Avita Medical Ltd (RCEL)

[Fmello]

AVITA Medical Submits PMA Supplement for Soft Tissue Repair

VALENCIA, Calif., and MELBOURNE, Australia, December 12, 2022 (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, announced today the submission of a Premarket Approval (PMA) supplement application to the U.S. Food and Drug Administration (FDA) for the company’s RECELL® System. The supplement, if approved, will expand the indication of RECELL to include soft tissue repair.

“The submission is a significant milestone in our effort to expand the label of RECELL into the soft tissue repair market opportunity,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “Soft tissue repair encompasses a broad label of RECELL applications and allows us to target all level 1 and level 2 trauma centers in the U.S. Once approved, this indication expands our current market opportunity by at least three times and is expected to create a significant growth opportunity for us beginning July 2023.” This PMA supplement includes the recently released results of the pivotal trial for soft tissue repair. The study met both co-primary endpoints, demonstrating that RECELL is statistically significant in donor sparing and statistically non-inferior in healing outcomes. For purposes of the clinical study, soft tissue injuries included any full-thickness acute skin defect, such as degloving or peeled back skin injuries, road rash, surgical wounds, and flesh-eating disease.

The RECELL System earned FDA Breakthrough Device designation for its proposed soft tissue repair indication. Under the program, AVITA Medical will receive prioritized review and interactive communication with the FDA throughout the premarket review phase. The standard FDA review timeline for label expansion through a PMA supplement is 180 days.

This PMA supplement application follows the original PMA approval of the RECELL System in September 2018.

AVITA Medical’s clinical trial in soft tissue repair has been funded in whole or in part with Federal funds from the Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract no. HHSO100201500028C