TMCI on Nasdaq

TREACE MEDICAL CONCEPTS, INC.

TREACE MEDICAL CONCEPTS, INC. is an American surgical and medical instruments and apparatus company.1 It is headquartered in Ponte Vedra, Florida.1 Its shares trade on Nasdaq under the symbol TMCI.1

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Last updated Oct 21, 2026.

Overview

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  • TickerTMCI on Nasdaq1
  • IndustrySurgical & Medical Instruments & Apparatus1
  • HeadquartersPonte Vedra, Florida1
  • Incorporated inFL2
  • Business address100 Palmetto Park Place, Ponte Vedra, Fl 320812
  • Filer categoryAccelerated filer2

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

79.8%Gross margin3
-25.5%Operating margin3
-27.7%Net margin3
1.6%Revenue growth, 20253
-67.6%Return on equity3
0.64×Debt to equity3
-$29.5MFree cash flow3

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue20¢$42.9M
  • Research and development10¢$20.3M
  • Other costs68¢$144.2M
  • Interest3¢$5.3M

Out of $212.7M in revenue.3 The company lost money this year.

Financial statements

Revenue45673$212.7M in 2025+440% since 2019
0$100.0M$200.0M$300.0M2019: $39.4M$39.4M20192020: $57.4M$57.4M2020+46%2021: $94.4M$94.4M2021+65%2022: $141.8M$141.8M2022+50%2023: $187.1M$187.1M2023+32%2024: $209.4M$209.4M2024+12%2025: $212.7M$212.7M2025+2%
Gross profit45673$169.8M in 2025+434% since 2019
0$50.0M$100.0M$150.0M$200.0M2019: $31.8M$31.8M20192020: $44.9M$44.9M2020+41%2021: $77.5M$77.5M2021+73%2022: $116.3M$116.3M2022+50%2023: $151.9M$151.9M2023+31%2024: $168.3M$168.3M2024+11%2025: $169.8M$169.8M2025+1%
Operating income45673-$54.2M in 2025+1432% since 2019
-$60.0M-$40.0M-$20.0M0$20.0M2019: -$3.5M-$3.5M20192020: $855.0K$855.0K20202021: -$16.5M-$16.5M20212022: -$34.8M-$34.8M2022+111%2023: -$51.4M-$51.4M2023+48%2024: -$55.7M-$55.7M2024+8%2025: -$54.2M-$54.2M2025−3%
Net income45673-$59.0M in 2025+1283% since 2019
-$60.0M-$40.0M-$20.0M02019: -$4.3M-$4.3M20192020: -$3.7M-$3.7M2020−14%2021: -$20.6M-$20.6M2021+460%2022: -$42.8M-$42.8M2022+108%2023: -$49.5M-$49.5M2023+16%2024: -$55.7M-$55.7M2024+13%2025: -$59.0M-$59.0M2025+6%

Every line of the income statement as filed: the last 3 fiscal years, latest first.3

Period ending2025-12-312024-12-312023-12-31
Revenue$212.7M$209.4M$187.1M
Cost of goods sold$42.9M$41.1M$35.2M
Gross profit$169.8M$168.3M$151.9M
Sales and marketing$140.9M$147.6M$140.9M
Research and development$20.3M$20.6M$15.4M
General and administrative$62.7M$55.7M$47.0M
Total operating expenses$223.9M$224.0M$203.4M
Loss from operations-$54.2M-$55.7M-$51.4M
Interest income$2.8M$4.9M$6.7M
Interest expense-$5.3M-$5.3M-$5.2M
Debt extinguishment loss-$2.7M$0$0
Other income, net$432.0K$324.0K$342.0K
Other non-operating income (expense), net-$4.8M-$55.0K$1.9M
Net loss-$59.0M-$55.7M-$49.5M
Unrealized gain (loss) on marketable securities-$25.0K-$66.0K$190.0K
Comprehensive loss-$59.0M-$55.8M-$49.3M
Net loss per share, basic-$0.93-$0.90-$0.81
Net loss per share, diluted-$0.93-$0.90-$0.81
Weighted-average shares used in computing net loss per share, basic63.3M shares62.1M shares60.9M shares
Weighted-average shares used in computing net loss per share, diluted63.3M shares62.1M shares60.9M shares

Compare TREACE MEDICAL CONCEPTS, INC. with another company

Corporate structure

TREACE MEDICAL CONCEPTS, INC. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of TREACE MEDICAL CONCEPTS, INC.

