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BioCardia previously confirmed alignment with the United States Food and Drug Administration (FDA) on the design of the 250-patient randomized, controlled trial and the minimum of 12-month primary composite endpoint of all cause death, reduction in major adverse cardiovascular events, and improvement in quality of life.
Results from the open label roll-in cohort of patients having chronic myocardial ischemia with refractory angina showed an average increase in exercise tolerance of 107 seconds and an average of 82% reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment.
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