By Chris Wack
SeaStar Medical Holding shares were up 36% to 26 cents after the company said it received U.S. Food and Drug Administration breakthrough device designation for its first-in-class, cell-directed Selective Cytopheretic Device.
The stock hit its 52-week low of 16 cents on Sept. 11, and is down 98% in the past 12 months.
The company’s Selective Cytopheretic Device is for use with patients in the hospital intensive care unit 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.
The breakthrough device designation is expected to speed up the clinical development and regulatory review of the SCD for use in this patient population.
SeaStar Medical’s Breakthrough Device submission included a first-in-human study under which a patient with severe chronic heart failure who was ineligible for heart transplantation or LVAD implantation was treated with the SCD. The patient achieved the primary endpoint of a successful LVAD implantation and was discharged to home. The procedure was safe and there were no SCD-related serious adverse events.
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