The U.S. Food and Drug Administration (FDA) has approved AVITA Medical, Inc.’s premarket approval (PMA) supplement for RECELL GO mini.
The RECELL GO System streamlines the preparation of spray-on skin cells. As a line extension of the RECELL GO system, the RECELL GO mini disposable cartridge is designed specifically to treat smaller wounds up to 480 square centimeters, compared to the standard RECELL GO disposable cartridge, which treats an area of 1,920 square centimeters.
Rollout will begin with trauma and burn centers that currently treat smaller wounds during the first quarter of 2025.
RECELL GO mini uses the same multi-use processing device as the standard disposable cartridge but features a modified cartridge optimized for smaller skin samples that reduces resource use and minimizes waste. This design provides an entry point for clinicians who may not have previously used the RECELL GO platform for smaller wounds, enabling broader accessibility and use in trauma and burn centers.
“The FDA approval of RECELL GO mini strengthens our ability to provide clinicians with fit-for-purpose solutions that meet the diverse needs of patients with full-thickness wounds,” says Jim Corbett, Chief Executive Officer of AVITA Medical, in a news release. “By introducing a treatment option specifically for smaller wounds, we are expanding the accessibility of RECELL to a wider range of patients. We believe this addition will drive greater adoption across trauma centers, where smaller wounds are common, and support our broader growth strategy.”
