SeaStar Medical Reports Real-World Outcomes for QUELIMMUNE Therapy in Pediatric Acute Kidney Injury

SeaStar Medical Holding Corporation (Nasdaq: ICU) has published real-world clinical data on the use of QUELIMMUNE™ therapy, also known as the Selective Cytopheretic Device for Pediatrics (SCD-PED), in the peer-reviewed journal Pediatric Nephrology. The publication reports outcomes from the SAVE Registry, a post-approval surveillance registry evaluating the device in pediatric patients with acute kidney injury (AKI) and sepsis requiring renal replacement therapy (RRT) .

The registry data reflect the experience of the first 21 pediatric patients treated with the QUELIMMUNE device. Observations indicate no device-related adverse events or infections. Survival outcomes were reported at multiple time points: 76 percent at Days 28 and 60, and 71 percent at Day 90. These survival rates align with historical trial data that supported regulatory approval, with analyses suggesting comparable mortality reductions relative to historical cohorts .

Additional registry analyses examined subgroups of patients with specific clinical profiles. Among those who required extracorporeal membrane oxygenation (ECMO), a 60 percent survival rate was observed at Day 90. For survivors without a history of end-stage renal disease or recent kidney transplant, 75 percent were independent of dialysis at Day 28 and 83 percent at Day 90 .

QUELIMMUNE received approval from the U.S. Food and Drug Administration in February 2024 under a Humanitarian Device Exemption for the treatment of pediatric patients (weight ≥ 10 kg and age ≤ 22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT. The SAVE Registry was initially designed to enroll up to 300 patients, but after submission of early registry data and discussion with the FDA, the target was reduced to 50 patients. Participating medical centers include multiple children’s hospitals across the United States .

The authors of the Pediatric Nephrology publication include clinicians and researchers with expertise in pediatric critical care and nephrology. The published report presents real-world outcomes from clinical practice and contributes additional safety and effectiveness data on the use of QUELIMMUNE therapy in this patient population. Continued registry enrollment will capture further outcome measures, including 28-day safety and 90-day survival and dialysis dependency, with plans to compare registry results to a control cohort of patients with similar illness severity .

The registry findings support existing clinical experience with QUELIMMUNE and extend observations beyond controlled trial settings. These data may inform clinical decision-making and contribute to ongoing assessment of therapeutic strategies for pediatric AKI associated with sepsis.