2026-02-09, 6:23:22 a.m.
DENVER, Febuary 9, 2026 — Leads & Copy —
SeaStar Medical Holding Corporation (Nasdaq: ICU) announced today the publication of early post-approval clinical experience from the use of the QUELIMMUNE (Selective Cytopheretic Device for Pediatrics, or SCD-PED) therapy in Pediatric Nephrology.
The publication highlights early experience from the SAVE Registry, evaluating the role of QUELIMMUNE therapy in treating critically ill pediatric patients with life-threatening Acute Kidney Injury (AKI) and sepsis requiring renal replacement therapy.
Observations from the first 21 pediatric patients with AKI and sepsis requiring renal replacement therapy showed no device-related adverse events or infections and no reports of immunosuppressive effects by the device. Preliminary 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 a 50% reduction in patient mortality at 60 days compared to historical data, similar to what was observed in the registration study reported in Kidney Medicine.
Additional analyses included survival of patients requiring extracorporeal membrane oxygenation (ECMO) 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 end-stage renal disease or a recent kidney transplant, 75% (9 of 12) and 83% (10 of 12) were dialysis free at Day 28 and Day 90, respectively.
Stuart Goldstein, MD, Director, Center for Acute Care Nephrology at Cincinnati Children’s and a member of the SeaStar Medical Scientific Advisory Board, stated that the real-world experiences of the QUELIMMUNE therapy mirror the results from the two registrational trials that enabled FDA approval of the therapy in critically ill patients with AKI and sepsis requiring renal replacement therapy.
Goldstein also noted the complexity of the patient population with respect to their comorbidities show a much broader array of use compared to the narrower patient selection in the registrational trials. He also believes there is a clear potential benefit from the QUELIMMUNE therapy with minimal downside risk to patient safety, with no device-related serious adverse events to date.
Kevin Chung, MD, Chief Medical Officer of SeaStar Medical, stated that Pediatric Nephrology is widely considered a key resource for clinicians and researchers dealing with childhood kidney disease. Chung added that the company is delighted that these data have undergone the scrutiny of their peer-review process and will now be available widely.
The SAVE Registry is a Post-Approval Study that is designed to collect additional safety and other clinical effectiveness data of the QUELIMMUNE therapy in the treatment of pediatric patients with AKI and sepsis requiring renal replacement therapy. FDA initially required the enrollment of 300 patients in the SAVE Registry. After submission of data to the FDA from the first 21 patients and discussion between SeaStar Medical and the Agency, FDA reduced its mandated target from 300 to 50 patients.
Medical institutions employing the QUELIMMUNE therapy will continue to collect data for up to the first 50 patients treated with QUELIMMUNE. Specific outcomes data will include 28-day safety, and 90-day survival and dialysis dependency with plans to compare the SAVE Registry data to an existing control group of patients with similar illness severity.
SeaStar Medical believes that initial real-world experience from the SAVE Registry will support broader adoption of the QUELIMMUNE therapy and complement the company’s ongoing effort to recruit patients into its adult NEUTRALIZE-AKI pivotal trial.
The QUELIMMUNE therapy has been adopted by nationally recognized children’s medical centers in the United States. Participants in the SAVE Registry are listed on ClinicalTrials.gov and include the following top-rated children’s medical centers: Children’s of Alabama, Lucille Packard Children’s Hospital Stanford, UCSF Benioff Children’s, Children’s Hospital of Atlanta – Arthur M. Blank, Children’s Hospital of Atlanta – Scottish Rite, Lurie Children’s Hospital of Chicago, Cincinnati Children’s Medical Center, CS Mott Children’s Hospital, Cleveland Clinic Children’s Hospital, Children’s Hospital of Philadelphia, Children’s Medical Center Dallas, Cook Children’s Hospital, and Texas Children’s Hospital.
SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. SeaStar Medical’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). SeaStar Medical’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA.
The company is currently conducting the NEUTRALIZE-AKI pivotal clinical trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy.
Source: SeaStar Medical
