QUÉBEC CITY, March 14, 2016 /PRNewswire/ - TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, has received feedback from the U.S. regulators regarding the company's recent application to extend claims for the STERIZONE® VP4 Sterilizer.
TSO3 announced in December 2015 that it had completed studies in order to support expanded use of the sterilizer in the U.S. and had filed for such claims. The expanded claims sought for the STERIZONE® VP4 Sterilizer correspond to increasing scrutiny by regulatory authorities over medical device reprocessing, particularly for colonoscopes and other complex medical devices used during minimally invasive surgical procedures. The claims sought in the U.S. represent similar claims for the STERIZONE® VP4 Sterilizer already available in Canada and those which will accompany the sterilizers' introduction in Europe this year.
"We recently received feedback from the agency suggesting that we evaluate our claims based on the type and manufacture of device," said R.M (Ric) Rumble, TSO3's president and CEO. "In addition, we have been asked to document that the use of the STERIZONE® VP4 Sterilizer process does not increase the reprocessing challenge for a given device, review our instructions for use so that additional clarity is available to our end-users, and repeat limited tests under slightly modified conditions."
"The questions and statements received are typical and consistent with the seriousness of elevating the standard of reprocessing for these extremely challenging medical devices," continued Rumble. "The minimal testing is planned or already underway, and we have requested meetings with the agency to discuss the work."
Additionally, TSO3 recently responded to a minor question pertaining to a separate and distinct clean-up 510(k) application. This clean-up application is specific to harmonizing the electromechanical design of the sterilizer such that the same configuration may be sold in all markets.
Regulatory clearance of the additional claims would represent an entirely new level of patient protection against ineffective device reprocessing resulting from the use of less robust disinfecting systems, particularly for flexible endoscopes.
About the STERIZONE® VP4 low temperature sterilizer
The STERIZONE® VP4 Sterilizer developed by TSO3 is a dual sterilant, low temperature sterilization system that utilizes vaporized hydrogen peroxide (H2O2) and ozone. Its single cycle can sterilize a large number and wide range of compatible devices, thereby allowing for a cost effective and error-free sterilization process. TSO3's unique Dynamic Sterilant Delivery SystemTM automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature. With its large 75 lb load capacity and a short cycle time, the STERIZONE® VP4 Sterilizer can enhance throughput and lower sterilization cost. The STERIZONE® VP4 Sterilizer was cleared for commercialization in the United States in December 2014.
More information about the STERIZONE® VP4 Sterilizer is available through TSO3's website, under the Products section: 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. 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 or contact Liolios Group at 949 574-3860 or email TOS@liolios.com or Renmark Financial Communications at 416 644-2020 or 514 939-3989 or by email at email@example.com.
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SOURCE TSO3 Inc.