Press Releases

FDA Market Clearance Received for the UniversalTM Deflectable Guide Catheter

South San Francisco, CA., January 30th 2002

BioCardia, Inc., a medical device company developing catheter systems for interventional cardiology and located in South San Francisco, California, announces that it has received FDA Market clearance for its Universal Deflectable Guide Catheter.

Coronary guide catheters are used to facilitate delivery of interventional devices such as balloon angioplasty catheters and stents to coronary arteries. BioCardia's Universal Deflectable Guide Catheter may provide the most significant advance to guiding catheter technology in over 20 years. More than 2 million guiding catheters are used to guide devices and perform procedures in the United States each year.

Interventional cardiologists and radiologists who have used the BioCardia Universal Deflectable Guide Catheter system have found that it offers significantly improved control while navigating the vasculature which varies considerably from patient to patient.

The Universal Guide was first invented by Dr. Rodney Badger, a Scientific Advisor to BioCardia and the Chairman of Cardiovascular Disease at the Utah Valley Regional Medical Center. Inventor Badger states, "My first design of a deflectable tip guiding catheter took form years ago. It was designed to solve two problems with guiding catheters for angioplasty; one, the variable anatomy that patients present, and two, increase support for delivery of intracoronary devices. Several successful catheter companies designed prototypes for use. Although they worked well, they never achieved the quality of design and ease of use that the BioCardia engineers have achieved. With this current design, the deflectable tip guiding catheter can not only be used today for coronary and ventricular procedures, it also has great potential for enabling intramyocardial drug delivery, performing electrophysiologic procedures, and simplifying procedures in peripheral arteries."

This steerable guide technology was developed by BioCardia as a platform access technology for BioCardia's percutaneous catheter systems for site specific drug delivery. These investigational systems include systems for intramyocardial, intrapericardial, and coronary sinus delivery of therapeutic agents such as stem cells therapies, gene therapies, protein therapies, and controlled release therapies.

"By making systems that are simple and easy to use we enable the development of a broad variety of local therapeutic strategies to treat disease," said company CEO and President, Peter Altman. "Further, this guide catheter may enable the advancement of other medical technologies that face access or navigation challenges."

BioCardia is already in discussions with a number of medical device companies who have interest in the BioCardia Universal Deflectable Guide technology to serve as a conduit for access in the chambers and vessels of the heart.

BioCardia will exhibit its guide technology as well as certain aspects of its drug delivery technologies at the American College of Cardiology meeting in Atlanta, Georgia this March.

The statements in this press release are forward-looking statements involving risks and uncertainties.

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