Organogenesis Holdings (NASDAQ:ORGO), a leader in regenerative medicine, has announced positive topline results from a prospective, multi-center randomized controlled trial (RCT) evaluating PuraPly AM for the treatment of diabetic foot ulcers (DFUs).
The study, which enrolled 170 patients, was designed to evaluate the safety and efficacy of PuraPly AM plus standard of care (SOC) compared to SOC alone.
The trial successfully met its primary endpoint, demonstrating statistically significant wound closure at 12 weeks for patients treated with PuraPly AM (p<0.0477).
PuraPly AM is a unique antimicrobial skin substitute that combines a native, cross-linked collagen matrix with polyhexamethylene biguanide (PHMB).
This combination is specifically engineered to manage the bioburden within the wound while providing a scaffold that supports the body’s natural healing process.
Organogenesis intends to submit the full results for publication in a peer-reviewed journal in the coming months.
The company believes that this high-level clinical evidence will be instrumental in supporting future coverage decisions and inclusion in clinical treatment guidelines.
This is particularly relevant as the Centers for Medicare & Medicaid Services (CMS) continues to evaluate reimbursement policies for skin substitutes and advanced wound care products in 2026.
Diabetic foot ulcers are a severe complication of diabetes, often leading to infections, hospitalizations, and amputations.
With a lifetime risk of development as high as 34% for diabetic patients, the demand for effective, evidence-based treatments remains a high priority for clinicians and payers alike.