SeaStar Medical Holding Corporation announced that the National Institutes of Health?s (NIH) National Heart, Lung, and Blood Institute has awarded a $3.6 million grant for a clinical trial to evaluate the Selective Cytopheretic Device Adult (SCD-ADULT, a member of the Company?s Quelimmune? product family) as a bridging strategy to left ventricular assist device (LVAD) implantation in patients with chronic heart failure (CHF) who have progressed to acute decompensated heart failure (ADHF). This grant award follows a Breakthrough Device Designation for cardiorenal syndrome granted by the U.S. Food and Drug Administration (FDA?s) Center for Biologics Evaluation and Research (CBER) in September 2023.

With current standard of care treatment, ADHF can accelerate worsening renal function in a feedback loop known as cardiorenal syndrome, which is associated with a poor prognosis. These patients are often ineligible for lifesaving LVAD implantation due to the severity of their condition. This grant was awarded to Innovative BioTherapies (IBT), which is led by SCD inventor H. David Humes, M.D., Professor, Division of Nephrology, Internal Medicine, University of Michigan and SeaStar Medical Scientific Advisor.

SeaStar Medical is expected to directly receive approximately one-quarter of the grant for serving as the contract research organization for the trial, which can be leveraged for other indications. The trial is expected to enroll 20 ICU patients with ADHF at four sites who are ineligible for LVAD or cardiac transplantation in order to determine whether the SCD-ADULT can improve these patients? condition such that they are able to bridge to LVAD implantation.

If successful, this study could pave the way for a marketing application to FDA.