursement TMCI estimate based on other publicly-traded peers participating in the foot and ankle market Pioneering the Future of 3D Bunion Correction®

19 The Leader in 3D Bunion Correction®

GAAP to Non-GAAP Reconciliations 20