SeaStar Medical Holding Corporation, a medical device company, has announced a significant $3.6 million grant from the National Institutes of Health’s National Heart, Lung, and Blood Institute. This funding is designated for a clinical trial to evaluate the effectiveness of the Selective Cytopheretic Device Adult (SCD-ADULT) in patients with chronic heart failure (CHF) who have progressed to acute decompensated heart failure (ADHF). The SCD-ADULT is part of SeaStar Medical's Quelimmune™ product family and aims to serve as a bridging strategy to left ventricular assist device (LVAD) implantation.
The clinical trial, led by Innovative BioTherapies (IBT) under the guidance of SCD inventor H. David Humes, M.D., will enroll 20 ICU patients with ADHF across four sites. These patients are currently ineligible for LVAD or cardiac transplantation. The study seeks to determine if the SCD-ADULT can improve their condition sufficiently to allow for LVAD implantation, potentially leading to FDA approval for this application.
This initiative follows the FDA's Breakthrough Device Designation for cardiorenal syndrome granted to SeaStar Medical in September 2023. The grant is based on promising results from a first-in-human case study and improved cardiac contractility in a canine model of CHF after SCD treatment, as published in the peer-reviewed journal PLOS One in April 2023.
Dr. Humes highlighted the novel approach of SCD therapy, which immunomodulates activated circulating leukocytes, offering a potential solution to the limitations of current therapeutic strategies for cardiorenal syndrome. SeaStar Medical CEO Eric Schlorff expressed optimism about the NIH's support and the potential for SCD-ADULT's approval in treating adult acute kidney injury and other conditions where hyperinflammation is a factor.
SeaStar Medical's innovative technologies aim to reduce the consequences of excessive inflammation on vital organs, offering life-saving solutions to critically ill patients. The company is also advancing its Quelimmune device for pediatric acute kidney injury, having received FDA approval for this application in February 2024.
