I have held and looked at the different iteration of the devices...

I have held and looked at the different iteration of the devices , the previous titanium device included a form of plastic not in the titanium but separate from it , I used the word composite for that .
I am not sure you can use the word comparable ,to make comparisons between the Oventus Optima MAD (mandible advancement device) and other MADs ,given no other company apart from Oventus has airways in the side of their devices or is adaptable for exvent which means the efficacy of the Optima falls between other MAD's and CPAP , so it is in a new market segment all of its own , so I doubt it is a crowded space for Optima
Yes the sales to date have been dismal , but the focus of the company to date has not been on sales it has been on R&D , market research and putting in place systems ie getting its ducks in a row .
There seems to be demand for the product by sleep centers in the USA given the exclusive agreements only occurring if minimum sales can be achieved - do any other MAD device manufacturers have that ?
Regarding R&D what Mel Bridges has evolved from Chris Hart's initial invention is pretty outstanding for such a small budget on R&D compared to the R&D spent by FPH , Resmed , SOM
I am guessing the retail price is around US$1500 the COG is going to be a moving target due to economies of scale but would have to be less than the titanium device .
The US sales is based on insurers paying all or part of the appliance cost as with CPAP currently
What is an EMA appliance ?