TSO3 PROVIDES UPDATE ON REGULATORY PROGRESS
Quebec City, July 15, 2013 – TSO3 Inc. (“TSO3”), is pleased to provide an update on its regulatory process for the STERIZONE® 125L+ Sterilizer, following a recent meeting with the US Regulatory Agency. While the Company cannot provide the full particulars of its communications, out of respect for the regulatory process as well as for competitive reasons, TSO3 reports being pleased with the discussions the Company had with the Agency.
Most importantly, this most recent dialogue with the Agency has led to their decision to work through the 510(k) process, rather than move to the de novo process, as previously discussed. While the TSO3 sterilizer has different technological characteristics, the Agency was able to conclude that the sterilizer could justify its Substantial Equivalence claim to a predicate device, allowing it to proceed through the 510(k) pathway for clearance. This revised direction in regulatory pathway is the direct result of further review by the Agency of the current file as well as additional discussions that took place over the course of the recent meeting.
“Although this change in approach will be a surprise to many, we are happy with this outcome. We believe that the de novo route may have generated uncertainty, while the 510(k) process is better defined in our view,” stated R.M. (Ric) Rumble, CEO of TSO3. “We learned at the meeting that we had not received the anticipated NSE letter (Non Substantially Equivalent), which would have led to the initiation of the de novo process, because the Agency wished to discuss the matter first. The recent meeting was open, collaborative and definitely signalled that we are moving forward. We remain confident in obtaining clearance,” 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.
The TSX has neither approved nor disapproved the information contained herein and accepts no responsibility for it.
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