ICU News & Events

SeaStar Medical announced that it has completed the required enrollment in the SAVE Registry, a Post-Approval Study, PAS, required by the FDA that is designed to confirm the safety of the Quelimmune therapy as a treatment for children with acute kidney injury due to sepsis or a septic condition requiring renal replacement therapy. The registry has successfully enrolled 50 patients, and the company will be reporting the 28-day safety results from the SAVE Registry to the FDA upon completion of its analysis of the data.

SeaStar Medical Holding Corporation announced the publication of early post-approval clinical experience from the use of the QUELIMMUNE therapy in the prestigious, peer-reviewed journal Pediatric Nephrology.The publication, co-authored by leading experts including Stuart Goldstein, Kelli Krallman, Meredith Harris, Rajit Basu, David Askenazi, Shina Menon, Matt Zinter, Steven Gorga, and H. David Humes, highlights early experience from the SAVE Registry, a post-approval surveillance registry, evaluating the role of the QUELIMMUNE therapy in the treatment of critically ill pediatric patients with life-threatening Acute Kidney Injury 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. In addition, 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 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.

SeaStar Medical announced today its key milestones for 2026. Key 2026 milestones for SeaStar Medical include the following: Broaden QUELIMMUNE adoption to include 15 additional top-ranked children's medical centers, more than doubling the total number of sites and building increased depth in customer orders. SeaStar Medical anticipates achieving approximately $2 million in net product revenue in 2026. Advance the SCD therapy for the adult AKI indication through completion of enrollment in the NEUTRALIZE-AKI pivotal trial near the end of 2026 and initiation of a modular PMA process. Evaluate broader applicability of the SCD therapy through the conduct of a pivotal trial of the SCD therapy in patients with acute CHF with cardiorenal syndrome awaiting LVAD implantation. Explore rapid regulatory pathways to commercialization of the SCD therapy as a first-in-class therapy, designed to save lives and spare organ function in numerous destructive hyperinflammatory conditions. SeaStar Medical will seek additional Humanitarian Use and Breakthrough Device Designations to potentially provide lifesaving support to these patients.