DENVER, March 5, 2026 — Leads & Copy —
SeaStar Medical Holding Corporation (Nasdaq: ICU) has completed enrollment in the SAVE Registry, a Post-Approval Study (PAS) required by the FDA to confirm the safety of its QUELIMMUNE™ therapy for children with acute kidney injury (AKI) due to sepsis or a septic condition needing renal replacement therapy (RRT). The company announced today that the registry has enrolled 50 patients, and it will report the 28-day safety results to the FDA after data analysis.
According to Eric Schlorff, CEO of SeaStar Medical, early results from the SAVE Registry, published in Pediatric Nephrology, provided clinical outcomes data on the safety and probable benefit of the QUELIMMUNE therapy. He added that they look forward to evaluating the safety data from the full cohort and submitting it to the FDA in the coming months.
Tim Varacek, Senior Vice President of Business and Commercial Operations, said the company anticipates further expansion of its customer base to children’s hospitals, where setting up and running a patient registry has slowed adoption of the QUELIMMUNE therapy. He stated there continues to be very strong interest in QUELIMMUNE adoption, and the company is pleased it has met the FDA’s registry enrollment requirements.
The QUELIMMUNE therapy is used by nationally recognized children’s medical centers in the United States. Participants in the SAVE Registry, listed on ClinicalTrials.gov, include 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.
The technology behind QUELIMMUNE, the Selective Cytopheretic Device (SCD) therapy, has potential applications for treating destructive hyperinflammation that shuts down organ function.
AKI involves a temporary loss of kidney function caused by conditions like sepsis, trauma, surgery, and infection. It can lead to destructive hyperinflammation, which damages other organs and can result in multi-organ dysfunction or failure and increased risk of death. Even after resolution, patients may face complications, including chronic kidney disease or end-stage renal disease (ESRD) requiring dialysis. Extreme hyperinflammation may also increase healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.
The QUELIMMUNE therapy is being commercialized for children (age ≤22 years) with AKI due to sepsis or a septic condition weighing 10 kilograms or more who are on antibiotics and being treated with Renal Replacement Therapy (RRT). Approved in February 2024 under a HDE application, medical institutions are required to participate in the SAVE Surveillance Registry and complete Institutional Review Board approvals prior to use of the QUELIMMUNE™ therapy. The SAVE Surveillance Registry is a Post-Approval Study (PAS) designed to confirm the safety of the QUELIMMUNE therapy, approved in 2024 for children with AKI and sepsis or a septic condition.
Data from two clinical studies of the QUELIMMUNE therapy, published in Kidney Medicine, showed a 77% survival rate in patients 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. Recent data presented from the first 21 patients in the SAVE Surveillance Registry mirror the clinical trial results.
In January 2025, SeaStar Medical was awarded the 2025 Corporate Innovator Award by the National Kidney Foundation for its significant contribution to improving the lives of pediatric patients with AKI based on the approval and introduction of the QUELIMMUNE™ therapy.
The NEUTRALIZE-AKI pivotal trial is evaluating the safety and efficacy of the SCD therapy in 339 adults with AKI in the ICU receiving CRRT. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the SCD therapy in addition to CRRT as the standard of care, compared with the control group receiving only CRRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90, and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.
The Selective Cytopheretic Device (SCD) therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation. The SCD therapy has potential broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing patients who today have few or no FDA-approved options for treating their disease. The SCD therapy is integrated with an existing CRRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This immunomodulation approach may promote long-term organ recovery, eliminate the need for future RRT, including dialysis, and prevent loss of life.
SeaStar Medical is a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure. SeaStar’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the U.S. Food and Drug Administration (FDA). It is the only FDA approved product for the ultra-rare condition of life-threatening acute kidney injury (AKI) due to sepsis or a septic condition in critically ill pediatric patients. SeaStar’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by FDA. The company is currently conducting a pivotal trial of its SCD therapy in adult patients with AKI requiring continuous renal replacement therapy (CRRT), a life-threatening condition with no effective treatment options that impacts over 200,000 adults in the U.S. annually.
Source: SeaStar Medical
