SeaStar Medical Holding Corporation (Nasdaq: ICU) is making strides in its NEUTRALIZE-AKI pivotal trial, with Stanford Medicine recently cleared to actively enroll subjects. This development brings the total number of active sites to 12, with 52 subjects currently enrolled, including contributions from two Department of Defense medical centers. The trial is designed to evaluate the safety and efficacy of SeaStar Medical's Selective Cytopheretic Device (SCD) in treating adults with acute kidney injury (AKI) in the intensive care unit (ICU) who are receiving continuous kidney replacement therapy (CKRT).
Stanford Joins the Fight Against AKI
The addition of Stanford Medicine as an active enrollment site is a significant boost for the NEUTRALIZE-AKI trial. "It goes without saying that Stanford is an incredibly important site," said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. The trial's progress is further supported by the U.S. Centers for Medicare and Medicaid Services (CMS), which has agreed to reimburse certain expenses for Medicare patients enrolled in the study. This decision is proving critical in recruiting new medical sites and accelerating the pace of enrollment.
NEUTRALIZE-AKI Trial Design and Endpoints
The NEUTRALIZE-AKI trial aims to enroll up to 200 adults across multiple clinical sites. The primary endpoint is a composite of 90-day mortality or dialysis dependency in patients treated with SCD plus CKRT, compared to a control group receiving only CKRT. Secondary endpoints include mortality at 28 days, ICU-free days within the first 28 days, major adverse kidney events at Day 90, and dialysis dependency at one year. Subgroup analyses will also explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.
Addressing AKI and Hyperinflammation
Acute Kidney Injury (AKI) is characterized by a sudden decline in kidney function, often resulting from conditions like COVID-19, sepsis, severe trauma, or surgery. AKI can trigger hyperinflammation, an overproduction of inflammatory cells and molecules that can damage other organs and lead to multi-organ dysfunction or failure. Even after AKI resolves, patients may face chronic kidney disease or end-stage renal disease, requiring dialysis. Hyperinflammation also contributes to increased healthcare costs, including prolonged ICU stays and reliance on dialysis and mechanical ventilation.
Selective Cytopheretic Device (SCD) Mechanism
The SCD is a patented, cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CKRT. Unlike traditional blood-purification methods, the SCD integrates with CKRT systems to modulate the immune response, transitioning proinflammatory monocytes to a reparative state and reducing the inflammatory activity of neutrophils. This approach aims to promote long-term organ recovery and potentially eliminate the need for future kidney replacement therapy.
Regulatory and Commercial Milestones
The SCD has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for adults with AKI, highlighting its potential to substantially improve outcomes over existing therapies. In July 2024, CMS granted Category B coverage for certain expenses related to the NEUTRALIZE-AKI trial. SeaStar Medical has also begun shipping QUELIMMUNE™, the SCD-Pediatric device, for pediatric patients with AKI and sepsis, following FDA approval under a Humanitarian Device Exemption (HDE).
Financial Stability and Future Outlook
In September 2024, SeaStar Medical announced the extinguishment of all interest-bearing debt, strengthening its financial position. With the NEUTRALIZE-AKI trial progressing and the commercialization of QUELIMMUNE™, SeaStar Medical is poised to make a significant impact on the treatment of AKI and hyperinflammation in both adult and pediatric populations.
