DENVER - SeaStar Medical Holding Corporation (NASDAQ:ICU), a medical device company specializing in therapies for hyperinflammation, has announced updates on its clinical trials for treating acute kidney injury (AKI). The company's NEUTRALIZE-AKI pivotal trial has enrolled 21 subjects across five clinical sites, with more sites preparing to join the study.
The trial is evaluating the safety and efficacy of SeaStar Medical's Selective Cytopheretic Device (SCD) in adult patients with AKI. The SCD is an extracorporeal therapy that aims to reduce the hyperinflammatory response in critically ill patients. The primary endpoint of the trial is a combined measure of 90-day mortality or dialysis dependency, with secondary endpoints including mortality at 28 days and major adverse kidney events at Day 90.
SeaStar Medical expects to conduct an interim analysis after reaching the 90-day primary endpoint with 100 enrolled subjects, projected for the second half of 2024. The trial plans to enroll up to 200 adults and will also consider the effectiveness of the SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.
In a related development, the U.S. Food and Drug Administration (FDA) granted a Humanitarian Device Exemption (HDE) Approval Order to the Quelimmune pediatric device in February 2024. The device is designed for children with AKI due to sepsis or a septic condition requiring kidney replacement therapy (KRT). The approval was based on pooled analysis from two studies showing a 77% survival rate and no dialysis dependency at 60 days post-treatment.
SeaStar Medical estimates that approximately 4,000 children annually could benefit from the Quelimmune pediatric device. The company is coordinating with several key target hospitals to expand commercial rollout in partnership with Nuwellis, Inc. during the second quarter.
The information in this article is based on a press release statement from SeaStar Medical.
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