- AVITA Medical ( NASDAQ: RCEL ) on Monday said its trial assessing the safety and effectiveness of its RECELL system for repigmentation of vitiligo lesions met its main goal.
- AVITA's RECELL system received U.S. FDA approval in 2018 for the treatment of burn wounds. The system is used to spray-on skin cells using a small amount of a patient's own skin.
- The vitiligo study compared repigmentation success rates using the RECELL treatment and standard of care phototherapy treatment.
- Vitiligo is a disorder in which the skin loses its pigment cells and leads to blotches and lesions where the skin color is lost.
- The study showed that 56% of RECELL treatments vs. 12% of control treatments resulted in repigmentation of more than 50% of the treated area.
- The study showed that 36% of RECELL treatments vs. 0% of control treatments resulted in repigmentation of at least 80% of the treated area.
- AVITA said it continued to plan for an FDA submission for the RECELL system to treat vitiligo by the end of this year.
- RCEL stock +4.8% to $6.50 after hours.
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AVITA Medical says trial evaluating its RECELL system to treat vitiligo met main goal