RE:RE:RE:RE:RE:Phil & Montel on CityTV Toronto this morningYou totally disagree with what exactly?
All I said is that every other medical device company starts as user pay model after approval, and that characterizing it as being cash pay forever is likely way too punitive.
The second argument I made was that the FDA’s rejection was NOT a positive for marketing, and that cash pay will likely not last forever, but could be sustained for a while.
So again… What are we disagreeing on?
In any case, what is the “go to treatment” for TBI, MS and CP? It’s physical therapy, years of it which ends up adding up. If there was another similar approved device, I would totally agree with you. The fact that these patients have no hope beyond physical therapy which on average has a limited impact, leads me to believe that many are likely to sign up for the PoNS treatment, even at a $30K cost.
The PoNS stimulates the tongue, from which both the Cranial Nerve VII (Facial Nerve) and Cranial Nerve V (Trigeminal Nerve) are connected to.
Research shows that electrical stimulation of the tongue (translingual neurostimulation – TLNS) stimulates two major cranial nerves: the trigeminal (the nerve responsible for sensations in the face, biting and chewing) and the facial (the nerve responsible for motor control of most of the muscles of facial expression).
In light of this, your comment on the FDA agreeing that Monarch’s path through the Trigeminal nerve is better than the PoNS Hypoglossal nerve seems slightly uninformed. Furthermore, both studies were conducted differently, for different conditions with different end points. You cannot simply claim absolute superiority from these data points.
FYI, just a little piece of advice. I speak with experts quite often on different topics (and I still make tons of mistakes). One thing I realized is that very often they have contradictory views/statements even when both have extensive knowledge and experience in their field. I do not wish to dismiss the comments of your contact at Sanofi, but you should not take as gospel… This does not imply he is right or wrong.
Prokofiev
steelinvestor wrote: prokofiev wrote: steelinvestor wrote: The business model is still a "User Pay" which greatly reduces the revenue potential
Not device gets instant reimbursment following approval. All medical device companies are "user pay" at first (18-24 months, somtimes much longer) until they slowly start getting reimbursement coverage from government and private payors. Helius have had numerous meetings with such payors in Canada and is working hard to get it reimbursed. Therefore, I think it is unfair to characterize this business as forever being “cash pay”.
I agree that the FDA's rejection for now is not a positive in terms of marketing, but all my checks point to a strong start in Canada at the two existing facilities. How long can cash pay be sustained on its own? That's difficult to say... But if patients are getting better and are sharing their success stories, it could last quite a while, especially if americans start traveling to Canada to get treated.
Prokofiev
Totally disagree...Devices that fall in the $2-3K category, maybe, but at $30K+, the market shrinks significantly. Its economics vs benifit and since the FDA did not clear for the worlds largest market (for whatever the reason), the market/patient will most definately pay attention. Would you take on a financial burden if the FDA failed the claims the Co makes?? For most of the population, $30K is a
huge amount and I would have to defer to the assesment of a seasoned industry exec (sanofi)....I think HSM will be a bit player for a long time before it will be taken seriously as the "go to" treatment protocol. I may well be Monarch's recently, FDA approved, "eTNS System" for stimulation of the trigeminal nerve that will be the "go to" . Helius claims the best path is the Hypoglossal nerve, Monarch believes it to be the Trigeminal nerve....FDA agreed with Monarch's research...