VasoPrep Surgical Announces De Novo Product Clearance by US Food and Drug Administration

MORRISTOWN, N.J., Jan. 5, 2015 /PRNewswire/ -- VasoPrep Surgical announced today the Food and Drug Administration's (FDA) clearance of its surgical marking pen for sale in the U.S. market. The Dye Marker™, a Class II internal tissue marker indicated for use prior to or during the harvesting and preparation of vein grafts used in bypass surgery, is used to demarcate selected sites and orientation of the vein graft prior to implantation. The device, cleared via the FDA's de novo pathway, is the first internal tissue marker cleared for use in the U.S. market.

"The FDA's clearance of the Dye Marker™ represents a significant milestone for VasoPrep and completes our first product line available for sale in the U.S.," said Cynthia Lander, Co-Founder and Chief Executive Officer of VasoPrep Surgical. "We hope that our products become important components of standard surgical vein harvest and provide surgeons with new tools to reduce surgical harvest-associated vein graft injury and spare bypass patients the clinical consequences that may be associated with vein graft failure."

Dr. Alan Dardik, Professor of Surgery at Yale School of Medicine and Chief of Vascular Surgery at VA Connecticut Healthcare Systems in West Haven, CT, said, "Recent data have shown that commonly used surgical skin markers can injure the vein graft. VasoPrep's vein marker and vein preparation kit products are real advances that give surgeons new options to reduce injury to vein grafts for bypass surgery." 

About VasoPrep Surgical's Products
The Dye Marker is the Company's second product to be cleared by the FDA this year, complementing its previously-510(k)-cleared Vein Preparation Kit, a sterilized convenience kit for use during preparation and irrigation of bypass grafts prior to use in bypass surgery. Both products will be available for sale in Q1 of 2015.

About VasoPrep Surgical
VasoPrep Surgical is a privately-held medical device company headquartered in Morristown, New Jersey, with manufacturing and distribution partners in the United States and Europe. VasoPrep is focused on the preservation of the structure and function of auto-transplanted veins used in peripheral vascular bypass/reconstruction and coronary artery bypass surgeries. For more information, visit the Company's website at www.vasoprep.com

Forward Looking Statement
Certain matters discussed in this communication about us and future performance, including, without limitation, future revenues, earnings, strategies, prospects, consequences and all other statements that are not purely historical constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ materially from those anticipated. Such statements are based on management's beliefs as well as assumptions made by and information currently available to management. When used herein, the words "anticipate," "intend," "estimate," "believe," "expect," "plan," "should," "hypothetical," "potential," "forecast," "project," variations of such words and similar expressions are intended to identify forward-looking statements. Factors that may cause actual results to differ are often presented with the forward-looking statements themselves.

SOURCE VasoPrep Surgical