Category: Uncategorized
- Published: 29 November -0001
Noveko achieved a new milestone in the process of approval by the FDA of its antimicrobial face masks
Noveko International Inc. (the \"Corporation\") is pleased to announce that its subsidiary, Noveko Inc. (\"Noveko\"), has completed a new step in the process for approval by the Food and Drugs Administration (the \"FDA\") of its 3xEz antimicrobial surgical mask. The FDA has in fact granted to Noveko a 510(k) submission number, which means, that, in principle, Noveko\'s application is now completed. However, the FDA, reserved its right to require additional information prior to approve, or not, the use of the Noveko\'s 3xEz antimicrobial surgical mask in the USA.
We remind that further to the July 19, 2007 guidance issued by the Center for Devices and Radiology Health, FDA, Noveko had to develop and then submit in September 2007 to the FDA a set of safety and performance protocols to meet the new high standards for antimicrobial surgical face masks of the US authorities; this has slowed down the approval process. On December 4, 2007, we announced that the FDA approved our protocols. Thereafter, we have fulfilled all the other formalities to complete our application, which result in the grant of this submission number. We remind also that in August 2007 Health Canada has issued an establishment licence allowing Noveko to market in Canada its antimicrobial face masks and, in July 2008, Noveko has obtained CE Marking for its antimicrobial face masks, confirming compliance with the requirements of the European Directives in regard to public health, safety and consumer protection.
Profile
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Noveko International Inc. is a public holding company listed on the Toronto Stock Exchange. Its subsidiaries specialize in the following fields of activities: i) development, manufacturing and selling of portable real-time ultrasound scanners for veterinary and human medicine, ii) development, manufacturing and selling of filtration fabrics, including antimicrobial face masks and air filters derived from its patented antimicrobial filtration technology, iii) development, manufacturing and selling of air quality systems, iv) development, manufacturing and selling of sanitizers and v) custom processing and distribution of steel products.
The information set forth in this press release includes certain forward-looking statements. Such statements are based on assumptions exposed to major risks and uncertainties. Although Noveko deems the expectations reflected in these forward-looking statements to be reasonable, the Company cannot provide any guarantee as to the materialization of the expectations reflected in these forward-looking statements. The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.
SOURCE: NOVEKO INTERNATIONAL INC.
Andr� Leroux, Chairman of the Board and Chief Executive Officer; Alain Bolduc, President and Chief Operating Officer, Noveko International Inc., (514) 344-3030; http://www.noveko.com