TSO3 Expands Duodenoscope Regulatory Filing StrategyWednesday, June 14, 2017
Quebec City, Canada and Myrtle Beach, United States, June 14, 2017 – TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, today announced that the Company now plans to seek 510(k) clearance for its STERIZONE® VP4 Sterilizer from US regulators for the terminal sterilization of the two duodenoscopes used in the majority of endoscopic retrograde cholangio-pancreatography (ERCP) procedures performed globally.
Plans are to launch regulatory filings with US regulators for both the Olympus TJF-Q180V and Pentax ED-3490TK duodenoscopes within weeks of each other beginning in July 2017. The Company’s goal is to receive US clearance by the end of 2017. Clearances already exist in Europe and Canada for the terminal sterilization of both of the duodenoscopes.
TSO3’s STERIZONE® VP4 sterilizer is already validated and cleared in the US, Europe and Canada to terminally sterilize multi-channel flexible endoscopes, such as video colonoscopes and gastroscopes, of up to 3.5 meters in length and with four or fewer channels.
“We are pleased to move forward and expand our duodenoscope regulatory strategy. Filing for US duodenoscope clearance is a natural and further step in our quest to help healthcare facilities improve their standard of care by providing sterile duodenoscopes and other endoscopes to their patients,” stated R.M.(Ric) Rumble TSO3’s President and CEO. “US regulatory clearance of duodenoscopes, along with our other healthcare-leading flexible endoscope claims, would help address industry concerns over the safety and effectiveness of less robust high-level disinfection systems.”
The Company also announced Dr. Mark Pasmore, its Vice President Research and Development, has resigned due to personal reasons. “In the short time Mark was with us, he made a positive and tangible impact on our organization and provided a solid scientific footing for the execution of our expanded regulatory strategy”, continued Mr. Rumble. “While we are sorry to see Mark go, we remain well positioned to continue to relentlessly pursue our scientific and regulatory objectives.”
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/.
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.
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Source: TSO3 Inc.
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