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AVITA Medical's RECELL GO Mini Receives FDA Approval for Smaller Wound Treatment

• AVITA Medical's RECELL GO mini has been approved by the FDA for treating smaller full-thickness skin defects, addressing a critical need in wound care. • The RECELL GO mini cartridge treats wounds up to 480 square centimeters, offering a resource-efficient option compared to the standard RECELL GO cartridge. • AVITA Medical plans to launch RECELL GO mini in trauma and burn centers during Q1 2025, expanding the accessibility of RECELL technology. • The approval strengthens AVITA Medical's strategy to broaden its impact on patient care by providing clinicians with tailored solutions for diverse wound sizes.

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.
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Reference News

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AVITA Medical Announces FDA Approval of RECELL GO mini, Optimizing Treatment for Smaller Wounds
finance.yahoo.com · Dec 23, 2024

The RECELL System is approved internationally for skin healing in burns, skin defects, and vitiligo, with approvals in A...

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AVITA Medical Announces FDA Approval of RECELL GO mini, - GlobeNewswire
globenewswire.com · Dec 23, 2024

AVITA Medical announced FDA approval for RECELL GO mini, a disposable cartridge designed for smaller wounds up to 480 sq...

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Avita Medical discloses FDA premarket approval for ECELL GO mini
markets.businessinsider.com · Dec 23, 2024

AVITA Medical's RECELL GO mini, FDA-approved, targets smaller wounds up to 480 sq cm, enhancing treatment accessibility ...

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AVITA Medical Announces FDA Approval of RECELL GO mini, Optimizing Treatment for ...
biospace.com · Dec 23, 2024

AVITA Medical's RECELL GO mini, approved by the FDA, is designed for treating smaller wounds up to 480 sq cm, complement...

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Cantor Fitzgerald bullish on Avita Medical after FDA approval for RECELL GO Mini
finance.yahoo.com · Dec 25, 2024

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