  • ARMISTICE CAPITAL, LLC Filed SCHEDULE 13G/A on TREACE MEDICAL CONCEPTS, INC., latest Aug 14, 2026 (8 filings since Nov 14, 2024)
  • John T. Treace Filed SCHEDULE 13G/A on TREACE MEDICAL CONCEPTS, INC., latest Aug 12, 2026 (5 filings since Feb 11, 2022)
  • BlackRock Filed SCHEDULE 13G/A on TREACE MEDICAL CONCEPTS, INC., latest Jul 30, 2026 (2 filings since Jan 29, 2024)
  • Bank of America Filed SCHEDULE 13G on TREACE MEDICAL CONCEPTS, INC., latest May 14, 2026
  • GAGNON SECURITIES LLC Filed SCHEDULE 13G/A on TREACE MEDICAL CONCEPTS, INC., latest Feb 12, 2026 (2 filings since May 15, 2025)
  • WILLIAM BLAIR INVESTMENT MANAGEMENT, LLC Filed SCHEDULE 13G/A on TREACE MEDICAL CONCEPTS, INC., latest Feb 9, 2026 (2 filings since Nov 12, 2025)
  • Morgan Stanley Filed SCHEDULE 13G/A on TREACE MEDICAL CONCEPTS, INC., latest Feb 3, 2025 (2 filings since Nov 8, 2024)
  • VANGUARD GROUP INC Filed SC 13G/A on TREACE MEDICAL CONCEPTS, INC., latest Nov 12, 2024 (4 filings since Feb 9, 2023)
  • AllianceBernstein Filed SC 13G/A on TREACE MEDICAL CONCEPTS, INC., latest Feb 14, 2024 (2 filings since Feb 14, 2023)
  • John R. Treace Filed SC 13G/A on TREACE MEDICAL CONCEPTS, INC., latest Feb 13, 2023 (2 filings since Feb 11, 2022)
  • CIBC Private Wealth Group LLC Filed SC 13G/A on TREACE MEDICAL CONCEPTS, INC., latest Mar 22, 2022 (2 filings since Jan 7, 2022)
  • TREACE MEDICAL CONCEPTS, INC. Ponte Vedra, Florida

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What TREACE MEDICAL CONCEPTS, INC. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$53.6M3 Dec 31, 2025$41.3M3 Dec 31, 2024+30.0%
Accumulated depreciation$23.9M3 Dec 31, 2025$15.3M3 Dec 31, 2024+56.0%
Property and equipment, net$29.8M3 Dec 31, 2025$26.0M3 Dec 31, 2024+14.6%
Operating-lease assets (leased space)$7.6M3 Dec 31, 2025$8.4M3 Dec 31, 2024−9.8%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$10.7M3 Dec 31, 2025$11.3M3 Dec 31, 2024−5.7%
Marketable securities, current$37.7M3 Dec 31, 2025$64.3M3 Dec 31, 2024−41.5%
Debt securities available for sale$37.7M3 Dec 31, 2025$64.3M3 Dec 31, 2024−41.5%

Intangibles and goodwill

ItemLatestA year beforeChange
Goodwill$12.8M3 Dec 31, 2025$12.8M3 Dec 31, 20240%
Intangible assets, net (excluding goodwill)$7.1M3 Dec 31, 2025$8.1M3 Dec 31, 2024−11.8%
Accumulated amortization$2.4M3 Dec 31, 2025$1.4M3 Dec 31, 2024+66.7%

Inventory

ItemLatestA year beforeChange
Inventory, total$36.0M3 Dec 31, 2025$39.3M3 Dec 31, 2024−8.2%

Properties, in its own words

As of December 31, 2025, we leased approximately 125,000 square feet for our corporate headquarters located in Ponte Vedra, Florida under a lease agreement which terminates in July 2032. We believe that this facility is sufficient to meet our current and anticipated needs in the future and that additional space can be obtained on commercially reasonable terms as needed. We currently have several subleases related to our previous and current corporate headquarters locations.

Item 2 of the 10-K filed Feb 27, 2026.10

Leadership

Who has led TREACE MEDICAL CONCEPTS, INC., and when. Pick a name to see everywhere that person has worked.

