Quebec City, May 2, 2014 – TSO3 Inc. (“TSO3”) (TSX: TOS) an innovator in low-temperature sterilization technology for medical devices in healthcare settings, today announced that the Company has submitted a new file to the US Regulatory Authorities for the purpose of obtaining clearance for the STERIZONE® low temperature Sterilizer in that market.
As per previous released communications, the Company has conducted a variety of tests to satisfy information requests contained in a guidance document provided by the US Regulatory Authorities in early 2014.
Testing completed provided data consistent with the Company’s expectations. The results and conclusions from the recent work were assembled into a new submission which has now been sent to the regulators for review.
“Previously, the Company had stated that after the new data was collected, it may take a few weeks to assemble a new file, which it did” stated R.M. (Ric) Rumble, President and CEO. “The task of aligning all previously collected and newly obtained data was significant. The document was thoroughly reviewed both internally and by our consultants prior its delivery. As we learn about the progress of the file’s review, we will update accordingly” concluded Mr. Rumble.
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.
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