SeaStar Medical Expands NEUTRALIZE-AKI Pivotal Trial 

SeaStar Medical Holding Corporation has added Brooke Army Medical Center (BAMC) and the U.S. Army Institute of Surgical Research (USAISR) to its lineup of NEUTRALIZE-AKI study sites.

The pivotal trial is evaluating the safety and efficacy of SeaStar Medical’s Selective Cytopheretic Device (SCD) in treating acute kidney injury (AKI) in adult ICU patients receiving continuous kidney replacement therapy (CKRT). The addition of these military medical facilities raises the number of active clinical sites to 11; 48 subjects have been enrolled to date.

The SCD received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for adults with AKI. In July 2024, the U.S. Centers for Medicare and Medicaid (CMS) granted Category B coverage for certain costs incurred by medical centers treating Medicare and Medicaid patients enrolled in the NEUTRALIZE-AKI pivotal trial.

“We are delighted these Department of Defense (DoD) facilities have joined our adult AKI trial,” SeaStar Chief Medical Officer Kevin Chung, M.D., stated. “BAMC and USAISR are where the most critically ill patients from the DoD and the south Texas region are treated. Having these two sites on board will help us achieve our goal of making this disease-modifying therapy available for all critically ill patients with AKI, regardless of the type of hospital.”

SeaStar Medical began shipping the SCD Pediatric brand QUELIMMUNE for pediatric patients with AKI and sepsis in July after receiving Humanitarian Device Exemption (HDE) approval from the FDA in February.

The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is expected to enroll up to 200 adults. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to CKRT, compared with the control group receiving only CKRT. Secondary endpoints include mortality at 28 days, ICU-free days in the first 28 days, major adverse kidney events at Day 90, and dialysis dependency at one year. The study will also include subgroup analyses to explore SCD therapy’s efficacy in AKI patients with sepsis and acute respiratory distress syndrome.

AKI is characterized by a sudden and temporary loss of kidney function and can be caused by various conditions such as COVID-19, sepsis, severe trauma, and surgery. AKI can cause hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after AIK is resolved, these patients may face chronic kidney disease or end-stage renal disease requiring dialysis, among other complications. Hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.

The Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CKRT and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CKRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis.

SeaStar Medical is a commercial-stage medtech company that develops and commercializes cell-directed extracorporeal therapies that target the effector cells driving systemic inflammation.