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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RCEL
News
- AVITA Medical, Inc. (NASDAQ: RCEL) had its "overweight" rating re-affirmed by analysts at Cantor Fitzgerald. They now have a $21.00 price target on the stock.MarketBeat
- AVITA Medical, Inc. (NASDAQ: RCEL) is now covered by analysts at D. Boral Capital. They set a "buy" rating and a $25.00 price target on the stock.MarketBeat
- AVITA Medical Announces FDA Approval of RECELL GO mini, Optimizing Treatment for Smaller Wounds [Yahoo! Finance]Yahoo! Finance
- AVITA Medical Announces FDA Approval of RECELL GO mini, Optimizing Treatment for Smaller WoundsGlobeNewswire
- AVITA Medical Announces FDA 510(k) Clearance for Cohealyx, Expanding its Addressable Market [Yahoo! Finance]Yahoo! Finance
RCEL
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- 11/7/24 - Miss
RCEL
Sec Filings
- 12/5/24 - Form 4
- 11/7/24 - Form 10-Q
- 11/7/24 - Form 8-K
- RCEL's page on the SEC website