The Food and Drug Administration (FDA) has extended approval of the RECELL® System in combination with meshed autografting to patients 1 month of age and older for the treatment of acute full-thickness thermal burns, including full-thickness stretching thermal burns extends to more than 50% of the total body surface area. Previously, the treatment was only approved for patients 18 years of age and older and for burns up to 50% of the total body surface area.
The RECELL System is a single-use autologous cell harvesting device intended for point-of-care use by a trained healthcare professional. The device allows a small skin sample to be taken which is used to produce a suspension of Spray-On Skin™ Cells in approximately 30 minutes. The resulting RES® Regenerative Epidermal Suspension, comprising keratinocytes, fibroblasts, and melanocytes, is applied directly to the wound.
The pediatric approval was based on data from the RECELL Compassionate Use (IDE 15945) and Continued Access (IDE 13053) studies, which were supported by the Biomedical Advanced Research and Development Authority within the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response. Findings showed that treatment with RECELL significantly reduced the mean number of pediatric transplant procedures compared to National Burn Repository data (1.6 treatments vs. 3.6 treatments, respectively).
In addition, under Compassionate Use, the median number of autograft procedures for patients with extensive burns treated with RECELL was 2. In a matched cohort of patients in the National Burn Registry, the median number of autograft procedures was 5.
“Supported by a significant body of clinical evidence and peer-reviewed publications, the RECELL system is rapidly becoming the standard of care for burn treatment, and we are committed to pursuing and realizing the full potential of this innovative regenerative technology platform to support other clinical indications where there is a significant unmet need,” said Dr. Mike Perry, AVITA Medical’s Chief Executive Officer.
The US Food and Drug Administration approves extended use of the RECELL® System for the treatment of extensive burns and pediatric patients. [press release]. Valencia, CA and Melbourne, Australia: AVITA Medical, Inc.; June 10, 2021.