Treace Highlights New Product Innovations and Updated Positive Clinical Study Data at the 2025 American Orthopaedic Foot & Ankle Society Annual Meeting

Rhea-AI Summary

Treace Medical Concepts (NASDAQ:TMCI), a medical technology company focused on bunion treatment, announced significant product innovations and clinical study updates at the 2025 AOFAS Annual Meeting. The company unveiled several new technologies including Nanoplasty®, Percuplasty™, SpeedMTP®, and IntelliGuide™ PSI, expanding their bunion treatment portfolio.

The ALIGN3D™ clinical study data showed promising results with low radiographic recurrence rates of 7.7% at 48 months and 4.8% at 60 months. The MTA3D™ study demonstrated early weight-bearing capabilities averaging 7.9 days and significant improvements in both midfoot and 3D bunion deformity correction at 12 months.

Positive

• Strong clinical data showing low recurrence rates of 4.8% at 60 months for Lapiplasty® Procedure
• Successful expansion of product portfolio with multiple new technologies
• Early weight-bearing capabilities demonstrated in both clinical studies (7.9-8.4 days)
• Significant improvements in patient-reported pain scores and outcomes

Negative

• Clinical studies still interim with incomplete patient follow-up (146/173 patients in ALIGN3D™, 33/60 in MTA3D™)

Insights

Medical Device Industry Analyst

Treace expands bunion product portfolio with 6+ innovations backed by strong clinical data showing durability and efficacy.

Treace Medical's announcement represents a significant expansion of their bunion correction portfolio with multiple new minimally invasive systems. The company is building upon their flagship Lapiplasty® and Adductoplasty® platforms with innovations like Nanoplasty®, Percuplasty™, and SpeedMTP® that address the full spectrum of bunion surgeries from different approaches.

The most compelling aspects are the two new minimally invasive surgical (MIS) platforms - Nanoplasty® and Percuplasty™ - which allow surgeons to perform 3D bunion corrections through extremely small incisions (1.5cm and 0.5cm respectively). These systems appear designed to overcome traditional MIS adoption barriers with guided instrumentation and enhanced fixation strength.

The updated clinical data from their multi-center studies provides substantial validation. The ALIGN3D™ study shows impressive 4-5 year durability with low recurrence rates of 7.7% at 48 months and just 4.8% at 60 months. This long-term efficacy data is critical for physician adoption, as bunion recurrence has historically been a significant clinical challenge.

Both studies demonstrated early weight-bearing capability (8.4 and 7.9 days respectively), which is a meaningful patient benefit compared to traditional approaches requiring extended non-weight bearing periods. The continued improvement in pain and patient-reported outcomes at extended timepoints further validates their technological approach to bunion correction.

The company is executing a comprehensive portfolio expansion strategy that includes MIS approaches, fusion options for arthritic patients, and workflow-enhancing technologies like 3D-printed patient-specific instrumentation - all supported by continued clinical evidence generation.

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:

• Nanoplasty^® MIS 3D Bunion Correction: The Nanoplasty^® procedure is designed to accelerate surgeon access to 3D MIS osteotomies and is performed through a single 1.5cm hidden incision on the side of the foot. Nanoplasty^® is a disruptive system for rapid adoption of MIS through a guided saw cut (no burr learning curve is required), instrumentation to dial-in the 3D correction, and the predictable strength of locking fixation designed to enable rapid weightbearing for patients.
• Percuplasty^™ Percutaneous 3D Bunion Correction: The Percuplasty^™ procedure is our second system designed to accelerate surgeon access to MIS osteotomies. Performed through 0.5cm percutaneous incisions, Percuplasty^™ is designed to bring a more efficient and predictable approach to MIS surgeons through self-drilling screw implants and elegant instrumentation that dials in the 3D correction and accurately targets implant placement.
• Percuplasty^™ MIS Power System: A specialized and scalable “plug and play” power drill that operates the single-use cutting burrs used in the Percuplasty™ procedure as well as a broad range of other minimally invasive procedures throughout the foot.
• SpeedMTP^® MTP Fusion System: SpeedMTP^® extends the benefits of SpeedPlate^® technology to provide surgeons with a fusion option to address bunion patients with arthritic great toe (MTP) joints. SpeedMTP^® combines our market-leading SpeedPlate^® dynamic compression fixation technology with our Fastpitch^® locking screws to rapidly deliver an ultra-low profile implant with high-strength and stability.
• IntelliGuide^™ PSI: IntelliGuide^™ PSI is a platform technology delivering personalized 3D-printed cut guides for Lapiplasty^® and Adductoplasty^® procedures. IntelliGuide^™ delivers intelligent pre-op 3D planning and titanium 3D-printed guides with integrated 3D correction for a streamlined surgical workflow.
• Micro-Lapiplasty^® Minimally Invasive System: The Micro-Lapiplasty^® system features specialized MIS instrumentation and the new SpeedPlate^® MicroQuad^™ implant, delivering robust, stable fixation through small incision approaches.
• New complementary technologies will also be featured, including SpeedAkin^™ Anatomic Compression Implant used in Akin osteotomy procedures, as well biologics commonly used in foot and ankle fusion procedures, including CortiFuse^™ Flowable Cortical Fibers and Treace’s line of procedure-specific Allograft Wedges.
  

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:

• Early return to weight bearing in a walking boot at an average 8.4 days;
• Low radiographic recurrence rates using HVA>15° of 7.7% (11 of 143 patients) at 48 months and 4.8% (4 of 84 patients) at 60 months; and
• Continued significant improvement in pain and patient-reported scores (VAS, MOxFQ, and PROMIS) at 60 months.
  

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:

• Early return to weight bearing in a walking boot at an average 7.9 days;
• Clinically significant improvement in radiographic measures of both midfoot (metatarsus adductus) and 3D bunion deformity correction at 12 months; and
• Clinically significant reduction in pain and patient-reported scores (VAS, MOxFQ, and PROMIS) at 12 months.
  

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
mhair@treace.net
(904) 373-5940

Investors:
Gilmartin Group
Philip Trip Taylor
IR@treace.net

FAQ

What are the latest clinical results for Treace's Lapiplasty® Procedure?

The ALIGN3D™ study showed low radiographic recurrence rates of 7.7% at 48 months and 4.8% at 60 months, with patients returning to weight bearing in about 8.4 days.

What new products did Treace Medical (TMCI) announce at AOFAS 2025?

Treace announced Nanoplasty®, Percuplasty™, SpeedMTP®, IntelliGuide™ PSI, and Micro-Lapiplasty® systems, expanding their bunion treatment portfolio.

What are the interim results of the MTA3D™ Adductoplasty® study?

The study showed patients returning to weight bearing in 7.9 days on average, with significant improvements in both midfoot and 3D bunion deformity correction at 12 months.

How does the Nanoplasty® procedure differ from traditional bunion surgery?

Nanoplasty® is performed through a single 1.5cm hidden incision and features guided saw cuts, 3D correction instrumentation, and locking fixation for rapid weight bearing.

What is the clinical evidence supporting Treace's bunion correction procedures?

Two major clinical studies (ALIGN3D™ and MTA3D™) demonstrate early weight bearing, low recurrence rates, and significant improvement in pain and patient-reported scores across multiple years of follow-up.