"The failure of the lab in lab model now suggests that the...

"The failure of the lab in lab model now suggests that the product itself is not marketable"

Given the high efficacy I still feel the product is marketable , especially with the PEP valve that is not yet cleared by the FDA in the USA, however the way it has been marketed clearly is not working from the stand point of a sustainable business model which means getting exponential revenue growth from its low base point .
Something is clearly wrong with how they have marketed the product , just an observation , I wonder if they should have concentrated just on Canada initially as a test bed as they already had full approval there for both the O2 vent and the valve .
All good in hindsight from an armchair though which I know as I personally failed with a business model which I moved to the USA , the culture there is totally different from EX British colonies like NZ Australia and Canada , and its not until you are on the ground there that you end up finding you are considered a foreigner and while Americans do like you on p personal level they tend to be wary about trusting you if new there , and the medical profession is the epitome of being cautious with new devices ie look at what happened with Avita's Recell initially when they tried to make a beach head in the USA .