TSO3 Updates on Extended US Claims Filed for Breakthrough Medical Device Sterilizer

TSO₃ Inc. (TSX:TOS) has received feedback from the US regulators regarding the company’s recent application to extend claims for the STERIZONE^® VP4 Sterilizer.
According to the news:

TSO₃ announced in December 2015 that it had completed studies in order to support expanded use of the sterilizer in the U.S. and had filed for such claims. The expanded claims sought for the STERIZONE^® VP4 Sterilizer correspond to increasing scrutiny by regulatory authorities over medical device reprocessing, particularly for colonoscopes and other complex medical devices used during minimally invasive surgical procedures. The claims sought in the U.S. represent similar claims for the STERIZONE^® VP4 Sterilizer already available in Canada and those which will accompany the sterilizers’ introduction in Europe this year.

R.M (Ric) Rumble, TSO₃‘s president and CEO commented:

We recently received feedback from the agency suggesting that we evaluate our claims based on the type and manufacture of device. In addition, we have been asked to document that the use of the STERIZONE^® VP4 Sterilizer process does not increase the reprocessing challenge for a given device, review our instructions for use so that additional clarity is available to our end-users, and repeat limited tests under slightly modified conditions.

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