
Core Insights - SeaStar Medical Holding Corporation has shipped its QUELIMMUNE™ device to a major academic medical center, marking its fourth commercial customer [1] - The QUELIMMUNE device is designed to treat critically ill children in the ICU suffering from acute kidney injury (AKI) and sepsis, demonstrating clinical results that reduce mortality and dialysis dependency [2][3] Company Overview - SeaStar Medical is a commercial-stage medical technology company focused on developing proprietary solutions to mitigate hyperinflammation effects on vital organs [8] - The company is pioneering cell-directed extracorporeal therapies that target inflammatory cells, aiming to provide life-saving solutions for critically ill patients [8] Product Details - QUELIMMUNE is a Selective Cytopheretic Device (SCD) that employs immunomodulating technology to target proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT) [5] - The device has received FDA approval under a Humanitarian Device Exemption (HDE) for use in children with AKI and sepsis, weighing 10 kilograms or more [3] Clinical and Economic Impact - Data indicates that AKI patients treated with QUELIMMUNE had no dialysis dependency 60 days post-treatment, potentially saving healthcare systems approximately $100,000 per patient annually due to avoided dialysis costs [3] - The average hospital cost for pediatric ICU patients with AKI exceeds $350,000, highlighting the economic benefits of adopting QUELIMMUNE [3]