Organogenesis Holdings Inc. (NASDAQ:ORGO) shares surged about 20% on Tuesday after the company reported that its PuraPly AM treatment met the primary endpoint in a randomized controlled trial targeting diabetic foot ulcers.
The prospective multi-center study involved 170 patients and found that PuraPly AM used alongside standard care achieved statistically significant wound closure rates at 12 weeks compared with standard care alone. The trial assessed both the safety and effectiveness of the product in treating non-healing diabetic foot ulcers.
PuraPly AM is a patented therapy that combines a native cross-linked collagen matrix with the antimicrobial compound polyhexamethylene biguanide, designed to control microbial burden and promote wound healing.
“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. We believe publication of these impactful results will strongly support PuraPly AM’s inclusion in future coverage policies, underscoring its critical role in the healing paradigm.”
The company said the findings add to the body of clinical evidence supporting broader insurance coverage for the treatment.
Organogenesis develops, produces and markets regenerative medicine products for advanced wound care as well as surgical and sports medicine applications.