Seastar Medical Holding Corporation ((ICU)) announced an update on their ongoing clinical study.
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Seastar Medical Holding Corporation (ICU) is spearheading a pivotal study titled ‘Feasibility Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) to Treat ICU Patients With Acute on Chronic Systolic Heart Failure With Worsening Renal Function Due to Cardiorenal Syndrome or Severe Right Ventricular Failure Awaiting Left Ventricular Assist Device Implantation.’ This study aims to explore the safety and potential benefits of the Selective Cytopheretic Device (SCD) in improving cardiac or renal function in patients with severe heart failure, providing a bridge to Left Ventricular Assist Device (LVAD) implantation.
The intervention being tested is the Selective Cytopheretic Device, an innovative immuno-regulating extracorporeal membrane device. It is designed to modulate the cardiodepressant effects associated with chronic heart failure by selectively sequestering activated systemic leukocytes, potentially improving heart function.
The study is interventional, utilizing a single-group model without masking, and primarily focuses on treatment. It will enroll 20 patients across up to five clinical sites, with each patient receiving daily four-hour SCD treatments for up to six days, followed by a six-month follow-up period.
Key dates for the study include its initial submission on February 7, 2019, and the most recent update on September 14, 2025. These dates are crucial as they mark the study’s progression and ongoing commitment to advancing treatment options for severe heart failure.
The potential market implications of this study are significant. If successful, the SCD could position Seastar Medical as a leader in innovative heart failure treatments, potentially boosting its stock performance and attracting investor interest. The involvement of collaborators like the National Heart, Lung, and Blood Institute and the University of Michigan further underscores the study’s credibility and potential impact.
The study is currently not yet recruiting, with further details available on the ClinicalTrials portal.