VASOPREP SURGICAL ANNOUNCES DE NOVO PRODUCT CLEARANCE BY US FOOD AND DRUG ADMINISTRATION
Clearance Completes Company’s First Product Line
Morristown, NJ— January 5, 2015 — 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, 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.
VASOPREP SURGICAL ANNOUNCES THE APPOINTMENT OF NEW CHIEF MEDICAL OFFICER JAMES HART
Morristown, New Jersey – April 2, 2014 – VasoPrep Surgical, LLC (“VasoPrep” or “VPS”) announced today the appointment of Dr. James Hart as its new Chief Medical Officer (“CMO”), effective as of April 1, 2014.
Before joining VasoPrep as its new CMO, Dr. James Hart, MD, FACS, FACC, FACCP worked with Johnson & Johnson (JNJ) family companies until his retirement from JNJ in February, 2014. Dr. Hart joined ETHICON, Inc. in 2003 as Worldwide Medical Director for Cardiovations and subsequently held positions of increasing responsibility, being named VP Medical Operations in 2006, Worldwide VP, Evidence Based Medicine and Chief Medical Officer for ETHICON in 2011 and, finally, Chief Medical Officer and VP Medical Affairs for JNJ’s Global Surgery Group in 2012.
Prior to joining JNJ, Dr. Hart practiced Cardiovascular and Thoracic surgery for 20 years, during which time he was a pioneer in the early evolution of minimally invasive cardiac surgery. He was a founding member of the International Society of Minimally Invasive Cardiothoracic Surgery and served on that organization’s Board of Directors. He has served as a guest reviewer or on the Editorial Boards of cardiothoracic peer-reviewed journals and was a co-author of the ACC/AHA Guidelines on Coronary Artery Bypass Graft (CABG).
Dr. Hart is a Fellow of the American College of Surgeons; the American College of Cardiology; and the American College of Chest Physicians.
“I am excited about the opportunity to join VasoPrep Surgical as its new Chief Medical Officer and am looking forward to bringing forth innovative solutions that optimize cardiac and vascular surgical outcomes”, said Dr. Hart.
“Dr. Hart brings significant senior executive experience and knowledge of the medical-surgical device industry to the management team. His expertise as a cardiothoracic surgeon will help propel VPS’s products into the surgeon community and perfectly complements that of vascular surgeon and VPS Co-Founder/Inventor, Dr. Colleen Brophy (Vanderbilt University)”, said Dr. Cynthia Lander, Co-Founder and Chief Executive Officer of VPS.
About VasoPrep Surgical, LLC
VasoPrep Surgical, LLC is a privately-held medical device company headquartered in Morristown, New Jersey, with manufacturing and distribution partners in the United States and Europe. The Company is focused on preservation of the structure and function of autotransplanted vessels used in peripheral vascular bypass/reconstruction and coronary artery bypass surgeries. VPS’s Vein Preparation kit is intended for the preparation and irrigation of autologous vein grafts following their harvest and prior to use in bypass surgery. The kit has been cleared for sale in the United States by the U.S. Food and Drug Administration under Premarket Notification (510k).
Forward Looking Statement:
Certain of the 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.