AVITA Medical (ASX:AVH) says its pivotal trial in the treatment of third-degree burns with the RECELL Autologous Cell Harvesting Device achieved its co-primary endpoints, demonstrating a statistically significant reduction in donor skin requirements versus standard of care while achieving comparable definitive wound closure.
The results were presented at the American Burn Association 50th Annual Meeting in Chicago by Dr James Holmes of Wake Forest Baptist Medical Center in North Carolina.
“Treatment with the RECELL Device achieved comparable healing, long-term scar and patient satisfaction outcomes using significantly less donor skin with no safety concerns,” said Dr Holmes. “I have had the opportunity to evaluate RECELL through several clinical trials and the FDA-approved Compassionate Use Program. I believe that the RECELL Device provides the opportunity to improve care for patients with severe burns.”
The RECELL Device is an investigational medical device designed to enable medical professionals to produce, at the point-of-care, a REGENERATIVE EPIDERMAL SUSPENSION (RES) using a small sample of the patient’s own skin.
The autologous suspension contains cells necessary to regenerate epidermis and provides a new way to achieve permanent closure in burns and other wounds while reducing the amount of skin harvested at the time of surgery. Reduction in donor-site skin requirements has important benefits from both clinical and health economic perspectives.
According to the presentation, the patient donor skin required to be harvested to treat burn sites with the RECELL Device was 32 percent less than the amount harvested to treat burn sites with the standard of care.
Despite the statistically significant reduction in donor skin required to treat with the RECELL Device, burn sites treated with the RECELL Device achieved definitive closure comparable to the burn sites treated with standard of care. At eight weeks post-treatment, 92 percent of the burn sites treated with RECELL achieved complete healing versus 85 percent for the sites treated with the standard of care, demonstrating non-inferiority.
The trial evaluated 30 patients ranging in age from nine to 68 years old with thermal, mixed-thickness burns, including full-thickness burns, covering five percent to 46 percent of their total body surface area.