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19.03.2018 12:01
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PR Newswire
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TSO3 Submits Response to US Regulators in Support of Terminal Sterilization of Duodenoscopes
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PR Newswire
QUEBEC CITY and MYRTLE BEACH, SC, March 19, 2018
QUEBEC CITY and MYRTLE BEACH, SC, March 19, 2018 /PRNewswire/ - TSO3 Inc. (TSX: TOS), ("TSO3" or the "Company"), an innovator in sterilization technology for medical devices in healthcare settings, today announced that it has provided its final Additional Information (AI) response to US Regulators in support of extending the claims of the Company's STERIZONE® VP4 Sterilizer to include the terminal sterilization of duodenoscopes.
In the AI response, the Company included data on modified leak test experiments, testing to confirm lack of fluid ingress occurring under the distal end cap of the devices, as well as real-world data from market research commissioned by TSO3 reflecting the actual use-life of duodenoscopes.
"The Company believes that its response is consistent with 510(k) requirements demonstrating the same intended use and the same technological characteristics as the predicate device, which is the existing cleared TSO3 STERIZONE® VP4 Sterilizer" stated R.M. (Ric) Rumble, TSO3's President and CEO. "The Company believes that the science supporting the data provided has met the same threshold as the predicate device with testing conducted on actual devices in simulated-use and in-use clinical conditions."
Original Equipment Manufacturer (OEM) labeling requires healthcare institutions using a method not listed in the OEM labeling to carefully inspect the duodenoscope for damage before each patient use and to repair the device as needed. TSO3 recommends rigorous inspection according to the instructions provided by the device manufacturer and TSO3 as an essential part of best practices designed to improve patient safety.
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/.
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 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.
SOURCE TSO3 Inc.
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