Organogenesis Holdings Inc. (NASDAQ: ORGO) announced completion of a randomized controlled trial evaluating its PuraPly AM product for treating diabetic foot ulcers. The study met its primary endpoint, demonstrating statistically significant wound closure at 12 weeks compared to standard care alone.

The multi-center trial enrolled 170 patients and compared PuraPly AM plus standard of care against standard care alone for non-healing diabetic foot ulcers. The treatment group achieved significantly better wound closure rates with a p-value of less than 0.0477.

"We are pleased to report primary endpoint achievement in this important study underscoring the clinical efficacy of PuraPly AM in the management of non-healing DFUs," said Patrick Bilbo, Chief Operating Officer of Organogenesis. "These wounds pose a significant burden to patients and are extremely costly to our healthcare system."

PuraPly AM combines a cross-linked collagen matrix with polyhexamethylene biguanide antimicrobial. The company stated it plans to publish the study results in a peer-reviewed journal and believes the results will support the product's inclusion in future coverage policies.

Organogenesis develops and manufactures regenerative medicine products for advanced wound care and surgical markets. The company is based in Canton, Massachusetts.