AVITA Medical Submits Response to FDA, Resuming Review Clock for RECELL GO PMA Supplement

VALENCIA, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced it has submitted its response to the U.S. Food and Drug Administration (FDA) for additional information requested in connection to its premarket approval (PMA) supplement for RECELL GO^™. This submission resumes the substantive interactive review process under the Breakthrough Devices Program.

The response addresses various questions and incorporates data from in-house testing to support the PMA supplement and fulfil the additional information request, which we received in October of 2023. Upon receipt by the FDA, the application of the PMA supplement resumes its 180-day real time review, with 90 days remaining in the review period. Therefore, we expect FDA approval on May 30, 2024, positioning us for a product launch on May 31, 2024.

“RECELL GO will enhance our capabilities and reach to continue our already impressive growth,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “RECELL GO reduces the training burden on medical professionals and our field sales organization. In doing so, we anticipate broader adoption of RECELL across various applications, ultimately amplifying our impact and transforming patient care."

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

About AVITA Medical, Inc.

AVITA Medical^® is a commercial-stage regenerative medicine company transforming the standard of care in wound care management and skin restoration with innovative devices. At the forefront of our platform is the RECELL^® System, approved by the Food and Drug Administration for the treatment of thermal burn wounds and full-thickness skin defects, and for repigmentation of stable depigmented vitiligo lesions. RECELL harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin^™ Cells, delivering a transformative solution at the point-of-care. This breakthrough technology serves as the catalyst for a new treatment paradigm enabling improved clinical outcomes. AVITA Medical also holds the exclusive rights to market, sell, and distribute PermeaDerm^®, a biosynthetic wound matrix, in the United States.

In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including burns, full-thickness skin defects, and vitiligo. The RECELL System is TGA-registered in Australia, received CE-mark approval in Europe and has PMDA approval in Japan.

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Authorized for release by the Chief Financial Officer of AVITA Medical, Inc.