SeaStar Medical Announces That Independent DSMB Recommends Continuing NEUTRALIZE-AKI Pivotal Trial Of Its Selective Cytopheretic Device Therapy For Adult Patients With Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

Author: Benzinga Newsdesk | September 24, 2025 03:25pm

SeaStar Medical Holding Corporation (NASDAQ:ICU), a commercial-stage healthcare company focused on transforming treatments for critically ill patients facing organ failure and potential loss of life, announced today that the independent Data Safety Monitoring Review Board (DSMB) has recommended the continuation of the NEUTRALIZE-AKI pivotal trial of the Selective Cytopheretic Device (SCD) therapy in adult patients with acute kidney injury (AKI) requiring continuous renal replacement therapy (CRRT).

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.

"We are encouraged by the DSMB's recommendation, which reinforces the overall safety profile of our SCD therapy and suggests a potential clinical benefit, which we are observing in the commercial setting with QUELIMMUNE in the pediatric population" said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. "Sample size re-estimations are well established practices in pivotal trials, and while an upward re-estimation will extend the trial timeline, we are optimistic it will strengthen the statistical power and provide critical care teams with greater confidence in the results."

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