QUEBEC CITY and MYRTLE BEACH, SC, Dec. 19, 2017 /PRNewswire/ - 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.

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