Sapheon Inc. announced today 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). 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 anounced 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. The Company's current focus is on an advanced
treatment for venous reflux disease, a condition requiring over 550,000
surgical procedures worldwide in 2012. VenaSeal® uses a proprietary
catheter system to deliver a specially formulated medical adhesive to
embolize and close the saphenous vein, eliminating the need for surgery,
thermal ablation, sedatives, and tumescent anesthesia. The VenaSeal
Sapheon Closure System is not commercially available in the United
States. Please visit www.sapheoninc.com
to learn more about Sapheon.
[ Back To NFVZone's Homepage ]