TSO3 to resubmit 510(k) for US regulatory clearance of STERIZONE 125L+ Sterilizer

TSO3 Inc. ("TSO3") (TSX: TOS) an innovator in sterilization technology for medical devices in healthcare settings using ozone, today announced that it has received instructions from US regulatory authorities to resubmit a 510(k) for its STERIZONE(R) 125L+ Sterilizer. As instructed by the Agency, TSO3 intends to provide additional data and to better establish the link between the sterilizer and a variety of accessory products used in the sterilizer, which are also subject to 510(k) clearance and have been previously submitted.

"TSO3 is eager to quickly provide additional data on the STERIZONE(R) 125L+ Sterilizer and to link the various accessory products together to support our superior claims", stated Mr. R.M. (Ric) Rumble, President and CEO of TSO3. "We estimate the time to complete the collection of data and modify the submission document will be approximately four weeks, which is about the same amount of time that it takes companies to respond to questions from the Agency during the review process. We remain absolutely confident in our ability to gain US regulatory clearance for this product, however, as it has always been the case, we are unable to accurately predict the timing of such clearance", Mr. Rumble concluded.