SeaStar Medical Holding Says QUELIMMUNE Therapy Adopted For Use By Nationally Recognized Texas Children's Hospital

Author: Benzinga Newsdesk | July 08, 2025 08:12am

SeaStar Medical Holding Corporation (NASDAQ:ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life announced today that the QUELIMMUNE therapy has been adopted for use by the nationally recognized Texas Children's Hospital. The QUELIMMUNE therapy was approved by the U.S. Food and Drug Administration (FDA) in 2024 under a Humanitarian Device Exemption application for pediatric patients with AKI due to sepsis or a septic condition on antibiotic therapy and requiring Renal Replacement Therapy (RRT). Clinical data from the FDA application and subsequently published in Kidney Medicine showed a 77% survival rate in patient treated with QUELIMMUNE versus standard of care, representing an approximate 50% reduction in loss of life compared to historical data in this patient population. No dialysis was required for survivors at Day 60 after ICU discharge.

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