Avita Medical submitted a Pre-Market Approval application for its ReCell Autologous Cell Harvesting Device for treatment of burn injuries to the FDA.
Avita Medical (ASX:AVH; OTCQX:AVMXY) submitted a Pre-Market Approval (PMA) application for its ReCell Autologous Cell Harvesting Device for treatment of burn injuries to the Food and Drug Administration (FDA).
As quoted in the press release:
Use of the ReCell Autologous Cell Harvesting Device is intended to reduce the amount of skin harvesting required relative to conventional treatment of burn injuries, which has important benefits from both clinical and health economic perspectives.
The PMA submission includes clinical data from the two U.S. randomized, controlled trials with combined enrollment of 131 patients at twelve leading burn centers across the United States. The later trial demonstrated over 30% reduction in donor skin harvesting while achieving comparable near-term healing and long-term scar outcomes for treatment of third-degree burn injuries.