RECELL System Receives FDA Approval

AVITA Medical, a global regenerative medicine company, announces that the U.S. Food and Drug Administration (FDA) has approved the Company’s Premarket Approval (PMA) application to market the RECELL Autologous Cell Harvesting Device to treat severe thermal burns in patients 18 years and older.

The RECELL System uses a small amount of a patient’s own skin to prepare Spray-On Skin Cells at the point of care in as little as 30 minutes, providing a new way to treat thermal burns. The two randomized, controlled clinical trials supporting the FDA approval demonstrated that treatment of acute burn wounds with the RECELL System required substantially less donor skin than required with conventional split-thickness autografts to achieve closure of burn wounds. Reduction in donor skin requirements provides key clinical benefits to patients and significant reductions in the cost of treatment.

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