AVITA Medical Submits FDA PMA Application to Expand Indication to Vitiligo

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[{"type":"text","content":"VALENCIA, Calif., and MELBOURNE, Australia, Dec. 19, 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) application to the U.S. Food and Drug Administration (FDA) for its RECELL® System. The application, if approved, will expand the indication of RECELL to include the treatment of stable vitiligo. “We are pleased to take the next step towards expanding the clinical application of RECELL into a treatment for vitiligo,” said Jim Corbett, AVITA Medical Chief Executive Officer. “RECELL offers first-in-class repigmentation of vitiligo lesions through the transplantation of melanocytes. Once approved, this indication will dramatically expand our reach in a huge market with limited treatment options. We anticipate a full launch of this treatment option in January 2025.” This PMA application includes the recently released results of the pivotal trial for vitiligo. The study achieved its primary effectiveness endpoint of super-superiority (p","length":1580,"tagName":"div"}]

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