Treace Announces Interim 3-Year ALIGN3D Clinical Study Data at the 2024 ACFAS Scientific Conference Demonstrating Sustained, Positive Outcomes of the Lapiplasty Procedure

PONTE VEDRA, Fla., Feb. 02, 2024 (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 through its flagship Lapiplasty and Adductoplasty Procedures, today announced three-year interim clinical data from its ALIGN3D post-market study supporting the use of the Lapiplasty procedure for treating bunions were presented in a podium presentation at the 2024 American College of Foot and Ankle Surgeons (“ACFAS”) Annual Scientific Conference.

“This interim data from the ALIGN3D study showed consistent, positive radiographic and patient-reported outcomes maintained at three years,” stated Daniel Hatch, DPM, of the Foot and Ankle Center of the Rockies in Greeley, Colorado and presenting surgeon.¹ “Importantly, by providing a comprehensive, 3D correction of the bunion deformity, study participants were able to quickly return to protected weightbearing in approximately eight days and get back to their active lifestyle with a low rate of clinical complications and recurrence.” 

“We are pleased that this three-year data from our prospective, multicenter ALIGN3D study continues to demonstrate sustained, successful patient outcomes from our proprietary Lapiplasty Procedure,” said John T. Treace, CEO, Founder and Board Member of Treace. “We believe these three-year clinical study results set a high standard for a commercial bunion technology and one that further differentiates Lapiplasty in the marketplace with our surgeons and their patients. We look forward to continuing to expand our market-leading body of clinical evidence, as we advance the standard of care for bunion surgery.”

ALIGN3D Clinical Study

The scientific presentation, titled “Three-Year Analyses of a Five-Year Prospective Multicenter Study Assessing Radiographic and Patient Reported Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing,” featured interim data from the prospective, five-year, multicenter ALIGN3D clinical study with 173 enrolled patients and demonstrated positive results following the Lapiplasty Procedure, which included: 

• Early return to weight bearing in a walking boot at an average 8.4 days;
• Low radiographic recurrence rates at latest visit of 0.9% using HVA>20° (1 out of 115) and 5.2% using HVA>15° (6 out of 115);
• 81% reduction in pain measured using the Visual Analog Scale (“VAS”) at 24 months (n=156);
• 86% and 85% improvement in walking/standing and social interaction patient-reported quality of life measures, respectively, using the Manchester-Oxford Foot Questionnaire (“MOxFQ”) through latest subject visit [mean 40.5 months (n=118)];
• Significant improvement in patient reported outcomes across all Patient-Reported Outcomes Measurement Information System (“PROMIS”) domains over time through latest subject visit [mean 40.5 months (n=113)]; and
• Low symptomatic non-union rate of 1.8% (3 out of 173).

The ALIGN3D study is ongoing, and patients are expected to be followed for five years. The Company has submitted its primary endpoint ALIGN3D manuscript to a top-tier, peer-reviewed foot and ankle journal at the end of 2023 and expects publication in 2024.