In productive communications towards a new filing
Ticker Symbol: TOS/TSX
Shares Outstanding: 57,939,451
QUEBEC CITY, Sept. 7 /CNW Telbec/ - TSO3 Inc. ("TSO3") (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, today announced that the Company is having productive discussions with US regulators, including a very recent face-to-face meeting. The Company is actively engaged in the changing US regulatory process intended to lead to the refilling for 510(k) clearance on its new generation sterilizer.
"Based on recent disclosure from the US Food and Drug Administration, we can see a changing emphasis on what is expected for devices to clear the 510(k) process," stated Charles O. Hancock, RAC, Regulatory Consultant for TSO3. "The Agency wants to make the process more predictable. This means more discussions and guidance upfront before filings, which is intended to lead to a more predictable and timely review", concluded Mr. Hancock.
"We understand the nature of the regulators' process and are confident we can respond to their need for scientifically valid explanations and justifications in a timely manner", commented R.M. (Ric) Rumble, TSO3's President and CEO. "This new process we are currently engaged in with the US regulators involves more discussions before we are ready to file. We see this positively as it will make the outcome of our filing more predictable. We are very confident in our ability to respond with a compliant submission and will disclose when we file our new application", added Mr. Rumble.
About TSO3
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 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.
For further information: Caroline Côté, Director, Corporate Communications and Investor Relations, 418 651-0003, Ext. 237, [email protected]; Source: TSO3 Inc.
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