Avita Medical (ASX:AVH) said today that it submitted its pre-market approval application to the FDA for its ReCell autologous cell harvesting device.
The company’s system is designed to reduce the amount of skin harvesting needed to treat burn injuries compared to conventional treatments.
The PMA application is supported by clinical data from two trials. The first trial showed a 97.5% reduction in donor skin harvested for the treatment of second-degree burn injuries. The second trial demonstrated over 30% reduction in donor skin harvesting, while meeting comparable healing and scar outcomes for the treatment of third-degree burns, Avita reported.
The submission also included a review of 55 cases where patients used ReCell for extensive burn injuries.
“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,” CEO Michael Perry said in prepared remarks.
“We continue to strengthen our organization in preparation for a successful U.S. commercial launch in 2018.”