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U.S. Food and Drug Administration Approves Expanded Use of the RECELL® System for the Treatment of Extensive Burns and Pediatric Patients
Expanded indication for use includes RECELL System for treatment of full-thickness acute burn wounds of all sizes in pediatric and adult patients VALENCIA,
About this update from Avita Medical, Inc.
[{"type":"text","content":"Expanded indication for use includes RECELL System for treatment of full-thickness acute burn wounds of all sizes in pediatric and adult patients\nVALENCIA, Calif. and MELBOURNE, Australia, June 10, 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, today announced that the U.S. Food and Drug Administration (FDA) has approved expanded use of the RECELL® System in combination with meshed autografting for the treatment of all sizes of acute full-thickness thermal burn wounds for both pediatric and adult patients. Specifically, RECELL is now indicated to treat full-thickness thermal burns in patients 1-month of age and older (removing the prior limitation of use in patients younger than 18 years of age). In addition, the indication now includes treatment for full-thickness thermal burns that extend beyond 50% total body surface area (TBSA). “We are pleased that the RECELL System, with both its clinical and health economic benefits, can now more broadly support surgeons in treating full-thickness burns of all sizes, including treatment of patients over 1-month of age,” said Dr. Mike Perry, AVITA Medical’s Chief Executive Officer. “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.” The revised indication for the RECELL System is based on clinical 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 (BARDA) within the U.S. Department of Health and Human Services (HHS), Office of the Assistant Secretary for Preparedness and Response (ASPR), under USG Contract HHSO100201500028C. As BARDA’s mandate includes building preparedness by expanding the indications of medical countermeasures (MCMs) for vulnerable populations, such as pediatrics, an independent contract option dedicated to this goal was exercised between BARDA and AVITA ...