CANTON, Mass., July 27, 2026
Organogenesis Holdings Inc. announced the publication of peer-reviewed clinical trial results demonstrating the effectiveness of Affinity™ when used alongside standard of care (SoC) in treating complex venous leg ulcers (VLUs). Published in the Journal of Wound Care, the findings come from a prospective, multicenter, randomized controlled trial (RCT) comparing Affinity + SoC with SoC alone in patients with some of the most difficult-to-treat chronic wounds. The study reported statistically significant improvements in wound closure at both 12 and 16 weeks for patients receiving Affinity, providing new clinical evidence supporting its use in advanced wound management. According to the company, the publication strengthens the growing body of evidence supporting Affinity across multiple chronic wound indications while highlighting its potential to improve outcomes in patients with longstanding venous leg ulcers.
Randomized Trial Demonstrates Superior Wound Closure Rates
The 206-patient randomized controlled trial assigned participants equally to receive either Affinity plus standard of care or standard of care alone following a four-week run-in period, with patients monitored for 24 weeks. The study evaluated two particularly challenging patient populations, including wounds that had persisted for more than six months and those present for over 24 months before treatment. Across both wound duration groups, patients treated with Affinity achieved significantly higher wound closure rates than those receiving standard care alone at weeks 12 and 16, meeting statistical significance (p<0.05). These findings demonstrate that the regenerative therapy can provide meaningful clinical benefit even in chronic wounds that have historically been difficult to heal and are associated with prolonged treatment and higher healthcare utilization.
Findings Expand Clinical Evidence for Affinity
According to Patrick Bilbo, Chief Operating Officer of Organogenesis, the results demonstrate the value of Affinity as a protective barrier for managing complex venous leg ulcers while strengthening previous evidence generated in diabetic foot ulcers (DFUs). The company noted that the latest publication builds upon an expanding portfolio of randomized clinical trials and real-world evidence, reinforcing the product’s effectiveness across multiple chronic wound types. Because venous leg ulcers represent one of the largest sources of long-term healthcare costs, particularly among Medicare beneficiaries, improved healing outcomes may offer meaningful clinical and economic advantages for patients, healthcare providers, and payers. The company believes these findings further support broader clinical adoption and reimbursement discussions for regenerative wound care therapies.
Advertisement
Regenerative Medicine Portfolio Continues to Grow
Affinity™ is a hypothermically stored human placental allograft composed of fresh amniotic membrane that retains its native extracellular matrix and living cells, allowing it to function as a protective barrier during wound healing. Unlike dehydrated or frozen alternatives, the product is minimally manipulated, aseptically processed, and preserved in its fresh state before clinical use. The latest peer-reviewed publication reinforces Organogenesis’ commitment to expanding evidence-based regenerative medicine solutions for advanced wound care and surgical applications. As chronic wounds continue to place a significant burden on healthcare systems worldwide, the positive clinical trial results strengthen the company’s position in the regenerative medicine market while supporting continued use of Affinity for patients with challenging venous leg ulcers and other chronic wound conditions.
Source:Organogenesis press release
