Avita Medical submits PMA supplement application for RECELL System

AVITA Medical announced the submission of a Premarket Approval supplement application to the U.S. Food and Drug Administration for the company’s RECELL System. The supplement, if approved, will expand the indication of RECELL to include soft tissue repair.This PMA supplement includes the recently released results of the pivotal trial for soft tissue repair. The study met both co-primary endpoints, demonstrating that RECELL is statistically significant in donor sparing and statistically non-inferior in healing outcomes. For purposes of the clinical study, soft tissue injuries included any full-thickness acute skin defect, such as degloving or peeled back skin injuries, road rash, surgical wounds, and flesh-eating disease. The RECELL System earned FDA Breakthrough Device designation for its proposed soft tissue repair indication. Under the program, AVITA Medical will receive prioritized review and interactive communication with the FDA throughout the premarket review phase. The standard FDA review timeline for label expansion through a PMA supplement is 180 days. This PMA supplement application follows the original PMA approval of the RECELL System in September 2018.