
Core Insights - SeaStar Medical Holding Corporation has published a health economic analysis indicating that the QUELIMMUNE therapy can save approximately $69,146 per hospitalization for pediatric patients with Acute Kidney Injury (AKI) in the ICU compared to standard continuous renal replacement therapy (CRRT) [1][4] - The QUELIMMUNE therapy has shown a 77% survival rate in treated patients, representing a potential ~50% reduction in loss of life compared to historical data [3][8] - The therapy is currently being adopted by leading children's medical centers, which may enhance its broader acceptance in the healthcare market [2] Economic Impact - The analysis estimates that the QUELIMMUNE therapy could offset its own costs, potentially leading to no out-of-pocket expenses for institutions for a median treatment duration of 6 days [1][4] - Modeled hospitalization costs for pediatric patients treated with QUELIMMUNE are estimated at $320,304, significantly lower than $457,092 and $389,451 for patients in the KID and ppCRRT cohorts respectively [4] Clinical Efficacy - QUELIMMUNE therapy has received FDA approval under a Humanitarian Device Exemption for pediatric patients with AKI due to sepsis, showing no dialysis required for survivors at Day 60 post-treatment [3][7] - A pivotal trial, NEUTRALIZE-AKI, is underway to evaluate the safety and efficacy of the SCD therapy in adults with AKI, which has received FDA Breakthrough Device Designation [4][10] Technology Overview - The QUELIMMUNE therapy utilizes patented Selective Cytopheretic Device (SCD) technology aimed at modulating the immune response to prevent destructive hyperinflammation in critically ill patients [11][14] - This therapy is the only FDA-approved option for treating life-threatening AKI due to sepsis in critically ill pediatric patients, addressing a significant unmet medical need [14]