U.S. Food and Drug Administration Approves Expanded Use of the RECELL® System for the Treatment of Extensive Burns and Pediatric Patients
Avita Medical, Inc. (RCEL)
Company Research
Source: GlobeNewswire
VALENCIA, Calif. and MELBOURNE, Australia, June 10, 2021 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today announced that the U.S. Food and Drug Administration (FDA) has approved expanded use of the RECELL® System in combination with meshed autografting for the treatment of all sizes of acute full-thickness thermal burn wounds for both pediatric and adult patients. Specifically, RECELL is now indicated to treat full-thickness thermal burns in patients 1-month of age and older (removing the prior limitation of use in patients younger than 18 years of age). In addition, the indication now includes treatment for full-thickness thermal burns that extend beyond 50% total body surface area (TBSA). “We are pleased that the RECELL System, with both its clinical and health economic benefits, can no
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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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- 4/23/24 - Form ARS
- 4/11/24 - Form 8-K
- RCEL's page on the SEC website