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HomeLatest Pharma-NewsAVITA medical receives U.S. FDA investigational device exemption approval of clinical feasibility...

AVITA medical receives U.S. FDA investigational device exemption approval of clinical feasibility study in order to evaluate Recell system for Vitiligo

Dec 30, 2019: AVITA Medical Limited announced that the U.S. FDA has approved the company’s Investigational Device Exemption (IDE) application to conduct a feasibility study evaluating the safety and effectiveness of the RECELL® Autologous Cell Harvesting Device (RECELL® System) for repigmentation of depigmented lesions associated with stable vitiligo.

Vitiligo affects approximately 6.5 million people in the United States, rivalling the predominance of psoriasis. Conversely, there are limited treatment options available to patients to permanently restore skin pigmentation.

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Vitiligo is a disease that causes loss of color, or pigmentation, in patches of skin that impacts the quality of life for those living with the condition.

Currently, there is no cure for vitiligo, nor a universally accepted method for limiting the spread of the disease.AVITA Medical will collaborate with a leading medical centre in order to conduct a pilot study with 10 patients, have vitiligo lesions that have been stable for at least one year.

Areas of the vitiligo lesion will be randomly treated with slightly altering cell suspensions prepared using RECELL to confirm response rates and best possible suspension parameters. https://www.avitamedical.com/uploads/pdf/AVH-Press-Release-Vitiligo-IDE-Approval-30DEC2019-FINAL.pdf

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