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% 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. The commercial launch of the BioMask has been widely anticipated by health and medical professionals in Asia and Europe. With CE certification now in hand, Filligent expects widespread adoption of the mask by medical institutions and governments during 2009. The BioMask will also be available to consumers for direct retail purchase in leading drugstore chains in Hong Kong and China during the same period. We expect FDA classification later in the year.
In 2008, Filligent developed a revolutionary technol
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