MARLBOROUGH, Mass., March 29, 2017 /PRNewswire/ -- CardioFocus, Inc., a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF), today announced the completion of a $20 million round in equity financing.
The company's current syndicate of institutional investors all participated in the financing. The proceeds will be used to support the company's expanding commercialization of its HeartLight® Endoscopic Ablation System, a catheter ablation technology designed for the treatment of AF. The device received CE Mark in 2009 and U.S. FDA approval in April 2016.
The financing will also further the company's technology development programs, including the ongoing clinical evaluation of its next-generation HeartLight® Excalibur Balloon™. 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 (PVI) procedures.
"We are extremely encouraged by the progress that we are seeing with our early commercialization efforts and the physician adoption of HeartLight in the U.S.," said Paul A. LaViolette, Executive Chairman of CardioFocus. "The completion of this financing serves as significant validation of the market's positive response to the therapy. Further, we are encouraged by the positive feedback we have received to date on the Excalibur Balloon and look forward to obtaining European regulatory approval and making the technology commercially available by year end," LaViolette added.
More than 2.3 million people in the United States suffer from atrial fibrillation (AF), and the numbers are climbing along with the growing older population.1 Catheter-based treatment of AF has created a global market in excess of $1.5 billion, currently growing at approximately 15 percent annually, making it one of the largest and highest growth medical device market opportunities.2 The global AF market is projected to amount to $2 billion in 2017.3
About the HeartLight Endoscopic Ablation System
The HeartLight Endoscopic Ablation System is a revolutionary catheter ablation technology designed for the treatment of atrial fibrillation (AF), the most common heart arrhythmia. The HeartLight System's direct visualization, titratable laser energy, and universal balloon design make it a new standard for pulmonary vein isolation (PVI) procedures. The HeartLight System is approved for use and commercially available in the United States and Europe. More than 4,000 patients with AF have been successfully treated with the system.
In the U.S., the HeartLight System is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation.
The Excalibur information discussed in this release is preliminary and investigative. The Excalibur Generation of the CardioFocus HeartLight System is not approved by the U.S. Food and Drug Administration (FDA) and is investigational in nature. Healthcare professionals should refer to/rely upon FDA-approved labeling for the products, and not the information discussed in this news release.
About CardioFocus, Inc.
CardioFocus Inc. is a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as Atrial Fibrillation (AF). The company's HeartLight® Endoscopic Ablation System is commercially available at leading institutions throughout the United States and Europe. CardioFocus is headquartered in Marlborough, Mass. For more information, visit www.cardiofocus.com.
Susan Benton Russell
1 Go AS, et al. Prevalence of diagnosed atrial fibrillation in adults. JAMA. 2001;285:2370-2375.
2 CardioFocus Data on File.
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SOURCE CardioFocus, Inc.