TS03 Inc Trust Units TSTIF

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Bernard & Echo

[echo2]

My apologies for the end of this sentence being deleted...

"It is typical in these controlled studies to process 3 consecutive scopes for the submissions to FDA for extended claims. TSO3 does not set this standard, but this is the typical FDA standard for 510k submissions to validate terminal sterilization efficacy in a half cycle, simulated use cycle, and following typical patient use without prophylactic antibiotics.

It should be understood that the VP4 has been used in perhaps thousands of cycles to terminally sterilize duodenoscopes following patient use, recommended cleaning protocol (without HLD) and using culturing surveillance without an incident of scope contamination (personal communication). As I have said before, I look forward to the publication of this data in a prominent peer reviewed journal such as the AJIC as soon as possible by the scientists and users involved in these ongoing studies, (though I realize getting such a study accepted, edited, reviewed, etc. and then published in a peer reviewed journal is a long process - ? will we see this before mid-2019?).