Avita’s ReCell Wins FDA Approval For Pediatric Burn Patients
Company CEO Michael Perry spoke with Medtech Insight about Avita Medical’s spray-on-skin system and his hopes for the product.
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The topical treatment is made from human skin cells and can be applied to speed the healing of deep thermal burns.
The Recell system of Spray-On Skin Cells combined with mesh autografts healed 98% of burns within four weeks in 23 pediatric patients treated under US FDA-approved compassionate use and continued access programs.
The resolution of a May 2020 warning letter to a breast implant manufacturer accounted for the only device-related close-out latter issued this month.