BioCardia Begins CardiAMP Pivotal Heart Failure Trial

January 3, 2017—BioCardia, Inc. announced the initiation of the CardiAMP Heart Failure pivotal trial.

According to the company, the randomized controlled multicenter CardiAMP study will enroll up to 260 patients to evaluate the company's CardiAMP cell therapy at up to 40 clinical sites in the United States. The trial has been initiated at two centers. At Johns Hopkins University in Baltimore, Maryland, the trial is led by Peter Johnston, MD, and Gary Gerstenblith, MD. David Anderson, MD, and Carl Pepine, MD, are leading the trial at the University of Florida at Gainesville in Gainesville, Florida.

BioCardia stated that the CardiAMP therapy for heart failure integrates a biomarker panel, a cell processing system for autologous bone marrow-derived cells, and a transendocardial delivery system. This therapy will be reviewed under the premarket approval regulations by the US Food and Drug Administration’s Center for Biologics Evaluation and Research division.