September 19, 2017 10:50 PM ET

Healthcare Equipment and Supplies

Company Overview of CardioFocus, Inc.

Company Overview

CardioFocus, Inc. develops an endoscopic ablation system for the treatment of cardiac disorders (atrial fibrillation) in the United States. It offers HeartLight Endoscopic Ablation System, a visually guided laser balloon technology for controlled and consistent pulmonary vein isolation treatment of paroxysmal atrial fibrillation. The company markets its products in the United States and Japan. 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: 59
Founder and Chief Technology Officer
Chief Financial Officer and Treasurer
Vice President of Operations
Compensation as of Fiscal Year 2017.

CardioFocus, Inc. Key Developments

CardioFocus Receives Approval for HeartLight Endoscopic Ablation System from the Japanese Ministry of Health, Labour and Welfare

CardioFocus, Inc. announced that the Japanese Ministry of Health, Labour and Welfare has approved the HeartLight Endoscopic Ablation System for the treatment of paroxysmal atrial fibrillation (AF) in Japan. The HeartLight System is a visually guided laser balloon technology for controlled and consistent pulmonary vein isolation (PVI) treatment of atrial fibrillation (AF). It provides an effective and safe treatment option for patients whose heart arrhythmias are insufficiently controlled with medication. To support Japanese approval, CardioFocus has established a distribution partnership with Japan Lifeline Co. Ltd. (JLL). Japan Lifeline will sell the HeartLight System through its electrophysiology division, which includes more than 200 field personnel across 44 offices. CardioFocus and JLL anticipate a commercial launch of the HeartLight System in the first quarter of 2018, after select medical centers have been trained and national reimbursement is in place. JLL will have dedicated personnel in the field, trained on the HeartLight System, to provide sales, marketing and clinical support for the launch.

Cardiofocus Announces Update on Atrial Fibrillation Studies

CardioFocus, Inc., has announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical studies currently underway. Collectively, up to 1,000 AF patients will be enrolled in these studies. The first study, titled, "CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation (CF)," is a prospective, multi-center, randomized study comparing the acute procedure and safety outcomes as well as long-term clinical outcomes of two groups of patients. One group is being treated with the HeartLight System and the other with a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) ablation catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of paroxysmal AF. The study will recruit up to 350 patients at approximately 10 centers throughout Europe. Dr. Andreas Metzner from Asklepios Klinik St. Georg in Hamburg, Germany is leading the study. A second randomized study, led by the Cardiovascular Center Bethanien (CCB) in Frankfurt am Main, Germany, will enroll a total of 400 patients in Europe. 100 patients with paroxysmal AF will be treated with the HeartLight System and 100 paroxysmal AF patients will be treated with the Cryoballoon. Additionally, 100 persistent AF patients will be treated with the HeartLight System and 100 persistent AF patients will be treated with the Cryoballoon. Comparisons across these groups will be analyzed. Drs. Boris Schmidt and Julian Chun, from CCB are the principal investigators for this study. Both previously authored a paper comparing the performance of the HeartLight System to ablation with the Cryoballoon in the paroxysmal AF population. That study showed a 73% success rate (freedom from AF) at 12 months with the HeartLight System as compared with 63% with the Cryoballoon. The third study, titled, "The Post-Approval Study (PAS) of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation," is evaluating the clinical outcomes of a cohort of patients treated during commercial use of the HeartLight System to confirm results of the successful US clinical pivotal study and study additional research questions. The study will include up to 250 enrolled patients and up to 25 sites in the US.Results from these three studies will provide additional clinical evidence on the performance of the HeartLight System in the AF population, helping to support its usage as a gold standard catheter ablation therapy.These studies follow positive data presented last month, at the Heart Rhythm Society's (HRS) 38th Annual Scientific Sessions in Chicago. Outcomes data on the HeartLight system were presented by Dr. Pieter Koopman of the Heart Center Hasselt in Hasselt, Belgium, Dr. Scott Gall of the Lancashire Cardiac Centre in the UK, Dr. Boris Schmidt, from CCB, Dr. Aditi Naniwadekar of the Helmsley Center for Cardiac Electrophysiology at Mt. Sinai Hospital, New York, and Dr. Rosa M. Figueras i Ventura of the Hospital Clinic of Barcelona.

CardioFocus, Inc Announces Initial Clinical Evaluation of Next-Generation HeartLight Excalibur Balloon

CardioFocus, Inc. announced the initial clinical evaluation of the HeartLight® Excalibur Balloon™, a next-generation technology designed for the treatment of atrial fibrillation. The Excalibur Balloon leverages the proven universal balloon design of the HeartLight Endoscopic Ablation System and introduces an advanced feature set that optimizes the speed and magnitude of target tissue contact during pulmonary vein isolation procedures. In addition to a more compliant construction that enables adaptive vein conformance, the Excalibur Balloon also incorporates proprietary Dynamic Response™ technology. This feature makes the balloon highly responsive to a range of user techniques and amounts of pressure applied, while optimizing vein contact. The result is a design meant to maximize the engagement of the balloon with the pulmonary veins, while decreasing the time required to complete ablation procedures. The HeartLight Excalibur Balloon is undergoing an initial clinical evaluation in Europe as part of a broader development program that seeks to confirm its design objectives.

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Recent Private Companies Transactions

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Date
Target
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February 15, 2017
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