Chief financial officer

  1. Mark Hair2021–now
2025
Board members and other officers (20)

Timeline

  1. Aug 7, 20268-K Results of operations32
  2. May 20, 20268-K Shareholder vote33
  3. May 8, 20268-K Results of operations34
  4. Apr 9, 20268-K Results of operations; Executive or director change; Regulation FD disclosure35
  5. Feb 27, 20268-K Results of operations36
  6. Jan 13, 20268-K Results of operations; Regulation FD disclosure37
  7. Dec 18, 20258-K Entered a material agreement; Ended a material agreement; New debt or obligation38
  8. Nov 6, 20258-K Results of operations; Executive or director change39
  9. Aug 7, 20258-K Results of operations40
  10. May 21, 20258-K Shareholder vote41
  11. May 8, 20258-K Results of operations42
  12. Apr 7, 20258-K Executive or director change43
  13. Apr 22, 2021New chief executive John T. Treace becomes CEO11

Calendar

Coming up

  1. Nov 5, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($0.26) a share, on Nov 6, 2025.44

When it reported results

  1. Aug 7, 2026Reported quarterly or annual results32
  2. May 8, 2026Reported quarterly or annual results34
  3. Apr 9, 2026Reported quarterly or annual results35
  4. Feb 27, 2026Reported quarterly or annual results36
  5. Jan 13, 2026Reported quarterly or annual results37
  6. Nov 6, 2025Reported quarterly or annual results39
  7. Aug 7, 2025Reported quarterly or annual results40
  8. May 8, 2025Reported quarterly or annual results42

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

376 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 44 major events, 251 insider forms, 32 large holders, 29 other. The latest 20:

  1. Oct 2, 20264 EDGAR
  2. Aug 24, 20264 EDGAR
  3. Aug 14, 2026SCHEDULE 13G/A EDGAR
  4. Aug 12, 20264 EDGAR
  5. Aug 12, 2026SCHEDULE 13G/A EDGAR
  6. Aug 12, 20264 EDGAR
  7. Aug 12, 20264 EDGAR
  8. Aug 7, 202610-Q EDGAR
  9. Aug 7, 20268-K EDGAR
  10. Jul 30, 2026SCHEDULE 13G/A EDGAR
  11. Jun 12, 20264/A EDGAR
  12. Jun 11, 20264 EDGAR
  13. Jun 1, 20264 EDGAR
  14. May 28, 20264 EDGAR
  15. May 20, 20268-K EDGAR
  16. May 19, 20264 EDGAR
  17. May 19, 20264 EDGAR
  18. May 19, 20264 EDGAR
  19. May 19, 20264 EDGAR
  20. May 19, 20264 EDGAR

The 376 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

197 open-market trades by officers, directors and large owners since October 2021: 45 buys and 152 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 24, 2026Treace John T.Chief Executive OfficerBuy11,000$4.34$47.7KForm 4
Aug 21, 2026Treace John T.Chief Executive OfficerBuy5,000$4.35$21.8KForm 4
Aug 20, 2026Treace John T.Chief Executive OfficerBuy39,944$4.44$177.4KForm 4
Jun 11, 2026Treace John T.Chief Executive OfficerBuy9,891$4.04$40.0KForm 4
Jun 11, 2026Treace John T.Chief Executive OfficerBuy22,887$4.04$92.5KForm 4
Jun 10, 2026Treace John T.Chief Executive OfficerBuy14,715$4.02$59.2KForm 4
Jun 10, 2026Treace John T.Chief Executive OfficerBuy29,430$4.02$118.3KForm 4
Jun 1, 2026Treace John T.Chief Executive OfficerBuy50,000$3.56$178.0KForm 4
May 28, 2026Treace John T.Chief Executive OfficerBuy61,202$3.02$184.8KForm 4
May 27, 2026Treace John T.Chief Executive OfficerBuy49,810$2.87$143.0KForm 4
May 26, 2026Treace John T.Chief Executive OfficerBuy4,508$2.79$12.6KForm 4
May 14, 2026Treace John T.Chief Executive OfficerBuy61,750$2.62$161.8KForm 4
May 13, 2026Treace John T.Chief Executive OfficerBuy49,013$2.46$120.6KForm 4
May 12, 2026Treace John T.Chief Executive OfficerBuy43,000$2.17$93.3KForm 4
Mar 17, 2025Scanlan Sean F.Chief Innovation OfficerSale50,000$7.97$398.5KForm 4
Mar 4, 2025Treace John T.Chief Executive OfficerBuy60,000$8.73$523.8KForm 4
Sep 16, 2024Treace John T.Chief Executive OfficerBuy50,000$5.31$265.5KForm 4
Aug 15, 2024TREACE JAMES TDirectorBuy84,000$5.96$500.6KForm 4
Aug 14, 2024Treace John T.Chief Executive OfficerBuy85,000$6.00$510.0KForm 4
Jun 11, 2024Treace John T.Chief Executive OfficerBuy45,000$5.88$264.6KForm 4

