Core Insights - Treace Medical Concepts, Inc. is showcasing new product innovations and presenting interim data from the ALIGN3D and MTA3D clinical studies at the AOFAS Annual Meeting 2025 [1][2] Product Innovations - The company is highlighting the full commercial release of its expanded bunion portfolio, which includes new technologies such as Nanoplasty, Percuplasty, SpeedMTP, and IntelliGuide PSI, aimed at improving surgical outcomes for bunion patients [2][4] - The Nanoplasty procedure allows for 3D minimally invasive osteotomies through a single 1.5cm incision, while Percuplasty utilizes 0.5cm percutaneous incisions for a more efficient approach [4] - SpeedMTP provides a fusion option for bunion patients with arthritic great toe joints, combining advanced fixation technology for stability [4] - IntelliGuide PSI offers personalized 3D-printed cut guides for enhanced surgical workflow [4] Clinical Study Presentations - The ALIGN3D clinical study presented interim data showing early return to weight bearing in an average of 8.4 days and low radiographic recurrence rates of 7.7% at 48 months and 4.8% at 60 months [5][6] - The MTA3D clinical study is assessing outcomes following combined Adductoplasty and Lapiplasty procedures, with interim data showing significant improvements in pain and patient-reported scores at 12 months [7][12] Company Overview - Treace Medical Concepts aims to advance the standard of care for surgical management of bunions and related midfoot deformities, addressing a market of approximately 65 million Americans, with an estimated 1.1 million surgical candidates annually [11] - The company has developed the Lapiplasty 3D Bunion Correction System, which corrects bunion deformities in all three planes and secures the unstable joint [11][13]

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]