Press Releases

BioCardia, Inc. Announces FDA Section 510(k) Approval for peripheral applications using the Morph Guide Catheter

South San Francisco, CA., February 17, 2005

BioCardia, Inc. announces the approval of its 510(k) application by the Food and Drug Administration for using its Morph Universal Deflectable Guide Catheter in peripheral cardiovascular surgical applications. The indications for use deem that the Morph is intended to provide a pathway through which medical instruments such as balloon dilation catheters, guide wires, or other therapeutic devices may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.

About BioCardia
Formed in 1999, BioCardia, Inc. is a leader in the development of catheter systems which enable local delivery of therapeutics to the heart and other organs. BioCardia currently is marketing the BioCardia Morph™ Deflectable Tip Guide Catheter and the company’s main focus continues to be in the developing field of biointerventional cardiology with emphasis on locally delivered agents. Biotherapeutic clinical trials are ongoing using BioCardia’s Helical Infusion System to deliver cell, gene, and protein therapies directly to the heart muscle.