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SeaStar Medical Activates Sentara Norfolk General Hospital and Provides Enrollment Update in Adult AKI Pivotal Trial
DENVER, Dec. 03, 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, Dec. 03, 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 the activation of Sentara Norfolk General Hospital in Norfolk, Virginia as its thirteenth active site in its NEUTRALIZE-AKI pivotal trial. The Company also reports the enrollment of nine critically ill adult acute kidney injury (AKI) patients in the trial during November, bringing total trial enrollment to 65 subjects. The NEUTRALIZE-AKI trial is evaluating the safety and efficacy of the Company’s proprietary therapeutic Selective Cytopheretic Device (SCD) in 200 adult patients with AKI in the intensive care unit (ICU) receiving continuous renal replacement therapy (CRRT). “We are thankful for the steady pace of site activations and continued brisk enrollment with our recently activated sites already contributing,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “The rate of enrollment has increased significantly with nearly two times the number of subjects enrolled in the first two months of the fourth quarter, compared with the total number for each of the previous three quarters of 2024. We are working to activate additional sites in December, which will help us reach our enrollment milestones sooner.” “Previously completed pilot studies demonstrate the SCD’s ability to save the lives of critically ill patients with AKI and to eliminate dialysis dependence, with additional benefits to the overall healthcare system,” said Eric Schlorff, SeaStar Medical CEO. “Given the addressable adult AKI population of approximately 210,000 patients in the U.S. each year, we estimate annual peak sales of approximately $1 billion for the SCD in this indication. AKI is only one of multiple high-value indications where hyperinflammation plays a role and we have preliminary evidence of effectiveness of the SCD in mitigating a variety of illnesses. We plan to pursue cardiorenal syndrome as our next clinical focus.” SeaStar Medical’s 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 subs...