TS03 Inc Trust Units TSTIF

RE:News

[echo2]

Again, very good progress toward establishing the VP4 as the new standard of care. As noted in the pr, the "questions and statements received are typical and consistent with the seriousness of elevating the standard of reprocessing for these extremely challenging medical devices." Given the considerable variability between different scopes, as expected, the FDA wants to assess the extended claims on a specific instrument by instrument basis as they build the case to move toward terminal sterilization as the new standard for each of these scopes, and they need to be reassured that terminal low temperature sterilzation with the VP4 is additive or complimentary to the high level disinfection process of the reprocessors and manual cleaning that might precede sterilization with clear instructions for end users. It looks as if TSO3 is already repeating the additional "limited tests under slightly modified conditions", and one wonders how quickly the FDA will meet with them, again. It will be a milestone just to establish a routine process recognized for obtaining each extended claim with the FDA for individual instruments and to continue to build upon the trust the FDA places in TSO3's sterilization solutions. The process will, no doubt, continue to be laborious (and a lot has certainly already been done and submitted), but the results are transformational for this industry.
Also interesting to hear reference to EU approval that will accompany the VP4's introduction to Europe THIS YEAR.
Look forward to further discussion and clarification of all this positive news at next week's cc!!
All is good and getting better for TOS!