RE:Why TSO3 Needs Its Own Marketing TeamDr. Wong, your points are excellent and well taken.
There seems to be some insecurity in the retail market that Getinge's relationship with TSO3 is tenuous. I don't think so at all.
I strongly anticipate FDA claim for duodenoscopes will be given to TSO3 before year end, as per Rumble's hints about excellent communications back and forth between TSO3 and the FDA in his recent pr. It is not a given, but I love our chances.
The AAMI meeting Jan 8 will give recommendations to the annual AAMI sterilization committee meeting in March 2018 with a re-write of the endoscope sterilization standards being undertaken presumably as of March. This will be a fundamental shift in favour of TSO3 and game changing process for health care providers.
Retail, and many institutional, investors don't seem to appreciate the implications of the FDA moving to demand IFU's as part of 510k's for any new endoscopes as of early August. This was startling news and came over a year before any of the most faithful TSO3 optimists thought they might mandate this, including me. The present AAMI and FDA process is now just to make this defacto new Spaulding Classification change official for scopes presently in use. And, TSO3 has proven, I believe, with recent data submitted to the FDA that they can sterilize these older scopes in use.
The AAMI and the FDA are not looking only at duodenoscopes. They are taking a view across the entire endoscope field, including all of the scopes noted on the list in the FDA decision last summer to request sterilization data for any new 510k submitted in future from August. Again, I firmly believe the market does not remotely appreciate the implications of the FDA's move to sterilization for new endoscopes this past August.
The FDA list on the table for AAMI is long, and includes endoscopes with elevator channels - duodenoscopes, but also colonoscopes, gastroscopes, ureteroscopes, bronchoscopes, nasopharyngoscopes, neurosurgical endoscopes (which should already be sterilized if they are ever used in a sterile operation).
The list of affected endoscopes is absolutely huge and is mostly in the enormous GI space that has been completely previously untapped as you, Dr. Wong, have noted. Some of these that are short larger single bore gastroscopes, for example, and not complex, but not the more significant scopes on the list are complex smaller channel longer and multichannel scopes like flexible duodenoscopes, colonoscopes and many ureteroscopes. The older H2O2 technology just does not work for these smaller longer multichannel scopes, like many colonoscopes and all duodenoscopes. H2O2 precipitates in and at the entrance to the narrow longer channel of these scopes and simply does not sterilize deep in the channel. On the other hand, O3 is not a transient vapour or a 'plasma' marketing ploy: Ozone is a gas and is itself a sterilant and it thus penetrates the depth of the lumen to increase the penetration of the sterilization process. In addition, whenever the O3 contacts any precipitated H2O2 sterilant around an end cap seal, in a channel, or on a surface, it reduces the H2O2 to water in another secondary sterilization reaction that incrementally increases the effectiveness of the H2O2 and leaves no residual H2O2 film behind.
The beauty of the VP4 is that it can sterilize all these endoscopes tested to date: the SPD workers don’t have to look in a manual to see which IFU applies or if the scope is complex or not, or what cycle of an old technology machine to use, or what can be safely put through an older inferior H2O2 sterilizer: all of the scopes can be sterilized by one technology, the VP4. And, larger loads as needed and in one simple cycle.
Long term investors might recall years ago that TSO3 was asked by FDA during their initial 510k application to reduce their cycle options from three to one. This was regarded as a delay by TSO3 supporters and investors and did delay approval by many months stalling the share price. However, FDA and TSO3 realized, during what I believe continue to be mutual and open communications back and forth between them, that a longer cycle and a shorter cycle were unnecessary to accomplish their goals, and that one midlength cycle running the H2O2 plus O3 purge sequence using TSO3's patented process as per the present technology was effective for all scopes tested and greatly simplified use.
It is my strong opinion that the FDA has been extremely forthcoming with advice and communication with TSO3 BECAUSE they see TSO3’s technology as THE answer to their ongoing nightmare of scope contamination problems. JNJ, Steris, and 3M (the latter two having only very toxic and inefficient ETO) are the big players at the AAMI table who are also funding the quasi-independent organization as a self-regulatory body recommending standards, but the FDA has the real power at the table. I don't think JNJ lobbying could any longer stall the inevitable process of mandating sterilization not just for new endoscope 510k's but for the list of scopes presently in use. The other interested parties will say they have standards of care and patient quality of care as their primary interests, but behind the scenes you can bet they are very worried about inevitably losing market share or the market altogether given their own inferior offerings. And, outsiders must realize that Steris and Olympus made no friends at the FDA with their past history of major non-compliance issues (with Steris 1, for example) and an initial lack of honestly reporting information regarding contamination and deaths from endoscopes as well as huge DOJ fines against the latter for bribes to get their endoscopes to be number 1 in the market.
On the other hand, significantly, the AAMI group with the FDA at the head of the table is again inviting input from independent scientists at their upcoming meeting in January, all of whom have recommended sterilization for endoscopes. And, the FDA has already plainly told the market with the below link last June they are moving relentlessly and rapidly to more reasonable and safe endoscope sterilization standards.
And, Getinge, as you have noted, is still working off their own consent decree problems - another reason they won’t buy TSO3 until FDA negotiations and approvals are done, as TSO3’s relationship with FDA is too good. TSO3 is taking the reins of directing US sales and marketing because - in addition to issues you have posted - TSO3 has an excellent relationship with FDA and Getinge knows this gives TSO3 as a separate entity a huge leg up over Getinge in moving forward as THE low temperature sterilization solution for the future.
TSO3 got their updated data to the FDA months ahead of the original expectations. The FDA is highly motivated to give TSO3 this extended claim prior to the January 8 meeting of AAMI so that they, the FDA and independent expert scientists, have a solution on the table at that time to meet the new Spaulding Classification changes. JNJ/Sterrad, for example, will no longer be able argue that there is no practical and effective way of terminally sterilizing these scopes. (Everyone accepts that ETO sterilizers, made by Steris and 3M, for example, are too inefficient with a 24 hour cycle, too toxic, and too carcinogenic to be an acceptable industry solution).
Getinge will advocate for and sell the VP4 for as long as they can leverage this disruptive technology to improve their US presence as a leader in the market as per your post, Dr. Wong. The only thing that will slow their cooperation with TSO3 is a hostile bid for TOS from JNJ, Steris, or others that Getinge cannot, in the end, match.
The reason we did not see $3+ following the recent pr is due to this seller of 2.5 M shares coming into the market as an overhang. But, that looks done.
Hellova buy. And, I did. And, I am. Buying, I mean. :)
I believe this is the FDA link:
https://www.federalregister.gov/documents/2017/06/09/2017-12007/medical-devices-validated-instructions-for-use-and-validation-data-requirements-for-certain-reusable