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FDA Approves Feasibility Study with SeaStar Medical’s Selective Cytopheretic Device in Adults with Cardiorenal Syndrome
Study to be conducted under $3.6 million NIH grant DENVER, Jan. 13, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a
About this update from Seastar Medical Holding Corporation
[{"type":"text","content":"Study to be conducted under $3.6 million NIH grant DENVER, Jan. 13, 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 the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) application to evaluate the safety and initial efficacy of SeaStar Medical’s Selective Cytopheretic Device (SCD-ADULT) in reducing inflammation in adult patients with acute heart failure with worsening renal function due to cardiorenal syndrome or severe right ventricular failure awaiting a left ventricular assist device (LVAD) implantation. This feasibility study is expected to enroll 20 patients at up to five clinical sites and will be funded by a previously announced $3.6 million National Institutes of Health (NIH) grant awarded to Innovative BioTherapies (IBT), which is led by SCD inventor H. David Humes, MD, Professor, Division of Nephrology, Internal Medicine, University of Michigan and SeaStar Medical Scientific Advisor. Dr. Humes will serve as lead investigator for the study and SeaStar Medical will act as clinical research organization (CRO). The FDA’s Center for Biologics Evaluation and Research (CBER) granted Breakthrough Device Designation for the SCD in cardiorenal syndrome with LVAD in September 2023. “Oftentimes patients with cardiorenal syndrome and worsening renal or cardiac function are ineligible for lifesaving LVAD implantation due to the severity of their condition,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “This study is designed to determine whether employing the SCD-ADULT to reduce hyperinflammation in these extremely ill patients can sufficiently improve their condition to bridge to LVAD implantation. Findings from this study could inform a future pivotal study in this population.” “We estimate the total addressable U.S. market for the SCD-ADULT in cardiorenal syndrome at more than $1 billion annually, making this a significant commercial opportunity for our company,” said Eric Schlorff, SeaStar Medical CEO. “As acting CRO for this study, we will receive a portion of the NIH grant while gaining valuable experience that may serve us well in future studies.” About Hyperinflammation Hyperinflam...