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US FDA awards humanitarian device exemption approval to SeaStar Medical’s Selective Cytopheretic Device for paediatric acute kidney injury

SeaStar Medical Holding Corporation, a leader in medical technology, announces FDA approval of the Selective Cytopheretic Device (SCD) Paediatric (SCD-PED) under a Humanitarian Device Exemption (HDE). This approval permits its use in children weighing over 10 kilograms with acute kidney injury (AKI) from sepsis, advancing SeaStar's Quelimmune product family. The SCD-PED, addressing hyperinflammation's impact on organs, can now be marketed as a Humanitarian Use Device (HUD).

Clinical studies demonstrate its efficacy in reducing mortality rates and dialysis dependency in pediatric AKI cases. SeaStar's US partner, Nuwellis, will initiate its commercial launch, followed by a comprehensive program rollout.

The FDA's approval was based on safety and potential clinical benefits observed in critically ill children with AKI. Quelimmune selectively targets proinflammatory cells during CKRT, mitigating hyperinflammation and promoting organ recovery, avoiding future KRT needs, including dialysis. SeaStar aims to redefine extracorporeal therapies, reducing excessive inflammation's consequences on vital organs.