Quebec City, June 30, 2011 – TSO3 Inc. (“TSO3”) (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, announced today that it has resubmitted documentation to the United States (U.S.) regulatory authorities for the company’s STERIZONE® 125L+ Sterilizer (3M™ Optreoz™ 125-Z). Such a filing is in support of obtaining clearance for the new generation sterilizer to be sold within the United States.
“Filing for clearance through the new regulatory process is a significant step towards the commercialization of our new generation sterilizer in the U.S.”, commented R.M. (Ric) Rumble, CEO of TSO3. “This filing comes after meetings have taken place with the regulators and additional information has been supplied and reviewed in person. These meetings have also allowed us to discuss the contents of the submission and an approach for its filing”, added Mr. Rumble. “We are pleased and confident with the package that has been assembled and we believe in a successful outcome”.
The STERIZONE® 125L+ Sterilizer is covered by a global commercial agreement between TSO3 and 3M™ under the brand name 3M™ Optreoz™ 125Z. 3M™ has initiated a phased introduction targeting 15 countries this year, in markets where regulatory clearances have already been received. Current regulatory clearances cover Canada, the European Union and selected countries of Latin America and Asia Pacific.
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 solution to other low temperature sterilization processes currently used in hospitals.
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.
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