SeaStar Medical Reaches New Study Enrollment Milestone

SeaStar Medical Holding Corporation has enrolled 125 patients in the NEUTRALIZE-AKI pivotal clinical trial and activated Methodist Hospital Metropolitan (San Antonio, Texas) as its 16th study site.

The company remains on track to compile results from the per protocol pre-specified interim analysis of the first 100 study patients this current quarter. The analysis is being conducted by the trial’s independent Data Safety Monitoring Review Board (DSMB). SeaStar Medical will disclose to stakeholders only the top-line decision from the DSMB analysis to preserve the trial’s integrity.

“We are very pleased to reach this new enrollment milestone in the NEUTRALIZE-AKI pivotal trial,” SeaStar Medical Chief Medical Officer Kevin Chung, M.D., said. “We are also thrilled to welcome Methodist Hospital Metropolitan as a key addition to our clinical trial sites. Its affiliate, Methodist Hospital, is one of our highest enrolling sites, and we believe their shared research teams and recruitment efforts should enable expedited recruitment and enrollment of patients in the NEUTRALIZE-AKI pivotal trial.”

Among the NEUTRALIZE-AKI trial sites are such notable institutions as Cleveland Clinic, Mayo Clinic, and Stanford Medical Center.

NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) is expected to enroll up to 200 adult patients with AKI requiring continuous renal replacement therapy (CRRT). The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to CRRT as the standard of care, compared with the control group receiving only CRRT. The study’s 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 the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.

“With respect to our upcoming interim analysis, the NEUTRALIZE-AKI pivotal trial is rigorously powered to detect a true efficacy signal, and confirming safety remains a top priority,” Dr. Chung stated. “This interim analysis seeks to validate the therapy’s safety profile and efficacy potential—critical factors in supporting a DSMB recommendation to proceed to full trial completion.”

The NEUTRALIZE-AKI trial protocol specifies that an interim analysis be conducted by the independent DSMB on the study’s primary endpoint when approximately half of patients (100 patients) achieve 90-day follow-up. The protocol specifies a very low probability of stopping the trial for efficacy at the interim analysis and would also require concurrence by the U.S. Food and Drug Administration (FDA). It also specifies the DSMB may recommend a sample size re-estimation to maintain a statistically significant CRRT plus SCD therapy effect by the study’s end based on interim results. And while SeaStar Medical believes it is unlikely, the DSMB could also recommend stopping the trial for futility.

AKI is characterized by a sudden and temporary kidney function loss 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 from AKI hyperinflammation 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 resolution, 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) therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates a cascade of events that wreak havoc in the patient’s body. The SCD therapy has broad applications in multiple acute and chronic kidney and cardiovascular diseases, representing nearly 1 million patients who currently have no FDA-approved options for treating their disease. Unlike pathogen removal and other blood-purification tools, the SCD therapy is integrated with an existing CRRT hemofiltration system to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery, eliminate the need for future RRT, including dialysis, and prevent loss of life.  

SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure and potential loss of life. SeaStar’s first commercial product, QUELIMMUNE (SCD-PED), was approved in 2024 by the FDA. It is the only FDA-approved product for the ultra rare condition of life-threatening AKI due to sepsis or a septic condition in critically ill pediatric patients. SeaStar’s Selective Cytopheretic Device (SCD) therapy has been awarded Breakthrough Device Designation for six therapeutic indications by the FDA, enabling the potential for a speedier pathway to approval and preferable reimbursement dynamics at commercial launch.