Altru Health System Improves Patient Care with Expanded Use of Cutting-Edge Sterilization Technology
Duodenoscopes Now Sterilized With a Low-Temperature Sterilizer
Grand Forks, N.D. – TSO3 Inc. (TSX: TOS) ("TSO3" or the "Company"),
an innovator in sterilization technology for medical devices in healthcare
settings, joins with Altru Health System in announcing the landmark U.S.
terminal sterilization of long, flexible gastrointestinal endoscopes,
like the duodenoscope, using TSO3’s paradigm-shifting STERIZONE®
technology.
“Being the inaugural facility to offer terminal sterilization of
endoscopes using the TSO3 technology, provides our patients with a level
of safety above current best-practice standards in the industry,”
says Stacie Avdem, Director of Surgical and Procedural Services at Altru
Health System.
“Altru has achieved industry-leading practices with centralization,
cleaning verification, and borescope inspection in endoscope reprocessing.
The ability to sterilize endoscopes, specifically duodenoscopes, is paramount
to achieving our mission of delivering world-class care to the residents
of our region. It shows our ongoing investment in and commitment to patient
safety,” says Jenni Gibbs, Manager of Central Sterile Department
at Altru Health System.
In May, U.S. regulators approved TSO3’s most recent 510(k) submission
for the terminal sterilization of multi-channeled flexible endoscopes
using the Company’s STERIZONE® VP4 Sterilizer. The new clearance
for the STERIZONE® VP4 Sterilizer allows a hospital-like Altru®
Health System to terminally sterilize gastrointestinal endoscopes that
have dimensions within the cleared intended use.
“Our mission, to provide a sterile device for every patient, is what
TSO3 works toward every day,” said R.M. (Ric) Rumble, TSO3’s
President, and CEO. “The recent and highly publicized infection
outbreaks associated with the use of flexible endoscopes have highlighted
the need for innovative approaches to reprocessing of these complex devices.
We are pleased to celebrate this major milestone with Altru® and are
working with customers in the U.S. and across the world that will soon
be sterilizing their endoscopes using our advanced technology.”
According to the U.S. Centers for Disease Control (“CDC”),
at least two million Americans are infected with antibiotic-resistant
bacteria each year, and more than 23,000 of them die. Included in those
statistics are patients who were infected in healthcare settings. One
type of antibiotic-resistant infection that was traced to contaminated
endoscopes was caused by Carbapenem-resistant Enterobacteriaceae (CRE),
a bacteria the CDC has designated as a “superbug”. This superbug
has a 50% mortality rate in infected patients.
About Altru Health System
Altru Health System is a regional-owned, integrated system with a general
acute care hospital, a specialty hospital, more than a dozen clinics in
Grand Forks and the region, and a large home care network. It employs
nearly 200 physicians and 4,000 staff and has an annual net operating
revenue of more than $549 million. As the first member of the Mayo Clinic
Care Network, Altru’s providers have access to clinically integrated
tools extending Mayo Clinic’s knowledge and expertise to patients.
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 are forward-looking
statements that involve certain risks, uncertainties and hypotheses, including,
but not limited to, the limited history of sales or distribution of the
Company, 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 favorable 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, 2017, 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.
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, duodenoscopes, 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).
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