Sapheon announced on 9 September 2013 that it has completed enrolment in the US pivotal study of the VenaSeal Sapheon Closure System. According to the company, 242 patients have been enrolled in the study.
VenaSeal is a minimally invasive, single use kit for the treatment of venous reflux by means of a tumescent-free, transcatheter delivery of Sapheon’s proprietary medical adhesive to the diseased great saphenous vein. The system is currently under investigation in a 1:1 randomised pivotal study at 10 US clinical sites to determine its safety and effectiveness compared to radiofrequency thermal ablation.
In addition, the company announced that it has raised US$19.8 million in its Series B Preferred equity offering from current and new accredited investors. The funding will support Sapheon’s US pivotal study through final submission to the FDA of the premarket approval application for the VenaSeal Sapheon Closure System.
Don Crawford, Sapheon’s president and CEO, stated, “We are fortunate to have attracted knowledgeable, sophisticated investors who recognise the potential for VenaSeal to become the future standard of care for a large and growing US patient population of venous reflux sufferers. We are also fortunate to have successfully recruited leading US physicians with large, active vein practices to participate as clinical investigators in our pivotal study. Achieving full enrolment 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 anaesthesia or post-procedure compression hose therapy.