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FDA Approves IDE Amendment to a Single-Arm Design for AVITA Medical’s Pivotal Study of the RECELL® System for Vitiligo Treatment
New single-arm design to evaluate 23 subjects at 15 clinical sites, versus previously approved 3-arm study of 84 subjectsThe 1:20 expansion ratio to be used
About this update from Avita Medical, Inc.
[{"type":"text","content":"New single-arm design to evaluate 23 subjects at 15 clinical sites, versus previously approved 3-arm study of 84 subjectsThe 1:20 expansion ratio to be used is the best-case scenario for patients as it requires the least amount of donor skin VALENCIA, Calif. and MELBOURNE, Australia, Aug. 16, 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 the U.S. Food and Drug Administration (FDA) has approved the company’s request to amend its pivotal clinical trial evaluating the safety and effectiveness of the RECELL® System for the repigmentation of stable vitiligo lesions to a streamlined single-arm trial design. The Company’s strategic decision to pursue a single cell suspension formulation (1:20 expansion ratio) is based on data from other research efforts that suggest the improbability of meaningful clinical performance differences amongst the three cell suspensions in the initial pivotal clinical trial design. “The simplified study design and reduced number of study subjects reflects confidence both in the exceptional safety profile of RECELL and in the anticipated high incidence of repigmentation with RECELL treatment, as we have seen in 11 peer-reviewed publications and in the treatment of more than 1,000 patients outside the U.S.,” said Dr. Mike Perry, Chief Executive Officer of AVITA Medical. “The design change allows this program to progress in a timely and cost-effective manner toward bringing a novel therapeutic option to an underserved population. Our ongoing multi-media outreach and clinical and advocacy group referral programs are generating significant interest in the trial. The program is on track, and we continue to believe we could be in a position to enter the U.S. market with the vitiligo indication, following successful completion of the clinical trial, as early as the second half of calendar year 2023.” Pivotal Trial DesignThe multi-center pivotal study includes 15 clinical sites to assess the safety and effectiveness of the RECELL System in treatment of depigmented vitiligo lesions in patients whose vitiligo is stable, meaning they have not had new vitiligo lesions or lesions that have expanded for at ...