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SeaStar Medical Activates 15th Site for its Adult Acute Kidney Injury Pivotal Trial
DENVER, Jan. 22, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"DENVER, Jan. 22, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that Mayo Clinic is now cleared to enroll subjects in the company’s NEUTRALIZE-AKI pivotal trial, increasing the number of activated sites to 15. “We are thrilled to activate another large academic center to our study,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “Enrollment in the trial currently stands at 76 with six subjects enrolled since the first of the year. We look forward to our next major milestone of reaching our 100th subject for our interim analysis soon.” The SCD previously received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for adults with AKI, which is awarded to a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement over available therapies on clinically significant endpoints. NEUTRALIZE-AKI Pivotal Trial The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is evaluating the safety and efficacy of SeaStar Medical’s proprietary therapeutic SCD in 200 adults with acute kidney injury (AKI) in the intensive care unit (ICU) receiving continuous renal replacement therapy (CRRT). The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to CRRT as the standard of care, compared with the control group receiving only CRRT 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. SeaStar Medical plans to conduct an interim analysis at the trial’s 90-day primary endpoint with the first 100 subjects. Given the current pace of enrollment, the company anticipates a Data Safety Monitoring Board (DSMB) recommendation on the interim results by mid-2025. Acute Kidney Injury (AKI) and Hyperinflammation AKI...