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SeaStar Sails on FDA Nod

SeaStar Medical Holding Corporation (NASDAQ: ICU) shares enjoy upward momentum Friday. The medical device company announced receipt of U.S. Food and Drug Administration (FDA) Breakthrough DeviceDesignation for its patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) for use with patients in the hospital intensive care unit (ICU) with acute or chronic systolic heart failure and worsening renal function due to cardiorenal syndrome or right ventricular dysfunction awaiting implantation of a left ventricular assist device (LVAD).

The Breakthrough Device Designation is expected to expedite the clinical development and regulatory review of the SCD for use in this patient population. This is only the ninth Breakthrough Device Designation granted by the FDA’s Center for Biologics Evaluation and Research (CBER) since the program’s inception in 2015.

“Cardiorenal syndrome is seen in the most severe cases of heart failure and is associated with a very poor prognosis,” said Chief Medical Officer Kevin Chung. “The SCD is able to halt the downward spiral often perpetuated by a hyperinflammatory state driven by the innate immune system, giving these patients a fighting chance.”

In addition to preclinical data, SeaStar Medical’s Breakthrough Device submission included a first-in-human study under a National Institutes of Health (NIH) grant to the University of Michigan under which a patient with severe chronic heart failure who was ineligible for heart transplantation or LVAD implantation was treated with the SCD.

ICU shares gained seven cents, or 38.8%, to 26 cents.

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