Further Expands Market Opportunity to Include Hammertoe Correction

Company Receives 510(k) Clearance for Second-Generation SpeedPlate™ Implant Fixation Platform Ahead of Full Market Launch in Fourth Quarter of 2023

PONTE VEDRA, Fla., Sept. 11, 2023 (GLOBE NEWSWIRE) -- 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) through its Lapiplasty^® 3D Bunion Correction™ Procedure, is pleased to announce the recent limited market release of several new complementary technologies for treating bunions and bunion-related procedures. These products will be available in limited market release in the U.S. through Treace’s bunion-focused sales team with a full market release expected in the fourth quarter of 2023.

The Company’s new Hammertoe PEEK Fixation System is designed to address hammertoe, claw toe and mallet toe deformities. Comprised of a convenient sterile-packed implant and instrument kit, the PEEK implant offers radiolucency and mechanical properties comparable to bone^1,2, as well as a cannulated system to facilitate streamlined insertion and allow for accurate implant placement.   Hammertoes often present concomitantly with bunions and are one of the most prevalent deformities in the foot resulting in approximately 700,000 surgical repairs per year in the U.S.³ 

In addition to the Hammertoe PEEK Fixation System, the LapiTome™ and RazorTome™ Osteotomes are two new sterile, single-use instruments that are designed to facilitate more efficient removal and release of bone slices and soft tissues in Lapiplasty^® and Adductoplasty^® cases. These new devices expand the Company’s current offering of SpeedRelease™ and TriTome™ sterile instruments, which were commercialized last year.

“In addition to the large and underpenetrated market for treating bunions, these new technologies are expected to meaningfully expand our addressable market opportunity to include additional procedures that complement our proprietary Lapiplasty^® and Adductoplasty^® procedures,” said John T. Treace, CEO, Founder and Board Member of Treace. “We are also looking forward to the upcoming full market launch of our second-generation SpeedPlate™ fixation platform in the fourth quarter, which will feature a portfolio of compressing anatomic implants, complemented by Micro-Lapiplasty^® minimally invasive instrumentation. Once fully available, these new product introductions are expected to begin contributing to our growth profile in the fourth quarter with a more meaningful contribution expected in 2024 and beyond.”    

All of these new product solutions will be on display at Treace’s exhibit booth (#119) at the upcoming American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting 2023 in Louisville, Kentucky from September 20-23, 2023.

More information on Treace’s products can be found at www.lapiplasty.com.

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 expectation that these new technologies and product introductions will meaningfully expand its addressable market opportunity and will significantly contribute to its growth profile in the fourth quarter and beyond. 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, and any subsequent Quarterly Report on Form 10-Q or Current Report 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.

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 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.

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

1. Treace Medical Concepts data on file.
2. Dong, X. N., et al. (2012). Journal of Biomechanics, 45(16), 2829–2834.
3. iData Research.
   

Contacts:

Treace Medical Concepts, Inc.
Julie Dewey, IRC
Chief Communications & Investor Relations Officer
jddewey@treace.com | 209-613-6945