The Food and Drug Administration (FDA) has expanded the approval of the RECELL® System in combination with meshed autografting to include patients 1 month of age and older for the treatment of acute full-thickness thermal burn wounds, including full-thickness thermal burns that extend beyond 50% total body surface area. Previously, the treatment had only been approved for patients 18 years of age and older and for burn wounds up to 50% total body surface area.
The RECELL System is a single-use, autologous cell harvesting device intended for use at the point of care by a trained health care professional. The device allows for the collection of a small skin sample that is used to produce a suspension of Spray-On Skin™ Cells in approximately 30 minutes. The resulting RES® Regenerative Epidermal Suspension, which includes keratinocytes, fibroblasts, and melanocytes, is directly applied 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 US 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 grafting procedures compared with data from the National Burn Repository (1.6 treatments vs 3.6 treatments, respectively).
Additionally, under Compassionate Use, the median number of autograft procedures for patients with extensive burns treated with RECELL was 2. In a matching cohort of patients in the National Burn Registry, the median number of autograft procedures was 5.
“Supported by a substantive body of clinical evidence and peer-review publications, the RECELL System is rapidly becoming the standard of care in burn treatment, and we are committed to pursuing and realizing the full potential of this innovative regenerative technology platform to address other clinical indications where significant unmet need exists,” said Dr Mike Perry, AVITA Medical’s Chief Executive Officer.
US Food and Drug Administration approves expanded 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.