September 28, 2018
Avita Medical announced today that it has submitted to the Food & Drug Administration (FDA) a Pre-Market Approval (PMA) application for its ReCell Autologous Cell Harvesting Device for treatment of burn injuries.
The company reports that 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.
AVITA Medical said the PMA submission includes clinical data from the two U.S. randomized, controlled trials with a 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. Results from the earlier trial demonstrate a 97.5% reduction in donor skin harvested for treatment of second-degree burn injuries. The submission also includes a review of 55 cases of compassionate use of ReCell for extensive burn injuries.
Avita Medical CEO, Dr. Michael Perry, on the PMA submission: “This PMA submission represents the culmination of years of effort by our Avita team and we are thrilled to have moved a step closer to making ReCell available to patients in the United States. Our clinical data are compelling and we look forward to potentially providing a novel and innovative therapeutic for the treatment of burns. Regarding commercial launch Perry added, “We continue to strengthen our organization in preparation for a successful U.S. commercial launch in 2018.”
Development of the PMA for the ReCell® device has been supported through Avita’s Contract with the Office of Biomedical Advanced Research and Development Authority (BARDA), within the Assistant Secretary for Preparedness and Response (ASPR), a division of the U.S. Department of Health and Human Services. Funding support from BARDA has been instrumental in various aspects of ReCell development including execution of Avita’s clinical trials and PMA preparation activities. Market approval of ReCell aligns with BARDA’s overarching goal of building national burn care preparedness, by securing effective medical countermeasures for burn injuries critical in a mass casualty scenario.