Press Releases

BioCardia announces completion of enrollment for Phase I adult stem cell clinical trial to treat chronic heart disease

South San Francisco, CA., July 17th, 2005

A clinical investigation of a noninvasive catheter-based therapy for deliv ering a patient’s own adult stem cells to the myocardium has completed patient enrollment and initial follow-up.

The trial, on Transendocardial Autologous Bone Marrow stem cells in Myocardial Infarction (the TABMMI trial), was performed at the Interventional Cardiology Division of the Swiss Clinic and the Diagnostic Institute in Buenos Aires, Argentina in collaboration with physicians at Stanford University in Palo Alto, California.

The TABMMI trial involves using a needle to withdraw a small volume of bone marrow from the hip bone of a patient in the morning. While the patient is resting, their marrow derived stem cells are isolated, washed, and counted. Later the same day, the patients enter a cardiac catheterization suite for noninvasive delivery of their own bone marrow stem cells to the heart. Cells are delivered through a catheter system that is threaded into the heart chamber from an opening in a blood vessel in the leg. Within the heart, a small helical needle is advanced into the myocardium to deliver cells to a number of different locations over a period of ten to twenty minutes. This “transendocardial” approach, developed by BioCardia, enables physicians to target and deliver to any site in the heart, including those that have poor blood flow.

Results will be submitted for presentation at upcoming cardiovascular scientific congresses and submitted for publication in appropriate peer reviewed cardiovascular scientific journals. S o far, the results are quite promising, with no procedural complications and statistically significant improvement in clinically important measures.

Dr. Simon Stertzer, Professor of Medicine at Stanford University and a BioCardia board member who was instrumental in the trial design stated, “To complete this safety series with such results in this patient population is a significant accomplishment. These preliminary results have great promise for this cell therapy strategy, but also support this delivery strategy for other biotherapeutic interventions.”

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. Biotherapeutic clinical trials are ongoing using BioCardia’s Helical Infusion System to deliver cell, gene, and protein therapies directly to the heart muscle.

For more information, contact: Investor Relations, BioCardia, Inc. 650-624-0900, .