ALIGN3D^™ Clinical Study Presentation¹

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^™ manuscript to a top-tier, peer-reviewed foot and ankle journal at the end of 2023 and expects publication in 2024.

1. The 2024 ALIGN3D^™ study data presentation is accessible here, which includes additional details such as patient demographics, inclusion/exclusion criteria, and complications reported in the study.