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See today's BioWorld MedTech
Home » FDA approval gives Avita’s Recell room for healthy growth
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FDA approval gives Avita’s Recell room for healthy growth

June 8, 2023
By Annette Boyle
The U.S. FDA granted premarket approval to Avita Medical Inc.’s Recell system for a wide range of full-thickness skin defects, potentially quintupling the company’s market opportunity. Recell is a cell harvesting device that produces and delivers a regenerative cell suspension using a small sample of the patient’s own skin. The Spray-On Skin cells, previously approved for use in severe burns, stimulate healing and repigmentation. “This is a landmark approval representing an inflection point for Avita Medical,” said Avita CEO Jim Corbett. “The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”
BioWorld MedTech Regulatory Dermatologic U.S. FDA PMA

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