Organogenesis publishes PREPARE trial results for PuraPly AM wound treatment

Organogenesis Holdings Inc. (Nasdaq: ORGO) announced the publication of results from the PREPARE trial, a prospective, multicenter, randomized controlled trial evaluating PuraPly AM plus standard of care compared to standard of care alone in hard-to-heal diabetic foot ulcers.

The trial results, published in the Journal of Wound Care, showed statistically significant improvements in wound closure at 12 weeks among patients treated with PuraPly AM plus standard of care. The trial achieved its primary endpoint, according to a company statement.

Patrick Bilbo, Chief Operating Officer of Organogenesis, said the PREPARE study adds to existing data for PuraPly AM, including real-world evidence from registry and comparative effectiveness studies, and health economics and outcomes research. "We expect this evidence to form the basis for future coverage decisions for PuraPly AM," Bilbo said.

PuraPly AM is described as a native, cross-linked extracellular matrix scaffold with antimicrobial properties. It 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.

The PREPARE trial results had been previously released before the peer-reviewed publication in the Journal of Wound Care.

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