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AVITA Medical Completes Enrollment in Pivotal Trial Evaluating the RECELL® System for Repigmentation of Stable Vitiligo
Topline data expected in second half of 2022 VALENCIA, Calif. and MELBOURNE, Australia, Dec. 15, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL,
About this update from Avita Medical, Inc.
[{"type":"text","content":"Topline data expected in second half of 2022\nVALENCIA, Calif. and MELBOURNE, Australia, Dec. 15, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, announced today that it has completed enrollment into its pivotal trial for the use of the RECELL® System for repigmentation of stable vitiligo. Currently, the RECELL System is indicated in the U.S. for use in the treatment of acute thermal burns. “Recruitment of the last patient in this blinded, randomized pivotal trial is a significant milestone and lays the groundwork for the regulatory approval and commercialization of the RECELL System in 2023 for use in patients with stable vitiligo,” said Dr. Mike Perry, Chief Executive Officer of AVITA Medical. “We look forward to sharing the topline data from this trial next year.” Vitiligo is a disease that attacks pigment-producing cells, called melanocytes, resulting in their destruction or malfunction. The result is a loss of pigmentation in patches of skin. Vitiligo affects up to 2% of the population worldwide,i including an estimated 3-6.5 million Americans.ii Vitiligo has a comparable market size and psychosocial impact to other major dermatology diseases including psoriasis (thick, scaly skin) and atopic dermatitis (red, cracked skin).iii iv v Like these diseases, those living with vitiligo may suffer from poor body image along with low self-esteem, leading to an impaired quality of life.vi “There is currently no cure for vitiligo and no FDA-approved treatment options, so this is a very exciting clinical trial,” said Dr. Anand Ganesan, professor of dermatology and biological chemistry in the University of California Irvine School of Medicine. “We believe the RECELL System has the potential to become an important new treatment option for the millions of people with stable vitiligo.” For more information about the RECELL System, please visit www.RECELLSystem.com. ABOUT AVITA MEDICAL, INC.AVITA Medical is a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications. AVITA Medical’s patented and proprietary collection and application technology provides i...