The Company is actively engaged in multiple ongoing biotherapeutic programs focused on strategies to provide regenerative medicine (RM) solutions for cardiovascular disease. RM repairs, replaces or regenerates cells/tissues/organs to restore impaired cardiac function and is built on the advances in interventional cardiology and biotechnology which enable the local targeted administration of biologic therapies.This therapeutic strategy is intended to provide treatment opportunities for patients who may not yet warrant implantable cardiac assist devices, and has promise for patients who have already received implantable devices to enhance recovery.
BioCardia intends for the Helix™ Transendocardial Delivery System to become 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.
BioCardia's Morph® Universal Deflectable Guides and AccessPro™ steerable sheath lines are based on the advances realized in steerable catheter shaft technology during development of the Helix Transendocardial Delivery System. These devices can significantly reduce procedure times by providing more control to physicians while reducing X-ray exposure. Morph steerable access products have been used to treat thousands of patients worldwide.
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.