Quebec City, April 17, 2013 – TSO3 Inc. (“TSO3”) an innovator in low-temperature sterilization technology for medical devices in healthcare settings, today announced that upon review of the current 510(k) submission for the STERIZONE® 125L+ Sterilizer, the US Regulatory Agency has recognized the quality of the science provided and the performance of the device, as well as the uniqueness of the TSO3 proprietary technology. The Agency is of the opinion that there is no predicate to this device available on the market and that it is eligible for the de novo classification as a new standard. After evaluation of this option, the Company has decided to pursue the de novo approval pathway. The Company believes that this will not affect the overall timeline for approval to market.
“The de novo classification process is being recommended by the US Regulatory Agency because TSO3 has a unique sterilization process”, said Charles Hancock, Regulatory Affairs Consultant for TSO3. “This sterilization process has distinct advantages over any other known process on the market today. The de novo classification will establish the TSO3 technology as a new standard in medical devices sterilization once approved”.
“We are pleased with the compliments expressed by the Agency on the quality of the science provided in this new filing”, said R.M. (Ric) Rumble, CEO of TSO3. “In a recent interactive review, the Agency’s regulatory team clearly indicated the de novo pathway as the way to go for approval. The Agency is allowing TSO3 to understand their requirements for de novo classification process in order to leverage the remaining time for review of the files contained in the current 510(k)”, added Mr. Rumble. “We are eager to follow this path which establishes TSO3 as the new standard to match in the future, and at this time, have no reason to believe that it will impact the overall timeline to gain approval to market the device. In the short term meetings have been requested to define the specifications to submit the de novo petition”.
510(k) Followed by de Novo Petition Pathway
The simplified file submitted to the Agency in late January 2013, was presented for clearance through the 510(k) review process. This process is based on establishing the substantial equivalence to an already marketed “predicate device”. As part of the 510(k) review process, the Agency has determined that the use of two sterilants in the technology developed by TSO3 is novel and should become a new standard, which can be accomplished through the de novo classification process. The de novo process will start once the Company has received an NSE Letter (Not Substantially Equivalent [to the predicate]), at which point the Company will have 30 days to petition for the de novo classification. The Agency will then have 60 days to respond. The receipt of an NSE letter is one of the prerequisites for eligibility to proceed with the de novo process classification. By not having a predicate, TSO3 has the option to proceed with a de novo petition.
Details on the de novo classification process may be found at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm273902.htm
TSO3 will host a telephone Conference Call today, April 17, 2013 at 8:30 a.m. (EDST). 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: 43597943.
Parties interested in attending in listen-in mode only are invited to join the live Webcast of the Conference Call accessible via CNW’s Website at:
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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