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AVITA Medical Gets FDA Approval on Vitiligo Treatment

By Ben Glickman

 

AVITA Medical said it had received premarket approval from the U.S. Food and Drug Administration for its treatment of vitiligo.

The company's RECELL System allows for repigmentation of skin lesions for patients with vitiligo, a disease which causes loss of pigment in areas of the skin.

The Valencia, Calif.-based medical company said its treatment was the first FDA-approved therapeutic device for single treatment of vitiligo, which affects up to 2% of the world's population.

Premarket approval by the FDA was based on the results of a trial evaluating the RECELL System for use in patients with vitiligo. The treatment technology has also previously been approved for treatment of burns and skin defects by the FDA.

Shares rose 0.47%, to $17.03, in late afternoon trading.

 

Write to Ben Glickman at ben.glickman@wsj.com

 

(END) Dow Jones Newswires

June 16, 2023 15:38 ET (19:38 GMT)

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