Québec City, July 27, 2015 – TSO3 Inc. (TSX: TOS) (“TSO3” or the “Corporation”) an innovator in sterilization technology for medical devices in healthcare settings, today confirmed that it is pursuing extended claims for its STERIZONE® Sterilizer for the Canadian, U.S. and European markets. These extended claims, when achieved, will allow sterilization of increasingly complex medical devices, which are currently only High Level Disinfected. In the U.S, regulatory authorities are currently reviewing recommendations to improve the safe reprocessing of complex medical devices such as colonoscopes, duodenoscopes as well as other complex instruments. Simultaneously, TSO3 continues to perform specific studies and compiles the required data to support regulatory requirements in each of the targeted markets.
Following a two-day meeting held earlier this year in May, the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee reviewed recommendations to reclassify certain devices from semi-critical to critical devices. These devices included colonoscopes, duodenoscopes as well as other complex instruments. Such a reclassification would require a shift from the current practice of High Level Disinfection to that of a more robust “terminal sterilization” process between patient uses.
“Although we cannot be sure of the regulators future guidance and direction, we believe that the market wants to move towards sterilization of these complex medical devices. To date there simply has been no technology available that could quickly and cost effectively, terminally sterilize these long, complex and delicate devices. Based on past and continuing studies with the instruments in question, we strongly believe that our STERIZONE®Sterilizer can offer this increased level of safety to the patient population.” stated R.M. (Ric) Rumble, President and CEO. “Based on our ongoing work, we know that sterilization is achievable (SAL-6); we also believe that in some cases device manufacturers will want to modify selected components of specific instruments in order to increase the longevity of the devices when repeatedly sterilized. It is clear that obtaining such a claim will provide significant clinical importance to our customers while enhancing the commercial opportunity for the Company and its shareholders. The Company expects documentation to be available this year and we will introduce the new claims in Canada first, and then expand to additional markets as clearances are obtained.” concluded Mr. Rumble.
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. It 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 Web site 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 any financing undertaken by TSO3) are forward-looking statements that involve certain risks, uncertainties and hypotheses, including, but not limited to, 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.
The TSX has neither approved nor disapproved the information contained herein and accepts no responsibility for it.
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