The US Food and Drug Administration (FDA) has approved Avita Medical's investigational device exemption (IDE) feasibility study for the use of ReCell Spray-On-Skin to treat hypertrophic dyspigmented scars.
The ReCell suspension contains basal keratinocytes, melanocytes, fibroblasts and langerhans cells which migrate across the wound surface and aid in regenerating skin’s normal color and texture.
The feasibility study is designed to evaluate the effectiveness of using ReCell for the treatment of existing scars in a single treatment session, measured as time-to-healing and aesthetic outcomes.
The treated scars will be assessed for healing and pain on a weekly basis during the initial four weeks post-treatment; at weeks 12 and 24 the treatment site will be assessed for healing and aesthetic outcomes by both the patient and the surgeon.
Avita Medical CEO William Dolphin said they believe that ReCell offers the potential to deliver 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 cosmetic markets," Dolphin said.
The company will submit the feasibility data to seek FDA approval for the pivotal trial protocol, after a 12-week follow-up with the 20th patient is completed.