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Emergency Filtration Products, Inc. (EFP) (PINKSHEETS: EMFP) announced that earlier today it had filed a 510(k) pre-market notification with the U.S. Food and Drug Administration (FDA) for its NanoMask™. The process, timing and results of any FDA submission will be determined solely by the FDA, though the company has requested an expedited review pursuant to FDA guidance.
The NanoMask is a surgical mask containing a hydrophobic filter medium coated with NanoFense™, a proprietary nano silver antimicrobial formulation developed by EFP's future merger partner Applied Nanoscience, Inc., (ANI) (PINKSHEETS: APNN). The NanoFense-treated filter medium has successfully arrested challenges posed by avian influenza (H9N2) and other dangerous and highly contagious pathogens, according to independent laboratory testing.
The NanoMask is intended for use in diverse, high-challenge venues where there is a potential for exposure to either pandemic, extreme biohazard or both. The NanoMask is also designed for use in surgical theater, emergency room, intensive care unit, cardiac care unit, and any occupational healthcare setting. As a first step, the current FDA notification is limited to these healthcare uses. The NanoMask reduces the risk of respiratory exposure to airborne splashes, particles, and microbes through efficient traditional mechanical filtration, and provides critical bioburden reduction via the NanoFense coating.
"After a considerable investment of time, money and management resources, we have submitted what we believe to be an accurate and complete 510(k) notification to the FDA," said Philip Dascher, CEO, EFP. "Upon receiving clearance from the FDA, EFP will immediately pursue a number of substantial domestic governmental and international sales opportunities -- especially in geographical areas more prone to avian influenza outbreaks -- that could create significant shareholder value. In addition, we look forward to consummating our merger with Applied Nanoscience on whose technology we rely."
Safe Harbor Statement
This release may contain statements that are forward-looking. Such statements are made based upon current expectations that are subject to risk and uncertainty. EFP and ANI do not undertake to update forward-looking statements in this news release to reflect actual results of and changes in assumptions or changes in other factors affecting such forward-looking information. The actual future plans and results of the companies could differ significantly from such forward-looking statements.
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