Quebec City, Canada and Myrtle Beach, United States, – May 9, 2018 – TSO3 Inc. (TSX: TOS) (“TSO3” or the “Company”), an innovator in sterilization technology for medical devices in healthcare settings, announced today that it has received clearance from US regulators for its most recent 510(k) submission for the terminal sterilization of multi-channeled flexible endoscopes using the Company’s STERIZONE® VP4 Sterilizer.
The new clearance for the STERIZONE® VP4 Sterilizer will allow a hospital to terminally sterilize gastrointestinal endoscopes that have dimensions within the cleared intended use. The technical characteristics of the devices that could fall within this cleared intended use statement include certain colonoscopes, duodenoscopes and gastroscopes which have 4 or less channels and up to 3.5 meters in length with internal diameters of 1.2 mm or greater.
“In 2009, TSO3 set itself on a path to bring about lasting and meaningful change to healthcare sterilization practices. The recent and highly publicized outbreaks associated with use of flexible endoscopes have highlighted the need for innovative approaches to reprocessing of these complex devices. Today, TSO3 is proud to announce that this clearance enables a significant step forward in achieving this change and our goal to provide a sterile instrument for every procedure. This advancement required significant effort and innovation both in technology and reprocessing practices. I am proud of the TSO3 team who made this possible. This clearance allows TSO3 to partner with healthcare systems to facilitate the terminal sterilization of these devices,” stated R.M. (Ric) Rumble, TSO3’s President and CEO.
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, duodenoscopes 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 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, 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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