Dec 4 2009
Multi-channel flexible endoscopes now indicated for use
TSO3 Inc. ("TSO3") (TSX: TOS), an innovator in low temperature sterilization technology for medical devices in healthcare settings through the use of ozone, today announced that the Company has received clearance from the US Food and Drug Administration to expand the intended use claims for its TSO3 STERIZONE(R) 125L Sterilizer. These new claims include the sterilization of packaged, multi-channel flexible endoscopes, such as colonoscopes, gastroscopes, bronchoscopes, ureteroscopes and choledochoscopes.
"During the past nine months, we have maintained an ongoing exchange of information with the US regulatory agency concerning our procedures and documentation supporting these expanded claims", stated R.M. (Ric) Rumble TSO3's President and CEO. "Today's clearance is important for the Company in two ways: First we have demonstrated that our systems are robust and we can pass the rigorous standards of the US agency in a timely manner. Second, these same procedures have been followed throughout the course of the recent development of our new cycles. These new cycles are intended to maintain the same sterile efficacy, while taking less time and being gentler on many medical devices. Having successfully completed this review, it gives us increased confidence in seeing a successful and prompt review for our new cycles, which we expect to submit in the coming weeks. I am very proud of the talented and dedicated team here that worked to achieve a timely positive review", Mr. Rumble concluded.
Earlier in 2009, TSO3 outlined its plans to; increase the utility of its sterilizer though the creation of new cycles; develop relationships leading to a channel partner and increase market opportunities via expansion outside of North America. In line with these targets and in addition to today's announcement concerning FDA clearance on packaged multi-channel flexible scopes, TSO3 announced on September 2, 2009, that it had entered into an exclusive negotiation period with 3M, for the distribution of the STERIZONE(R) 125L Sterilizer including these new cycles through 3M's Global Infection Prevention operation.