H.I.G. Capital News

CardioFocus' HeartLight® System Granted FDA Approval for Treatment of Atrial Fibrillation (AF)

More than 3,400 patients worldwide treated with HeartLight System to date

Validates definitive clinical results from U.S. multi-center pivotal study

MARLBOROUGH, MA - April 4, 2016 - CardioFocus, Inc. today announced that it has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its HeartLight® Endoscopic Ablation System for the treatment of patients with paroxysmal atrial fibrillation (AF). The approved PMA submission contained comprehensive safety and effectiveness data from the Company's multi-center HeartLight U.S. Pivotal Clinical Study, a randomized, controlled study in which a total of 353 participants were randomized at 19 leading arrhythmia centers across the United States1.

Results from the pivotal trial, announced at Heart Rhythm 2015, showed that when performing a single ablation procedure using the HeartLight System, the majority of patients experienced freedom from paroxysmal AF at 12 months. In addition, both the primary safety and efficacy endpoints were met.

AF is the most common cardiac arrhythmia affecting more than 33 million people globally, and an estimated 2.7-6.1 million people in the United States. Catheter-based treatment of AF has created a market in excess of $1.5 billion, currently growing at approximately 15% annually, making it one of the largest and highest growth medical device market opportunities.

With the granting of PMA approval, CardioFocus becomes one of very few manufacturers possessing a specific indication for catheter ablation therapy of paroxysmal AF. Specifically, in the United States, the HeartLight System is now indicated for the treatment of drug refractory recurrent symptomatic paroxysmal AF.

The HeartLight System differs from other AF solutions that rely on x-ray or mapping support for guidance, by allowing the electrophysiologist to control the delivery of therapeutic laser energy, for the first time under direct visual guidance, to electrically and durably isolate the pulmonary veins (PVs). The HeartLight System is designed to provide the clinician maximum procedural flexibility with a highly compliant balloon that easily accommodates diverse PV anatomies and laser energy that the clinician delivers under direct endoscopic visualization.

Co-principal investigator Andrea Natale, MD, FACC, FHRS, Executive Medical Director at the Texas Cardiac Arrhythmia Institute, Center for Atrial Fibrillation at St. David's Medical Center in Austin, TX commented, "This was a large study and the device clearly met both primary safety and efficacy endpoints. I am confident these results, produced by physicians who were new to the laser balloon, demonstrate the promise of the HeartLight technology in routine clinical use."

Further, co-principal investigator Vivek Y. Reddy, MD, Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital and The Helmsley Trust Professor of Medicine at the Icahn School of Medicine at Mount Sinai observed, "Novel medical devices have a challenging path to approval and are evaluated through intensive comparison with control arm devices that are inherently more familiar to the study investigators. The short learning curve of the new HeartLight System will enable even new users to quickly and efficiently deliver durable therapy to their patients."

Frank Cuoco, MD, FACC Associate Professor of Medicine, Division of Cardiology at the Medical University of South Carolina in Charleston, SC was one of the highest enrollers of patients in the HeartLight study, and added, "We are excited about the approval of the HeartLight endoscopically-guided laser ablation catheter. Based on our experience in the CardioFocus pivotal study and the successful results from the EU, I am confident that this new laser balloon catheter will offer our patients an outstanding treatment option for atrial fibrillation. The flexibility of the compliant balloon, which is intuitive to use under direct visual guidance, is one of its primary appeals. I found the learning curve to be very short."

On behalf of CardioFocus, Vice President of Regulatory & Clinical Affairs Burke Barrett said, "The achievement of the HeartLight System PMA approval is a major milestone and the result of dedicated teamwork among our employees, the clinical sites and study participants, and we are grateful for this remarkable support. It is also important to highlight the efficiency and professionalism of the FDA, reflected in this PMA review from filing to approval in eight months. The HeartLight System represents a novel approach to ablation for the treatment of AF and we look forward to making it available in the U.S. for electrophysiologists and their patients."

The U.S. pivotal clinical study results are added to dozens of independent studies supporting the CardioFocus HeartLight System. Several published EU single-center studies have reported high rates up to 80% of freedom from AF recurrence measured one year or more after the performance of a single ablation procedure. To date, more than 3,400 patients worldwide have been treated using the CardioFocus HeartLight System.

CardioFocus is finalizing preparations to commercialize the HeartLight System in the United States.

About the HeartLight® Endoscopic Ablation System
The HeartLight® Endoscopic Ablation System is a unique catheter ablation technology designed for the treatment of atrial fibrillation (AF), the most common heart arrhythmia. The system incorporates an endoscope to provide physicians with the capacity to see within the heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation. In the United States, the HeartLight® System is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The HeartLight® System consists of the HeartLight® Catheter, the Endoscope, Balloon Fill Media and the HeartLight® Console.

About CardioFocus, Inc.
CardioFocus, Inc. is a medical device manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF). The HeartLight® Endoscopic Ablation System is commercially available at leading institutions throughout Europe and now in the United States. CardioFocus is headquartered in Marlborough, MA, USA. For more information on the company and its technology, please visit www.CardioFocus.com.

1 Dukkipati, S.R., et. al., J Am Coll Cardiol 2015;66:1350–60

Company Contact:
Renny Clark
Chief Financial Officer
(508) 658-7281
wrclark@cardiofocus.com

Media Contact:
Kirsten Thomas
(508) 280-6592
kthomas@theruthgroup.com