TS03 Inc Trust Units TSTIF

RE:RE:RE:RE:Liability

[echo2]

Excellent analysis. Thanks. But, I do disagree with your statements that the FDA has only accepted ETO to sterilize infected scopes. In 2015 in their initial response to the scope contamination issue (and prior to TSO3 obtaining approval for multichannel scopes including, now, duodenoscopes) the FDA included ETO as a possible mitigating option in addition to trying HLD twice for contaminated scopes, because no definitive solution was available at that time. But, there are now numberous published independent studies showing ETO (as well as HLD x 2 and HLD + ETO) is inadequate to sterilze many of these offending scopes. The FDA has yet to change their guidelines, as they tend to follow not lead, and they are perhaps loath to create a defacto monopoly for the VP4 regarding sterilization of duodenoscopes and colonoscopes. TSO3's VP4 remains the only low temperature sterilization process that has a recognized claim with FDA to terminally sterilize these complex scopes. And, you are correct that ETO takes 24-48 hours turn around, is toxic/carcinogenic, inefficient, not widely accessible for many, and more costly. The VP4 can sterilze a larger load in an hour, more effectively and more cost efficiently.