Sapheon Inc. announced that it has submitted the second module of the pre-market approval (PMA) application for the VenaSeal Sapheon Closure System to the U.S. Food and Drug Administration (FDA). In a release, the Company noted: The submission, which was completed on December 18, 2013 , represents steady progress on the modular PMA application for VenaSeal, a minimally invasive, single use kit intended for the treatment of venous reflux (varicose veins) disease. The first module, submitted in September 2013 , was reviewed by the FDA and accepted without deficiencies within a single review cycle. VenaSeal is currently under clinical investigation in a 1:1 randomized pivotal study (the VeClose Study) to determine its safety and effectiveness compared to radio frequency thermal ablation. The VeClose Study, authorized under an FDA -approved investigational device exemption (IDE), has clinical investigators at 10 sites in the U.S. for the treatment of 242 study patients and was fully enrolled in September 2013 . The company expects the 3-month assessments of patients enrolled in the VeClose Study to be completed this month and the study's primary efficacy end-point of vein closure, as adjudicated by an independent core laboratory, to be reported shortly thereafter. Sapheon also announced full subscription to its $10 million bridge convertible note financing. The offering, which was introduced at the October 2013 OCTANe Medical Device & Investor Forum , was fully subscribed within six weeks as a result of strong interest by the company's existing investors. "2013 was an exciting year for Sapheon," said Don Crawford , President and CEO. "In 2014, the focus for our team is on preparations for a 2015 U.S. product launch and eventual market leadership in the treatment of venous reflux disease." Sapheon is also sponsoring two other VenaSeal studies: a 70- patient European post-market evaluation at seven sites within Germany , the UK , The Netherlands and Denmark that completed enrollment in September 2012 ; and a 38-patient feasibility study conducted in the Dominican Republic that completed enrollment in July 2011 . The company has agreed to continue to follow the patients in these two studies for a period of three years. The clinical data collected in these studies will be used to support the PMA application as well as reimbursement in markets outside the United States . The VenaSeal Sapheon Closure System received CE Mark approval in September 2011 . Since that time, VenaSeal has been used to treat over 1,700 veins in patients in Europe and Hong Kong without tumescent anesthesia or post-procedure compression hose therapy. At this time, the VenaSeal Sapheon Closure System is limited to investigational use within the United States . Sapheon Inc. is a privately held medical device company whose mission is to develop new approaches and disruptive technologies for the treatment of vascular disease. ((Comments on this story may be sent to email@example.com ))
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