MORRISVILLE, NC – Sapheon Inc. announced today that it has raised $19.8 million in its Series B Preferred equity offering from current and new accredited investors. The funding will support Sapheon’s U.S. pivotal study through final submission to the FDA of the PMA application for the VenaSeal Sapheon Closure System®.
In addition, Sapheon announced full enrollment of 242 patients in the U.S. pivotal study of the VenaSeal Sapheon Closure System. VenaSeal—a minimally invasive, single use kit for the treatment of venous reflux (varicose veins) by means of a tumescent-free, transcatheter delivery of Sapheon’s proprietary medical adhesive to the diseased great saphenous vein—is currently under investigation in a 1:1 randomized pivotal study at 10 U.S. clinical sites to determine its safety and effectiveness compared to radio frequency thermal ablation.
Don Crawford, Sapheon’s President and CEO, stated, “We are fortunate to have attracted knowledgeable, sophisticated investors who recognize the potential for VenaSeal to become the future standard of care for a large and growing U.S. patient population of venous reflux sufferers. We are also fortunate to have successfully recruited leading U.S. physicians with large, active vein practices to participate as clinical investigators in our pivotal study. Achieving full enrollment in the study in six months speaks to the high degree of interest and enthusiasm our investigators have in the potential of VenaSeal to provide a novel, efficacious solution to venous reflux disease.”
The VenaSeal Sapheon Closure System received CE Mark approval in September 2011. Over 1,000 veins in patients in Europe and Hong Kong have been successfully treated with VenaSeal without tumescent anesthesia or post-procedure compression hose therapy.
Sapheon Inc. is a privately held medical device company whose mission is to develop new approaches and disruptive technologies for the treatment of vascular disease. The Company’s current focus is on an advanced treatment alternative for venous reflux disease, a condition requiring over 550,000 surgical procedures worldwide in 2012. The VenaSeal System uses a proprietary medical adhesive to close the saphenous vein, eliminating the need for surgery, ablation, sedatives, anesthesia, and the use of harsh chemicals. The VenaSeal Sapheon Closure System is not commercially available in the United States. Please visit to learn more about Sapheon.