BioCardia Announces Activation of CardiAMP Heart Failure II Phase 3 Pivotal Study Recently Approved by FDA - Seite 2

About the CardiAMP Autologous Cell Therapy Program

CardiAMP Cell Therapy – FDA designated as a Breakthrough therapy – uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The CardiAMP HF trial is supported by the Maryland Stem Cell Research Fund and the Centers for Medicare and Medicaid Services. The proprietary CardiAMP cell procedure kits and their dedicated proprietary catheter delivery system are manufactured at BioCardia’s facility in Sunnyvale, California. CAUTION - Limited by United States law to investigational use. 

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms for the treatment of heart disease. BioCardia also acts as a biotherapeutic delivery partner supporting other cell, gene, and protein therapies for the treatment of heart failure, chronic myocardial ischemia, and acute myocardial infarction. For more information visit: www.BioCardia.com.

Forward Looking Statements 

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, the activation of clinical sites and the enrollment of patients in the CardiAMP II Trial, statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, and overall market conditions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.