Quebec City, Canada and Myrtle Beach, United States, April 26, 2018 – TSO3 Inc. (TSX: TOS), (“TSO3” or the “Company”), an innovator in sterilization technology for medical devices in healthcare settings, today announced that an independent laboratory has completed studies demonstrating the efficacy of the STERIZONE® VP4 Sterilizer for inactivation of prions.
Prions are abnormal, pathogenic agents believed to cause transmissible spongiform encephalopathies (TSEs), such as Variant Creutzfeldt-Jakob Disease. TSEs are rapidly progressive, uniformly fatal neurodegenerative diseases that can infect humans and animals. Prions generated great public concern after an outbreak of bovine spongiform encephalopathy occurred in many European countries and scientific evidence indicated its transmission to humans. Prions are unique in demonstrating a high level of resistance to conventional device reprocessing methods and have been linked to patient-to-patient transmission via contaminated medical devices.
“This study reinforces the broader clinical applications of our sterilization technology”, stated R.M. (Ric) Rumble TSO3’s President and CEO. “Results obtained by the independent laboratory confirmed the efficacy and performance of the STERIZONE® VP4 Sterilizer for prion inactivation. This data enables the Company to pursue approval from regulators in Europe to be listed as a device that inactivates these challenging infectious agents”.
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 Food and Drug Administration (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/.
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. TSO3also 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.
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