North Carolina company Sapheon Inc. has announced that it has raised $19.8 million, which will support its U.S. pivotal study through final submission to the FDA of the PMA application for the VenaSeal Sapheon Closure System®.
Sapheon’s current focus is on an advanced treatment alternative for venous reflux disease(varicose veins), 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 received CE Mark approval in September 2011 and 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 has announced full enrollment of 242 patients in the U.S. pivotal study of the VenaSeal Sapheon Closure System. VenaSeal 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.
The $19.8 million was raised in a Series B Preferred equity offering from current and new accredited investors
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.”
Source: Sapheon, Inc., Business Wire