Core Viewpoint - SeaStar Medical Holding Corporation has activated 14 sites for the NEUTRALIZE-AKI pivotal trial, which is assessing the safety and efficacy of its Selective Cytopheretic Device (SCD) for treating acute kidney injury (AKI) in ICU patients undergoing continuous renal replacement therapy (CRRT) [1][9]. Market Opportunity - The annual U.S. total addressable market for the SCD in adult AKI is estimated to be between 6.3 billion, presenting a significant opportunity relative to the clinical trial costs of approximately $15 million [2]. Clinical Trial Details - The NEUTRALIZE-AKI trial aims to enroll up to 200 adults, with the primary endpoint being a composite of 90-day mortality or dialysis dependency among patients treated with SCD in addition to CRRT [11]. - As of now, 70 subjects have been enrolled, with an interim analysis planned at the trial's 90-day primary endpoint [9]. Device Technology - The SCD is a patented cell-directed extracorporeal device that utilizes immunomodulating technology to target proinflammatory neutrophils and monocytes during CRRT, aiming to reduce hyperinflammation and improve organ recovery [13]. Regulatory Status - The SCD has received FDA Breakthrough Device Designation for adults with AKI, indicating it may offer substantial improvement over existing therapies [10].
SeaStar Medical Activates 14th Hospital for its Adult AKI Pivotal Trial