TSO3 Files New and Simplified Submission to the US Regulatory Agency Company seeking United States clearance for its STERIZONE(®) 125L+ Sterilizer Ticker: TSX - TOS Shares Outstanding: 65,888,182 QUEBEC CITY, Jan. 28, 2013 /CNW Telbec/ - TSO(3) Inc. (TSX: TOS) ("TSO(3)" or the "Corporation") an innovator in sterilization technology for medical devices in healthcare settings, today announced that consistent with its December 14 2012 disclosure, the Company has filed a new and simplified submission with the US regulatory agency seeking commercial clearance of its STERIZONE(®)125L+ Sterilizer in that market. The simplified submission presents a single cycle sterilizer offering improved claims. The Agency had acknowledged this new approach by TSO(3), after reviewing answers to questions raised from the previous submission and asked the Company to re-file a new, cleaned up and simplified submission. "Obtaining US regulatory clearance remains our top priority", stated R.M. (Ric) Rumble, CEO of TSO(3). "We believe the submission is complete and the use of a single cycle with expanded claims increases our confidence in making tangible progress towards US regulatory clearance". The submission by TSO(3) will first undergo an "acceptance review" to ensure that the file is administratively complete as per the Agency's requirements. According to the most recently updated US regulatory guidelines, the Agency should provide such assessment within 15 calendar days. If the file is accepted, the Agency will grant a file number and will initiate the "substantive review" process. Complete US regulatory guidelines for 510(k) clearances can be found at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments /ucm089735.htm About TSO(3) TSO(3), founded in Québec City in 1998, specializes in the research and development of innovative, high-performance medical instrument sterilization technology with high commercial potential. TSO(3) 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 TSO(3), visit the Company's Web site at www.tso3.com The statements in this release and oral statements made by representatives of TSO(3) relating to matters that are not historical facts (including, without limitation, those regarding the timing or outcome of any financing undertaken by TSO(3)) 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 TSO(3) 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. Caroline Côté Director - Investor and Business Relations (418) 651-0003, Ext. 237 Email:email@example.com SOURCE: TSO3 INC. To view this news release in HTML formatting, please use the following URL: http://www.newswire.ca/en/releases/archive/January2013/28/c8999.html CO: TSO3 INC. ST: Quebec NI: HEA HEA -0- Jan/28/2013 11:00 GMT
TSO3 Files New and Simplified Submission to the US Regulatory Agency
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