CardioFocus, a developer of the Endoscopic Ablation System for the transcatheter treatment of atrial fibrillation, announced the completion of a US$30.6M private financing to continue the commercialisation of the CardioFocus’ system in Europe and the initiation of a US IDE pivotal study for the same product.
The company’s new investors are: Fletcher Spaght Ventures, Manatuck Hill Partners and First Alliance and Capital Invest Ltd. Previous investors such as SV Life Sciences, H.I.G. BioVentures, Accuitive Medical Ventures, The Aurora Funds, Oxford Bioscience Partners, Kestrel Venture Management and KBL Healthcare Investors also participated in this financing.
“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 and managing partner at SV Life Sciences. “Three dozen physicians in sixteen different leading cardiovascular centres 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 and CEO of CardioFocus.
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, California, USA.
A focused launch of the CardioFocus Endoscopic Ablation System began in late 2010 and will proceed at key institutions in Europe in 2011. A multicentre US IDE pivotal study is expected to commence during the first half of 2011.
The CardioFocus Endoscopic Ablation System was CE marked in September 2009 and is not yet approved by the FDA.