SeaStar Medical Updates Subject Enrollment In Its NEUTRALIZE-AKI Pivotal Trial With The Selective Cytopheretic Device In Adults With Acute Kidney Injury

Author: Benzinga Newsdesk | December 28, 2023 09:33am

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 12 subjects in the NEUTRALIZE-AKI pivotal clinical trial evaluating 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).

 

"Over the past six weeks we have enrolled five subjects in this clinical trial while also continuing progress in activating additional clinical sites," said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. "We are grateful to the dedicated investigators and their research staff who are working diligently to help validate the efficacy and safety of the SCD in this vulnerable population."

"We look forward to providing periodic updates on patient enrollment and site activations as this important trial progresses," said Eric Schlorff, CEO of SeaStar Medical. "We believe the more than 200,000 U.S. adult patients each year with AKI who require CKRT deserve a better treatment option. To that end, we are committed to advancing our pivotal clinical trial with the goal of saving lives and improving quality of life by eliminating dialysis dependency through renal recovery."

SeaStar Medical expects to receive U.S. Food & Drug Administration (FDA) approval for its SCD Pediatric (SCD-PED) under a Humanitarian Device Exemption (HDE) for use in children weighing 10 kilograms or more with AKI and sepsis or a septic condition requiring continuous CKRT anytime within the next 30 to 45 days and to commence commercialization of the SCD-PED in Q1 2024.

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