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BioCardia Receives CE Mark for New Helix™ Transendocardial Delivery Catheter

New Device Optimized for Enlarged Ventricles, Increasing Potential Patient Pool for Transendocardial Delivery of Stem Cell Therapy

January. 10, 2014

SAN CARLOS, CA — BioCardia®, Inc., a leader in cardiovascular regenerative medicine, today announced receipt of the CE Mark for its Helix 953L Catheter as part of its Helix Transendocardial Delivery System for infusion of biologics to the heart. The new catheter is optimized for larger, dilated hearts, while maintaining compatibility with smaller hearts. It also does not require biotherapeutic programs already using the Helix system for delivery to develop new compatibility data. The Helix 953L catheter will be commercially available in the European Union in the coming months.

The Helix Transendocardial Delivery System is a steerable, two-catheter system that enables delivery of biologic therapies to the heart muscle from within the chamber of the heart. The catheter design minimizes the risks associated with navigating within the heart, while reducing procedure times. A helical-shaped needle screws into the myocardium for stable delivery, and contrast delivered from the needle confirms engagement with targeted tissue.

“The Helix system was initially designed to optimize safety, ease of use and efficiency in delivering biologic therapy where the heart needs it the most,” said BioCardio Chief Executive Officer Peter Altman. “We possess deep experience in this field, including extensive clinical experience in the U.S. with this new product. The Helix 953L catheter is another step towards our goal of a family of synergistic products providing therapeutic solutions in cardiovascular regenerative medicine.”

The Helix Transendocardial Delivery System has received the CE Mark and is commercially available in the European Union. It is currently being used for investigational biotherapeutic programs in the United States and is not approved for sale in the U.S.

About BioCardia®
BioCardia, Inc., headquartered in San Carlos, CA is a privately held company developing regenerative biologic therapies to treat cardiovascular disease. 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.


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