SeaStar expands NEUTRALIZE-AKI trial with two military medical facilities

SeaStar Medical announces the activation of Brooke Army Medical Center and the United States Army Institute of Surgical Research, expanding the number of sites in its NEUTRALIZE-AKI pivotal trial. This trial is evaluating the safety and efficacy of SeaStar Medical’s innovative Selective Cytopheretic Device in treating acute kidney injury in adult ICU patients receiving continuous kidney replacement therapy. With the inclusion of these prestigious military medical facilities, SeaStar Medical now has 11 active clinical sites with 48 subjects enrolled to date. The SCD has received U.S. Food and Drug Administration Breakthrough Device Designation for adults with AKI, which is awarded to the SCD as a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement over available therapies on clinically significant endpoints. In July 2024, the U.S. Centers for Medicare and Medicaid granted Category B coverage for certain expenses incurred by medical centers treating Medicare and Medicaid patients enrolled in the NEUTRALIZE-AKI pivotal trial. Among other accomplishments, SeaStar Medical began shipping the SCD Pediatric, brand named QUELIMMUNE, for pediatric patients with AKI and sepsis indications in July 2024, having received Humanitarian Device Exemption approval from the FDA earlier in 2024. Additionally, the Company paid-off all interest-bearing debt in September 2024.