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

Core Insights - Treace Medical Concepts, Inc. announced positive four-year interim results from its ALIGN3D™ study, demonstrating the effectiveness of the Lapiplasty Procedure for bunion treatment [1][2][3] Company Overview - Treace Medical Concepts is focused on advancing surgical management standards for bunions and related midfoot deformities, with an estimated 1.1 million annual surgical candidates in the U.S. [5][6] - The company has developed the patented Lapiplasty 3D Bunion Correction System, which addresses the root cause of bunions by correcting deformities in three planes [6] Clinical Study Details - The ALIGN3D™ study is a multicenter, prospective clinical study evaluating the Lapiplasty Procedure's outcomes, with 173 patients enrolled across seven clinical sites [3] - Key findings from the study include: - Early return to protected weight-bearing at an average of 7.7 days and return to athletic shoes at 6.5 weeks [5] - Low radiographic recurrence rates of 0.8% for HVA>20° and 8.4% for HVA>15° at 48 months [5] - Significant improvements in pain and patient-reported outcomes, with an 81% improvement in pain and 89% improvement in walking/standing [5] Market Positioning - The publication of the ALIGN3D™ study results is expected to enhance the market differentiation of the Lapiplasty Procedure among surgeons and patients [2] - The company aims to expand its clinical evidence base and continue improving the standard of care for bunion surgery [2]