Nuwellis' Strategic Partner, SeaStar Medical, Receives FDA Approvable Letter For Its Pediatric Selective Cytopheretic Device
Portfolio Pulse from Benzinga Newsdesk
SeaStar Medical, a strategic partner of Nuwellis, Inc. (NASDAQ:NUWE), has received an Approvable Letter from the FDA for its pediatric Selective Cytopheretic Device (SCD-PED). The device provides a new therapy option for children with acute kidney injury and sepsis. Nuwellis and SeaStar Medical have an exclusive U.S. license and distribution agreement for Nuwellis to distribute the SCD-PED. The approval of this device will represent a new revenue stream for Nuwellis.
October 31, 2023 | 12:10 pm
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Nuwellis, Inc. is set to benefit from the FDA's Approvable Letter to SeaStar Medical for its pediatric device. This approval will open a new revenue stream for Nuwellis.
The FDA's Approvable Letter to SeaStar Medical for its pediatric device is a positive development for Nuwellis, Inc. as it has an exclusive U.S. license and distribution agreement with SeaStar Medical. This approval will allow Nuwellis to distribute the device, opening a new revenue stream for the company.
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