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Avita Medical Receives U.S. FDA Investigational Device Exemption Approval of Clinical Feasibility Study to Evaluate RECELL System for Vitiligo

30 Dec 2019  |  08:28:00  |  Associate analysts  |  Increase  |  Decrease  |  

Original announcement: AVITA Receives FDA IDE Approval to Evaluate RECELL for Vitil

Avita Medical announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational Device Exemption (IDE) application to conduct a feasibility study evaluating the safety and effectiveness of the RECELL Autologous Cell Harvesting Device (RECELL System) for repigmentation of depigmented lesions associated with stable vitiligo. The randomized controlled study's primary effectiveness measure is the percent area of repigmented skin 24 weeks after treatment, as evaluated by a clinician blinded to the treatment assignment.

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