Core Viewpoint - SeaStar Medical Holding Corporation is advancing its NEUTRALIZE-AKI pivotal trial for its Selective Cytopheretic Device (SCD) aimed at treating acute kidney injury (AKI) and has received FDA Breakthrough Device Designation for this indication [1][2][8]. Group 1: Trial Progress and Enrollment - Mayo Clinic has been cleared to enroll subjects in the NEUTRALIZE-AKI trial, increasing the number of activated sites to 15 [1]. - Current enrollment in the trial stands at 76, with six subjects enrolled since the beginning of the year, aiming to reach 100 subjects for an interim analysis soon [2][4]. Group 2: Trial Details - The NEUTRALIZE-AKI trial is evaluating the safety and efficacy of the SCD in 200 adults with AKI in the ICU receiving continuous renal replacement therapy (CRRT) [3]. - The primary endpoint is a composite of 90-day mortality or dialysis dependency, with secondary endpoints including 28-day mortality and major adverse kidney events at Day 90 [3]. Group 3: Device and Market Potential - The SCD employs immunomodulating technology to target proinflammatory cells during CRRT, aiming to reduce hyperinflammation and promote organ recovery [7]. - The estimated annual U.S. total addressable market for the SCD in adult AKI is between 6.3 billion, indicating significant commercial potential [6].
SeaStar Medical Activates 15th Site for its Adult Acute Kidney Injury Pivotal Trial