Quebec City, March 12, 2012 – TSO3 Inc. (“TSO3”) (TSX: TOS), an innovator in sterilization technology for medical devices in healthcare settings, today announced that it will provide additional data to the US Regulatory Agency in support of obtaining 510(k) clearance for its new sterilizer in the US market. The Company had previously responded to questions from the Agency and some of the answers now require additional clarification. The Company will resubmit with the required information as promptly as the new data is available.
“The Agency is seeking additional data to support our superior claims, which will require some more time to collect”, stated R.M. (Ric) Rumble, President and CEO of TSO3. “This is a dynamic situation; we had recently responded to questions on the open files and were preparing to address a last data point which had been requested, when we learned that additional clarification to a limited number of questions would be coming”, explained Mr. Rumble. “We believe this to be a timing issue and not one that concerns the inherent science of our technology, however it causes us to resubmit our file when the new data is ready and respond with the full data set requested by the Agency. Based on the performance of the product and all other data available to the Company, we remain extremely confident in our ability to meet the regulatory agency’s requirements. As soon as we are able to provide accurate timing on refilling, we will disclose further information”, concluded Mr. Rumble.
TSO3 will be holding its fourth quarter and full year conference call on Wednesday March 14, at which time highlights from fiscal 2011 and recent events will be discussed, including an update on regulatory activities.
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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