Sapheon has sealed the deal, pulling in $19.8 million in new funding to help take its varicose vein treatment through the regulatory finish line.
The company, with operations in Morrisville, NC, and Galway, Ireland, says both new and existing investors participated in the preferred Series B equity offering, though it did not disclose specifics. Such a cash infusion comes in handy now that Sapheon has reached full enrollment in the 242-patient pivotal study for its VenaSeal Sapheon Closure System, a kit used to treat venous reflux through transcatheter delivery of a medical adhesive to close the saphenous vein. The 1:1 randomized pivotal study is ongoing at 10 U.S. clinical sites, testing its safety and effectiveness compared to radio frequency thermal ablation.
Funding will also help the company support final FDA submission of its PMA application for the product, which has had a CE marking since September 2011 and has treated more than 1,000 patients in Europe and Hong Kong.
VenaSeal is essentially a medical adhesive designed to help patients avoid surgery, ablation, anesthesia or harsh chemicals that are the norm, the company explains. Varicose veins aren't the most dramatic medical device space out there, but as the company notes, it is a highly lucrative one. The condition required more than 550,000 surgical procedures around the world in 2012, according to Sapheon's estimates, and the surgical, ablation and chemical options out there are invasive or expansive. Minimally invasive is better in those circumstances, and can arguably have a cost advantage, too--a major selling point in a healthcare environment where cost-effectiveness has gained importance. And the U.S.'s expanding aging population offers an important market to target.
Sapheon president and CEO Don Crawford said in a statement that the company's investor base recognizes "the potential for VenaSeal to become the future standard of care for a large and growing U.S. patient population of venous reflux sufferers."
Crawford also noted that the pivotal study achieved full enrollment in just 6 months, which he said shows a "high degree of interest and enthusiasm" for the product.
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