AVITA Medical (ASX:AVH) files RECELL application with FDA

AVITA Medical (ASX:AVH) has submitted an Investigational Device Exemption (IDE) supplement with the US Food and Drug Administration (FDA) for a clinical trial to investigate the RECELL® System for the treatment of vitiligo.

Avita is a regenerative medicine company with a technology platform for unmet medical needs in therapeutic skin restoration.

The data from the pivotal trial will form the basis of the FDA submission for consideration to expand use of the RECELL® System for repigmentation of depigmented lesions associated with stable vitiligo.

In parallel, and as previously announced, we are also conducting a complementary and more scientifically-oriented feasibility study.” Vitiligo affects approximately 6.5 million people in the United States rivalling the prevalence of psoriasis, however, there are limited treatment options available to patients to permanently restore skin pigmentation.

Vitiligo is a disease resulting in loss of colour, or pigmentation, in patches of skin and there is currently no cure.

Shares in AVITA Medical (ASX:AVH) shares are trading 3.06 per cent lower at 48 cents.
 
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