A new, minimally invasive treatment uses ultrasound and medical glue to seal up potentially problematic varicose veins in the leg.
Investors have just injected $19.8 million into Morrisville, North Carolina-based medical device company Sapheon Inc., the company said today. The investors were not disclosed, but VP of Administration Harry Phillips said they include individuals in 24 U.S. states and 12 other countries.
With the Series B, the company plans to continue its 242-patient U.S. pivotal study, slated to wrap up next July, and apply to the FDA for premarket approval thereafter.
Rather than using liquid chemicals to scar and close off twisted and inflamed veins, or treating them with laser or heat, Sapheon takes the approach of gluing the affected veins shut to re-route blood to other healthy veins in the leg. It’s commercializing a disposable kit for doctors to administer its proprietary medical adhesive in an office setting.
Using ultrasound, a physician guides a catheter to the affected part of the vein through a small access site in the skin. The physician uses the VenaSeal dispenser to drop small amounts of glue in the vein and applies pressure to the skin to close it. Sapheon touts its closure system as a minimally invasive procedure that does not require multiple needle sticks or post-treatment medication or use of compression garments.
Varicose veins, also known as venous reflux disease, are for many people an asymptomatic cosmetic problem. They occur when valves inside the veins break and blood cannot circulate properly, causing blood to pool in the legs rather than returning to the heart. For some people, though, they can cause leg pain, swelling, blood clots and skin ulcers.
EU regulators approved Sapheon’s system in September 2011. The current U.S. clinical study is a testing the system’s safety and effectiveness against radio frequency thermal ablation at 10 sites.
BTG, a British pharmaceutical company, is developing an injectible foam-based treatment that could be under FDA review around the same time as Sapheon’s device. Millennium Research Group projected that new, easy-to-use office-based treatments like these will drive rapid growth in the U.S. market for treatment of varicose veins.