Quebec City, December 14, 2012 – TSO3 Inc. (TSX: TOS) (“TSO3” or the “Corporation”) an innovator in sterilization technology for medical devices in healthcare settings, today announced that the Company is simplifying its approach for US regulatory clearance of the STERIZONE® 125L+ Sterilizer, with a single cycle which offers improved claims. The Agency acknowledges the TSO3 approach and requests a cleaned-up and simplified filing for consistency throughout the entire document filed in April 2012.
Last June, the Company received a set of questions based on its April 2012 submission. As previously stated, these questions centered on the chemistry and the detailed mechanism of action that relates to the sterilizer’s performance. The sterilizer’s three preprogrammed cycles using different conditions seemed to complicate the submission. The Agency agreed with a proposal to simplify the submission by reducing the number of cycles initially available to one from three, while increasing the claims and utility of that one cycle to accommodate all but a few instruments. TSO3has conducted tests to verify the performance resulting from these revised conditions. That information will be incorporated in the new submission.
“This request for a cleaned up and simplified filing was one outcome that was anticipated based on our interactions with the Agency over the last few months and our detailed responses to their questions. As such, efforts to complete such a document began once our response was submitted and we anticipate that this new submission will be ready in late January, or early February”, stated R.M. (Ric) Rumble, CEO of TSO3. “The Company remains focused on this single priority and will continue to allocate the required resources to obtain access to the key market”, he concluded.
TSO3 will host a telephone Conference Call today, December 14, 2012 at 8:30 a.m. (ET). Analysts and Institutional Investors are invited to participate in the call. The numbers to dial for access are 514-807-9895 (Montréal area), 647-427-7450 (Toronto area) or the Toll-Free number 1 888 231-8191. Please dial-in with the following identification number to join the conference call: 59331726.
Other interested parties may listen to the live Webcast of the Conference Call accessible via CNW’s Website at: http://www.newswire.ca/en/webcast/detail/1089105/1186533
The Webcast will be archived for 90 days.
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 solutions 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.
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