Sapheon, says it is making progress both financially and in regulatory matters.
The medical device firm, which moved to Morrisville two years ago and recently raised $20 million, has provided the FDA with more information as it seeks approval for technology to treat varicose veins.
The latest information was submitted in December, Sapheon reported Monday. “The first module, submitted in September 2013, was reviewed by the FDA and accepted without deficiencies within a single review cycle,” the firm said in a statement.
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.
Sapheon on Monday also said it had closed on $10 million in additional financing. The first batch of options and warrants were sold on Nov. 15 – and 49 individual investors anted up in $25,000 pieces.
Investors in the company are spread across 24 states and several countries, according to Vice President of Administration Harry Phillips.
The seven-year-old company moved to Morrisville in October of last year in order to capitalize on the benefits offered by the Triangle’s bustling life science community, according to Phillips.
Phillips describes his company’s treatment this way:
“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.”
The company has said that it expects to launch VenaSeal in the first half of 2015.