Treace Medical announces updated ALIGN3D study data at AOFAS Meeting 2023

Treace Medical Concepts will highlight new product innovations and present new interim data for the ALIGN3D clinical study at the American Orthopaedic Foot & Ankle Society Annual Meeting 2023 in Louisville, Kentucky from September 20-23, 2023. Several technologies will be highlighted at Treace’s booth at the AOFAS conference, including: SpeedPlate Implant Fixation Platform: This new platform of Lapiplasty fixation technology is designed for rapid insertion while providing dynamic compression of the joint surfaces. Since it can be implanted through a small 2cm incision, the SpeedPlate technology not only offers broad applicability with the Company’s standard Lapiplasty and Adductoplasty systems, but also serves as the enabling fixation technology for our Micro-Lapiplasty system. Full commercial launch of the SpeedPlate technology is anticipated in the fourth quarter of this year. Micro-Lapiplasty Minimally Invasive System: This advanced instrumentation option is designed to further reduce the incision size and related tissue dissection with the Lapiplasty procedure. The advanced instrument set, including the Micro-Lapiplasty 3-n-1 Guide and other specialized surgical instruments, allows the deformity correction and joint preparation steps of the patented Lapiplasty Procedure to be performed through a 2cm incision. The Micro-Lapiplasty System is currently in limited clinical release with full commercial launch expected in the fourth quarter of this year. New Lapiplasty Innovations: Recently commercialized innovations, including the LapiTome and RazorTome Osteotomes and Hammertoe PEEK Fixation System, will also be featured at Treace’s booth and in hands-on training workshops. The ALIGN3D clinical study poster presentation, “Primary Endpoint Analysis for a Prospective Multicenter Study Assessing Radiographic Recurrence and Patient Outcomes Following Triplanar Tarsometatarsal Arthrodesis with Early Weightbearing”, will be presented by Robert Santrock, MD of Dovetail Orthopedics, Fernandina Beach, FL on September 21 from 10:00 am to 10:45 am ET. The interim analysis includes 173 patients treated with the Lapiplasty Procedure with an average follow-up of 33.4 months. The data showed: Early return to weight bearing in a walking boot at an average 8.4 days; Low recurrence rate, defined as loss of radiographic correction, was observed in 0.7% of patients at 24 months and 1.1% at 36 months; and 81% reduction in pain reported at 24 months post-procedure. The interim analysis also continued to report statistically significant improvement in patient-reported outcomes, including a 92% and 93% improvement in walking/standing as well as social interaction at 36 months post-procedure, respectively, using the Manchester-Oxford Foot Questionnaire scoring system. Additionally, at 36 months post-procedure, less than 5% of patients were unsatisfied with the overall results of the procedure. The Company plans to submit its primary endpoint ALIGN3D manuscript for publication in a top-tier peer-reviewed foot and ankle journal later in 2023.