--Application Included Successful Viral Inactivation Study that Enhances PeriPatch's
Position as Tissue of Choice for Third-Party Implantable Cardiovascular Products--
--CE Marking Will Enable LeMaitre Vascular to Sell its PeriPatch-Based XenoSure®
Product in Europe--
VANCOUVER, Feb. 8 /PRNewswire-FirstCall/ -Neovasc Inc. (TSXV: NVC), today announced that it has received CE mark designation for the use of its PeriPatch-BV™ bovine-derived biological tissue patches in surgical implantation procedures. PeriPatch-BV products, which are derived from pericardium tissue, are used in a variety of general surgical and cardiovascular applications, including the XenoSure® product marketed by LeMaitre Vascular, Inc. and as components in implantable heart valves and other medical devices. CE marking confirms that PeriPatch-BV pericardial tissue products conform to the applicable European Directive and allows them to be implanted in patients in all member states of the EU, the European Economic Area and Switzerland. The CE mark designation is expected to facilitate the approval of additional products in Europe that incorporate sterile and non-sterile PeriPatch-BV tissue as a sub-component, such as transcatheter heart valves.
As a prerequisite for obtaining the CE mark designation, Neovasc had to demonstrate the efficacy of its proprietary treatment processes used to inactivate viruses during PeriPatch fabrication. The viral inactivation study Neovasc conducted for the CE mark application confirmed the excellent performance of PeriPatch-BV on this critical parameter.
"Neovasc has an established presence in Europe with our PeriPatch-EQ equine-derived tissue products, and we look forward to expanding our European footprint with the launch of our PeriPatch-BV products derived from bovine pericardium, through our exclusive agreement with LeMaitre Vascular for certain vascular applications, as well as through other distribution partners," commented Neovasc CEO Alexei Marko.
Mr. Marko added, "We believe that the approval of our CE mark application by European regulators validates the viral inactivation and other critical performance features of our bovine-derived pericardial tissue products, which should provide a streamlined regulatory pathway for our industry customers incorporating PeriPatch-BV tissue as components in their own products. Neovasc is currently the leading independent supplier of biological leaflet material to companies developing next-generation transcatheter heart valves, and we expect this approval to further enhance our leadership position."
LeMaitre Vascular markets its PeriPatch-based XenoSure product pursuant to an exclusive distribution and purchase option agreement with Neovasc.
About PeriPatch™ Tissue
PeriPatch is flexible collagen tissue derived from specially treated bovine or equine pericardium. Neovasc's proprietary process creates implantable, biocompatible tissue that retains the strength and physical characteristics of natural tissue. Neovasc uses PeriPatch tissue in the manufacture of its surgical patch product line for cardiac and vascular reconstruction and repair and in general surgical procedures. It is also being incorporated into a wide range of implantable devices, such as minimally invasive heart valves that are under development by the company's industry partners and customers. PeriPatch products have more than 20 years of positive implant history and are FDA cleared, CE marked and EDQM certified.
About Neovasc Inc.
Neovasc Inc. is a specialty vascular device company that develops, manufactures and markets medical devices for the rapidly growing vascular and surgical marketplace. The company's current products include the Neovasc Reducer™, a novel product in development to treat refractory angina, as well as a line of advanced biological tissue technologies that are used to enhance surgical outcomes and as key components in a variety of third-party medical products. For more information, visit: www.neovasc.com.
Statements contained herein that are not based on historical or current fact, including without limitation statements containing the words "anticipates," "believes," "may," "continues," "estimates," "expects," and "will" and words of similar import, constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, among others, the following: general economic and business conditions, both nationally and in the regions in which the Company operates; history of losses and lack of and uncertainty of revenues, ability to obtain required financing, receipt of regulatory approval of product candidates, ability to properly integrate newly acquired businesses, technology changes; competition; changes in business strategy or development plans; the ability to attract and retain qualified personnel; existing governmental regulations and changes in, or the failure to comply with, governmental regulations; liability and other claims asserted against the Company; and other factors referenced in the Company's filings with Canadian securities regulators. Although the Company believes that expectations conveyed by the forward-looking statements are reasonable based on the information available to it on the date such statements were made, no assurances can be given as to the future results, approvals or achievements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company does not assume the obligation to update any forward-looking statements except as otherwise required by applicable law.
SOURCE Neovasc Inc.