The ReCell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, Avita said.
Results from the trial were published in the Journal of Burn Care & Research, the Melbourne and Valencia, Calif.-based company said.
Data from the 101-patient study indicated that burn sites treated with the ReCell device required 97.5% less donor skin than burn sites treated with the standard-of-care treatment, which used a 2:1 meshed autograft. Results also indicated a significant reduction in patient-reported pain, increased patient satisfaction and improved donor scar outcomes.
“Reducing the amount of donor skin required to achieve complete and definitive burn wound closure opens the possibility for treating extensive and complex burns sooner than the current standard of care. These findings have potential implications for a paradigm shift in the approach used to achieve rapid and permanent closure of burn injuries. Furthermore, achieving definitive closure using less skin compared with standard autografting may decrease the number of surgical procedures as well as reducing hospital length of stay, thus decreasing the overall costs related to the treatment of burn injuries,” study first author Dr. James Holmes of Winston-Salem, N.C.’s Wake Forest University School of Medicine said in a press release.
The trial is being used, along with another pivotal trial, to support Avita’s FDA premarket approval application seeking indications for treating individuals with burn injuries.
Funding for the trial came from the US Biomedical Advanced Research and Development Authority and the US Department of the Army, Avita Medical said.
Earlier this month, Avita Meidcal said that it raised $12.3 million to back the U.S. launch of its Recell wound treatment.