CardioFocus, Inc. Raises $30.6 Million in Private Financing

Proceeds Support Initiation of US Pivotal Trial, Expansion of European Commercialization

News provided by

Feb 28, 2011, 06:00 ET

MARLBOROUGH, Mass., Feb. 28, 2011 /PRNewswire/ -- CardioFocus, Inc., developer of the Endoscopic Ablation System for the transcatheter treatment of Atrial Fibrillation, announced the completion of a $30.6M private financing. New investors in the round include Fletcher Spaght Ventures, Manatuck Hill Partners and First Alliance & Capital Invest, Ltd. All previous investors also participated in this financing; SV Life Sciences, H.I.G. BioVentures , Accuitive Medical Ventures, The Aurora Funds, Oxford Bioscience Partners, Kestrel Venture Management and KBL Healthcare Investors. Proceeds will be used to continue the commercialization of CardioFocus' system in Europe and commence a US IDE Pivotal study.

"The continued participation of our existing investors and the addition of several significant professional healthcare investors validate the substantial clinical and commercial progress underway at CardioFocus," said James Garvey, Chairman & Managing Partner at SV Life Sciences. "Three dozen physicians in sixteen different leading cardiovascular centers have worked with CardioFocus products, demonstrating the active interest of leading catheter ablation experts to gain a real time view of the anatomy they are treating," commented Stephen Sagon, President & CEO of CardioFocus, Inc.

Using the CardioFocus Endoscopic Ablation System, the rate of acute isolation of the pulmonary veins has been reported at over 99% in several published, peer reviewed articles. Chronic pulmonary vein isolation has also been reported to be near 90% when assessed at 3 months. The Company expects more published scientific studies and further presentations on the CardioFocus Endoscopic Ablation System technology throughout the year, including the upcoming May 2011 Heart Rhythm Society Meeting in San Francisco, CA.

A focused launch of the CardioFocus Endoscopic Ablation System began in late 2010 and will proceed at key institutions in Europe in 2011. A multi-center US IDE Pivotal study is expected to commence during the first half of 2011.

The scientific information discussed in this news release is preliminary and investigative. The CardioFocus Endoscopic Ablation System is not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the system. Only FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Healthcare professionals should refer to/rely upon FDA-approved labeling for the products, and not the information discussed in this news release.