SeaStar Medical Reports Enrollment Momentum in Its Pivotal Adult AKI Trial

Core Insights - SeaStar Medical Holding Corporation is advancing its pivotal NEUTRALIZE-AKI trial, with total enrollment reaching 46 subjects in a recent 10-day period, aiming for 200 participants in total [1][2][3] - The trial evaluates the safety and efficacy of the Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) undergoing continuous kidney replacement therapy (CKRT) [1][3] - The primary endpoint of the trial includes a composite of 90-day mortality or dialysis dependency, with secondary endpoints assessing various health outcomes [3] Company Overview - SeaStar Medical is a commercial-stage medical technology company focused on developing solutions to mitigate hyperinflammation effects on vital organs [7] - The company’s proprietary SCD device employs immunomodulating technology to target proinflammatory cells, potentially promoting long-term organ recovery [5][7] - The SCD-Pediatric device, QUELIMMUNE™, has received FDA approval for use in critically ill children with AKI and sepsis, indicating the company's commitment to expanding its product offerings [6] Industry Context - Acute Kidney Injury (AKI) is a significant health concern characterized by sudden loss of kidney function, often leading to hyperinflammation and multi-organ dysfunction [4] - The implications of AKI extend beyond immediate health risks, contributing to increased healthcare costs due to prolonged ICU stays and reliance on dialysis [4]