January 3, 2017 — BioCardia Inc. announced in December the initiation of the CardiAMP Heart Failure pivotal trial, a randomized, controlled, multi-center study of up to 260 patients evaluating CardiAMP cell therapy at up to 40 clinical sites in the United States.
The trial has been initiated at two leading centers: at Johns Hopkins University, under the leadership of Peter Johnston, M.D., and Gary Gerstenblith, J.D., M.D.; and the University of Florida at Gainesville, under the leadership of David Anderson, M.D., and Carl Pepine, M.D.
The CardiAMP Therapy for heart failure integrates a biomarker panel, a cell processing system for autologous bone marrow-derived cells, and a unique transendocardial delivery system. This therapy will be reviewed under the premarket approval (PMA) regulations by the U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER) division.
BioCardia is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the company’s biotherapeutic product candidates in clinical development. The company's current products include the Helix transendocardial delivery system and the Morph steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.
For more information: www.biocardia.com