Noveko International Inc. receives FDA approval on a series of key test protocols for its antimicrobial face masks

    EKO / TSX Venture Exchange

    MONTREAL, Dec. 4 /CNW Telbec/ - NOVEKO INTERNATIONAL INC. ("Noveko" or
the "Company") is pleased to announce that its subsidiary Noveko Inc. has
received FDA approval on a series of key test protocols submitted for FDA
evaluation in September 2007 - thereby achieving a major milestone in the FDA
Premarket Notification. This approval will enable Noveko Inc. to fulfill the
last formalities toward filing its 510(K) Submission and to thus become the
first company to bring to market an FDA-approved antimicrobial surgical face
mask. The successful completion of this step follows the June 2007 issuance of
a pre-IDE number, subsequent to which Noveko Inc. conducted the final test
protocols for its two types of Noveko(TM) face masks: 3xEz (surgical mask) and
5dEZR (surgical respirator) in collaboration with laboratories that are among
the most experienced in food and drug additives, specifically CIBA Expert
Services and Nelson Laboratories (Utah, U.S.).
    Due to the novelty of its antimicrobial technology, Noveko Inc had to
validate the reliability of several test procedures along with the standard
face mask test methods. Pursuant to the July 19, 2007 guidance issued by the
Center for Devices and Radiology Health, FDA, on medical devices that include
antimicrobial agents, Noveko Inc. developed a set of safety and performance
protocols to meet the new high standards for antimicrobial surgical face masks
and surgical respirators.
    "Noveko Inc is proud to be the first company to propose a solution for
the comprehensive evaluation of antimicrobial bioeffectiveness based on
real-life dynamic simulations (reproducing human breathing). These test
protocols used the latest advancements in analytical techniques. In addition,
we have received further guidance and advice from the FDA on the Indication
for Use Statement and the strategy toward the filing of an application for the
next generation of antimicrobial products," indicated Dr. Konstantin Goranov,
Chief Technical Officer of Noveko Inc.
    In August 2007, Noveko Inc. was issued a Health Canada establishment
licence, allowing it to market its antimicrobial face masks in Canada, and its
production chain set up with Canadian, U.S. and Asian companies is
operational. Furthermore, Noveko Inc. also obtained its first order of
antimicrobial face masks from Medi-Select, a leading distributor of medical
supplies and equipment. This first order of several million face masks
representing sales of $2.3 million is scheduled for delivery in early 2008.
    Besides Canada, Noveko Inc. is targeting several geographic markets,
especially the United States and various Asian, Eurasian, European and African
markets, with the support of medical product distributors, a sales force and
certain manufacturers. In a global face mask market estimated at approximately
US$8 billion, North America alone represents annual sales of some
US$800 million, of which the Canadian market accounts for about
US$200 million. By receiving FDA Premarket Notification in the near term,
Noveko Inc. will be well positioned to accelerate its development of the U.S.


    Noveko International Inc. currently has four subsidiaries: S.A.S. ECM,
Noveko Inc., Laboratoire SyMa Inc. ("SyMa") and Bolduc Leroux Inc. ("BLI").
ECM specializes in the design and marketing of portable real-time ultrasound
scanners for use in veterinary and human medicine. Noveko Inc. develops the
Company's biomedical and environmental business, specifically its patented
antimicrobial filtration technology and derivative products (Noveko(TM)
antimicrobial face masks and air filters). SyMa specializes in the manufacture
of sanitizers, more specifically the antimicrobial products (for hands, feet
and surfaces) sold under the Azuro(TM) trademark. For its part, BLI
specializes in the custom processing and distribution of steel products based
on client specifications and designs. It has also developed and markets a line
of downdraft particle extraction tables for various markets. Operating since
September 2002, the Company was listed on the TSX Venture Exchange on
February 3, 2004.

    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 TSX Venture 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;; Marie-Claude
Leroux, Morin Public Relations, (514) 289-8688, ext. 224, Cell: (514)

Organization Profile

Noveko International Inc.

More on this organization

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890