EKO / TSX
MONTREAL, Sept. 3 /CNW Telbec/ - 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
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.
For further information:
For further information: André 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