AVITA Medical Receives U.S. FDA Investigational Device Exemption Approval of Clinical Feasibility Study to Evaluate RECELL System for Vitiligo
Avita Medical, Inc. (RCEL)
Company Research
Source: Business Wire
Study expected to commence in first half of 2020 VALENCIA, Calif. & MELBOURNE, Australia--(BUSINESS WIRE)--AVITA Medical Limited (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in therapeutic skin restoration, announced today that the U.S. Food and Drug Administration (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(i), rivalling the prevalence of psoriasis(ii); however, there are limited treatment options available to patients to permanently restore skin pigmentation,” said Dr. Mike Perry, AVITA Medical Chief Executive Officer. “We’re pleased with the FDA’s decision which allows us to begin
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News
- AVITA Medical to Announce First Quarter 2024 Financial Results [Yahoo! Finance]Yahoo! Finance
- AVITA Medical to Announce First Quarter 2024 Financial ResultsGlobeNewswire
- AVITA Medical, Inc. (NASDAQ: RCEL) was downgraded by analysts at BTIG Research from a "buy" rating to a "neutral" rating.MarketBeat
- AVITA Medical Updates Expected First Quarter 2024 Revenue [Yahoo! Finance]Yahoo! Finance
- AVITA Medical Updates Expected First Quarter 2024 RevenueGlobeNewswire
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RCEL
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- 4/11/24 - Form 8-K
- RCEL's page on the SEC website