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Interim Analysis of ALIGN3D Prospective Multicenter Study

Assessing Radiographic and Patient Outcomes Following the Lapiplasty® Procedure

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.
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