FDA approves AVITA Medical's RECELL study for Vitiligo

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Regenerative medicine company AVITA Medical (ASX:AVH) has announced that the US FDA has approved its Investigational Device Exemption (IDE) application to conduct a feasibility study evaluating the safety and effectiveness of the RECELL Autologous Cell Harvesting Device for repigmentation of depigmented lesions associated with stable vitiligo.

“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,” said CEO Dr Mike Perry.

“We’re pleased with the FDA’s decision which allows us to begin our vitiligo study in the first half of 2020. Based on the outcomes of the feasibility study, we anticipate proceeding with a pivotal clinical trial to pursue FDA approval of the RECELL System as a cell-based repigmentation treatment option for stable vitiligo.”

Vitiligo is a disease resulting in loss of colour, or pigmentation, in patches of skin. It impacts the quality of life for those living with the condition and there is currently no cure.

AVITA Medical said it will collaborate with a leading medical centre to conduct a pilot study with 10 patients who have vitiligo lesions.

"Areas of the vitiligo lesion will be randomly treated with slightly varying cell suspensions prepared using RECELL to confirm response rates and optimal suspension parameters," it said.

The company said the study’s primary effectiveness measure is the per cent area of repigmented skin 24 weeks after treatment, as evaluated by a clinician blinded to the treatment assignment.