TSO3 Responds to U.S. Regulators on Extended Claims and Provides Operations Update
QUÉBEC CITY, June 1, 2016 /PRNewswire/ - TSO3 Inc. (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, announced today that it has responded to a previously announced request for additional information by the U.S. Food and Drug Administration (the FDA) and that it has substantially completed its improvements to its manufacturing facility in Québec.
TSO3 has formally responded to a previously announced FDA request for additional information regarding expanded claims the Company has sought for its STERIZONE® VP4 Sterilizer. These expanded claims, when cleared, will allow for the repeated terminal sterilization by the STERIZONE® VP4 Sterilizer of complex multi-channeled flexible devices such as colonoscopes and gastroscopes. The claims sought in the U.S. represent similar claims for the STERIZONE® VP4 Sterilizer already available in Canada and claims which will accompany the sterilizers' introduction in Europe this year. TSO3's response allows the FDA to continue their review for market clearance on extended claims for the STERIZONE® VP4 Sterilizer in the U.S.
The Company also announced that it has substantially completed its operational improvements to its assembly facility in Québec City. These improvements are designed to increase assembly capacity and efficiency within the physical limitations of the Company's current location.
"We are pleased that we continue to make progress with regulatory authorities regarding our extended claims for colonoscopes and other multi-channel flexible endoscopes," said R.M. (Ric) Rumble, TSO3's President and CEO. "Additionally, we are pleased with the progress with our assembly facility. The production and operational improvements we made had a minimal impact on second quarter 2016 production, and we now believe we are in a position to ship sterilizers this quarter at quantities consistent with the first quarter of 2016."
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/
About TSO3
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 [email protected] or Renmark Financial Communications at 416 644-2020 or 514 939-3989 or by email at [email protected].
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 sales, 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 clearance to market its products on a worldwide basis;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.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities, in any jurisdiction in which such offer, solicitation or sale would be unlawful.
The TSX has neither approved nor disapproved the information contained herein and accepts no responsibility for it.
SOURCE TSO3 Inc.
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