Avita Medical, a Northridge-based regenerative medicine company, announced it has initiated an FDA study of its ReCell Spray-On-Skin product for the treatment of raised or discolored scars.
The protocol permits the company to treat 20 patients with scars at up to four U.S. study sites. It is designed to test the effectiveness of the treatment in a single session in comparison to the current standard of care involving dermabrasion of the scar, which often requires multiple treatment sessions. Avita will seek FDA approval for clinical trials following completion of the study.
Enrollment in the study commenced with the treatment of three of the 20 patients that will be treated under the FDA-approved protocol.
ReCell is approved for sale in Europe, Australia, and China.
"ReCell has shown the potential to provide significant benefits over current options in the treatment of acute and chronic wounds and for a wide range of skin defects,” CEO Dr. William Dolphin said in a prepared statement. “We are confident that this study will demonstrate the effectiveness of ReCell in the corrective treatment of scars, making ReCell directly applicable and immediately relevant to the very large aesthetic markets.”