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June 30, 2015 6:12 PM ET

Healthcare Equipment and Supplies

Company Overview of CardioFocus, Inc.

Company Overview

CardioFocus, Inc. develops and manufactures HEARTLIGHT endoscopic ablation systems for the treatment of cardiac disorders, including atrial fibrillation. It serves clients in the United States. CardioFocus, Inc. was formerly known as Rare Earth Medical, Inc. and changed its name to CardioFocus, Inc. in June 1999. The company was incorporated in 1990 and is based in Marlborough, Massachusetts.

500 Nickerson Road

Suite 500-200

Marlborough, MA 01752

United States

Founded in 1990

Phone:

508-658-7200

Fax:

508-480-0600

Key Executives for CardioFocus, Inc.

Chief Executive Officer, President and Director
Executive Chairman
Age: 56
Founder and Chief Technology Officer
Chief Financial Officer and Treasurer
Vice President of Operations
Compensation as of Fiscal Year 2014.

CardioFocus, Inc. Key Developments

CardioFocus, Inc. Partners with Japan Lifeline Co., Ltd. for Distribution of the HeartLight Laser Balloon to Treat Atrial Fibrillation

CardioFocus, Inc. announced that it has executed an exclusive, multi-year distribution agreement with Japan Lifeline Co., Ltd. Atrial fibrillation (AF) is the most common sustained arrhythmia and presents elevated risk factors for both stroke and death. It is estimated that more than 1 million people in Japan currently suffer from this debilitating disease. Individuals affected by AF have been increasing worldwide due to an aging population and continued increases in the prevalence and incidence of AF are expected.

CardioFocus Announces HeartLight(R) Now Available in Spain for the Treatment for Atrial Fibrillation

CardioFocus, Inc. announced that its technology is now available in Spain for clinical use. Physicians at Hospital Universitari i Politecnic La Fe in Valencia were the first in the country to offer the innovative catheter ablation technology for the treatment of AF, the most common heart rhythm disorder in the world. The HeartLight EAS is the first catheter ablation system to incorporate an endoscope for direct visualization of the pulmonary vein in a beating heart, in real time and without radiation. It also includes a compliant balloon catheter designed for improved contact with the area surrounding the pulmonary veins, irrespective of individual patient anatomy, and a laser energy source designed to deliver more efficient, precise, and durable ablation treatment.

CardioFocus, Inc. Completes Enrollment in HeartLight(R) U.S. Pivotal Trial

CardioFocus, Inc. announced that it has concluded enrollment of its U.S. pivotal trial evaluating the HeartLight system, for the treatment of symptomatic paroxysmal AF. The randomized, controlled trial completed enrollment of over 400 patients from 21 leading research sites across the United States. The two-arm study investigated the use of the endoscopically guided HeartLight catheter in comparison to ordinary radiofrequency ablation using the NaviStar(R) THERMOCOOL(R) Catheter (Biosense Webster). A single ablation procedure was conducted in the HeartLight arm, while a repeat ablation was permitted with the THERMOCOOL system. The primary endpoints include an assessment of safety and an evaluation of efficacy, which is defined as freedom from documented, symptomatic AF at one year. With these findings, CardioFocus plans to submit a Premarket Approval (PMA) filing with the U.S. Food and Drug Administration (FDA) for HeartLight EAS following the completion of follow-up. The HeartLight system is CE marked and is commercially available for this indication in the European Union and Australia. The HeartLight EAS is the first catheter ablation system to incorporate an endoscope for direct visualization of the cardiac anatomy in a beating heart, in real time and without radiation. It includes a compliant balloon catheter designed for improved contact with the pulmonary vein ostium (opening) irrespective of individual patient anatomy, and a laser energy source designed for more efficient, precise and durable ablation therapy.

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