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:
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
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.
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-0- Jan/28/2013 11:00 GMT
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