All 197 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025John T. Treace54$755.4K$5.4M56
2025Mark L. Hair56$510.0K$5.2M56
2025Sean F. Scanlan44$446.4K$2.3M56
2025Scot M. Elder50$432.1K$2.1M56
2025Gaetano M. Guglielmino56$440.0K$468.5K56
2024Chief Executive Officer,$723.4K$6.6M56
2024Chief Legal & Compliance$409.3K$4.6M56
2024Chief Financial Officer$490.1K$4.5M56
2024Chief Commercial Officer$37.3K$3.2M56
2024Chief Innovation Officer$419.3K$3.1M56
2023Founder and Board Chair$684.4K$8.4M56
2023Chief Financial Officer$458.0K$4.7M56
2023OfficerCorporate Secretary$376.8K$3.2M56
2023Chief Innovation Officer$380.6K$2.9M56

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 100. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
Armistice Capital, LLC6,364,000$25.3M0.7%No change
Bank Of America Corp /de/3,305,100$13.2M0.0%+90,807
Gagnon Securities LLC3,029,543$12.1M2.3%−2,172,343
Vanguard Capital Management LLC2,028,479$8.1M0.0%+566,972
Gagnon Advisors, LLC1,534,034$6.1M3.9%New
Aqr Capital Management LLC1,497,673$6.0M0.0%+435,833
BlackRock, Inc.1,380,021$5.5M0.0%−1,960,002
Marshall Wace, Llp1,328,592$5.3M0.0%+1,063,659
CIBC Bancorp USA Inc.1,216,044$4.8M0.0%−2,309
Millennium Management LLC738,628$2.9M0.0%−409,487
Weber Capital Management LLC /adv589,617$2.3M2.0%No change
D. E. Shaw & Co., Inc.583,277$2.3M0.0%−257,992
Geode Capital Management, LLC573,796$2.3M0.0%−437,047
Citadel Advisors LLC516,994$2.1M0.0%−308,581
Goldman Sachs Group Inc492,116$2.0M0.0%+104,431
Stifel Financial Corp435,009$1.7M0.0%+258,917
UBS Group AG366,445$1.5M0.0%−176,460
Jacobs Levy Equity Management, Inc363,729$1.4M0.0%+99,995
Raymond James Financial Inc331,110$1.3M0.0%−26,446
Morgan Stanley320,026$1.3M0.0%+100,319
Vanguard Fiduciary Trust Co292,504$1.2M0.0%−25,500
Charles Schwab Investment Management Inc282,538$1.1M0.0%−46,301
State Street Corp234,271$932.4K0.0%−1,001,247
Susquehanna International Group, Llp214,219$852.6K0.0%+197,170
Jain Global LLC210,987$839.7K0.0%+168,949

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How TREACE MEDICAL CONCEPTS, INC. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARTREACE MEDICAL CONCEPTS, INC.1
  • CIK0001630627
  • Employer ID (EIN)47-105261110
  • Filer statusAccelerated filer not an emerging growth company; not a smaller reporting company; not a shell company10
  • Incorporated inDelaware10
  • Fiscal year endsDecember 311
  • Industry code (SIC)3841 Surgical & Medical Instruments & Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address100 Palmetto Park Place, Ponte Vedra, FL 320811
  • Phone(904) 373-59401
  • Shares outstanding65,034,552 as of Jul 31, 20269
  • Public float$265.9M as of Jun 30, 202510
  • AuditorGRANT THORNTON LLP, Jacksonville, Florida PCAOB ID 248; it also attests to the company’s internal control over financial reporting10
  • On EDGAR sinceJan 21, 20151
  • Filings442 in all: 4 (263), 8-K (47), 3 (22), 10-Q (17), SCHEDULE 13G/A (12), SC 13G/A (10), 144 (7), SC 13G (7)1
    All 31 form types

