Clinical TrialJul 27, 2026, 04:09 PM
Organogenesis Affinity RCT Shows Significant VLU Closure
AI Summary
Organogenesis Holdings Inc. announced the publication of positive results from a prospective, multicenter, randomized controlled trial (RCT) evaluating its product, Affinity, for complex venous leg ulcers (VLUs). The trial demonstrated statistically significant improvements in wound closure at weeks 12 and 16 for the Affinity + standard of care group compared to standard of care alone. These findings, published in the Journal of Wound Care, reinforce Affinity's clinical benefit for hard-to-heal wounds and complement existing data for diabetic foot ulcers.
Key Highlights
- Affinity + standard of care (SoC) showed statistically significant improvements in wound closure at weeks 12 and 16 for complex venous leg ulcers (VLUs).
- The randomized controlled trial (RCT) involved 206 patients, randomized 1:1 to Affinity + SoC or SoC alone.
- Significant improvements were observed across two baseline wound duration strata (more than 6 months and more than 24 months).
- The results were published in the Journal of Wound Care.
- Affinity is a hypothermically stored human placental allograft, minimally manipulated and preserved in a fresh state.
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