DENVER , Nov. 03, 2026 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company focused on transformational treatments for critically ill patients facing organ failure and potential loss of life, announced today the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry (SAVE Registry) has fulfilled the post-approval study requirements as outlined in the original Humanitarian Device Exemption (HDE) approval of QUELIMMUNE. “We are grateful for this decision by FDA and believe it will enable us to expand the potential life-saving benefits of our QUELIMMUNE therapy to more critically ill children with life-threatening AKI,” stated Eric Schlorff , CEO of SeaStar Medical . “These kids typically have about a 50% survival rate with traditional supportive care alone, and we believe this decision will be a win-win for patients, their families, health care providers, and the overall health care system.” Results from the SAVE Registry were recently presented at a late-breaking presentation at ASN Kidney Week 2026. The presentation highlighted the clinically meaningful and statistically significant improved survival of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening AKI and sepsis requiring renal replacement therapy (RRT). Data from the SAVE Registry patients showed no device-related adverse events. This late-breaking presentation at ASN Kidney Week 2026 reported a clinically meaningful and statistically significant improvement in 90-day survival of 65.1% for the QUELIMMUNE (SCD-PED) patients (N=43) versus only 47.5% (P = 0.043) for patients from clinically aligned cohorts from the Kids’ Inpatient Database (KID) (N=196). Statistically significant increases for both in-hospital and 60-day survival were also seen in the primary analysis for patients treated with QUELIMMUNE (SCD-PED) compared to the KID cohorts. KID is the largest publicly available, all-payer pediatric inpatient care database in the United States representing a broad range of diagnoses, procedures, and clinical severity. The ASN Kidney Week 2026 late-breaking poster presentation is available on the Healthcare Professional section of the SeaStar Medical website . “It is hard to describe how sick these children really are. Many are fighting sepsis and multi-organ failure at the same time,” stated Kevin Chung , MD, Chief Medical Officer of SeaStar Medical . “The SAVE Registry gives us crucial real-world evidence on both safety and probable benefits in these patients, and we are grateful to the pediatric teams and families who made it possible. We remain committed to collecting data wherever feasible, so that we keep learning how best to use QUELIMMUNE for the children who need it most.” FDA’s decision now enables hospitals to employ the QUELIMMUNE therapy without the research infrastructure that the SAVE Registry demanded, which will expand access to critically ill pediatric patients with sepsis-associated AKI on RRT at medical centers that previously could not participate. SeaStar Medical will continue to voluntarily enroll patients in the SAVE Registry at medical centers that choose to take part to continue to build on the real-world evidence for the use of QUELIMMUNE. The QUELIMMUNE therapy has been adopted by many of the highest rated children’s medical centers in the United States . The patented technology behind QUELIMMUNE is known as the Selective Cytopheretic Device (SCD) therapy that has broad potential applications for the treatment of destructive hyperinflammation that shuts down organ function and causes loss of life. About QUELIMMUNE The QUELIMMUNE ® (SCD-PED) therapy is being commercialized for children with AKI and sepsis or septic condition weighing 10 kilograms or more and aged ≤22 years who are on antibiotics and being treated in the ICU with RRT. It was approved in February 2024 under a Humanitarian Device Exemption application. Data from two clinical trials of the QUELIMMUNE therapy, 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, and 87.5% of survivors had normal kidney function at Day 60 after ICU discharge. QUELIMMUNE was approved by FDA under a Humanitarian Device Exemption based on safety and probable benefit. The effectiveness of this device for this use has not been demonstrated. Adverse reactions observed in clinical studies include hypotension, hypothermia, tachycardia, hyperglycemia, and thrombocytopenia. Additional risks may include blood loss or extracorporeal circuit complications. QUELIMMUNE must be used with citrate anticoagulation. For complete risk information, please see: https://seast