SeaStar Medical reports enrollment momentum in adult AKI trial

SeaStar Medical Holding announces the enrollment of four additional subjects in a 10-day period in its pivotal NEUTRALIZE-AKI trial, bringing total trial enrollment to 46. This trial is evaluating the safety and efficacy of SeaStar Medical’s proprietary therapeutic Selective Cytopheretic Device in adults with acute kidney injury, AKI, in the intensive care unit receiving continuous kidney replacement therapy. “We are encouraged to see a recent uptick in enrollment following a slow summer period due to low census across many of the ICUs participating in this trial,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “Finishing this pivotal trial is a major priority for our company and will bring us one step closer to commercialization of what we believe is a practice-changing therapy in critically ill adults. Our next major step is an interim analysis at the halfway point, which will help inform our Data and Safety Monitoring Board that can recommend concluding the study early if statistical significance is reached. Regardless, we are working to expand the number of trial sites by more than a dozen to accelerate towards our original goal of enrolling 200 subjects as quickly as possible.”