TSO3 new generation sterilizers allowed CE Mark labeling

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.