BioCardia, Inc. is a pioneering clinical-stage company dedicated to regenerative medicine, focusing on the development of advanced cellular and cell-derived therapies for a range of cardiac and respiratory ailments. Central to its pipeline is the CardiAMP Cell Therapy System, designed to address heart failure and chronic myocardial ischemia. Additionally, BioCardia is advancing an allogeneic cell therapy program, also targeting cardiac and pulmonary conditions. The company is further exploring a specific allogeneic cell therapeutic platform. This investigational treatment, derived from culture-expanded mesenchymal cells sourced from bone marrow, is currently undergoing Phase I/II trials for patients suffering from ischemic systolic heart failure. Beyond its therapeutic candidates, BioCardia also provides innovative delivery solutions. These include the Helix biotherapeutic delivery system, engineered to precisely administer treatments directly into the heart muscle via an internal penetrating helical needle, and a line of Morph deflectable guides and sheaths. BioCardia maintains its headquarters in Sunnyvale, California.
BioCardia Presents CardiAMP HF II Trial Design at Heart Failure Society of America Annual Scientific Meeting
BioCardia will present the CardiAMP HF II trial design in a poster at the Heart Failure Society of America Annual Scientific Meeting in Phoenix, October 9-12.
The study is a multicenter, double-blind randomized trial testing high-dose autologous cell therapy in ischemic heart failure patients with reduced ejection fraction who remain on guideline-directed therapy. FDA recently agreed the ongoing trial may be sufficient to support approval, and has granted category B designation in three trials.
The company continues parallel regulatory submissions with FDA and Japan's PMDA while advancing the confirmatory trial with world-class centers.