Core Insights - SeaStar Medical Holding Corporation presented new data from the SAVE Registry, indicating no device-related adverse events or immunosuppression, alongside strong survival rates for pediatric patients with Acute Kidney Injury (AKI) [1][9] - The Selective Cytopheretic Device (SCD) therapy shows potential in modulating the immune response, shifting monocytes towards an anti-inflammatory phenotype, which may improve treatment outcomes for critically ill pediatric patients [1][5] Company Developments - SeaStar Medical hosted an educational symposium featuring leading experts discussing pediatric AKI, the QUELIMMUNE SAVE Registry, and the immunomodulatory effects of the SCD therapy [3][6] - The QUELIMMUNE therapy, approved in February 2024, is designed for critically ill pediatric patients with life-threatening AKI and sepsis requiring Renal Replacement Therapy (RRT) [6][15] Clinical Data - Presentations at the conference highlighted an 18-month post-approval clinical experience from the SAVE Registry, showing survival rates of 69% at Day 28 and Day 60 for patients treated with QUELIMMUNE [4] - Data from the SAVE Registry indicated a 76% survival rate at Day 28 and Day 60, and a 71% survival rate at Day 90, demonstrating a 50% reduction in mortality compared to historical data [9][7] Research Insights - In vitro studies demonstrated that the SCD therapy induces monocyte phenotype switching towards an anti-inflammatory and reparative state, which may help in managing hyperinflammatory conditions associated with AKI [5][10] - The SCD therapy is integrated with existing continuous renal replacement therapy (CRRT) systems, targeting pro-inflammatory monocytes to promote organ recovery and potentially eliminate the need for future dialysis [14] Industry Recognition - SeaStar Medical received the 2025 Corporate Innovator Award from the National Kidney Foundation for its contributions to improving pediatric AKI treatment through the QUELIMMUNE therapy [8]
SeaStar Medical Showcases New Positive Data from the QUELIMMUNE SAVE Registry and an Analysis of the Unique Immunomodulatory Mechanism of the SCD Therapy at AKI & CRRT 2026