Nuwellis’ Distribution Partner, SeaStar Medical, Receives FDA Humanitarian Device Exemption for Pediatric Selective Cytopheretic Device Quelimmune™
Nuwellis, Inc. (NUWE)
Company Research
Source: GlobeNewswire
MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its distribution partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), has received Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for Quelimmune™, its pediatric Selective Cytopheretic Device. Quelimmune provides a new therapy option for children weighing 10 kg or more who have acute kidney injury (AKI) and sepsis or a septic condition requiring continuous kidney replacement therapy (CKRT) in a hospital intensive care unit. Nuwellis has an exclusive U.S. license and distribution agreement with SeaStar Medical to distribute Quelimmune and will market and distribute the device to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy. With FDA HDE in place for Quelimmune, Nuwellis will begin commer
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NUWE
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- Nuwellis, Inc. Announces Fourth Quarter and Full Year 2023 Financial ResultsGlobeNewswire
- Nuwellis, Inc. To Report Fourth Quarter and Full Year 2023 Financial Results on March 5, 2024GlobeNewswire
NUWE
Sec Filings
- 4/29/24 - Form 424B4
- 4/29/24 - Form EFFECT
- 4/17/24 - Form S-1/A
- NUWE's page on the SEC website