TS03 Inc Trust Units TSTIF

RE:RE:RE:RE:RE:RE:News but not numbers !

[echo2]

There are many factors at play here. TSO3 is making it clear to users, and secondarily to investors, that they are actively continuing to test various important endoscopes in the market and to make their own IFU's for these, particularly relevant to the problematic ERCP scope contamination issue for which regulators are seeking a solution. TSO3 already has the unique and only FDA claim in the industry to sterilize the most common duodenoscope, the Olympus Q180V as well as colonoscopes. Olympus, for example, and for reasons already made clear here (they make their own HLD machine and they refuse to endorse or work with a competing product), will never be motivated to put out an IFU for any of the products of a competitor or some company that appears to threaten their revenues.

But, people should be aware that the latest draft of the new standards for reprocessing of all and flexible endoscopes (that should go to a final public draft after next week's AAMI meeting March 19 and 20) continues to specifically allow not only OEM's but STERILIZATION MANUFACTURERS to make IFU's for endoscopes. This is extremely important and not appreciated by the market!! This is new and is not, at present, standard of practice, though I can't see an inspector from the Joint Commission chastizing a hospital or end user in this time of flux and anticipated change to improve patient care if an end user presently employs an IFU that has been written and tested by a sterilizer manufacturer for a scope or a series of scopes. As I have stated before, this change to regulations will allow TSO3 to do IFU's and publicly share information with anyone, not only end users, on a host of scopes, including the flexible endoscopes such as duodenoscopes, gastroscopes, and colonoscopes for which they are the ONLY FDA recognized terminal sterilization solution.

TSO3 is simply letting us know that they are continuing down this path of testing new flexible endoscopes and that they will be ready when the new standards of practice (anticipated to be published this Fall) formally recognize their ability to provide the industry and end users with IFU's and data for a host of flexible endoscopes. This move means that TSO3 is and will no longer restricted by OEM's (who are trying to push their outdated and inadequate HDL systems) trying to limit adoption of and lose market share to TSO3's groundbreaking technology.