Business
SeaStar Medical Announces Details of the Selective Cytopheretic Device Pivotal Study in Critically ill Adults with Acute Kidney Injury
The NEUTRALIZE-AKI study will evaluate safety and efficacy of the SCD’s ability to target and neutralize the highly activated proinflammatory neutrophils and
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"The NEUTRALIZE-AKI study will evaluate safety and efficacy of the SCD’s ability to target and neutralize the highly activated proinflammatory neutrophils and monocytes that drive hyperinflammation DENVER, Feb. 15, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces details of its pivotal NEUTRALIZE-AKI study evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT). The recently approved study will be initiated in March and is expected to enroll up to 200 patients at up to 30 U.S. clinical trial sites. This randomized, controlled study, called NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via seLective cytopheretIc device - a randomiZEd clinical trial in Acute Kidney Injury), will evaluate the safety and efficacy of the SCD to quell the hyperinflammatory process and cytokine storm by targeting and neutralizing activated effector cells in critically ill adults with AKI requiring CKRT, a condition with a high mortality rate. The study’s primary endpoint is a composite of 90-day mortality or dialysis dependency among patients treated with SCD in addition to CKRT standard of care, compared with the control group receiving CKRT standard of care alone. Secondary endpoints include mortality at Day 28, 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 subgroups to explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome (ARDS). “We are eager to begin this study that addresses life-threatening hyperinflammation in the setting of critical illness. An estimated six million American adults and children are diagnosed with AKI each year, and more than 200,000 require CKRT as part of their care,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “We believe the SCD holds potential to change practice by improving outcomes in all ICU patients with this unmet medical need caused by highly activated neutrophils and monocytes.” The SCD is a patented, cell-directed extracorporeal therapy that selectively targets the most highly activated proi...