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 1000 clinical cases with a perfect safety record. 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.