Treace Announces Peer-Reviewed Publication of Four-Year Results of the ALIGN3D™ Lapiplasty® Multicenter Prospective Clinical Study

Rhea-AI Summary

Treace Medical Concepts (NASDAQ:TMCI), a medical technology company specializing in bunion surgery solutions, has published four-year interim results from its ALIGN3D™ multicenter prospective study in the Journal of Foot & Ankle Surgery. The study, which followed 139 of 173 patients, demonstrated strong outcomes for the Lapiplasty® Procedure.

Key findings include an early return to protected weight bearing at 7.7 days, transition to athletic shoes at 6.5 weeks, and notably low recurrence rates of 0.8% using HVA>20° and 8.4% using HVA>15° at 48 months. Patient outcomes showed significant improvements, with an 81% reduction in pain and 89% improvement in walking/standing capabilities through the 48-month period.

Positive

• Low radiographic recurrence rates of 0.8% using HVA>20° at 48 months
• Significant patient improvements with 81% pain reduction and 89% walking/standing improvement
• Quick recovery with weight bearing at 7.7 days and return to athletic shoes at 6.5 weeks
• Results demonstrate sustained successful outcomes over a long-term 4-year period

Negative

• None.

Insights

Medical Technology Analyst

Treace's Lapiplasty shows strong 4-year clinical results with very low recurrence rates, validating their bunion correction approach.

The publication of four-year interim results from Treace's ALIGN3D multicenter prospective study represents significant clinical validation for their Lapiplasty Procedure. The data demonstrates remarkably low recurrence rates of just 0.8% (using HVA>20°) and 8.4% (using HVA>15°) at the 48-month mark - metrics that are crucial for both surgeon adoption and patient confidence.

What makes these results particularly compelling is the durability of correction. Bunion recurrence is a well-known challenge with traditional osteotomy procedures, often requiring revision surgeries. The study also documents impressive functional improvements with an 81% reduction in pain and 89% improvement in walking/standing functionality through the MOxFQ scoring system.

From a clinical adoption perspective, the early weight-bearing data (average 7.7 days) and return to athletic shoes (6.5 weeks) addresses a key patient concern about recovery time. The robust sample size of 139 patients with four-year follow-up from the original 173 participants provides statistical credibility to these findings.

This peer-reviewed publication in the Journal of Foot & Ankle Surgery establishes a substantial evidence base that Treace can leverage to drive physician education and adoption. For medical technology companies, this level of clinical validation is often a critical inflection point that helps transition a procedure from novel technology to standard of care, particularly when published in respected specialty journals with long-term data.

PONTE VEDRA, Fla., Aug. 05, 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 the peer-reviewed publication of the four-year interim results from its ALIGN3D™ multicenter prospective study demonstrating positive clinical and radiographic outcomes of the Lapiplasty^® Procedure in the Journal of Foot & Ankle Surgery.

The published results entitled, “Four-Year Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing for Hallux Valgus: A Multicenter Prospective Study” include interim data on 139 of 173 study patients treated with at least four years of follow-up from Lapiplasty^® in the prospective, five-year, multicenter ALIGN3D™ clinical study. The data showed:

• Early return to protected weight bearing at an average of 7.7 days and return to athletic shoes at 6.5 weeks;
• Low radiographic recurrence rates of 0.8% using HVA>20° and 8.4% using HVA>15° at 48 months; and
• Continued significant improvement in pain and patient-reported outcome scores (VAS, MOxFQ and PROMIS), including an 81% improvement in pain and 89% improvement in walking/standing on the MOxFQ scoring system through 48 months.
  

John T. Treace, CEO, Founder and Chairman of Treace said, “We are pleased to announce this new peer-reviewed publication from our flagship ALIGN3D™ study demonstrating sustained, successful patient outcomes from our proprietary Lapiplasty^® Procedure out to four years. This long-term, multicenter, prospective study sets a high standard for a commercial bunion technology and further differentiates Lapiplasty^® in the marketplace with surgeons and patients. We look forward to expanding our market-leading body of clinical evidence as we continue to focus on advancing the standard of care for bunion surgery.”

“These interim results from the ALIGN3D™ study showed consistent, positive radiographic and patient-reported outcomes maintained at four years,” stated Daniel Hatch, DPM, of the Foot and Ankle Center of the Rockies in Greeley, Colorado and publication author.¹ “Importantly, by consistently performing a comprehensive 3D correction of the bunion deformity, the recurrence rates with the Lapiplasty^® Procedure are very low and compare favorably to long-term studies of traditional osteotomy with high rates of recurrence.²”

The full publication, which includes additional details such as patient demographics, inclusion/exclusion criteria, and complications reported in the studies, is available on the Journal of Foot & Ankle Surgery website https://www.jfas.org/article/S1067-2516(25)00210-8/fulltext.  

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.

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 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, as well as 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.

¹ Daniel Hatch, DPM is a member of Treace’s Surgeon Advisory Board and a paid consultant for Treace.

² Lalevee M, et al. Recurrence Rates With Longer-Term Follow-up After Hallux Valgus Surgical Treatment With Distal Metatarsal Osteotomies: A Systematic Review and Meta-analysis. Foot & Ankle International. 2023;44:210-222.

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 4-year clinical results of Treace Medical's ALIGN3D study for Lapiplasty?

The study showed 0.8% recurrence rates (HVA>20°), 81% pain reduction, and 89% improvement in walking/standing through 48 months, with patients returning to weight bearing at 7.7 days.

How effective is the Lapiplasty Procedure for bunion treatment according to the latest study?

The procedure showed high effectiveness with low recurrence rates of 0.8% using HVA>20° at 48 months, significantly better than traditional osteotomy procedures which have higher recurrence rates.

What is the recovery time for Treace Medical's Lapiplasty Procedure?

Patients returned to protected weight bearing at an average of 7.7 days and were able to wear athletic shoes at 6.5 weeks post-procedure.

How many patients were included in TMCI's ALIGN3D clinical study?

The study included 139 of 173 study patients with at least four years of follow-up from the Lapiplasty® Procedure.

What improvements in pain did patients experience with the Lapiplasty Procedure?

Patients experienced an 81% improvement in pain and 89% improvement in walking/standing on the MOxFQ scoring system through 48 months.