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BioCardia Announces CMS Approval of Coverage for CardiAMP Cell Therapy Confirmatory Phase III Heart Failure Study

DAIC

CMS has reviewed the CardiAMP Heart Failure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage. CMS has reviewed the CardiAMP Heart Failure II Trial and approved the investigational product, related and routine items and services for purposes of Medicare coverage.

CMS 111
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Patient Enrollment Commenced in Pivotal Phase 3 Trial of CardiAMP Cell Therapy for the Treatment of Ischemic Heart Failure

DAIC

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.