AVITA Medical submits FDA PMA application for RECELL System to treat stable vitiligo

AVITA Medical, Inc.

PMA submitted to FDA to expand RECELL indication to stable vitiligo; received Breakthrough Device designation.
Pivotal trial met primary endpoint of super-superiority (p<0.025) on repigmentation success rates.
Standard FDA review timeline for PMA is 180 days; full launch anticipated January 2025 if approved.
Vitiligo affects up to 6.5M Americans (~1.3M stable); limited treatment options exist.
This PMA follows original RECELL approval for burns in September 2018.

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