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Stock impact report

U.S. Food and Drug Administration Approves Expanded Use of the RECELL® System for the Treatment of Extensive Burns and Pediatric Patients

Avita Medical Limited (RCEL)  More Company Research Source: GlobeNewswire
PDF VALENCIA, 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 no [Read more]
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