SeaStar Medical Reaches Interim Enrollment Target for NEUTRALIZE-AKI Pivotal Trial of SCD Therapy for Adult Patients with Acute Kidney Injury

Core Points - SeaStar Medical has reached the halfway point in the NEUTRALIZE-AKI pivotal clinical trial, allowing for an interim analysis by the independent Data Safety Monitoring Review Board (DSMB) [1][2] - The NEUTRALIZE-AKI trial is evaluating the Selective Cytopheretic Device (SCD) therapy for adult patients with Acute Kidney Injury (AKI) requiring continuous renal replacement therapy (CRRT) [2][4] - The trial aims to enroll up to 200 patients, with the primary endpoint being a composite of 90-day mortality or dialysis dependency [4][5] - The SCD therapy has shown improved treatment outcomes in prior studies compared to standard care, and the interim analysis will assess its safety and efficacy [3][4] Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its first product, QUELIMMUNE, approved by the FDA in 2024 for a rare condition of AKI in pediatric patients [9] - The company has received Breakthrough Device Designation from the FDA for its SCD therapy across six therapeutic indications, facilitating a faster approval process [9][7] - The SCD therapy targets over-active immune cells to mitigate hyperinflammation, with potential applications in various acute and chronic kidney and cardiovascular diseases [8][9] Clinical Trial Details - The NEUTRALIZE-AKI trial has enrolled 100 patients so far, with the interim analysis focusing on the primary endpoint after 90-day follow-up [4][5] - Secondary endpoints include mortality at 28 days, ICU-free days, major adverse kidney events at Day 90, and dialysis dependency at one year [4] - The DSMB will conduct the interim analysis and may recommend adjustments to the trial based on the results, including potential sample size re-estimation [5]