    S-8 (6), 10-K (5), DEF 14A (5), DEFA14A (5), 5 (4), ARS (4), CORRESP (4), D (3), D/A (3), SCHEDULE 13G (3), 424B5 (2), UPLOAD (2), 10-Q/A (1), 4/A (1), 424B4 (1), 8-A12B (1), CERT (1), DRS (1), EFFECT (1), S-1 (1), S-1/A (1), S-1MEF (1), S-3ASR (1)

  • Latest filingsAnnual report (10-K) Feb 27, 2026
    Quarterly report (10-Q) Aug 7, 2026
    Proxy statement (DEF 14A) Apr 6, 2026
    Latest 8-K (8-K) Aug 7, 2026

Securities registered for trading

ClassSymbolExchange
Common stock, $0.001 par valueTMCIThe Nasdaq Global Select Market

From the cover page of the 10-K filed Feb 27, 2026 (Section 12(b) of the Exchange Act).10

Risk factors and legal proceedings

The risks TREACE MEDICAL CONCEPTS, INC. names in Item 1A of its 10-K filed Feb 27, 2026: 65 risks under these headings, as written.10

  • Risks Related to Our Financial Condition and Capital Requirements
  • We have incurred losses in the past and may be unable to achieve or sustain profitability in the future.
  • If we are unable to successfully market and sell our existing and new products, we may be unable to maintain and grow our revenue or earnings as anticipated, which may have a material adverse effect on our results of operations.
  • The terms of our new loan agreements require us to meet certain operating and financial covenants, place restrictions on our operating and financial flexibility, and expose us to the risk of being declared in default and having the full loan balance accelerated.
  • We have a limited operating history and face an evolving pace of growth. If we fail to scale our business effectively, our business could be materially and adversely affected.
  • We may need additional capital in the future to fund operations or to make opportunistic acquisitions, and such additional capital, if needed, may not be available on acceptable terms, if at all.
  • Risks Related to Our Business and Industry
  • We operate in a very competitive business environment, and if we are unable to compete successfully against our existing or potential competitors, our business, financial condition, and results of operations may be adversely affected.
  • Our sales have been and may continue to be adversely affected due to larger competitors utilizing their established contracts and dominant market positions in unrelated service lines to induce customers to buy their bunion correction systems instead of our products through purchase commitments, rebate payments and/or volume-based pricing agreements.
  • Our revenue is primarily generated from sales of the Lapiplasty System, and we are, therefore, highly dependent on it and the market acceptance and growth of our other existing and new products for our success.
  • If we fail to continue to develop and retain an effective direct sales force and sales management teams, it could negatively impact our revenues, and we may not generate sufficient revenue to achieve profitability.
  • We rely in part on independent sales agencies and stocking distributors to sell our products to customers, and if we are unable to maintain an effective network of independent sales agencies and stocking distributors, we may not achieve our anticipated revenue growth.
The other 55 risks
  • Discounted sales of products in advance to hospitals and ambulatory surgery centers and stocking distributors may delay reorders and decrease revenue in subsequent periods and have reduced and may continue to reduce our gross margins.
  • Our long-term growth depends on our ability to enhance our products and develop and commercialize additional products in a timely manner. If we cannot innovate, we may not be able to develop or exploit new products or procedures in time to remain competitive.
  • The seasonality of our business creates variance in our quarterly revenue, which makes it difficult to compare or forecast our financial results.
  • Industry trends have resulted in increased downward pricing pressure on medical services and products, which may affect our ability to sell our products at prices necessary to support our current business strategy.
  • Our business plan relies on certain assumptions about the market for our products; however, the size and expected growth of our addressable market has not been established with precision and may be smaller than we estimate, and even if the addressable market is as large as we have estimated, we may not be able to capture additional market share.
  • Product liability lawsuits, warranty claims and quality system problems could harm our business.
  • Our employees and independent contractors, including independent sales representatives and other consultants, service providers and other vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have an adverse effect on our results of operations.
  • Infectious disease outbreaks have adversely affected, and in the future may adversely affect, our business, financial condition and results of operations.
  • Risks Related to Administrative, Organizational and Commercial Operations and Growth
  • If hospitals, ambulatory surgery centers and other health care facilities do not approve or curtail the use of our products, our sales may not increase or may decline.
  • We may be unable to successfully demonstrate to surgeons or key opinion leaders the merits of our products and technologies compared to those of our competitors or to address the evolving surgeons' and key opinion leaders' preference for minimally invasive osteotomies and MTP fusions, which may make it difficult to establish our products and technologies as a standard of care and continue achieving market acceptance.
  • Our inability to maintain contractual relationships with health care professionals could have a negative impact on our research and development and medical education programs.
  • If adequate levels of reimbursement from third-party payors for procedures using our products are not obtained or maintained, surgeons and patients may be reluctant to use our products, we may find it necessary to reduce the price for our products, and our business will suffer.
  • If we experience problems with, or are required to change, our suppliers or manufacturers, we may be unable to meet customer orders for our products in a timely manner or within our budget.
  • If surgeons fail to safely and appropriately use our products, or if we are unable to train podiatrists and orthopaedic surgeons on the safe and appropriate use of our products, we may be unable to achieve our expected sales, growth or profitability.
  • Our brand and reputation may be diminished due to real or perceived issues with our procedures or our products, which could have an adverse effect on our business, financial condition, results of operations and prospects.
  • The loss of any member on our executive management team or our inability to attract and retain highly skilled members of our sales management and marketing teams and engineers could have a material adverse effect on our business, financial condition and results of operations.
  • Performance issues, service interruptions or price increases by shipping carriers could adversely affect our business and harm our reputation and ability to provide our products on a timely basis.
  • Any future international expansion will subject us to additional costs and risks that may have a material adverse effect on our business, financial condition and results of operations.
  • Risks Related to Our Intellectual Property
  • Our competitors have and could continue to develop and commercialize products similar to ours even though we have patents and other intellectual property rights protecting our products, and if we are unable to enforce these rights successfully, we may be unable to gain significant market share and to operate our business profitably.
