Stock symbol: TSX: TOS
Outstanding shares: 72,888,182
QUEBEC CITY, July 15, 2013 /CNW Telbec/ - TSO3 Inc. ("TSO3") an innovator in low-temperature sterilization technology for medical
devices in healthcare settings, is pleased to provide an update on its
regulatory process for the STERIZONE® 125L+ Sterilizer, following a recent meeting with the US Regulatory
Agency. While the Company cannot provide the full particulars of its
communications, out of respect for the regulatory process as well as
for competitive reasons, TSO3 reports being pleased with the discussions the Company had with the
Most importantly, this most recent dialogue with the Agency has led to
their decision to work through the 510(k) process, rather than move to
the de novo process, as previously discussed. While the TSO3 sterilizer has different technological characteristics, the Agency was
able to conclude that the sterilizer could justify its Substantial
Equivalence claim to a predicate device, allowing it to proceed through
the 510(k) pathway for clearance. This revised direction in regulatory
pathway is the direct result of further review by the Agency of the
current file as well as additional discussions that took place over the
course of the recent meeting.
"Although this change in approach will be a surprise to many, we are
happy with this outcome. We believe that the de novo route may have generated uncertainty, while the 510(k) process is
better defined in our view," stated R.M. (Ric) Rumble, CEO of TSO3. "We learned at the meeting that we had not received the anticipated
NSE letter (Non Substantially Equivalent), which would have led to the
initiation of the de novo process, because the Agency wished to discuss the matter first. The
recent meeting was open, collaborative and definitely signalled that we
are moving forward. We remain confident in obtaining clearance,"
concluded Mr. 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:
Vice President - Investor and Business Relations
418 651-0003, Ext. 237