The procedure is performed on site at bedside and takes approximately 25 minutes to complete and does not require laboratory facilities, off-site culture of tissues or specialized staff.
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.
Under the base contract BARDA made an initial investment of US$16.9 million to support Avita's ongoing U.S. clinical regulatory program towards FDA Premarket Approval (PMA), and to procure 5,000-plus ReCell devices.
[9] In 2009 the United States Armed Forces Institute of Regenerative Medicine provided Avita with a US$1.45 million grant to hasten the approval of the ReCell kit with the U.S. Food and Drug Administration.
[10] In 2018 a burn center in Phoenix, Arizona held a press conference to discuss the ongoing results of using ReCell to treat a woman with flesh-eating bacteria also known as necrotizing fasciitis.