newsfilter
← Latest News
GlobeNewswire·

Organogenesis Announces Publication of Peer-Reviewed Clinical Trial Results Demonstrating Clinical Benefit of Affinity™ in the Most Challenging and Complex Venous Leg Ulcers

  • Organogenesis Holdings Inc. published results from a prospective, multicenter randomized controlled trial evaluating Affinity plus standard of care (SoC) versus SoC alone for complex venous leg ulcers.
  • The trial involved 206 patients randomized 1:1, with a four-week run-in period followed by 24 weeks of patient monitoring.
  • Results published in the Journal of Wound Care showed statistically significant improvements in wound closure at weeks 12 & 16 for the Affinity + SoC group across both wound duration strata (>6 months & >24 months).
  • The study provides peer-reviewed evidence that Affinity acts as a protective barrier, addressing one of the most difficult-to-treat chronic wound populations.
  • These findings complement existing Affinity data for diabetic foot ulcers, reinforcing clinical & economic rationales for expanded coverage of the product.
  • Affinity is a hypothermically stored human placental allograft composed of fresh, unaltered amniotic membrane that retains its native extracellular matrix & living cells.
  • Forward-looking statements in the release highlight risks including CMS 2026 Medicare reimbursement changes, competition, technological obsolescence, & potential future losses.
  • Investor inquiries are directed to Mike Piccinino of ICR Healthcare, while media inquiries should contact Cheston Turbyfill.