Organogenesis Announces Publication of Peer-Reviewed Clinical Trial Results Demonstrating Clinical Benefit of Affinity™ in the Most Challenging and Complex Venous Leg Ulcers
Rhea-AI Summary
Organogenesis (Nasdaq: ORGO) reported peer-reviewed results from a 206-patient, prospective, multicenter randomized controlled trial evaluating Affinity plus standard of care (SoC) versus SoC alone in complex venous leg ulcers (VLUs). Results published in the Journal of Wound Care showed statistically significant improvements (p<0.05) in wound closure at weeks 12 and 16 for the Affinity + SoC arm across two baseline wound duration strata: wounds present >6 months and >24 months.
The trial included a four-week run-in and 24-week follow-up. According to Organogenesis, these data strengthen the evidence base for Affinity as a protective barrier in some of the hardest-to-heal chronic wounds and complement existing randomized and real‑world data in diabetic foot ulcers, supporting the clinical and economic rationale for broader coverage in VLUs and DFUs.
Positive
- 206-patient RCT in complex venous leg ulcers with 1:1 randomization
- Statistically significant higher wound closure at weeks 12 and 16 (p<0.05)
- Evidence across two strata (wounds >6 months and >24 months duration)
- Peer-reviewed publication in the Journal of Wound Care
- Data complement existing Affinity results in diabetic foot ulcers
Negative
- None.
News Market Reaction – ORGO
In the Jul 28 session, ORGO declined 0.78%, reflecting a mild negative market reaction. Argus tracked a peak move of +3.4% during that session. Our momentum scanner triggered 10 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 06 | FDA review acceptance | Positive | +0.8% | FDA accepted ReNu's BLA and assigned an April 2027 target action date |
| Apr 06 | Clinical trial endpoint | Positive | +0.9% | PuraPly AM trial achieved statistically significant DFU wound closure endpoint |
| Sep 25 | Phase 3 trial update | Negative | -12.4% | Second Phase 3 ReNu study missed its primary endpoint despite improved pain reduction |
| Nov 11 | Phase 3 interim data | Positive | -1.4% | Interim analysis supported continued enrollment without modifications or sample-size increases |
| Oct 01 | Clinical trial publication | Positive | +1.1% | NuShield publication reported statistically superior wound closure in diabetic foot ulcers |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Four of five tag-specific clinical-trial events aligned with their subsequent 24-hour price reactions; one positive clinical update diverged.
Key Terms
randomized controlled trial medical
venous leg ulcers medical
standard of care medical
baseline wound duration medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
CANTON, Mass., July 27, 2026 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced published results from a prospective, multicenter, randomized controlled trial (RCT) evaluating Affinity plus standard of care (SoC) compared to SoC alone in the management of complex venous leg ulcers (VLUs). The results were published in the Journal of Wound Care demonstrating statistically significant improvements in wound closure at weeks 12 and 16 for the Affinity + SoC group across two wound duration strata studied, providing compelling new peer-reviewed evidence for one of the most difficult-to-treat wound populations in chronic wound care.
“These clinically meaningful results demonstrate the value of Affinity as a protective barrier in challenging VLUs,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “Paired with our DFU data, this strengthens the case that Affinity delivers meaningful outcomes for the patients who need it most.”
The 206-patient trial, which randomized 1:1 to Affinity + SoC or SoC alone, followed patients for 24 weeks after a four-week run-in period. Across both baseline wound duration (BWD) strata, which included wounds present for more than 6 months and wounds present for more than 24 months, the Affinity + SoC group achieved significantly higher rates of wound closure than SoC alone at weeks 12 and 16 (p<0.05).
This trial builds on the growing body of evidence for Affinity, now spanning RCTs and real-world data, across multiple chronic wound indications. These findings reinforce the benefit of Affinity in the hardest-to-heal wounds, the population that drives the greatest clinical burden and cost in VLU treatment. As VLU costs continue to grow, particularly within the Medicare population, these results present a meaningful step forward for patients, clinicians, and payers. This VLU data set complements existing Affinity evidence in diabetic foot ulcers (DFUs), reinforcing the clinical and economic rationale for expanded coverage across two of the most prevalent and costly chronic wound types.
About Affinity
Affinity is the only hypothermically stored human placental allograft composed of fresh, unaltered amniotic membrane that retains its native extracellular matrix scaffold and living cells for use as a protective barrier. Never dehydrated or frozen, Affinity is minimally manipulated, aseptically processed, and uniquely preserved in a fresh state. Affinity is intended for use as a protective barrier in the management of acute and chronic wounds.
About Organogenesis Holdings Inc.
Organogenesis Holdings Inc. is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the Advanced Wound Care and Surgical and Sports Medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care. For more information, visit www.organogenesis.com.
Forward-Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include statements relating to the expected benefits to patients from using Affinity and to the Company from the sale of Affinity. Forward-looking statements are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to: (1) the impact of any changes to the coverage and reimbursement levels for Affinity and the Company’s other products, particularly in light of CMS’ updated 2026 Medicare reimbursement and coverage changes; (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred losses in the prior periods and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production or obtain supply of its products in sufficient quantities to meet demand; (10) the Company’s ability to build out its Smithfield, Rhode Island facility on time and on budget; and (11) other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company’s Form 10-K for the year ended December 31, 2025 and its subsequently filed periodic reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.
Contacts Investor Inquiries: ICR Healthcare Mike Piccinino, CFA OrganoIR@westwicke.com Press and Media Inquiries: Cheston Turbyfill cturbyfill@organo.com