Treace Medical announces interim three-year ALIGN3D study data

Treace Medical Concepts 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 Annual Scientific Conference. 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 HVAgreater than20 degrees and 5.2% using HVAgreater than15 degrees ; 81% reduction in pain measured using the Visual Analog Scale at 24 months; 86% and 85% improvement in walking/standing and social interaction patient-reported quality of life measures, respectively, using the Manchester-Oxford Foot Questionnaire through latest subject visit; Significant improvement in patient reported outcomes across all Patient-Reported Outcomes Measurement Information System domains over time through latest subject visit; and Low symptomatic non-union rate of 1.8%. 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. In addition to the ALIGN3D data, interim data from the Company’s Mini3D prospective, multicenter study was presented in a poster presentation at ACFAS titled “Interim Analysis of a Prospective Multicenter Study Assessing Radiographic and Patient Outcomes Following a Mini-Open Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing.” This poster presentation included data from 103 enrolled patients and demonstrated favorable clinical and patient-reported outcomes with a mini-incision approach at an average follow-up time of 7.4 months post-procedure, including: Early return to weight-bearing in a walking boot at an average 7.8 days; Maintenance of radiographic correction through 12 months; Significant reduction in pain and significant improvement in patient reported outcomes through 12 months; and Favorable scores for scar quality using the Patient and Observer Scar Assessment Scale.