Avita Medical (ASX:AVH) said today that a pivotal trial of its ReCell autologous cell harvesting device met its co-primary endpoints.
The device, designed to help heal deep, full-thickness burns, demonstrated a statistically significant reduction in donor skin requirements compared to the standard of care and achieved comparable wound closure, Avita touted.
“Treatment with the ReCell device achieved comparable healing, long-term scar and patient satisfaction outcomes using significantly less donor skin with no safety concerns,” investigator Dr. James Holmes said in prepared remarks.
The company’s device enables medical professionals to create a regenerative epidermal suspension using a small sample of the patient’s own skin at the point-of-care, according to Avita.
Avita’s pivotal trial assessed 30 patients with thermal, mixed-thickness burns covering 5 – 46% of their total body surface area. Patients served as their own control – two comparable burn sites were selected on each patient. One site was treated with meshed autograft, while the other side was treated with the ReCell device and more widely-meshed autograft.
The company reported that the patient donor skin required to treat burn sites with the ReCell device was 32% less than the amount harvested with the standard of care. Eight weeks after treatment, 92% of the sites treated with ReCell achieved complete healing versus 85% of the sites treated with the standard of care.
Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.