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Press release from CNW Group

TSO3 File Passes US Regulatory Acceptance Review - STERIZONE® 125L+ Sterilizer 510(k) request to now undergo substantive review process

Monday, February 04, 2013

TSO3 File Passes US Regulatory Acceptance Review - STERIZONE® 125L+ Sterilizer 510(k) request to now undergo substantive review process06:30 EST Monday, February 04, 2013Ticker:  TSX - TOS     Shares Outstanding: 65,888,182QUEBEC CITY, Feb. 4, 2013 /CNW Telbec/ - TSO3 Inc. (TSX: TOS) ("TSO3" or the "Corporation") an innovator in sterilization technology for medical devices in healthcare settings, today announced that its new simplified filing to the US regulatory agency for clearance to commercialize the STERIZONE® 125L+ Sterilizer in that market, passed the acceptance review step, ensuring that the file is administratively complete as per the Agency's requirements.The Agency has granted TSO3's file a 510(k) number and will now initiate the "substantive review" process. As per the Agency's most recent guidelines dated December 31, 2012, the Agency targets to respond within 60 days of filing, while maximum agency clock is of 90 days. The Company has 180 days total clock to respond to Agency questions. Complete US regulatory guidelines for 510(k) clearances can be found at:http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089735.htmAs per the Company's disclosure of December 14, 2012, the simplified submission from TSO3 presents a single cycle sterilizer offering improved claims. The Agency had acknowledged this new approach by TSO3, after reviewing answers to questions raised from the previous submission and asked the Company to re-file a new, cleaned up and simplified submission.About TSO3TSO3, 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.comThe 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.SOURCE: TSO3 INC.For further information: Caroline Côté Director - Investor and Business Relations (418) 651-0003, Ext. 237 Email: ccote@tso3.com