It first gained fame in the treatment of victims of the 2002 Bali bombings, and now the spray-on skin developed by Perth’s Professor Fiona Wood is seeking pre-market approval from the US Food and Drug Administration.
Avita Medical has submitted the application for its ReCell Autologous Cell Harvesting Device, used in the treatment of burns.
The device works by taking a small amount of healthy skin from a patient, dissolving the cells with an enzyme, and creating a solution that is sprayed over the burned area. The revolutionary treatment regenerates skin, heals more quickly and creates less scarring than traditional skin grafting and meshing techniques.
The FDA application includes clinical data from two randomised, controlled trials conducted with 131 patients at 12 leading burn centres across the US.
One of the trials demonstrated an over 30 per cent reduction in donor skin harvesting while achieving comparable near-term healing and long-term scar outcomes for treatment of third-degree burns. Results from the other trial demonstrated a 97.5 per cent reduction in donor skin harvested for the treatment of second-degree burn injuries. Another 55 cases in which ReCell was granted compassionate use approval for extensive burn injuries were also reviewed.
“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,” Avita Medical’s Chief Executive Officer Dr Michael Perry said.
“Our clinical data are compelling and we look forward to potentially providing a novel and innovative therapeutic for the treatment of burns.”
The company expects to launch ReCell in the US market in 2018. It is approved for use in Europe, Australia, China and Canada.
The clinical trials were supported by funding from the US Government’s Office of Biomedical Advanced Research and Development Authority, which aims to prepare the country for public health emergencies, including mass casualty scenarios.
In 2002, 28 gravely injured victims of the terrorist bombs that exploded in the Bali tourist area of Kuta were air-lifted to Royal Perth Hospital. As head of the hospital's burns unit, Wood oversaw the emergency treatment, which included the use of the then experimental spray-on skin.