NEWS
SeaStar Medical Ships First QUELIMMUNE Product Order to U.S. Distribution Partner
SeaStar Medical (Nasdaq: ICU) has announced the initial commercial sale of its QUELIMMUNE™-Pediatric to U.S. distributor Nuwellis. QUELIMMUNE, a patented cell-directed extracorporeal therapy, targets highly activated neutrophils and monocytes responsible for hyperactive immune responses in pediatric acute kidney injury (AKI) patients. The device is FDA-approved under a Humanitarian Device Exemption to treat pediatric AKI in patients weighing 10 kilograms or more. Initial studies show QUELIMMUNE has a probable benefit in reducing mortality and dialysis dependency. SeaStar Medical anticipates a significant commercial rollout by Q4 2024, with prestigious pediatric hospitals expected to meet HDE requirements this quarter. The company is also enrolling patients in the NEUTRALIZE-AKI trial for adults, presenting a multibillion-dollar market opportunit
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