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Avita Gets FDA IDE Approval Of Study To Evaluate RECELL System For Vitiligo

Avita Medical Limited (RCEL, AVH.AX) said that the U.S. Food and Drug Administration
has approved the company's Investigational Device Exemption or 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 is a disease resulting in loss of color, or pigmentation, in patches of skin that impacts the quality of life for those living with the condition.There is currently no cure for vitiligo, nor a universally accepted method for limiting the spread of the disease. Although many treatments are being used for the management of vitiligo, they are often temporary with a high rate of recurrence.

The company noted that it will collaborate with a leading medical center to conduct a
pilot study with 10 patients who have vitiligo lesions that have been stable for at least one year. 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.

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