AVITA Medical gains as FDA expands label for RECELL System
Grandbrothers/iStock Editorial via Getty Images
- AVITA Medical (NASDAQ:RCEL) added ~6% before the market opened Thursday after announcing that the FDA approved its premarket approval (PMA) supplement, expanding the use of its RECELL System as a treatment for full-thickness skin defects.
- The agency had granted a prioritized review for the company’s supplement for RECELL System. “The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings,” CEO of Avita Medical Jim Corbett remarked.
- Mr. Corbett added that the company more than doubled its field sales force in the first few months of the year, expecting the FDA decision. The company is ready to launch the product for the expanded indication from July 1, 2023.
- The FDA first approved RECELL System, a spray formulation of living cells, in September 2018 as a treatment for severe burns.
More on Avita
- Avita Medical falls 23% as chief commercial officer departs
- AVITA Medical: At A Crossroads