TSO3 received FDA approval to expand their current sterilization process which now would include the sterilization of packaged, multi-channel flexible endoscopes, such as colonoscopes, gastroscopes, bronchoscopes, ureteroscopes and choledochoscopes. This news has pushed TOS's sp to a new 52 week high this morning. More news is expected in regards to their ongoing negotiations with 3M which should be released on or before December 21, 2009. I still rate TOS a BUY and recommend you take a close look at it.
<< Multi-channel flexible endoscopes now indicated for use Stock symbol: TSX: TOS Outstanding shares: 47,863,402 >>
QUEBEC, Dec. 4 /CNW Telbec/ - 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", statedR.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.
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. The Company's first product, the TSO3 STERIZONE(R) 125L Sterilizer, is designed for sterile processing centers in the hospital environment. The Company believes that its technology represents an advantageous replacement solution to other low temperature sterilization processes currently used in hospitals.
In contrast to other methods, the ozone sterilization process developed and patented by TSO3 combines attributes that answer market needs for: efficacy, costs savings, increased safety for patients and hospital staff, and a "green" environmentally safe process.
The TSO3 STERIZONE(R) 125L Sterilizer is cleared for commercialization by the US and Canadian regulatory agencies for sterilization of metal and heat sensitive instruments, as well as for devices with diffusion-restricted spaces, such as rigid endoscopes having a single stainless steel channel. In 2009, the Company received clearance from Health Canada for sterilization of additional complex medical instruments, including multi-channel flexible endoscopes.
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.