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First Patient Enrolled in SeaStar Medical’s Pivotal Clinical Trial with the Selective Cytopheretic Device in Adults with Acute Kidney Injury
DENVER, June 20, 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, June 20, 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 enrollment of the first patient in the NEUTRALIZE-AKI pivotal clinical trial to evaluate the safety and efficacy of its 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 are delighted to enroll the first patient into our pivotal trial following the successful resolution of a supply-chain issue that temporarily impacted the sourcing of tubing connectors that are part of the SCD sets,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “Nearly two dozen hospitals and academic centers have signed on to begin the process of onboarding as clinical trial sites. These sites are at various stages of activation with several anticipated to begin enrollment very soon.” “We believe that reprogramming activated neutrophils and monocytes represents a major breakthrough for managing hyperinflammation in acute illness. Initiating trial enrollment is another important step in making the potentially lifesaving SCD therapy available to more than 200,000 U.S. adult patients each year with AKI who require CKRT as part of their standard of care,” said Eric Schlorff, CEO of SeaStar Medical. About the NEUTRALIZE-AKI Pivotal Trial 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 days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroup analyses to explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. About Hyperinflammation Hyperinflammation is the overproduction or overactivity of inflam...