Organogenesis Announces Publication of Peer-Reviewed PREPARE Trial Results Demonstrating Clinical Benefit of PuraPly®AM for Hard-to-Heal Diabetic Foot Ulcers
Peer-reviewed results showed statistically significant improvements in wound closure at 12 weeks with PuraPly AM plus standard care.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Organogenesis (ORGO) announced publication of previously released PREPARE trial results showing improved wound closure with PuraPly AM in hard-to-heal diabetic foot ulcers.
The results appeared in the Journal of Wound Care. PREPARE was a prospective, multicenter, randomized controlled trial, following patients across multiple sites and comparing randomly assigned treatments. It evaluated PuraPly AM plus standard of care against standard of care alone. The trial achieved its primary endpoint and showed statistically significant improvements in wound closure at 12 weeks among patients receiving the combination.
Organogenesis expects the evidence to form the basis for future coverage decisions for PuraPly AM; those decisions were not announced as completed.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointPREPARE achieved its primary endpoint, with statistically significant wound-closure improvements at 12 weeks versus standard care alone.
- Minor pointPreviously released PREPARE results were published in the peer-reviewed Journal of Wound Care.
- Minor point. Forward-looking: it has not happened yet and may not happen.Organogenesis expects the evidence to underpin future coverage decisions for PuraPly AM.
Negative
- None.
Key Figures
- Wound closure assessment
- 12 weeks
- Statistically significant improvement reported for PuraPly AM plus standard of care versus standard of care
Historical Context
-
Reported significant wound-closure improvements at weeks 12 and 16 in venous leg ulcers.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
randomized controlled trial medical
diabetic foot ulcers medical
statistically significant technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
CANTON, Mass., Oct. 12, 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 the publication of previously released results from PREPARE1, a prospective, multicenter, randomized controlled trial (RCT) evaluating PuraPly®AM (PCMP) plus standard of care (SoC) compared to SoC alone in hard-to-heal diabetic foot ulcers (DFUs). The trial achieved its primary endpoint, and the results published in the Journal of Wound Care demonstrate statistically significant improvements in wound closure at 12 weeks among patients treated with PuraPly®AM plus SoC, providing clinical evidence supporting the use of PuraPly®AM in one of the most costly and difficult-to-treat chronic wound populations.
"The PREPARE study adds to our large and growing body of data for PuraPly AM, including real-world evidence from registry and comparative effectiveness studies, and health economics and outcomes research," said Patrick Bilbo, Chief Operating Officer of Organogenesis. "We expect this evidence to form the basis for future coverage decisions for PuraPly AM. Peer-reviewed data continues to differentiate us in a recalibrated market where Organogenesis is gaining share while competitors without comparable evidence are pivoting away from wound care or exiting the market altogether."
About PuraPly®AM
PuraPly®AM is a patent-protected native, cross-linked extracellular matrix scaffold with sustained antimicrobial effectiveness within the product to support wound healing as a protective barrier. PuraPly®AM is indicated for the management of partial- and full-thickness wounds, including diabetic foot ulcers, pressure injuries, venous leg ulcers, surgical wounds and traumatic 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 and tissue 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 “future,” “plan,” “believe,” “intend,” “seek,” “anticipate,” “expect,” “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 Company’s expectations and beliefs regarding PuraPly AM’s inclusion in future coverage policies and opportunities for PuraPly AM to generate revenue for the Company. Forward-looking statements with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company are based on current expectations that 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 coverage and reimbursement levels for PuraPly AM 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; (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; (11) whether the Company is able to obtain regulatory approval for and successfully commercialize ReNu; and (12) 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.
1 Prospective, Randomized controlled trial assessing the Efficacy of a native type 1 collagen extracellular matrix plus Polyhexamethylene biguanide Antimicrobial and standard of Care versus standard of Care alone in the Management of hard-to-heal diabetic foot ulcers.
Contacts Investor Inquiries: ICR Healthcare, Mike Piccinino, CFA, OrganoIR@westwicke.com Press and Media Inquiries: Cheston Turbyfill, cturbyfill@organo.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Organogenesis's PREPARE trial show for PuraPly AM in diabetic foot ulcers?
PREPARE achieved its primary endpoint, showing statistically significant improvements in wound closure at 12 weeks with PuraPly AM plus standard of care compared with standard of care alone. The prospective, multicenter, randomized controlled trial evaluated hard-to-heal diabetic foot ulcers.