Covalon Responds To FDA's Request For Further Information.MISSISSAUGA, Ontario For the First Nation, see . Mississauga (pronounced: [ˌmɪsɪˈsɑgə] listen -- Covalon Technologies Ltd. (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension VENTURE:COV COV Composés Organiques Volatiles (French) COV Compuestos Orgánicos Volátiles (Spanish: Volatile Organic Compounds) COV Coefficient of Variation COV City of Villians (game) ) is extremely pleased to announce that it has responded to the FDA's request for further information regarding the company's 510(K) Pre-Market Notification for its ColActive(TM) wound dressing. ColActive(TM) is a novel, proprietary collagen wound dressing developed by Covalon which will be marketed by Hartmann-Conco Inc. through an exclusive distribution agreement for the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . The collagen wound dressing category is an important in one in the United States and Medicare/Medicaid reimbursement is significant. Since there are few suppliers of collagen dressings Covalon and Hartmann expect to have significant impact in this market. The Hartmann-Conco group comprises of several wholly-owned subsidiaries in 36 countries and other joint venture operations. It is one of the leading companies in its branch of industry with a sales revenue of EURO 1.3 billion in 2003 and employing 10,000 people. Hartmann-Conco is a world-class manufacturer of wound-dressings and other surgical and hygiene products. Hartmann-Conco is owned by Paul Hartmann AG, a major global manufacturer of wound care products, with its head office located in Heidenheim Germany. Covalon Technologies Ltd. is an advanced medical biosystems company that has developed and patented advanced therapeutic biomaterials for wound care and surgical applications as well as coatings. Polymer chemistry Polymer chemistry or macromolecular chemistry is a multidisciplinary science that deals with the chemical synthesis and chemical properties of polymers or macromolecules. and surface coating Surface coating A substance applied to other materials to change the surface properties, such as color, gloss, resistance to wear or chemical attack, or permeability, without changing the bulk properties. technology have been combined to create a range of time-release drug delivery platforms that are applied to many medical devices to treat many critical conditions. A variety of applications for these technologies have been identified and specific products have been developed. The products offer features and benefits providing solutions to many of the problems caused by current devices and their material properties, which are used by most medical device manufacturers and suppliers. The problems include infection, poor biocompatibility biocompatibility the quality of not having toxic or injurious effects on biological systems. biocompatibility 1. The extent to which a foreign, usually implanted, material elicits an immune or other response in a recipient 2. , and microbial microbial pertaining to or emanating from a microbe. microbial digestion the breakdown of organic material, especially feedstuffs, by microbial organisms. attachment. The TSX Venture Exchange TSX Venture Exchange Originally called the Canadian Venture Exchange (CDNX), this was a result of the merger of the Vancouver and Alberta stock exchanges. The goal of TSX Venture Exchange is to provide venture companies with effective access to capital while protecting investors. has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. The TSX Venture Exchange has in no way passed upon the merits of the proposed transaction and has neither approved nor disapproved of the contents of this release. This document contains forward-looking statements. These statements relate to future events or future performance. In some cases, forward-looking statements can be identified by terminology such as "may", "will", "should", "expect", "plan", "anticipate", "believe", "estimate", "predict", "potential", "continue" or the negative of any of these terms or comparable terminology. Such statements reflect the current views of management of the Company with respect to future events. Actual events or results may differ materially. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company disclaims any obligation to up0date any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments. COVALON TECHNOLOGIES LTD. (TSX VENTURE:COV) |
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