SeaStar Medical Holding Corporation, listed on Nasdaq as ICU, is a medical device company specializing in combatting the detrimental effects of hyperinflammation on vital organs. The company has recently received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its groundbreaking Selective Cytopheretic Device (SCD).
This device is intended for use in hospital intensive care units (ICUs) to aid patients dealing with acute or chronic systolic heart failure and declining renal function due to cardiorenal syndrome or right ventricular dysfunction, with the goal of preparing them for left ventricular assist device (LVAD) implantation.
The FDA's Breakthrough Device Designation is anticipated to streamline the clinical development and regulatory review process for the SCD when used in this patient group. Cardiorenal syndrome, a severe complication often associated with advanced heart failure, has a grim prognosis. The SCD offers promise by addressing hyperinflammatory states driven by the innate immune system.
The SCD represents a pioneering approach to managing hyperinflammation in critically ill chronic heart failure patients. Its Breakthrough Device Designation, previously granted for adult acute kidney injury (AKI), combined with encouraging data from studies across various medical conditions, underscores the SCD's potential to address unmet medical needs related to hyperinflammation.
Hyperinflammation, characterized by excessive inflammatory cell activity, can lead to organ damage, multi-organ failure, and even death, often referred to as a cytokine storm. Notably, the SCD stands out as it specifically targets the most highly activated proinflammatory neutrophils and monocytes, setting it apart from other blood-purification tools.