(RTTNews) - SeaStar Medical Holding Corporation (ICU), a commercial-stage healthcare company, yesterday announced that the independent Data Safety Monitoring Review Board (DSMB) has recommended the continuation of the NEUTRALIZE-AKI pivotal trial. Shares were trading 45.97% lower at $0.67 in after-hours.
NEUTRALIZE-AKI is a pivotal trial of the Selective Cytopheretic Device (SCD) therapy in adult patients with acute kidney injury (AKI) requiring continuous renal replacement therapy.
AKI is characterized by a sudden and temporary loss of kidney function and can be caused by a variety of conditions, such as sepsis, severe trauma, surgery, and COVID-19. Acute kidney injury (AKI) requiring continuous kidney replacement therapy is a significant complication in ICU patients, with mortality rates exceeding 50%.
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 along with zero device-related adverse events, which is in agreement with the preliminary results from the QUELIMMUNE SAVE pediatric registry reported in July 2025 and the earlier published safety profile of the Selective Cytopheretic Device in October 2023.
In addition, DSMB have also 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 for the trial.
Based on the current rate of enrollment, patient enrollment is estimated to be completed near the end of 2026.
The trial's primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with the Selective Cytopheretic Device (SCD) therapy in addition to Continuous Renal Replacement Therapy (CRRT), compared with the control group receiving only the standard CRRT.
Selective Cytopheretic Device (SCD) is a therapy designed to reduce inflammation and improve outcomes in critically ill patients, especially those with kidney failure or sepsis.
Continuous Renal Replacement Therapy (CRRT) is a renal dialysis treatment used in intensive care units for patients with acute kidney injury (AKI). It removes waste and excess fluid continuously over 24 hours (unlike standard intermittent dialysis).
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
