Avita Medical (ASX:AVH) received a 510(k) clearance from the US Food and Drug Administration for Cohealyx, which is used to facilitate wound healing, according to a Friday filing with the Australian bourse.
Preclinical studies in porcine models showed that Cohealyx generated strong tissue to support split-thickness skin grafts in a two-stage procedure earlier than competitors, the filing said.
The company plans to develop clinical data for Cohealyx next year for its commercial launch, according to the filing. It expects to start commercialization efforts in the US in the second quarter of 2025.
Shares rose more than 1% in morning trade Friday.
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