Review board recommends SeaStar Medical continue with NEUTRALIZE-AKI trial

SeaStar Medical (ICU) announced that the independent data safety monitoring review board has recommended the continuation of the NEUTRALIZE-AKI pivotal trial of the Selective Cytopheretic Device therapy in adult patients with acute kidney injury requiring continuous renal replacement therapy. The interim analysis by the independent DSMB evaluated the safety and potential clinical benefit of the first 100 patients enrolled in the NEUTRALIZE-AKI pivotal clinical trial. The DSMB reported no device-related safety concerns, with zero device-related adverse events. This is consistent with the previously published safety profile of the SCD therapy as well as the preliminary results from the QUELIMMUNE SAVE pediatric registry. A signal of potential clinical benefit in the treatment group across key study outcome measures. To ensure the study is adequately powered to validate the potential clinical efficacy signal, the DSMB recommended increasing the total enrollment from 200 to 339 patients, consistent with the trial’s statistical analysis plan. To date, 137 patients have been enrolled, representing significant progress toward this target. SeaStar Medical is taking proactive steps to accelerate enrollment to meet the new target. It estimates patient enrollment will be complete near the end of 2026, based on the current enrollment rate of clinical trial sites and the addition of several new sites in the NEUTRALIZE-AKI trial.