  • We are and may be involved in additional lawsuits or other proceedings to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful. If we were to lose intellectual property lawsuits or other proceedings, our intellectual property rights would be impaired and, if we were found to impair the intellectual property rights of others, a court could require us to pay significant damages and/or prevent us from selling our products.
  • We have been and may continue to be subject to claims that we or our employees have misappropriated the intellectual property of a third party, including trade secrets or know-how, or are in breach of non-competition or non-solicitation agreements with our competitors and third parties may claim an ownership interest in intellectual property we regard as our own.
  • Continuing to obtain and maintain patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • If we fail to execute invention assignment agreements with our employees and contractors involved in the development of intellectual property or are unable to protect the confidentiality of our trade secrets, the value of our products and our business and competitive position could be harmed.
  • Patent terms may not be sufficient to effectively protect our products and business for an adequate period of time.
  • Changes in U.S. patent laws may limit our ability to obtain, defend and/or enforce our patents.
  • We may be unable to enforce our intellectual property rights throughout the world.
  • If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest, and our competitive position may be harmed.
  • Risks Related to Regulatory Matters
  • We are subject to substantial government regulation that could have a material adverse effect on our business.
  • Our relationships with customers, physicians, other health care providers, and third-party payors are subject to federal and state health care fraud and abuse laws, false claims laws, physician payment transparency laws and other health care laws and regulations. If we or our employees, independent contractors, consultants, service providers, or vendors violate these laws, we could face substantial penalties.
  • We may not receive, or may be delayed in receiving, the necessary clearances or approvals for our future products or modifications to our current products, and failure to timely obtain necessary clearances or approvals for our future products or modifications to our current products would adversely affect our ability to grow our business.
  • Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market.
  • Legislative or regulatory reforms may have a material adverse effect on us.
  • Our products must be manufactured in accordance with federal and state quality regulations and are subject to FDA inspection, and our failure to comply with these regulations could result in fines, product recalls, product liability claims, limits on future product clearances, reputational damage and other adverse impacts.
  • The misuse or off-label use of our products may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
  • Our products may cause or contribute to adverse medical events or be subject to failures or malfunctions that we are required to report to the FDA, and if we fail to do so, we could be subject to sanctions that could harm our reputation, business, financial condition and results of operations. The discovery of serious safety or efficacy issues with our products, or a recall or a market withdrawal of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact on us.
  • Actual or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements could adversely affect our business, results of operations and financial condition.
  • Our information technology systems may be subject to breaches, cyber-attacks or other disruptions that could, among other adverse consequences, cause us to violate laws, regulations and contractual obligations, could impair our ability to operate our business and could adversely affect our business, results of operations, financial condition, cash flows, reputation or competitive position.
  • The clinical study process is lengthy and expensive with uncertain outcomes. We have limited long-term data regarding the safety and efficacy of our products. Results of earlier studies may not be predictive of future clinical trial results, or the safety or efficacy profile for such products.
  • Risks Related to Ownership of Our Common Stock
  • The market price of our common stock may be volatile and fluctuate substantially.
  • If we must reduce our previously-stated annual financial guidance or if our operating and financial performance in any given period does not meet any guidance that we provide to the public, the market price of our common stock may decline, as it has in the past.
  • If we do raise additional capital, stockholders may be subject to dilution.
  • We may seek to grow our business through acquisitions or investments, strategic alliances, or other initiatives, which could have a material adverse effect on our operating results, dilute our stockholders' ownership, increase our debt or cause us to incur significant expense.
  • If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our stock could decline.
  • We have in the past and may in the future be subject to short-selling strategies that may drive down the market price of our common stock and negatively affect our reputation.
  • We have not paid dividends in the past and do not expect to pay dividends in the future, and, as a result, any return on investment may be limited to appreciation in the price of our stock.
  • Insiders will continue to have substantial influence over us, which could limit your ability to affect the outcome of key transactions, including a change of control.
  • Our business could be negatively impacted by corporate citizenship and ESG matters and/or our reporting of such matters.
  • Anti-takeover provisions in our amended and restated certificate of incorporation and bylaws, and Delaware law, could discourage a change in control of our company or a change in our management.
  • Our amended and restated certificate of incorporation and amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the sole and exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders' abilities to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • General Risk Factors
  • Macroeconomic conditions, including inflation, interest rates, softening consumer sentiment, higher insurance costs, and tariff policies, may affect demand for elective procedures, reduce gross margins, increase inventory costs, and otherwise adversely affect our business, financial condition and results of operations.
  • We, along with our suppliers, are dependent on various information technology systems, and failures of, interruptions to, or unauthorized tampering of those systems could have a material adverse effect on our business.
  • Our operations are vulnerable to interruption or loss due to natural or other disasters, power loss, strikes and other events beyond our control.
  • Failure to establish and maintain an effective system of internal controls could result in material misstatements of our financial statements or cause us to fail to meet our reporting obligations or fail to prevent fraud in which case, our stockholders could lose confidence in our financial reporting and the market price of our common stock could decline.
  • Changes in tax laws or regulations that are applied adversely to us or our customers may seriously harm our business.
  • Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.

