The AVITA Medical Ltd (ASX: AVH) share price will be on watch on Monday after the release of a positive announcement.
What did AVITA announce?
This morning AVITA announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) application.
This application relates to its plan 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.
AVITA’s Chief Executive Officer, Dr. Mike Perry, appeared pleased with the news and notes the significant market opportunity.
He said: “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.”
“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,” he added.
What is vitiligo?
Vitiligo is a disease resulting in loss of colour, or pigmentation, in patches of skin that impacts the quality of life for those living with the condition.
At present there is no cure for the disease, nor is there a universally accepted method for limiting its spread.
And although many treatments are being used for the management of vitiligo, they are often temporary with a high rate of recurrence.
Andy Quick, AVITA’s Chief Technology Officer, notes that the RECELL System has been used successfully to treat vitiligo.
He explained: “This study expands on peer-reviewed, published effectiveness outcomes to confirm the feasibility of RECELL as a treatment for repigmentation in cases of stable vitiligo. Given the RECELL System’s broad approval outside of the U.S., more than 1,000 vitiligo patients have already been treated globally and reported repigmentation.”
AVITA will now collaborate with a leading medical centre 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.
The randomised controlled study’s primary effectiveness measure will be the percent area of repigmented skin 24 weeks after treatment.
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