- AVITA Medical ( NASDAQ: RCEL ) on Monday said it had submitted a premarket approval supplement application to the U.S. FDA for its RECELL system to expand the indication to include soft tissue repair.
- The company's RECELL system had previously been approved by the FDA for the treatment of acute thermal burns in both adults and children.
- "Once approved, this indication expands our current market opportunity by at least three times and is expected to create a significant growth opportunity for us beginning July 2023," RCEL CEO Jim Corbett said in a statement .
- The RECELL system had earlier got a FDA breakthrough device designation for its proposed soft tissue repair indication.
- RCEL stock +1.2% to $6.71 in morning trade.
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AVITA Medical seeks FDA nod to expand indication of its system to treat thermal burns