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SeaStar Medical and Nuwellis Enter into a U.S. License and Distribution Agreement for SeaStar Medical’s Selective Cytopheretic Device (SCD) for Pediatric Acute Kidney Injury (AKI)
Approximately 4,000 children in the U.S. with AKI require Continuous Kidney Replacement Therapy (CKRT) DENVER and MINNEAPOLIS , Dec. 29, 2022 (GLOBE NEWSWIRE)
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"Approximately 4,000 children in the U.S. with AKI require Continuous Kidney Replacement Therapy (CKRT) DENVER and MINNEAPOLIS , Dec. 29, 2022 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical) and Nuwellis, Inc. announce an exclusive U.S. license and distribution agreement by Nuwellis of SeaStar Medical’s Selective Cytopheretic Device (SCD) for the treatment of acute kidney injury (AKI) in children. Nuwellis will market and distribute the SCD through its direct salesforce to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy. SeaStar Medical expects the U.S. Food and Drug Administration (FDA) to complete a substantive review of a Humanitarian Device Exemption (HDE) for the use of SCD in children (>20 kg.) with AKI during the first quarter of 2023, with a potential commercial introduction in the second quarter of 2023. SCD is a patented, cell-directed extracorporeal therapy that selectively targets the most activated pro-inflammatory neutrophils and monocytes to stop the cytokine storm that frequently causes organ failure and possible death in critically ill patients. The therapy works with CKRT to target and neutralize pro-inflammatory neutrophils and monocytes, allowing the body to return to homeostasis. Clinical studies have demonstrated SCD’s potential to eliminate dialysis dependency, shorten ICU time and restore the lives of critically ill patients.1,2,3 “Nuwellis’ established relationships with pediatric nephrology and intensive care key opinion leaders make them the ideal marketing partner for SCD in this indication,” said Eric Schlorff, Chief Executive Officer of SeaStar Medical. “With Nuwellis, we have a proven, efficient means to reach our target customers while allowing SeaStar Medical to advance additional indications including a planned pivotal clinical trial in the adult acute kidney injury population, which we expect to initiate during the first quarter of 2023.” “We share a commitment with SeaStar Medical to bring potentially lifesaving therapies to children undergoing CKRT therapy,” said Nestor Jaramillo, Jr., President and CEO of Nuwellis. “To this end, we are also currently developing a new, fully integrated pediatric CKRT device designed to provide care for small babies and children under 20 kg., and we remain committed to devel...