TSO3 UPDATES ON REGULATORY ACTIVITIES
Quebec City, January 30, 2014 – TSO3 Inc. (“TSO3”), an innovator in low-temperature sterilization technology for medical devices in healthcare settings, today provided an update on US Regulatory activities. This update comes after the Company received written communication from the Agency in response to additional documentation the Company supplied to the Agency late in 2013. The Company had asked the Agency at that time to comment on continued availability of a 510(k) pathway to market and the proposed data to be supplied in a new 510(k) submission. In addition the Company requested that the Agency address an outstanding question concerning one of the accessories associated with the file.
“While the Agency’s response is open for interpretation, based on a detailed and thorough review with its internal and external regulatory consultants, the Company believes that the response contains sufficient guidance to follow up with a 510(k) submission that will meet the Agency’s requirements”, stated R.M. (Ric) Rumble, TSO3 President and CEO.
“Within the quarter, we will aim to complete limited additional testing to include in a new file. We have confirmation that the 510(k) process will continue to be the pathway towards clearance and the Agency has given us guidance on the data required for clearance. We intend to prepare and submit a new 510(k) as quickly as possible once the additional data is obtained, taking into account the guidance just received from the Agency”, Rumble continued. “Timing for the clearance is still difficult to predict but we believe we have identified the required additional information to include in the filing. No further significant presubmission discussions with the Agency are expected prior to the re-filing of the submission”, concluded 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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