TMCI - Treace Announces Interim 3-Year ALIGN3D™ Clinical Study Data at the 2024 ACFAS Scientific Conference Demonstrating Sustained Positive Outcomes of the Lapiplasty® Procedure | Benzinga
PONTE VEDRA, Fla., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. ("Treace" or the "Company") (NASDAQ: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™ ...