AVITA Medical, Inc. (NASDAQ: RCEL) announced results from its multicenter, randomized controlled PermeaDerm-I clinical study, showing that PermeaDerm, a biosynthetic wound matrix, achieved comparable clinical outcomes to cadaveric allograft at 70% lower product cost.

The study met its primary endpoint with statistical significance (p<0.001). Mean treatment cost was $148.70 per 1% total body surface area (%TBSA) treated with PermeaDerm, compared with $497.10 for allograft, representing a savings of approximately $348 per %TBSA.

The trial enrolled 40 patients across 11 U.S. burn centers with wounds involving up to 30% TBSA. Patients were randomized following surgical excision to receive either PermeaDerm or cadaveric allograft before definitive split-thickness skin grafting.

As an off-the-shelf product, PermeaDerm reduced preparation time by 95.7% compared with allograft by eliminating tissue tracking, thawing, and meshing requirements. Approximately 94% of PermeaDerm patients achieved at least 95% graft take one week following autografting, and all patients in both groups achieved 95% or greater wound healing by eight weeks. No adverse events were attributed to PermeaDerm.

"These results demonstrate that PermeaDerm provided clinical performance comparable to allograft with the added benefit of product transparency enabling direct visualization of the wound bed," said Anju Saraswat, MD, Associate Burn Director and Assistant Professor of Surgery at Atrium Health Wake Forest Baptist Burn Center and study investigator.

Cary Vance, President and Chief Executive Officer of AVITA Medical, said the study "establishes compelling clinical and economic evidence supporting PermeaDerm as a modern alternative to allograft."

At final follow-up, all responding investigators and patients reported satisfaction, with responses rated as satisfied or very satisfied.

The company hosted a Key Opinion Leader webinar on August 18 to review the clinical data. Additional study details are available at ClinicalTrials.gov under identifier NCT06750809. The information above is based on a company press release.