TSO3 receives notification of conformity allowing new sterilization system to
be sold in the European Union
Stock symbol:TSX: TOS Outstanding shares: 57,891,957
Sterilizers to bear the CE Mark
QUEBEC CITY, March 4 /CNW Telbec/ - TSO3 Inc. (TSO3) (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings using ozone, today announced that documentation supplied to the European Notified Body conforms to the new Medical Device Directive for Class IIb medical devices; an enhanced European standard to be enforced starting April 2010. This notification allows the Company to label its new generation sterilizers with the CE Mark, which is a requirement to place products in the European Union; the second largest sterilization market after the United States.
"We are pleased that a review of our quality system, electromechanical design and microbiological data, has been independently validated as meeting the new Medical Device Directive (M5). Our new sterilizer is among the first to comply with this enhanced mandatory standard, a requirement all sterilizer manufacturers will need to meet", stated Mr. R.M. (Ric) Rumble, President and CEO of TSO3. "The ability to label our product with the CE Mark is consistent with our plans to commercialize our sterilization technology globally".
On December 16 2009, TSO3 announced a global channel partnership with 3M(TM) Infection Prevention Division, for the exclusive supply and distribution of its new sterilizer through 3M's worldwide operations under the 3M(TM) Optreoz(TM) brand.
Also in December 2009, TSO3 filed for regulatory clearances in Canada, Europe and the United States. TSO3 has now received authorizations from both Health Canada and the European Notified Body. United States regulatory clearance is currently under review.
The new sterilizer offers three sterilization cycles in a single unit and is able to quickly and gently sterilize packaged simple and complex medical devices. These devices range from general surgical instruments, to short and long, rigid and flexible endoscopes, including complex multi-channel devices.
About TSO3
TSO3, founded in Québec City in 1998, specializes in the research and development of innovative, high-performance medical instrument sterilization technology with high commercial potential. TSO3 designs products for sterile processing areas in the hospital environment and offers an advantageous replacement solutions to other low temperature sterilization processes currently used in hospitals.
For more information about TSO3, visit the Company's Web site at www.tso3.com
The statements in this release and oral statements made by representatives of TSO3 relating to matters that are not historical facts (including, without limitation, those regarding the timing or outcome of any financing undertaken by TSO3) are forward-looking statements that involve certain risks, uncertainties and hypotheses, including, but not limited to, general business and economic conditions, the condition of the financial markets, the ability of TSO3 to obtain financing on favourable terms and other risks and uncertainties.
The TSX has neither approved nor disapproved the information contained herein and accepts no responsibility for it.
For further information: Caroline Côté, Director, Corporate Communications and IR, TSO3 Inc., (418) 651-0003, Ext. 237, [email protected]; Source: TSO3 Inc.
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