TS03 Inc Trust Units TSTIF

RE:Question about Q170 Olympus modified scopes....

[echo2]

It is my understanding that TSO3 did not make any claims about the Olympus Q180V or the other duodenoscopes in the pr. On the other hand, as you have noted, the upgraded Q180V appears to fall within the parameters of the FDA revised 510K for the VP4. Remember that TSO3 last fall obtained approval for the claim to terminally sterilize the Q180V from Health Canada so there should be little doubt that the VO4 can sterilize the upgraded Q180V, and one can presume TSO3's scientific team is working on assembling data to show the efficacy of the VP4 in terminally sterilizing this scope.

If I were in charge if an endoscopy unit using this scope, I would expect that the VP4 could sterilize the Q180V, and I might interpret the new extended claims in this way and this would be an interpretation that might arguably be valid. That TSO3 did not specifically highlight this extremely important claim for the VP4 might, as you have suggested, imply that they don't wish to make this logical presumption even given the FDA's approval parameters as these scopes have led to Olympus and other manufacturers presently to be the subject of a number of class action and other legal proceedings in the US.

I expect that TSO3 will imminently provide the FDA and Olympus with further confirmation of the VP4's efficacy regarding the upgraded Q180V and allow the FDA to make this claim clear to Olympus and, one would hope, to the general public as well as patients and health care providers. This is not, as you know, a small point, and it will be another extremely prominent feather in TSO3's cap! But, I would not expect Getinge's sales force to be using this as a selling point quite yet, or at least until there is further clarification from the FDA and/or from Olympus.

This further underscores my point that going forward we will find that manufacturers and scopes coming onto the market, as well as those scopes already in use, will want to have the TSO3 standard of care 'stamp' on them to let the market know that they can be terminally sterilized and are safe. The industry will be coming to TSO3. And, with the blessing of the FDA.