SeaStar Medical expands QUELIMMUNE Surveillence Registry

SeaStar Medical (ICU) has added a nationally-recognized, Texas-based children’s hospital to its growing customer base of QUELIMMUNE therapy users. The QUELIMMUNE therapy was approved by the U.S. Food and Drug Administration in 2024 under a Humanitarian Device Exemption to treat pediatric patients with life-threatening, ultra-rare Acute Kidney Injury due to sepsis or a septic condition on antibiotic therapy and requiring Renal Replacement Therapy. As part of SeaStar Medical’s QUELIMMUNE approval, these notable medical institutions also committed to participate in the SAVE Surveillance Registry that is recording safety outcomes as well as various other organ-related and life-saving outcomes for pediatric patients treated with QUELIMMUNE versus those on standard of care treatment. Analyses of early data from this Registry are expected to be presented at a medical conference later this year.