US FDA Approves AVITA Medical’s RECELL GO Mini Disposable Cartridge to Treat Smaller Wounds

AVITA Medical, Inc., a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, announced that the US Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for RECELL GO mini. 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.

RECELL GO mini addresses a critical need in the full-thickness skin defect market, which includes a high volume of smaller wounds. As part of the RECELL GO platform, 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 centres.

“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,” said Jim Corbett, chief executive officer of AVITA Medical. “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 centres, where smaller wounds are common, and support our broader growth strategy.”

The company expects RECELL GO mini to serve as a growth driver within the broader RECELL GO platform, further advancing AVITA Medical’s strategy to expand its impact on patient care. Rollout will begin with trauma and burn centres that currently treat smaller wounds during the first quarter of 2025.

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

AVITA Medical is a commercial-stage regenerative medicine company transforming the standard of care in wound care management and skin restoration with innovative devices.

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