QUEBEC CITY and MYRTLE BEACH, SC, July
20 2017 /PRNewswire/ - TSO3 Inc. (TSX: TOS), an
innovator in sterilization technology for medical devices in
healthcare settings, today announced that the Company has filed a
510(k) submission with US regulators for its STERIZONE®
VP4 Sterilizer for the terminal sterilization of duodenoscopes used
in endoscopic retrograde cholangio-pancreatography (ERCP)
procedures. If awarded such claim, TSO3's
STERIZONE® VP4 Sterilizer would become the first and
only validated sterilizer technology in the US with a cleared label
claim for the terminal sterilization of
duodenoscopes.
TSO3's filing is supported by laboratory data
that validates that the STERIZONE® VP4 Sterilizer, with
its dual sterilants of hydrogen peroxide and ozone, can terminally
sterilize multi-channel flexible endoscopes with a distal end
elevator mechanism (duodenovideoscopes). If achieved, the
claim will match existing claims already made by the Company in
Canada and Europe.
"This submission is another step towards improving upon the
existing standard of care in healthcare sterile reprocessing.
Duodenoscopes have historically been defined as "semi-critical"
devices, and are not required to have a validated terminal
sterilization claim at this time. Our approach has been to
demonstrate that these devices can in fact be terminally sterilized
and offer healthcare facilities the ability to use our more robust
process to process devices known or suspected to be contaminated
with multidrug resistant organisms (MDRO)", stated R.M. (Ric) Rumble, TSO3's President
and CEO. "New US regulatory requirements recently published
require manufacturers to provide validated sterilization methods
with future submissions for new semi-critical devices such as
duodenoscopes, bronchoscopes, gastroscopes, colonoscopes and other
endoscopes. TSO3's unique existing endoscope
sterilization claims, along with a potential expanded duodenoscope
claim, position the STERIZONE® VP4 Sterilizer to be an
integral part of a healthcare institution's infection control
strategy."
About the STERIZONE® VP4 Sterilizer
The STERIZONE® VP4 Sterilizer is a low-temperature
sterilization system that utilizes the dual-sterilants of vaporized
hydrogen peroxide (H2O2) and ozone
(O3) to achieve terminal sterilization of heat and
moisture sensitive medical devices. Its single pre-programmed cycle
can sterilize a large number and wide range of compatible devices,
creating a cost-effective sterilization process with error free
cycle selection. The device's unique Dynamic Sterilant Delivery
System™ automatically adjusts the quantity of injected sterilant
based on the load composition, weight and temperature. This
capability removes the guesswork and potential for human error, as
there is no need to sort instruments and choose the appropriate
cycles as with other machines.
The STERIZONE® VP4 Sterilizer is the only terminal
sterilization method that is FDA cleared to sterilize
multi-channeled flexible endoscopes (with a maximum of four
channels) of up to 3.5 meters in length, such as video colonoscopes
and gastroscopes - an industry first for any medical device
sterilization process.
The STERIZONE® VP4 Sterilizer is also the only
cleared low temperature sterilizer that can process a mixed load
consisting of general instruments, single channel flexible
endoscopes, and single or double channel rigid endoscopes in the
same cycle with load weights of up to 75 lb. The ability to
run mixed loads significantly reduces labor costs by minimizing the
amount of instrument sorting required, while maximizing the device
turns (more productivity from increased throughput capacity).
More information about the STERIZONE® VP4
Sterilizer is available through TSO3's website, under
the Products section at
http://www.tso3.com/en/products/sterizone-vp4/.
About TSO3
Founded in 1998, TSO3's activities encompass the
sale, production, maintenance, research, development and licensing
of sterilization processes, related consumable supplies and
accessories for heat-sensitive medical devices. The Company designs
products for sterile processing areas in the hospital environment
that offer an advantageous replacement solution to other low
temperature sterilization processes currently used in hospitals.
TSO3 also offers services related to the maintenance of
sterilization equipment and compatibility testing of medical
devices with such processes.
For more information about TSO3, visit the Company's
website 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 TSO3's regulatory filings,
revenue, business or operations) are forward-looking statements
that involve certain risks, uncertainties and hypotheses,
including, but not limited to, the ability of the Company to obtain
the required regulatory clearances to market its products, 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 uncertainties. Although
TSO3 believes that the expectations reflected in such
forward-looking statements are reasonable, it can give no assurance
that such expectations will prove to have been correct. The
complete versions of the cautionary note regarding forward-looking
statements as well as a description of the relevant assumptions and
risk factors likely to affect TSO3's actual or projected
results are included in the Management's Discussion and Analysis
for the year ended December 31, 2016, which is available on
the Company's website. The forward-looking statements contained in
this press release are made as of the date hereof and
TSO3 does not assume any obligation to update or revise
any forward-looking statements, whether as a result of new
information, future events or otherwise unless expressly required
by applicable securities laws.
This press release shall not constitute an offer to sell or
the solicitation of an offer to buy, nor shall there be any sale of
these securities, in any jurisdiction in which such offer,
solicitation or sale would be unlawful.
SOURCE TSO3 Inc.