Record Monthly Enrollment Achieved in SeaStar Medical’s Pivotal Adult AKI Trial

DENVER, Nov. 01, 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, reports setting a new monthly enrollment record with 10 critically ill acute kidney injury (AKI) patients added to the NEUTRALIZE-AKI pivotal trial during the past month, bringing total enrollment to 56. This trial is evaluating the safety and efficacy of the Company’s proprietary therapeutic Selective Cytopheretic Device (SCD) in adults with AKI in the intensive care unit (ICU) receiving continuous renal replacement therapy (CRRT).

“The pace of enrollment in our NEUTRALIZE-AKI trial has quickly accelerated, with 14 new subjects enrolled in slightly more than six weeks,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “With three new clinical sites joining our trial in October and more due to be activated by December, we are optimistic that this pace will continue and likely even increase.”

“A total of 12 clinical sites are now activated and we are optimistic about enrollment continuing at a rapid pace,” said Eric Schlorff, SeaStar Medical CEO. “Last month another prestigious teaching hospital and two premier military medical facilities opened for enrollment, which is in keeping with our strategy of clinical site selection. Critically ill patients with AKI are admitted to all types of facilities, whether top research institutions, community hospitals or government facilities. The range of institutions participating in the NEUTRALIZE-AKI trial demonstrates the ease with which our potentially lifesaving SCD can be incorporated into standard hemofiltration equipment, and helps set the stage for future commercialization. Our goal is to maximize access to the approximate 210,000 patients with AKI in the U.S. each year who may benefit from our device, regardless of where they are treated.”

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 substantial improvement over available therapies on clinically significant endpoints. In July 2024, the Centers for Medicare & Medicaid Services granted Category B coverage for certain expenses incurred by medical centers when treating Medicare or Medicaid patients enrolled in NEUTRALIZE-AKI.

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