About BioCardia

BioCardia was founded in 1999 to enable biointerventional cardiology and is headquartered in San Carlos, California.

BioCardia's Helix Biotherapeutic Delivery business remains committed to being the platform of choice for delivery of therapeutic agents to the myocardium. Novel biotherapeutic approaches have enormous promise in addressing unmet clinical needs in hundreds of thousands of patients suffering from cardiovascular diseases each year. The Helix Biotherapeutic Delivery platform is currently the enabling delivery system in use in multiple ongoing clinical trials.

BioCardia's Morph Access Innovations business is based on the advances realized in steerable catheter shaft technology that were developed to support the Helix biotherapeutic delivery business. BioCardia has a growing family of FDA cleared Morph deflectable guide catheters that have been used in more than 5000 clinical cases. The Morph Access Innovations engineering team is utilizing the core technology and vision of our scientific advisors to advance the capabilities for all interventional and minimally invasive procedures. We anticipate launching new products to advance the field in the coming years.

BioCardia’s manufacturing facility is an FDA registered facility with California Devices Manufacturing License #63126, and has achieving certification to the ISO 13485:2003 Standard under the scope of design, development, manufacture and distribution of catheters for use in delivery of therapeutic agents directly to the heart, and of guiding catheters for use in peripheral and coronary vasculature and chambers of the heart.

Please click here to view our ISO 13485 certificate.