RE:$$$$Agree, Cash. But, what you are referring to is the Spaulding Classification, moving many instruments presently listed as semi-critical devices, such as duodenoscopes, ureteroscopes, colonoscopes, bronchoscopes, (all of which have been repeatedly found to be contaminated despite properly performed high level disinfection), to the critical category. The fact is that these instruments were initially not generally used to perform surgeries where the mucous membrane barrier is penetrated purposelfully or violated inadvertently, but now they are, routinely. And, these scopes are more complex with each new generation. It will take a few years for the regulatory authorities to modify the Spaulding Classification, as Dr. Rutala, for example, has wisely recommended, due to the number of older scopes in use and the lack of adequate approved sterilization protocols and devices recognized by the FDA existing in the field, (with the VP4 being, of course, the only sterilizer approved for most complex scopes, and soon to be submitting for approval by FDA for the existing Olympus and Pentax duodenoscopes- as they are already approved in Canada and the EU). Again, most if not nearly everyone in the scope and low temperature field was surprised that the FDA moved so quickly to mandate sterilization data and protocols for future devices after August 8 this year. Also note that the FDA's demand for sterilization data for a 510K does not only apply to GI scopes and bronchoscopes but also to other devices including the water based heater -cooler devices implicated recently in cardiac patient contaminations with rare bacteria.
My guess is that TSO3 has not commented yet on the FDA's proclamation mandating sterilization for new premarket approvals of scopes because they cannot prejudice or prejudge any future FDA or manufacturer 510K application data or sterilization process. But, TSO3 is obviously in the driver's seat here.
Getinge has been, IMHO, too slow to get the VP4 into the market for two reasons, both of which have been mentioned by you and others: 1) internal Getinge disorganization during their recent corporate restructuring, internalizing the Atrium et al staff following that calamatous acquistion, and the apparent lack of direction of senior leadership, at least in N. America... despite hiring a dedicated low temperature sales staff in the EU recently for the VP4, for example... 2) Getinge lacks the motivation to advance the VP4 technology because they are only earning a % of each sale presently, and they might just prefer to wait, only meeting agreed minimums for the time being, until the have the money or credit line to allow their management moves to acquire TOS before really blitzing to take over the market and to really take advantage of this cash cow, and sell this revolutionary advance in patient care technology.
Would it be a good move at this point for Rumble to move to ditch Getinge and go forward on our own? They might not want to get rid of this slow plodding but somewhat helpful partner quite yet, at least at this early stage of market penetration; but, they are definitely capable, IMHO, of standing up to Getinge and letting them know that we shareholders and they as management see dropping Getinge as a definite option, should we remain independent when this deal is complete in 2020.
On the positive side, I am sure physicians, hospitals, and other health care providers are telling themselves they would rather be the first in their areas to purchase a VP4 rather than be the last to buy a Sterrad!
As I stated some time ago, the sky is very very blue for TSO3!