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SeaStar Medical Announces that Stanford Medicine is Cleared to Actively Enroll Subjects in the Adult Acute Kidney Injury Pivotal Trial
DENVER, Oct. 23, 2024 (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, Oct. 23, 2024 (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 Stanford Medicine is cleared to actively enroll subjects in the NEUTRALIZE-AKI pivotal trial. With the recent addition of two Department of Defense medical centers, 12 sites are now activated to enroll subjects in the trial with enrollment at 52. “It goes without saying that Stanford is an incredibly important site,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “The recent decision by the U.S. Centers for Medicare and Medicaid Services (CMS) to reimburse certain expenses for Medicare patients enrolled in this trial is proving critical in recruiting new medical sites. We are delighted that Stanford will be working with us to help change the standard of care for our most critically ill patients.” SeaStar Medical’s Selective Cytopheretic Device (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. In July 2024, CMS granted Category B coverage for certain expenses incurred by medical centers treating Medicare or Medicaid patients enrolled in the NEUTRALIZE-AKI pivotal trial. NEUTRALIZE-AKI Pivotal TrialThe 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 adults with acute kidney injury (AKI) in the intensive care unit (ICU) receiving continuous kidney replacement therapy (CKRT). The trial is expected to enroll up to 200 adults. 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 ...