Grandbrothers AVITA Medical ( NASDAQ: RCEL ), a biotech focused on wound care management, traded higher on Thursday after the U.S. Food and Drug Administration (FDA) greenlighted its next-gen cell harvesting device, RECELL GO.
RECELL GO is designed to streamline the preparation of a patient’s own skin cells for direct application in treating thermal burn wounds and full- thickness skin defects. Avita ( RCEL ) said the device is expected to launch in the U.S.
in June. Its U.S.
regulatory clearance comes after AVITA ( RCEL ) responded to additional information the FDA required in connection with a premarket approval (PMA) supplement the company had submitted for RECELL GO in June 2023. Avita ( RCEL ) initially won FDA clearance for its RECELL PMA in 2018 to treat thermal burn injuries in adults. Subsequent label expansions have vastly expanded its addressable market to more than $2.
8B in the U.S. alone, Seeking Alpha analyst Wall Street Titan wrote in December with a Strong Buy rating on the stock.
More on AVITA Medical AVITA Medical: Financial Challenges Ahead, Despite Innovative RECELL Device AVITA Medical, Inc. (RCEL) Q1 2024 Earnings Call Transcript AVITA Medical: Unconvincing Growth Amid Fierce Competition In The Burn Care Sector AVITA downgraded by Piper Sandler over sales outlook AVITA Medical GAAP EPS of -$0.73 misses by $0.
24, revenue of $11.1M misses by $0.07M.
