EKO / TSX
MONTREAL, Nov. 6 /CNW Telbec/ - Noveko International Inc. ("the Company") announces that it is refocusing its strategy for the marketing of its Noveko(TM)masks and respirators in North America. In this regard, the initial 510(k) submission for the Noveko(TM) 3xEZ antibacterial surgical mask to the US Food and Drug Administration ("the FDA") ("the initial FDA submission") has been withdrawn. The prevailing A (H1N1) influenza virus pandemic context and the time and cost imperatives associated with the initial FDA submission process - which took longer and proved more complex than initially expected, moreover being limited to the Noveko(TM) 3xEZ surgical mask which had only an antibacterial claim - led the Company's management to refocus its strategy to prioritize the accelerated marketing of its Noveko(TM) masks and respirators in the United States, outside healthcare institutions, as well as in North America, globally.
The Company will submit to the National Institute for Occupational Safety and Health ("NIOSH") an application for the certifications (N95, N99) still generally used in the North American market, for its Noveko(TM) masks and respirators, which it could not do while the initial FDA submission was underway. "We believe that the North American population would benefit from having faster access, as is the case in many other markets worldwide, to our antimicrobial masks and respirators, which have been tested and proven effective not only in filtering out, but also in neutralizing a broad spectrum of viruses and bacteria. Even though Noveko(TM) masks integrate antimicrobial ingredients, some markets still seek NIOSH recognition when making their purchasing decisions, although NIOSH standards are only particle filtration standards," indicated Barry McDonald, Chief Technical Officer of the Company. Noveko Inc. ("Noveko") also plans to submit the mask product labelling to the US Environmental Protection Agency ("the EPA") for certification for industrial use, as the antimicrobial chemical additive incorporated into Noveko(TM) masks and respirators is already EPA registered under the US Federal Insecticide, Fungicide and Rodenticide ("FIFRA") Program.
The Company's refocused strategy will simultaneously concentrate on developing the test protocols and obtaining the required performance data to support a new 510(k) application to market its Noveko(TM) masks and respirators with an antiviral claim for healthcare institutions in the United States. As previously announced by the Company on September 11, 2009, at a formal pre-IDE (investigational device exemption) meeting with the FDA, the parties held discussions with respect to an additional claim that would allow Noveko(TM) masks and respirators to be marketed as a medical device reducing the exposure to airborne influenza particles. The FDA has indicated that it would treat any file supporting such an antiviral claim in priority. Furthermore, a new submission by Noveko would allow the Company to include all the improvements currently developed in the design and antimicrobial properties of the Noveko(TM) masks and respirators since the filing of the initial FDA submission.
"We are confident that the experience acquired throughout the initial FDA submission process will be highly useful for a new 510(k) application to gain FDA clearance for our masks and respirators with an antiviral claim. Furthermore, a new submission will be supported by an enhanced product performance overall. Finally, we do not expect our repositioning strategy to have any negative impact on mask sales worldwide. On the contrary, it will give us easier and faster access to a wider market," added André Leroux, Chairman of the Board and Chief Executive Officer of the Company.
Noveko International Inc. offers innovative solutions in the environmental and medical fields worldwide. Through its subsidiaries, the Company specializes primarily in the following business segments: the development, manufacturing and marketing of derivative products from its patented antimicrobial filtration technology, including air filters, surgical masks and respirators, along with other products with antimicrobial properties such as AZURO(TM) hand sanitizers - and the development, manufacturing and marketing of medical equipment, primarily portable real-time ultrasound scanners for use in human and veterinary medicine.
Certain statements set forth in this press release constitute forward-looking statements. In some cases, these statements are identified by the use of terms such as "may", "could", "might", "intend", "should", "expect", "project", "plan", "believe", "estimate" or other comparable variants. These statements are based on the information available at the time they are written, on assumptions made by management and on the expectations of management, acting in good faith, regarding future events, including those relating to economic conditions, fluctuations in exchange rates and operating expenses, and the absence of unusual events entailing supplementary expenditures. Although management considers these assumptions and expectations reasonable based on the information available at the time they are written, they could prove inaccurate. Forward-looking statements are also subject, by their very nature, to known and unknown risks and uncertainties such as those related to the industry, acquisitions, labor relations, credit, key officers, supply and product liability. The actual results of Noveko International Inc. could differ materially from those indicated or underlying these forward-looking statements. The reader is therefore recommended not to unduly rely on these forward-looking statements. Forward-looking statements do not reflect the potential impact of special items, any business combination or any other transaction that may be announced or occur subsequent to the date hereof. Unless otherwise required under securities laws, the Company does not intend and undertakes no obligation to update or revise the forward-looking statements to account for new information, new events or new circumstances.
SOURCE Noveko International Inc.
For further information: For further information: Chantal Vennat, Director, Investor Relations and Corporate Communications, Noveko International Inc., (514) 875-0606; http://www.noveko.com