AVITA Medical, Inc. announced that the U.S. Food and Drug Administration has approved its premarket approval supplement for the RECELL GO? System, its next-generation autologous cell harvesting device that harnesses the regenerative properties of a patient?s own skin to treat thermal burn wounds and full-thickness skin defects. When choosing RECELL, clinicians and patients can realize several significant advantages over traditional skin grafting: Improved healing is achieved using significantly less donor skin Pain is reduced, closure is faster, and the aesthetic appearance at the RECELL-harvested donor site is improved Fewer procedures are required for definitive closure There's a reduction in the length of stay for burns covering less than 50% Total Body Surface Area (TBSA) RECELL GO introduces enhanced features that streamline the preparation of Spray-On Skin?

Cells. This next-generation device significantly reduces the training burden on medical staff, improves workflow efficiency in the operating room, and controls the RECELL Enzyme? incubation time to ensure optimal cell yield and viability.

These advancements simplify the user interface, enabling medical teams to provide quality care readily and consistently to their patients. In the United States, the Company will launch RECELL GO in its top burn treatment centers in June, and other existing accounts will be converted to RECELL GO throughout the year. New accounts will receive RECELL GO with their first order, eliminating the need for conversion.

The supplement follows the original PMA of RECELL Autologous Cell Harvesting Device and subsequent PMA supplements.