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Filligent receives CE certification for its anti-infective medical face mask
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Filligent (HK)
: 18 February, 2009 (New Product) |
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Hong Kong based biotech company, Filligent has achieved CE certification for its innovative, anti-infective medical face mask. |
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Called the BioMask, the device is the first in a series of new products in Filligent's anti-microbial personal care range, BioFriend, to be launched during 2009. By complying with the European Community's Medical Devices Directive 93/42/EEC, Filligent has met the stringent EU requirements for design, efficacy and safety of its innovative, germ-killing BioMask.
Due to its anti-microbial properties, the BioMask is a powerful weapon in the fight to contain and stop the spread of infectious respiratory diseases such as SARS and bird flu. During outbreaks of infectious disease, the ability to halt transmission, during early stages, could be critical in preventing the development of a full-blown pandemic.
The BioMask is based on an ′intelligent filtration’ technology and is fabricated from a scientifically designed and tested multilayer material which has in its internal structure an active layer which has highly targeted anti-microbial properties. The active layer detects, traps, and then rapidly kills pathogens, within minutes of contact.
This patented BioFriend textile layer CAPTURES pathogens by mimicking the sites on human cells to which they normally attach, and DESTROYS them by disrupting their surfaces (viruses) and cell walls (bacteria). Many viruses, including influenza viruses, are known to bind to a terminal sialic acid residue on the surface of the human cell membrane. The binding agent in the BioFriend textile mimics the binding action of sialic acid on influenza viruses.
Typical face masks (including standard surgical masks and N95s) do not kill airborne pathogens. They are based on a passive mechanical filtration design only. Thus, microbes on or inside the mask can stay alive for many hours, greatly increasing the likelihood of cross-contamination. When compared to the tight-fitting N95 face mask, the BioMask is far superior in terms of efficacy, comfort and breathability.
As part of the CE testing process, the BioMask was sprayed with live aerosolized Influenza A virus equivalent to 50 times the amount contained in a normal sneeze. (Bird flu is a strain of the Influenza A virus.) More than 99.9 percent of the viruses were killed after less than one minute. Similar tests were conducted on other key pathogens, with similar results. When the BioMask was tested in terms of all the major routes of exposure, oral and dermal, it showed no harmful effects on humans. The BioMask has been tested for dermal biocompatibility following internationally recognized standards set out in ISO10933: Biological Evaluation of Medical Devices. Tests were conducted to evaluate cytotoxicity to cells, skin irritation on contact, and skin sensitization after repeated contact. No cytotoxicity, irritation or incidence of sensitization was observed.
Filligent will unveil the BioMask to the world's leading infectious disease experts at the Asia Pacific Congress of Medical Virology, 26-28 February 2009, in Hong Kong.
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