Nuwellis Provides Regulatory Update On SeaStar Medical's Selective Cytopheretic Device Use In Pediatric Acute Kidney Injury Under A Humanitarian Device Exemption
Portfolio Pulse from Benzinga Newsdesk
Nuwellis, Inc. (NASDAQ:NUWE) announced that its distribution partner, SeaStar Medical, received correspondence from the FDA indicating that SeaStar's Selective Cytopheretic Device (SCD) Pediatric is approvable under a Humanitarian Device Exemption for use in children with acute kidney injury. An Approvable Letter is expected to be issued within a month. Nuwellis and SeaStar entered into a U.S. license and distribution agreement for SeaStar's SCD for pediatric AKI in December 2022.
October 10, 2023 | 12:04 pm
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POSITIVE IMPACT
Nuwellis may see a positive impact as its partner SeaStar Medical's device is approvable by the FDA. This could potentially increase the company's market and distribution reach.
The FDA's indication of approval for SeaStar's device, which Nuwellis has a distribution agreement for, could potentially increase Nuwellis' market reach and distribution. This could lead to increased sales and revenue for the company.
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IMPORTANCE 80
RELEVANCE 100