AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) has announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for RECELL GO® mini. This approval marks a significant advancement in wound care management, providing a tailored solution for smaller full-thickness skin defects.
RECELL GO Mini: Optimized for Smaller Wounds
The RECELL GO mini disposable cartridge is designed to treat wounds up to 480 square centimeters, contrasting with the standard RECELL GO cartridge, which covers an area of 1,920 square centimeters. This miniaturized device addresses a critical need for treating smaller wounds, commonly encountered in trauma and burn centers.
Addressing Unmet Needs in Wound Care
Full-thickness skin defects often present as smaller wounds, requiring precise and efficient treatment. The RECELL GO mini utilizes the same multi-use processing device as the standard cartridge but features a modified design optimized for smaller skin samples. This modification reduces resource use and minimizes waste, offering an economically viable option for clinicians.
Clinical Impact and Accessibility
"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 centers, where smaller wounds are common, and support our broader growth strategy."
Integration and Future Rollout
As part of the RECELL GO platform, the mini version integrates seamlessly into existing clinical workflows. AVITA Medical plans to roll out RECELL GO mini across trauma and burn centers in the first quarter of 2025. The company anticipates that this new offering will serve as a growth driver within the broader RECELL GO platform, further advancing AVITA Medical’s strategy to expand its impact on patient care.
