AVITA Medical Submits FDA PMA Supplement for RECELL GO

VALENCIA, Calif., June 29, 2023 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today announced its submission of a premarket approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for RECELL GO™. The supplement follows the original PMA of its RECELL Autologous Cell Harvesting Device and subsequent PMA supplements.

With its innovative capabilities, RECELL GO revolutionizes the current, manually operated RECELL device by eliminating the need for manual management of skin samples. RECELL GO will utilize single-use processing cartridges integrated into a durable AC powered processing device. The automated workflow streamlines the critical steps of enzyme incubation, buffer rinse, mechanical disaggregation, and filtering, transforming the production process of Spray-On Skin™ Cells.

“This step is pivotal to advancing our platform and strategic growth plans,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “The submission is a testament to our unwavering commitment to innovation and dedication to patient care. Upon approval, RECELL GO will serve as the catalyst that accelerates our growth trajectory. By significantly reducing the burden on medical professionals, we anticipate increased adoption of RECELL across our indications, amplifying our impact and transforming the lives of patients.”

As previously announced, RECELL GO maintains the FDA Breakthrough Device designation from predecessor devices. Under the Breakthrough Device program, the submission will receive prioritized, interactive review with an expected January 2024 approval.

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

ABOUT AVITA MEDICAL, INC.

AVITA Medical^® is a regenerative medicine company leading the development and commercialization of devices and autologous cellular therapies for skin restoration. The RECELL^® System technology platform, approved by the FDA for the treatment of thermal burn wounds and full-thickness skin defects and for repigmentation of stable depigmented vitiligo lesions, harnesses the regenerative properties of a patient’s own skin to create Spray-On Skin™ cells. Delivered at the point-of-care, RECELL enables improved clinical outcomes. RECELL is the catalyst of a new treatment paradigm and AVITA Medical is leveraging its proven and differentiated capabilities to develop first-in-class cellular therapies for multiple indications.

In international markets, our products are approved under the RECELL System brand to promote skin healing in a wide range of applications including burns, soft tissue repair, vitiligo, and aesthetics. The RECELL System is TGA-registered in Australia, received CE-mark approval in Europe and has PMDA approval in Japan.

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FORWARD-LOOKING STATEMENTS

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