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AVITA Medical Announces FDA Approval of RECELL for Skin Repigmentation in Vitiligo Patients
VALENCIA, Calif. and MELBOURNE, Australia, June 16, 2023 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company
About this update from Avita Medical, Inc.
[{"type":"text","content":"VALENCIA, Calif. and MELBOURNE, Australia, June 16, 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 that the U.S. Food and Drug Administration (FDA) has approved its application for premarket approval (PMA) of its RECELL® System for the treatment of vitiligo. RECELL for repigmentation of stable depigmented vitiligo lesions is the first FDA-approved therapeutic device offering a one-time treatment at the point-of-care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas, offering a safe and effective treatment for vitiligo. “RECELL represents first-in-class treatment for repigmentation through the delivery of normal, healthy skin cells,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “This is a breakthrough approval for AVITA Medical, significantly expanding the clinical applications for RECELL, and demonstrates our continued commitment to patient care. We look forward to offering a meaningful one-time treatment option for patients with stable vitiligo across the U.S.” PMA approval was based upon results from the company’s pivotal trial evaluating the safety and effectiveness of the RECELL System for repigmentation of stable vitiligo lesions. The study compared repigmentation success rates with RECELL treatment in areas of skin resurfaced using ablative laser, versus standard of care (control) treatment in another area. Repigmentation was evaluated by an expert central review committee (CRC) at 6 and 12 months after treatment. The CRC reported 36% of RECELL treatments (versus 0% of control treatments) resulted in repigmentation of at least 80% of the treated area at 6 months, establishing super-superiority for the primary endpoint (p","length":2407,"tagName":"div"}]