Quebec City, Canada and Myrtle Beach, United States, September 7, 2017 – TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, today announced that a major hospital in Canada has initiated terminal sterilization of duodenoscopes with the Company’s STERIZONE® VP4 Sterilizer. Additionally, the Company has successfully completed both a Quality System compliance inspection by US regulators and four weeks of comprehensive sales and marketing training with personnel from its exclusive distribution partner, the Getinge Group.
The Company announced that the second largest hospital in Canada has completed the installation of multiple STERIZONE® VP4 Sterilizers and is now using these sterilizers to terminally process duodenoscopes used on patients undergoing endoscopic retrograde cholangio-pancreatography (ERCP) procedures. The Company’s STERIZONE® VP4 Sterilizer is the only validated system cleared for the terminal sterilization of duodenoscopes (US claim pending clearance) as well as other complex multi-channeled flexible endoscopes such as colonoscopes and gastroscopes.
Terminal sterilization of duodenoscopes represents an entirely new level of patient protection as compared to the less robust disinfecting systems in use today. Disinfecting processes are under increasing public and regulatory scrutiny given a number of documented cases of duodenoscope-related patient-to-patient transfer of antibiotic resistant micro-organisms, some of which have led to patient deaths.
“For the first time in history, an industry leading medical facility is terminally sterilizing duodenoscopes using a validated process, a major advancement in healthcare and patient safety, and they are using TSO3 technology,” stated R.M. (Ric) Rumble, TSO3’s President and CEO. “Terminal sterilization is now an option for healthcare facilities who are concerned about scope-related patient-to-patient transfer of contaminants. Ineffective endoscope reprocessing is a pressing global healthcare issue and we believe sterilization is a major part of the solution. TSO3 is now working with additional leading healthcare facilities in Canada, in the United States and in Europe on STERIZONE® VP4 Sterilizer installations for the specific purpose of terminally sterilizing duodenoscopes and other endoscopes.”
TSO3 also announced the successful completion of a routine Quality System compliance inspection by US regulators. The Company passed the inspection without any reportable findings – which is considerable given the rapid expansion of the Company. The Company has and continues to follow a continuous improvement based regulatory compliance program which was commended by the regulators.
Lastly, the Company announced the completion of a comprehensive four week training program for customer facing representatives from its exclusive distributor, the Getinge Group. This training was conducted by in-house staff and satisfied medical facility end users. It covered selling and marketing material, technical information, clinical input, and customer Q&A preparation.
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 https://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. 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.
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