Covalon Responds to FDA's Request for Further InformationApril 04, 2005
MISSISSAUGA, ONTARIO--(CCNMatthews - April 4, 2005) - Covalon Technologies Ltd. (TSX VENTURE:COV) 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. 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 and surface coating 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, and microbial attachment.
The TSX Venture Exchange 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 update 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.
For further information please contact: William Jackson Chief Financial Officer Covalon Technologies Ltd. T: (905) 568-8400 F: (905) 568-5200 www.covalon.com
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