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AVITA Medical Achieves Positive Topline Pivotal Trial Results for Treatment of Stable Vitiligo Using the RECELL® System
The study achieved its primary effectiveness endpoint of super-superiority AVITA Medical continues to plan for submission to FDA by the end of 2022 VALENCIA,
About this update from Avita Medical, Inc.
[{"type":"text","content":"The study achieved its primary effectiveness endpoint of super-superiority AVITA Medical continues to plan for submission to FDA by the end of 2022 VALENCIA, Calif. and MELBOURNE, Australia, Sept. 12, 2022 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (Company), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today announced positive topline results from a pivotal randomized, controlled trial evaluating the safety and effectiveness of the RECELL® System for repigmentation of stable vitiligo lesions. The study compared repigmentation success rates, in a design where each patient randomly received RECELL treatment in one portion of depigmented area and treatment with the study control in another portion of depigmented area. The study control treatment was the standard of care narrowband ultraviolet-B phototherapy, which is typical first-line treatment for vitiligo. Repigmentation was evaluated 6 months after treatment by an expert central review committee (CRC). The CRC reported the following: Fifty-six percent (56%) of RECELL treatments (versus 12% of control treatments) resulted in repigmentation of more than 50% of the treated areaThirty-six percent (36%) of RECELL treatments (versus 0% of control treatments) resulted in repigmentation of at least 80% of the treated area, establishing super-superiority for the primary endpoint (p","length":1847,"tagName":"div"}]