The Research Triangle is already one of the largest life science hubs in the United States, and one of the region’s most recent additions is making plenty of news: Sapheon.

The medical device firm, which moved to Morrisville two years ago, recently raised nearly $20 million and last week applied for FDA approval of its technology for treating varicose veins. In an exclusive Q&A, Sapheon’s vice president of administration talks about the company, its technology, its funding and why Morrisville in now where it calls home.

Harry Phillips noted that Sapheon moved to the area in October of 2012 after five years of operations in Santa Rosa, Calif. The firm has 24 employees, and even though it just closed on $19.8 million in funding, Phillips said it is “not actively hiring at present.” However, he pointed out that Sapheon has expanded since moving east. Don Crawford, the chief executive officer, has held that post since October 2009.

WRALTechWire’s Q&A with Phillips:

  • Why locate in Morrisville?

To be located in an area known for its biotechnology and healthcare businesses, to better coordinate with our business in Europe and to obtain better access to employees with experience in medical device manufacturing. We made five key hires after re-locating to the RTP area.

  • Can you provide more information about your investors – who are they and where are they located?

Our investors are individual accredited investors who, in most cases, have medical or industry familiarity with venous reflux disease. They are located in 24 states in the US as well as Australia, Austria, Canada, Germany, Hong Kong, Ireland, Italy, The Netherlands, Norway, Spain, Switzerland and the UK.

  • Your technology sounds very interesting. Can you provide an explanation in layman’s terms as to how it works?

Venous reflux disease refers to “insufficiency” in the great saphenous vein. The valves in the vein are weakened and do not stop blood from flowing back along the vein. This is known as reflux and is the root cause of medically significant varicose veins. The treatment for this is to remove the great saphenous vein from the circulatory system. Historically, this was accomplished by surgery and vein stripping in which the diseased vein segment is physically removed from the body.

More recently, vein removal has been accomplished by thermal ablation or the use of heat generated by radio frequency or laser to destroy the vein internally by burning the vein tissue. While thermal ablation has the advantage of not having to open the leg surgically to remove the vein, it requires the use of heat to physically destroy the vein and large amounts of local tumescent anesthesia injected into the leg via multiple needle sticks during the procedure.

Sapheon’s VenaSeal approach eliminates the need for burning the vein tissue and tumescent anesthesia by using a proprietary medical grade adhesive to close the vein.

Here is a link to an animation showing the procedure: http://www.venaseal.com/how-venaseal-works/

  • What other products and technologies are under development?

We are developing other products that complement the VenaSeal Sapheon Closure System but are not disclosing the details at this time.

  • What background/expertise and motivation did your founder and CMO Rod Raabe have in developing this new technology and forming a company?

Rod Raabe, Sapheon’s co-founder and Chief Medical Officer, is a licensed M.D. and practicing physician with over 25 years’ experience as an interventional radiologist. His medical practice over the years has involved countless vein procedures as well as neurological procedures involving the use of medical adhesive to stop arterial bleeding in the brain caused by aneurism.

Dr. Raabe was inspired to ask “if we can use medical adhesive to stop arterial bleeding in the brain, why could medical adhesive not be used to close a diseased vein in the leg?” As an experienced inventor, he sought out an experienced business partner with whom to found Sapheon and ultimately partnered with Don Crawford.

Background on Sapheon
 

Last week, Sapheon has filed for regulatory approval for its device. Sapheon said that it expects to launch VenaSeal in the first half of 2015.

VenaSeal is a minimally invasive device developed to treat venous reflux disease, more commonly called varicose veins. An estimated 550,000 surgical procedures were done worldwide in 2012 to treat the condition. Sapheon’s device uses a proprietary medical adhesive to close the saphenous vein, which eliminates the need of a surgical procedure employing heat to burn and destroy the vein.

While VenaSeal still awaits FDA approval, it is already approved in Europe. Since receiving the European CE Mark in 2011, Sapheon says that its device has been used to treat more than 1,000 veins in patients in Europe and Hong Kong.

The VenaSeal has been studied in trials at 10 sites in the United States treating 242 patients. In addition to those studies, Sapheon said it is sponsoring two other VenaSeal studies. The first is a 70-patient European post-market evaluation at seven sites in Germany, the United Kingdom, the Netherlands and Denmark. The second study is a 38-patient feasibility study in the Dominican Republic. Clinical data from all of the studies will be used to support Sapheon’s application for approval with the FDA and also to support the company’s case to payers for reimbursement.