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SeaStar Medical Announces Activation of First Clinical Site in Pivotal Trial with Selective Cytopheretic Device in Critically Ill Adults with Acute Kidney Injury
DENVER, April 19, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"DENVER, April 19, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the activation of Good Samaritan Regional Medical Center in Corvallis, Oregon, as the first clinical site in its pivotal NEUTRALIZE-AKI trial. This trial, expected to include up to 30 U.S. sites, is evaluating the safety and efficacy of SeaStar Medical’s patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT). “We recently received FDA approval to begin this pivotal trial and activated the first clinical site in record time, with many more sites expected to come onboard in the near term,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “Previous clinical studies with the SCD have demonstrated reduced mortality and dialysis dependency in these critically ill patients, and we look forward to rapid enrollment of eligible patients into the NEUTRALIZE-AKI trial to validate these results.” “We are honored to be the first clinical site activated in the NEUTRALIZE-AKI clinical study and are eager to evaluate the SCD therapy’s potential to improve outcomes for these critically ill patients,” said Brian Delmonaco, MD, FACEP, Medical Director of Samaritan Health Services Pulmonology and Critical Care Medicine and the principal investigator for Good Samaritan Regional Medical Center. Four non-COVID completed studies evaluating the safety and feasibility of the SCD in adults and pediatric patients with AKI requiring CKRT showed Day 60 reductions in mortality of up to 50% and no dialysis dependency, compared with 15% to 25% dialysis dependency in historical controls. The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective CytopheretIic Device - a randomiZEd clinical trial in Acute Kidney Injury) pivotal trial is expected to enroll up to 200 patients. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to CKRT as the standard of care, compared with the control group receiving only CKRT standard of care. Secondary endpoints include mortality at 28 days, ICU-free day...