SeaStar Medical announces preliminary results from SAVE Surveillance Registry

SeaStar Medical (ICU) announced preliminary results from the SAVE Surveillance Registry presented on Saturday, September 27, 2025, at the 5th International Symposium on Acute Kidney Injury in Children. The SAVE Registry presentation highlighted the role of QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury and sepsis requiring Renal Replacement Therapy. Data from the first 21 pediatric patients with AKI and sepsis requiring RRT showed zero device-related adverse events or infections and no reports of immunosuppressive effects by the device. In addition, outcomes analyses show a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90. These new data are on track to validate or potentially exceed a 50% reduction in loss of life compared to historical data, as reported in Kidney Medicine. Additional analyses included survival of patients requiring extracorporeal membrane oxygenation and independence from renal replacement therapy for pediatric patients without a history of end-stage renal disease or a recent kidney transplant. The evaluation of five patients concomitantly treated with the QUELIMMUNE therapy and ECMO showed a 60% survival rate at Day 90. Among pediatric patient survivors without a history of ESRD or a recent kidney transplant, 75% and 82% were dialysis free at Day 28 and Day 90, respectively. The SAVE Surveillance Registry is a Real-World Evidence surveillance program that is designed to confirm safety and efficacy of the QUELIMMUNE therapy. Medical institutions employing the QUELIMMUNE therapy will continue to collect RWE for up to the first 300 patients treated with QUELIMMUNE. Specific outcomes data will include 90-day survival and dialysis dependency along with safety data with plans to compare to an existing control group of similar illness severity. SeaStar Medical believes that initial results from the SAVE Surveillance Registry will support broader adoption of the QUELIMMUNE therapy, inform payer discussions, and complement the company’s ongoing effort to recruit patients into its adult NEUTRALIZE-AKI pivotal trial.