TSO3 Files New and Simplified Submission to the US Regulatory Agency

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:ccote@tso3.com 
SOURCE: TSO3 INC. 
To view this news release in HTML formatting, please use the following URL: 
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CO: TSO3 INC.
ST: Quebec
NI: HEA HEA  
-0- Jan/28/2013 11:00 GMT
 
 
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