A small California-based medical device company has decided to manufacture a key component for its innovative system for treating varicose veins in the Triangle.
Sapheon, which already has five employees in Research Triangle Park, anticipates hiring 7 to 10 additional workers locally before the end of the year, said CEO Don Crawford. The company also is looking for 7,000 square feet of space for manufacturing and offices.
Founded in 2008, Sapheon's Venaseal system was approved in Europe in September and also has been approved in Australia. The company, which has raised more than $11 million from private investors, plans a "full launch" of the system in Europe at the end of March.
The system includes a proprietary medical adhesive that is delivered to varicose veins via a special, disposable catheter. The adhesive, which will be made in the Triangle, seals the vein closed.
Crawford said the Venaseal system avoids the pain and bruising of current procedures and, unlike them, no anesthesia is required. Current procedures also require physicians to invest $50,000 in equipment, which they could avoid by switching to Venaseal.
"It's a single-use device," Crawford said. "There's no need for capital equipment."
Sapheon is currently in discussions with the U.S. Food and Drug Administration on the path the company needs to take to win regulatory approval here. The company's conservative estimate is that, if all goes well, it could be available in the U.S. in the second half of 2014.
Crawford said more than 1 million procedures to treat varicose veins are conducted annually in Europe and the U.S. Varicose veins can produce swelling and pain and "can be quite limiting in daily life," he said.
"It's a billion-dollar business globally and we have plans to be the leader with disruptive technology that benefits the patients and physicians," Crawford said.