Feb 25 2010
-- Allows Export of Neovasc Tissue Products to Europe as an Intermediate Product Used in the Manufacture of Implantable Medical Devices --
Neovasc Inc. (TSXV: NVC), today announced that it has received Canadian Food Inspection Agency (CFIA) approval to export its processed pericardial tissue products to Europe as an "intermediate product" under the requirements of Annex I of EC Regulation # 2007/2006. This approval allows European customers to import Neovasc's porcine and bovine pericardial tissue materials for use in the manufacture of their own medical devices. It is provided through CFIA in accordance with (European) EC Regulation # 1774/2002, which sets out that animal derived products imported into Europe from a non-member-country must meet certain standards that are equivalent to those applied by the European Community. The CFIA approval is recognized by all regulatory bodies within the European Community. Neovasc is the only supplier to have CFIA intermediate product approval for implantable pericardial tissue.
"Receipt of this CFIA approval makes it substantially easier for our European customers to import Neovasc's tissue products for incorporation into their own medical devices such as minimally invasive heart valves," commented Alexei Marko, CEO of Neovasc. "We believe that CFIA approval along with the EDQM certification that the company received in December will have significant value for our customers and facilitate the commercialization of new products that incorporate Neovasc's proprietary tissue."
SOURCE Neovasc Inc.