Stock symbol: TSX: TOS
Outstanding shares: 73,000,906
QUEBEC CITY, Jan. 30, 2014 /CNW Telbec/ - TSO3 Inc. ("TSO3"), an innovator in low-temperature sterilization technology for medical
devices in healthcare settings, today provided an update on US
Regulatory activities. This update comes after the Company received
written communication from the Agency in response to additional
documentation the Company supplied to the Agency late in 2013. The
Company had asked the Agency at that time to comment on continued
availability of a 510(k) pathway to market and the proposed data to be
supplied in a new 510(k) submission. In addition the Company requested
that the Agency address an outstanding question concerning one of the
accessories associated with the file.
"While the Agency's response is open for interpretation, based on a
detailed and thorough review with its internal and external regulatory
consultants, the Company believes that the response contains sufficient
guidance to follow up with a 510(k) submission that will meet the
Agency's requirements", stated R.M. (Ric) Rumble, TSO3 President and CEO.
"Within the quarter, we will aim to complete limited additional testing
to include in a new file. We have confirmation that the 510(k) process
will continue to be the pathway towards clearance and the Agency has
given us guidance on the data required for clearance. We intend to
prepare and submit a new 510(k) as quickly as possible once the
additional data is obtained, taking into account the guidance just
received from the Agency", Rumble continued. "Timing for the clearance
is still difficult to predict but we believe we have identified the
required additional information to include in the filing. No further
significant presubmission discussions with the Agency are expected
prior to the re-filing of the submission", concluded Rumble.
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 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.com
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
The TSX has neither approved nor disapproved the information contained
herein and accepts no responsibility for it.
SOURCE: TSO3 Inc.
For further information:
President & CEO
418 651-0003, Ext. 254