BCDA - BioCardia rises 30% on FDA breakthrough device tag for CardiAMP system for heart failure

The U.S. Food and Drug Administration (FDA) granted breakthrough device designation to BioCardia's (NASDAQ:BCDA) CardiAMP Cell Therapy System to treat heart failure. The company said it is believed to be the first cardiac cell therapy to receive the FDA's breakthrough device status. The CardiAMP Cell Therapy Heart Failure Trial in the U.S. is currently enrolling patients to evaluate the effectiveness of the system in improving survival, reducing major adverse cardiac events, enhancing functional capacity, and improving quality of life for patients. The company said the system has shown no incidence of mortality at one year in its phase 2 trial or in the 10-patient roll-in cohort from the phase 3 trial that is currently enrolling. CardiAMP Cell Therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure. BCDA +29.94% premarket to $2.04

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BioCardia rises 30% on FDA breakthrough device tag for CardiAMP system for heart failure