TSO3 Allowed Expanded Claims for Revolutionary STERIZONE® VP4 Sterilizer
STERIZONE® VP4 Sterilizer Achieves Industry First: Terminally Sterilize up to Eight Channels in a Single Device
QUÉBEC CITY, Oct. 26, 2015 /CNW Telbec/ - TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, has received clearance from Health Canada, the Canadian equivalent of the Unites States FDA, to sell the STERIZONE® VP4 Sterilizer with extended claims in the Canadian market place.
With these claims, the TSO3 STERIZONE® VP4 Sterilizer becomes the only low temperature sterilization system available in the market today that is capable of sterilizing complex medical instruments, such as colonoscopes and other multi-channel flexible scopes.
One reason medical scopes are difficult to clean is because they have many internal channels that can harbor bacteria. Since their parts can be sensitive to the elevated temperatures that are typically involved in sterilization, the only alternative has been disinfection.
However, disinfection is significantly less effective than sterilization because it does not necessarily kill all harmful microorganisms, especially resistant bacterial spores. Low temperature sterilization with the STERIZONE® VP4 Sterilizer offers a more effective solution, since it involves a proprietary physical and chemical process that thoroughly destroys all types of microbiological organisms. Further, the STERIZONE® VP4 can sterilize up to eight channels in a single device, an industry first for any medical device sterilization process.
"This important clearance represents the introduction of an entirely new level of patient care and safety," said TSO3 president and CEO, Mr. R.M. (Ric) Rumble. "Canadians can now be treated with fully sterilized instruments rather than those which were simply disinfected, with this being critically important given how these devices are used."
The expanded claims received for the STERIZONE® VP4 Sterilizer correspond to increasing scrutiny by regulatory authorities over medical device reprocessing, particularly for colonoscopes and other complex medical devices used during minimally invasive surgery procedures. Much of this concern stems from patient-to-patient transfer of multidrug-resistant bacteria, which are not inactivated by high-level disinfection, but are inactivated with the STERIZONE® VP4. Published reports confirm the significant risk of device-related transfer of antibiotic resistant microbes, which can lead to patient injury or death.
"The allowance of these claims helps support our pursuit of similar claims in other international markets, including the United States," added Mr. Rumble. "In these markets, which are substantially greater than Canada, we believe our STERIZONE® VP4 Sterilizer maintains these unrivaled capabilities and the equal promise of revolutionizing the medical industry's standard of care."
About the STERIZONE® VP4 Low Temperature Sterilizer
The STERIZONE® VP4 Sterilizer developed by TSO3 is a dual sterilant, low temperature sterilization system that utilizes vaporized hydrogen peroxide (H2O2) and ozone. Its single cycle can sterilize a large number and wide range of compatible devices, thereby allowing for a cost effective and error-free sterilization process. TSO3's unique Dynamic Sterilant Delivery SystemTM automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature. With its large 75 lb. load capacity and a short cycle time, the STERIZONE® VP4 Sterilizer can enhance throughput and lower sterilization cost. The STERIZONE® VP4 Sterilizer was cleared for commercialization in the United States in December 2014.
More information about the STERIZONE® VP4 Sterilizer is available through TSO3's website, under the Products section: 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. It 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 web site at www.tso3.com or contact Liolios Group at (949) 574-3860 or email [email protected].
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 uncertainties.
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.
The TSX has neither approved nor disapproved the information contained herein and accepts no responsibility for it.
SOURCE TSO3 Inc.
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