Treace Medical's Lapiplasty 3D Associated With Early Weightbearing After Foot Surgery, Interim Data Shows

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  • Medical device company Treace Medical Concepts Inc TMCI has announced interim results from the ALIGN3D clinical study, a post-market 5-year study designed to evaluate outcomes of Lapiplasty 3D Bunion Correction in the surgical management of symptomatic hallux valgus.
  • Hallux valgus is the most common foot deformity.
  • Data were presented at the American College of Foot and Ankle Surgeons Annual Scientific Conference.
  • Data on the 128 study participants included in the interim analysis demonstrated:
    • Early return to weight-bearing in a walking boot at an average of 8.3 days.
    • Significant improvements in radiographic measurements of 3-dimensional bunion correction (hallux valgus angle, intermetatarsal angle, and tibial sesamoid position).
    • 1.4% recurrence rate observed (1/72 patients) at 12 months post-surgery.
    • Significant improvements in patient-reported pain reduction and quality of life measurements at six months were reported, maintained at 12 months post-procedure.
  • Final patient follow-up for the primary endpoint is anticipated in the first half of 2023.
  • Price Action: TMCI shares are down 1.81% at $29.82 during the market session on the last check Wednesday.
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