AVITA Medical Receives U.S. FDA Investigational Device Exemption Approval of Pivotal Study Evaluating RECELL System for Soft Tissue Reconstruction
AVITA MEDICAL (AVMXY)
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Source: Business Wire
First RECELL System clinical trial in the U.S. focused on acute soft tissue injuries, defects, and reconstruction; study expected to commence within next 6 months VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--AVITA Medical (ASX: AVH, OTCQX: AVMXY), a regenerative medicine company focused on the development and commercialization of innovative therapies leveraging the healing properties of a patient’s own skin, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) application to conduct a pivotal trial evaluating the safety and effectiveness of the RECELL® Autologous Cell Harvesting Device (RECELL® System) in combination with meshed autografting for the treatment of acute full-thickness skin defects, such as degloving (a type of injury where the skin is ripped from the underlying tissue), crush wounds (a break in the external surface of the body), abrasions, lacerations, and surgical wounds.“FDA
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