Posted by Michael Wonder on 24 Sep 2018
Avita Medical announces FDA approval of the Recell system for the treatment of severe burns in the U.S
21 September 2018 - Point-of-care regenerative medicine technology approved to treat second and third-degree burns using Spray-On Skin Cells product.
Avita Medical today announced that the U.S. FDA approved the Company’s Premarket Approval (PMA) application to market the Recell Autologous Cell Harvesting Device (Recell System) to treat severe thermal burns in patients 18 years and older. The Recell System uses a small amount of a patient’s own skin to prepare Spray-On Skin Cells at the point of care in as little as 30 minutes, providing a new way to treat thermal burns.
The two randomised, controlled clinical trials supporting the FDA approval demonstrated that treatment of acute burn wounds with the Recell System required substantially less donor skin than required with conventional split-thickness autografts to achieve closure of burn wounds. Reduction in donor skin requirements provides key clinical benefits to patients and significant reductions in the cost of treatment.
