PONTE VERDE, Fla., Sept. 10, 2025 (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 bunions and related midfoot deformities, today announced it will highlight new product innovations and present new interim data for the ALIGN3D™ and MTA3D™ clinical studies at the American Orthopaedic Foot & Ankle Society (AOFAS) Annual Meeting 2025 in Savannah, Georgia from September 10-13, 2025.
“We are excited to highlight the full commercial release of our expanded bunion portfolio at AOFAS, which now provides surgeons with best-in-class solutions to address the entire spectrum of bunion surgery,” said John T. Treace, CEO, Founder and Chairman of Treace. “With the addition of Nanoplasty®, Percuplasty™, SpeedMTP®, and IntelliGuide™ PSI, we are building on the success of Lapiplasty® and Adductoplasty® to advance our Company’s focused mission to improve surgical outcomes for bunion patients. We also look forward to sharing compelling clinical evidence from prospective, multicenter studies that continues to differentiate our flagship Lapiplasty® and Adductoplasty® procedures.”
Treace will feature clinical data, several new technologies at its AOFAS exhibit booth and host surgeon training events on these innovations, including:
ALIGN3D™ Lapiplasty® Clinical Study Presentation
The ALIGN3D™ Lapiplasty® clinical study podium presentation, “Four- and Five- Year Analysis of a Prospective Multicenter Study Assessing Radiographic Recurrence and Patient Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing”, will be presented by Daniel Farber, MD, Lehigh Valley Orthopedic Institute (Bethlehem, PA).
The featured interim data from the prospective, five-year, multicenter ALIGN3D™ clinical study included interim analysis of 146 of 173 total patients treated with at least four years of follow-up following the Lapiplasty® Procedure. The data showed:
MTA3D™ Adductoplasty® Clinical Study Presentation
Interim data from the MTA3D™ Adductoplasty® study will also be presented AOFAS in a poster presentation titled, “Interim 1-Year Analysis of a Multicenter Prospective Study Assessing Radiographic and Patient Outcomes Following Combined Metatarsus Adductus and Hallux Valgus Correction with Early Weightbearing” by Mark Easley, MD of Duke University (Durham, NC).
The featured interim data from the prospective, five-year, multicenter MTA3D™ clinical study of the patients undergoing both the Adductoplasty® and Lapiplasty® procedures included interim analysis of 33 of 60 patients treated with at least one year follow-up. The data showed:
All AOFAS presentations, which include additional details such as patient demographics, inclusion/exclusion criteria, and complications reported in the studies, will be available on Treace’s website at www.lapiplasty.com/surgeons/journal-publications/ following their presentations at AOFAS. More information on Treace’s products can be found at www.lapiplasty.com.
About the ALIGN3D™ Clinical Study
The ALIGN3D™ clinical study is a prospective, multicenter, post-market clinical study designed to evaluate outcomes of the Lapiplasty® 3D Bunion Correction® procedure in the surgical management of symptomatic hallux valgus. The study evaluates consistency and reliability of correction of all three dimensions of the bunion deformity with the Lapiplasty® Procedure, as well as maintenance of such correction following accelerated return to weight-bearing, initially in a walking boot. The primary effectiveness endpoint is radiographic recurrence of the hallux valgus deformity. Key secondary endpoints include change in three-dimensional radiographic alignment; clinical radiographic healing; time to start of weight-bearing in a boot and in shoes; pain; quality of life; and range of motion of the big toe joint. The study enrolled 173 patients, aged 14 to 58 years, at 7 clinical sites in the United States with 13 participating surgeons. Final patient follow-up for the primary endpoint was completed in the first half of 2023, and study completion with 5-year data is expected in 2026.
About the MTA3D™ Clinical Study
The MTA3D™ clinical study is a prospective, multicenter, post-market study designed to evaluate the combined Adductoplasty® and Lapiplasty® Procedures for patients in need of metatarsus adductus and hallux valgus corrective surgery. The study will evaluate for consistent, maintained radiographic correction and patient reported outcome scores following combined Adductoplasty® and Lapiplasty® procedures. The primary effectiveness endpoint is maintenance of radiographic correction of the hallux valgus and metatarsus adductus deformities. Key secondary endpoints include clinical radiographic healing, time to start weight-bearing in a boot and shoes; pain; quality of life; and range of motion of the big toe joint. The study will treat up to 80 patients, aged 14 years and up, at up to 13 clinical sites in the United States. Patients will be followed for 5 years following the procedures.
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 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 bunion surgeons and address the four classes of bunions, Treace introduced its Adductoplasty® Midfoot Correction System, designed for reproducible surgical correction of midfoot deformities, the SpeedMTP® Rapid Compression Implant for addressing bunions through big toe joint fusions, and two systems for minimally invasive osteotomy surgeries: the Nanoplasty® 3D Minimally Invasive Bunion Correction System and the Percuplasty™ Percutaneous 3D Bunion Correction System. Treace continues to expand its footprint in the foot and ankle market with the introduction of its SpeedPlate® Rapid Compression Implants, an innovative fixation platform with broad versatility across Lapiplasty®, Adductoplasty® and SpeedMTP® procedures, as well as other common bone fusion procedures of the foot. 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
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(904) 373-5940
Investors:
Gilmartin Group
Philip Trip Taylor
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