- The independent Data Safety Monitoring Review Board (DSMB) has recommended the continuation of SeaStar Medical Holding Corp.'s **NEUTRALIZE-AKI pivotal trial** for its Selective Cytopheretic Device (SCD) therapy in adult patients with acute kidney injury (AKI).  **[1831868_0001193125-25-215608_icu-ex99_1.htm:0]** **[1831868_0001193125-25-215608_icu-20250924.htm:1]** **[1831868_0001193125-25-215608_icu-ex99_1.htm:1]** 
- An interim analysis of the first 100 patients revealed **zero device-related safety issues** and indicated a signal of **potential clinical benefit** in the treatment group.  **[1831868_0001193125-25-215608_icu-ex99_1.htm:0]** **[1831868_0001193125-25-215608_icu-ex99_1.htm:1]** 
- To enhance statistical power, the DSMB advised increasing the total patient enrollment from 200 to **339 patients**.  **[1831868_0001193125-25-215608_icu-20250924.htm:1]** **[1831868_0001193125-25-215608_icu-ex99_1.htm:1]** 
- Patient enrollment for the trial is now estimated to be complete near the **end of 2026**.  **[1831868_0001193125-25-215608_icu-ex99_1.htm:1]**

SeaStar Medical Holding (ICU)