BioCardia Announces FDA Breakthrough Device Designation for CardiAMP Cell Therapy System for Heart Failure

Feb 3, 2022 By MarketDepth

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BioCardia, Inc. (NASDAQ: BCDA) has announced that the United States Food and Drug Administration has granted Breakthrough Device Designation for the CardiAMP Cell Therapy System for the treatment of heart failure.  The CardiAMP Cell Therapy utilizes a patient’s own bone marrow cells delivered to the heart in a minimally invasive catheter-based procedure.  The therapy adds a pre-procedural screening assay to identify patients that may be likely responders.  “It is exciting for the field of cardiology that the FDA has recognized the potential of a cell therapy to improve the lives of patients struggling with heart failure. Getting this therapy fast-tracked and to patients more quickly than traditional methods would give us new options and a greater armamentarium to assist our patients in need. I am enthusiastic about completing the U.S. pivotal trial of the CardiAMP Cell Therapy to build the body of evidence necessary to support this accelerated FDA path,” said Carl Pepine, MD, MACC, Professor in the Division of Cardiovascular Medicine at the University of Florida.

FDA Breakthrough Device

“We thank the FDA for granting Breakthrough Device Designation to the CardiAMP Cell Therapy System and recognizing its potential to provide more effective treatment for heart failure, a major achievement for this unique therapy,” said Peter Altman, Ph.D., President and Chief Executive Officer of BioCardia. “The published results from our clinical trials to date  [3][4][5],[6][7] have met our high expectations in showing the therapy’s ability to address the loss of heart function in ischemic heart failure.  We look forward to completing our Phase III trial and engaging with the FDA as we move closer to the prospect of benefiting patients whose lives are severely impacted by this disease.”