Sapheon has begun an FDA PMA approval submission for its varicose vein treatment, a major milestone days after winning nearly $20 million in new venture funding.
The company disclosed it has submitted its first module in the application process, with a few more to follow in the coming months. If all goes according to plan, Sapheon is now on track for what it said will be a "timely FDA review," and a commercial launch by the first half of 2015.
Sapheon, which is based in Morrisville, NC, and Galway, Ireland, has had a CE mark since 2011 for its VenaSeal Sapheon Closure System, a kit used to treat venous reflux by delivering a medical adhesive through a catheter to close the saphenous vein. Gaining U.S. approval has been a longer process, so the start of a PMA submission is a major accomplishment.
The company's 242-patient pivotal study will help support its PMA application, which recently reached full enrollment. Testing has involved 10 different sites around the U.S. At least two other studies will back the PMA effort. One is a 70-patient European post-market evaluation at 7 sites in Germany, the U.K., The Netherlands and Denmark, a trial that completed enrollment in September 2012. Another, a 38-patient feasibility study in the Dominican Republic, finished enrolling patients in July 2011.
Sapheon expects its product to be a significant advance over the standard of care, which typically includes expensive and invasive surgery, anesthesia, ablation or harsh chemicals. More than 550,000 surgical procedures for varicose veins were needed around the world in 2012, the company calculates.
Earlier in September, Sapheon announced it had nailed down $19.8 million in a preferred Series B equity offering, attracting both new and existing investors.
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