CryoCor Clinical Progress Update

CryoCor, Inc., a development stage medical technology company, announced that they continue to accumulate clinical experience with its Cardiac Cryoablation System. This growing experience comes from commercial use of the product in Europe and Asia and from clinical trial use in the United States. Most noteworthy from Europe, one customer has declared that over 100 patients have been successfully treated to date with the CryoCor Cardiac Cryoablation System at the Academic Hospital Maastricht in the Netherlands. All of these patients were treated either under the CE Mark clinical trial, or during the initial commercial release of the CryoCor Cardiac Cryoablation System. The physicians, Dr. Luz-Maria Rodriguez, Dr. Carl Timmermans and Professor Harry H.J.M. Crijns, are the first medical group to use the CryoCor System exclusively for all cardiac ablation procedures performed at their center. These 100 patients have suffered from various cardiac arrhythmias, including atrial fibrillation, atrial flutter, and other supraventricular tachycardias. Additionally, these physicians continue to evaluate other applications of the system, including utilization for the treatment of ventricular tachycardia. We are very enthusiastic to have this new treatment for the good of our patients. We see many benefits for our patients and, after overcoming the necessary learning curve, we can apply the new therapy in less time than radiofrequency (RF) ablation, said Dr. Luz-Maria Rodriguez, Head of the Electrophysiology Department, Academic Hospital Maastricht. Successful experience with the CryoCor Cardiac Cryoablation System in the U.S. for the FDA-regulated treatment of typical atrial flutter and paroxysmal atrial fibrillation continues to accumulate as well. The company reported that in the U.S. over 20 patients have been successfully treated to date for atrial flutter with use of the CryoCor System. In addition, the company has also treated over 25 patients for paroxysmal atrial fibrillation. These procedures are being performed as part of feasibility studies under Investigational Device Exemptions (IDEs) granted by the U.S. FDA. Outlining their next steps in the U.S., CryoCor says that it expects to complete the initial patient enrollment for the atrial flutter feasibility study by 1Q 2003. The company then will file for FDA approval to proceed with a non-randomized pivotal trial necessary to support a U.S. Premarket Approval (PMA) application to the FDA. Additionally, the company will continue enrollment and treatment of patients for the paroxysmal atrial fibrillation. In February 2003, CryoCor supported the use of its proprietary system during a live demonstration for over 3,000 attendees at the XII World Congress on Cardiac Pacing and Electrophysiology in Hong Kong. Dr. Hung-Fat Tse, Dr. Cathy Lam, and Prof. Chu-Pak Lau at Queen Mary Hospital performed the procedure. The case was a pulmonary vein (PV) isolation procedure to treat atrial fibrillation, where all four PVs were isolated successfully, and the patient is doing very well. The live case demonstrated to the participants of the World Congress that cryoablation can be used safely and effectively to perform ablation for atrial fibrillation, said Dr. Tse. With our continued use of the CryoCor system, and with refinements we have made in its clinical technique, we have found that we can treat AF with a four-hour cryoablation procedure.