FDA approves AVITA Medical’s IDE application to assess RECELL system
Category: #health  By Pankaj Singh  Date: 2019-12-30
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FDA approves AVITA Medical’s IDE application to assess RECELL system

AVITA Medical Limited, a regenerative medicine firm addressing unmet medical needs in therapeutic skin restoration, has reportedly announced that its IDE (Investigational Device Exemption) application to carry out a feasibility study assessing the effectiveness and safety of RECELL System was approved by U.S. FDA (Food and Drug Administration). The company developed this device to help in repigmentation of lesions that are depigmented due to stable vitiligo.

Vitiligo results in loss of pigment, color, in patches of skin that affects the quality of life for people living with these conditions. Currently, there is no treatment available that cures vitiligo, nor a widely accepted method for restricting the progression of the disease. Although, many treatments are being used for the management of vitiligo, they are temporary with a high rate of recurrence.

Speaking on which Mike Perry, CEO, AVITA Medical said that around 6.5 million people are affected by vitiligo in the U.S, rivaling the prevalence of psoriasis. However, there is a lack of treatment options available for patients to restore their skin pigmentation permanently.

Perry added that with this approval, the company will begin its vitiligo study in the two quarters of 2020. Depending upon the results of the feasibility study, the company would proceed with a vital clinical trial to get FDA approval for this device as a cell-based repigmentation therapy for treating stable vitiligo.

Andy Quick, CTO, AVITA Medical said that this study gives published, peer-reviewed effectiveness results to verify RECELL’s feasibility as a treatment for stable vitiligo. RECELL System is widely approved outside of the United States. Over 1,000 patients with vitiligo have been treated worldwide and reported repigmentation, added Quick.

Sources cite that AVITA medical will partner with a renowned medical center to carry a pilot study that would enroll 10 patients that have stable vitiligo lesions for a minimum of one year. Vitiligo lesion areas will be randomly cured with little varying cell suspensions that are prepared with RECELL to confirm optimal suspension parameters and response rates.
 

Source credit: https://www.avitamedical.com/uploads/pdf/AVH-Press-Release-Vitiligo-IDE-Approval-30DEC2019-FINAL.pdf



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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