Legal proceedings

Except as described below, we are not a party to any legal proceedings which we believe would have a material adverse effect on our business or results of operations. From time to time, we may become involved in various legal proceedings that arise in the ordinary course of our business.

On April 11, 2025, a shareholder filed a class action complaint in the United States District Court for the Middle District of Florida (captioned McCluney v. Treace Medical Concepts, Inc. et al. Case No. 3:25-cv-00390-WWB-PDB) against us and certain of our officers on behalf of all persons who purchased or otherwise acquired our stock between May 8, 2023 and May 7, 2024 alleging that we and certain of our current executives violated the federal securities laws by making false or misleading statements and failing to disclose material adverse facts about our business, operations and prospects. Specifically, the complaint alleges that we failed to disclose the impact of competition on demand for and utilization of our products and the need to accelerate our plans to offer a new osteotomy product and that our positive statements about our business, operations, and prospects were materially misleading and/or lacked a reasonable basis. The plaintiffs seek unspecified monetary damages, costs, and attorneys’ fees. On July 1, 2025, the court appointed the lead plaintiff and lead counsel. The plaintiffs filed an amended complaint on July 31, 2025, and we filed a motion to dismiss on September 5, 2025. The action is in the preliminary stage. We dispute the allegations in the complaint and intend to defend against this complaint vigorously. Based on the preliminary nature of the proceedings in this action, the outcome remains uncertain, and we cannot reasonably estimate the potential impact, if any, on our business or financial statements at this time. We are insured for Directors and Officers liability for amounts in excess of the retention and up to the policy limits.

The opening of Item 3, Legal Proceedings.10

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