{"id":800020,"date":"2025-01-13T08:36:16","date_gmt":"2025-01-13T13:36:16","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-feasibility-study-with-seastar-medicals-selective-cytopheretic-device-in-adults-with-cardiorenal-syndrome\/"},"modified":"2025-01-13T08:36:16","modified_gmt":"2025-01-13T13:36:16","slug":"fda-approves-feasibility-study-with-seastar-medicals-selective-cytopheretic-device-in-adults-with-cardiorenal-syndrome","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-approves-feasibility-study-with-seastar-medicals-selective-cytopheretic-device-in-adults-with-cardiorenal-syndrome\/","title":{"rendered":"FDA Approves Feasibility Study with SeaStar Medical\u2019s Selective Cytopheretic Device in Adults with Cardiorenal Syndrome"},"content":{"rendered":"
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\n Study to be conducted under $3.6 million NIH grant\u00a0<\/em>\n <\/p>\n

\n DENVER, Jan. 13, 2025 (GLOBE NEWSWIRE) — <\/strong>
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\n SeaStar Medical Holding Corporation<\/u>
\n <\/a> (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\u2019s 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.<\/p>\n

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<\/u><\/a> 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\u2019s Center for Biologics Evaluation and Research (CBER) granted Breakthrough Device Designation for the SCD in cardiorenal syndrome<\/u><\/a> with LVAD in September 2023.<\/p>\n

\u201cOftentimes patients with cardiorenal syndrome and worsening renal or cardiac function are ineligible for lifesaving LVAD implantation due to the severity of their condition,\u201d said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. \u201cThis 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.\u201d<\/p>\n

\u201cWe 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,\u201d said Eric Schlorff, SeaStar Medical CEO. \u201cAs 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.\u201d<\/p>\n

\n About Hyperinflammation<\/strong>\n <\/p>\n

Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic or damaging to vital organs, and result in multi-organ failure and even death. This is known as the cytokine storm.<\/p>\n

\n Selective Cytopheretic Device<\/strong>\n <\/p>\n

The Selective Cytopheretic Device (SCD) is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT) and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CRRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future renal replacement therapy (RRT), including dialysis.<\/p>\n

In addition to cardiorenal syndrome with LVAD, the SCD has been awarded FDA Breakthrough Device Designation in the following indications:<\/p>\n