Quebec City, Canada and Myrtle Beach, United States, December 19, 2017 – TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, announced today that it has had further dialogue with US Regulators in connection with their recent request for additional information (AI) regarding the Company’s submission to extend claims of its STERIZONE® VP4 Sterilizer to include terminal sterilization of duodenoscopes.
The Company now believes that the information it has provided to the Regulators addresses the majority of items listed within the initial AI request. For the remaining items, Regulators have recommended including additional data to support the claims.
“We continue to work productively with US regulators in pursuit of this new indication for use of our sterilizer,” stated Ric (R.M.) Rumble, President and CEO of TSO3 Inc. “The Company has continued its testing and data compilation to further support our claims as a natural part of our internal processes. We believe these data, combined with the real-world data being collected from respected healthcare institutions utilizing our sterilizer to routinely sterilize these duodenoscopes, will allow us to effectively respond to the remaining items in the request for additional information. Our next written exchange with Regulators is planned prior to the end of the year, after which another discussion will be scheduled in early 2018. The Company expects that final labeling could be submitted after that time.”
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 75lbs. 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://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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