Stock symbol: TSX: TOS
Outstanding shares: 57,897,451
QUEBEC CITY, June 8 /CNW Telbec/ - TSO3 Inc. ("TSO3") (TSX: TOS) an innovator in sterilization technology for medical devices in healthcare settings using ozone, today announced that it has received instructions from US regulatory authorities to resubmit a 510(k) for its STERIZONE(R) 125L+ Sterilizer. As instructed by the Agency, TSO3 intends to provide additional data and to better establish the link between the sterilizer and a variety of accessory products used in the sterilizer, which are also subject to 510(k) clearance and have been previously submitted.
"TSO3 is eager to quickly provide additional data on the STERIZONE(R) 125L+ Sterilizer and to link the various accessory products together to support our superior claims", stated Mr. R.M. (Ric) Rumble, President and CEO of TSO3. "We estimate the time to complete the collection of data and modify the submission document will be approximately four weeks, which is about the same amount of time that it takes companies to respond to questions from the Agency during the review process. We remain absolutely confident in our ability to gain US regulatory clearance for this product, however, as it has always been the case, we are unable to accurately predict the timing of such clearance", Mr. Rumble concluded.
TSO3, founded in Québec City in 1998, specializes in the research and development of innovative, high-performance medical instrument sterilization technology with high commercial potential. TSO3 designs products for sterile processing areas in the hospital environment and offers an advantageous replacement solution to other low temperature sterilization processes currently being used in hospitals.
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.
SOURCE TSO3 Inc.
For further information: For further information: Caroline Côté, Director, Corporate Communications and Investor Relations, (418) 651-0003, Ext. 237, email@example.com; Source: TSO3 Inc.