Funds to Be Used for Commercial Acceleration and Global Launch of Breakthrough HeartLight® X3 System

CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced the completion of a $55 million round of financing.

The company’s current syndicate of institutional investors participated in the financing, and included senior debt financing from Kennedy Lewis Investment Management (“Kennedy Lewis”). The proceeds will be used to accelerate the commercial introduction of the HeartLight Endoscopic Ablation System and global launch of the breakthrough HeartLight X3 System, which received European CE Mark approval in March.

Earlier this month, CardioFocus announced results from the pivotal confirmatory study of the HeartLight X3 System during the Heart Rhythm Society’s 40th Annual Scientific Sessions. The results of the trial, which included 60 patients, demonstrated superior procedural times when compared to the first generation HeartLight System and impressive clinical outcomes. In the trial, the HeartLight X3 System consistently achieved very rapid pulmonary vein isolation (PVI), in as few as three minutes for a single vein. The presentation also noted that 99 percent of the pulmonary veins were isolated with the HeartLight X3 System with fluoroscopy times that were under seven minutes.

“This substantial investment will enable broader adoption of the HeartLight System and support a successful commercial launch of the HeartLight X3 System globally,” said Paul A. LaViolette, Executive Chairman of CardioFocus. “We are committed to continued innovation and are very excited about the potential the HeartLight X3 System has to significantly advance the way AFib is treated.”

More than 33 million patients worldwide suffer from AFib, the most common type of cardiac rhythm disorder.1 The HeartLight X3 System is a third generation AFib ablation technology, building upon the advanced features of the HeartLight Endoscopic Ablation System, which performs PVI using laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AFib. Using direct tissue visualization, titratable laser energy, and compliant balloon technology, the HeartLight X3 System’s unique RAPID mode leverages a precise motor control system that enables uninterrupted, high-speed, circumferential lesion creation under direct control of the physician resulting in consistently reduced procedure times.

The HeartLight X3 System is only approved for use in Europe. The HeartLight X3 System is not available for sale in the U.S.

About CardioFocus, Inc.
CardioFocus is a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AFib), the most common heart arrhythmia. The company’s FDA-approved HeartLight Endoscopic Ablation System has successfully treated more than 6,500 patients in the United States, Europe and Japan. The HeartLight System is a revolutionary catheter ablation technology that along with direct visualization and titratable laser energy, represents a new standard for AFib ablation. CardioFocus is headquartered in Marlborough, MA. For more information, visit www.CardioFocus.com.

About Kennedy Lewis Investment Management
Kennedy Lewis is an opportunistic credit manager established by David Chene, formerly a Managing Direct with Carval Investors, and Darren Richman, most recently a Senior Managing Director with The Blackstone Group. Kennedy Lewis’ Life Sciences group is led by Rich Gumer and provides long-term, flexible growth financing to commercial stage healthcare companies.

1 Chugh SS, Havmoeller R, Narayanan K, et al.; Worldwide Epidemiology of Atrial Fibrillation: A Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47.

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