Northridge, Calif. — The Food and Drug Administration has approved Avita Medical’s investigational device exemption feasibility study for the use of ReCell Spray-On-Skin in the treatment of hypertrophic dyspigmented scars.
The FDA protocol permits Avita to treat 20 patients with pre-existing scars at as many as four U.S. study sites. The treated scars will be assessed for healing and pain on a weekly basis during the initial four weeks post-treatment, and at weeks 12 and 24 the treatment site will be assessed for healing and aesthetic outcomes by both the patient and the surgeon.
In a company news release, Avita CEO William Dolphin, M.D., said, “We believe that ReCell offers the potential to deliver significant benefits over currently available options in the treatment of acute and chronic wounds and skin defects. This study will allow us to demonstrate the use of ReCell in the corrective treatment of existing scars with application to the very large cosmetic markets.”
The study is designed to assess the effectiveness of using ReCell for the treatment of existing scars in a single treatment session, compared to the current standard of care, which involves dermabrasion and often requires multiple sessions.
Data obtained from this feasibility study will be used to design a larger clinical investigation. Once the 12-week follow-up with the 20th patient is completed, Avita will submit the feasibility data to the FDA and will seek approval for the pivotal trial protocol.
Avita Medical is currently conducting an FDA-approved study for the use of ReCell in the treatment of acute burn wounds.