Upcoming News and Catalysts While most are focussed only on the upcoming extremely significant FDA approval for VP4 sterilization of duodenoscopes that will have tremendously positive implications on many fronts for TSO3, including causing a pop in the share price, there are many other catalysts in near future that will be very and incrementally positive for TSO3 and solidify its position as the premier low temperature solution, (and the only low temperature terminal sterilization solution for GI suites and for hospitals aware of, affected by, and wanting to definitively prevent the scope contamination issues in the news and on lawyers case loads lately).
Among upcoming potential catalysts:
- Soon to be published scientific paper in Canadian Journal of Infection Control that demonstrates TSO3's (patented) and FDA recognized validation techniques and protocols for testing of sterilization of complex scopes, particularly deep in the tiny lumens. No other low temperature sterilizer uses these important and industry first validation protocols and no other low temp sterilizer except TSO3 can make the claims soon to be demonstrated and made public by this publication.
- Continued regulatory support from the FDA in terms of mandating sterilization for complex scopes and further modifying regulations under pressure from other government bodies including Senator Murray's committee that should recognize the VP4's solution to contamination problems and patient injuries and death such as occurred at the Seattle hospital in her district. When will we see formal reclassification according the Spaulding Classifcation from semi-critical to critical imminent for a host of scopes, including duodenoscopes, colonoscopes, ureteroscopes, and bronchoscopes, as the VP4 gains further regulatory approval and endorsement? The new regulation mandating sterilization protocols as part of pre-market approval or 510k’s for new scopes came surprisingly early. Once the VP4 is recognized to sterilize all of these scopes, including duodenscopes, the FDA and others can speed their implementation of an update to the Spaulding Classification, but was the recent requirement of sterilization not a message to the market that they are considering these fundamental revisions to the Spaulding Classification much sooner than expected?
- Rumble noted during the cc that expressions of interest and orders received for the VP4 are now greater than all of the unit numbers previously shipped to date to Getinge, indicating a potential for TSO3 to be unable to meet demand in very near future, though to avoid the situation of having back orders,…
- Announcement of TSO3 plans for a new, probably US, facility with capacity to produce multiples (?4-5 x) of the existing Quebec manufacturing facility. And, Rumble has stated this expansion will be funded internally and not require any financing.
- FDA 510k application for the new pass-through VP4 that has already been released in the EU.
- Update on the 80L, which given the experience of getting the VP4 to market should be made more cheaply, efficiently, and profitably
- US listing, preferably on NASDAQ, to increase accessibility and exposure to large and small investors south of the border, increasing liquidity, again without requiring an unnecessary financing and without dilution of existing shareholders.
- Continued entry into the exciting, rapidly growing, and under-appreciated greenfield GI area for terminal sterilization of scopes, including not just duodenoscopes (awaiting approval in US, but recognized as sterilized in Canada and EU) but also colonscopes, ureteroscopes, etc., where the VP4 is the only validated terminal sterilization solution and where the clearly inferior VPro and Sterrad simply cannot compete and cannot make claims close to those of the VP4.
- New stable Getinge management with support for common goal of promoting and selling TSO3's products and TSO3's present ongoing focussed education of Getinge's new dedicated sales and support staff. (I hope Getinge has not just been hiding behind the excuse of their internal problems as the reason for their slow VP4 launch to date. And, I hope Bennett is not just planning a hostile move to take over TSO3 at a ludicrously cheap price, such as $6, once the Getinge Special Meeting gives rubber stamp approval to their capital raise in a few days! Getinge knows potential sales are 5 - 10 x present over even the near to medium term. If they do make a move, now, wise shareholders as well as management and the BOD must send a clear message “No!” to any such opportunistic bid!)
- Announcement of further strategic, prominent, and large group agreements for installations of multiple VP4 units by forward looking hospitals and GI facilities that are leaders in their fields and want to remain the best, by offering their patients only the best sterilization solution. We have heard of Vancouver General, but I strongly suspect there are more deals and announcements to come, especially with prominent US hospitals and hospital groups.
Regarding this last item of announcements of installs with large, extremely reputable, and prominent US hospitals, GI facilities, as well as huge purchasing groups, again, I believe the reason Getinge and TSO3 have been trying to keep their particular installs and huge interest in the VP4 quiet, is that the competition, specifically JNJ and Steris, will do anything to prevent a prominent hospital or group, or any health care facility or organization, from getting their VP4's installed, and up and operating. The low temperature field is rapidly expanding in hospitals, and the market has been extremely tightly held and a prized cash cow for JNJ and Steris and their much larger sales forces, and these two will do nearly anything to prevent the newcomer on the block from gaining the traction and recognition that is due TSO3 and their superior offering. But, the better product will always prevail: as Rumble noted during the cc, one health care executive in Europe recently ordering a VP4 noted that he would “much rather be the first to purchase a VP4 than the last to buy a Sterrad".
Use of the clearly superior VP4 is a paradigm change in this industry. Again, I just hope we don't get bought out for $6, but are given the opportunity to see this company expand and grow to its incredible potential at least for the next 2 - 3 years, with a production facility capable of producing 1000 units per year, literally tons of accompanying consumables, and the cash flow and profits to match!
You’ve gotta love that selling of 2 x 100 lots of shares into bid at 2.78 by Anonymous at the 4:00 close on Friday, dropping the share price by .04. Somebody knows how to manipulate the price down… :) I hope management surprises the shorts with unexpected positive news, again, and squashes them once more at their nefarious game that has nothing to do with fundamentals.
Personally, I continue to accumulate at these ridiculous levels. WKH