FDA

Avita Medical wins FDA investigational device exemption approval for Recell System for vitiligo

Avita Medical (ASX:AVH) said it received FDA investigational device exemption approval for a study to evaluate its Recell System for vitiligo.

The company plans to conduct a feasibility study to evaluate the system’s safety and effectiveness for repigmentation of depigmented lesions that are associated with stable vitiligo.

“Vitiligo affects approximately 6.5 million people in the U.S., rivaling the prevalence of psoriasis; however, there are limited treatment options available to patients to permanently restore skin pigmentation,” CEO Mike Perry said in a news release. “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 Recall System as a cell-based regimentation treatment option for stable vitiligo.”

Avita Medical plans to collaborate with a leading medical center to conduct the pilot study with 10 patients who have vitiligo lesions that have been stable for at least one year. Lesions will be randomly treated with slightly varying cell suspensions prepared using Recall to assess response rates and optimal suspension parameters.

“This study expands on peer-reviewed, published effectiveness outcomes to confirm the feasibility of Recall as a treatment for regimentation in cases of stable vitiligo,” chief technology officer Andy Quick said. “Given the Recall System’s broad approval outside of the U.S., more than 1,000 vitiligo patients have already been treated globally and reported repigmentation.”

Original Article: (https://www.massdevice.com/avita-medical-wins-fda-investigational-device-exemption-approval-for-recell-system-for-vitiligo/)

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