Copied from my InvestorVillage post...
Just for some clarification on the PR and what it means...
The de Novo classification is exactly what was expected, especially since the FDA announcement that they were going to crack down a bit more on what they allow for predicate devices. But even before then, it was the plan, with at best an outside hope that just maybe they could convince the FDA that snake arms are substantially equivalent to wristed rods. Considering the bulk of the advantage Titan is claiming has to do with the snake arms, they obviously don't believe they are substantially equivalent and they would have been foolish to think the FDA would see it any differently. Never hurts to ask, I supposed.
So all the planning they have been doing has been exactly in line with what they know is coming. They plan further comms with the FDA (Q1 2021) to ensure their IDE application sails through as smoothly as possible when they file for it. So far, so good.
Ah, but once we get approved, we have a snake-armed platform which could be used as a predicate device for other competitors. Or so it would seem. That is where we rely more heavily on Mr. Brar's world-class global award winning IP program to fend off potential competitors from sneaking into our snake space. With unique methods of actuation and a tighter grip on new tech by the FDA, they are not likely to be much looser with the predicate designation for snake arms; everyone will probably be required to perform their full due diligence activities, just like us. Except Medtronic. By then, they should actually own our entire IP portfolio and be actively marketing the Medtronic or Covidien Enos system!
My real point is that today's PR could be misinterpreted as a negative, when in fact it is positive on several levels:
We have open lines of communications with the FDA and are using them fully, so they won't surprise us and we won't surprise them.
We have a fairly clear pathway, unofficially agreed upon, for regulatory clearance.
It is the pathway we have been preparing for all along.
Coupled with more recent patent announcements, we also have locks on ancillary supplies for conducting our cases for trials, providing additional learning opportunities and potential for further refinement by the time we are on the market.
Also, a multi-decade history of robotic surgery has shown reasonable safety and efficacy for existing platforms, further enhancing our potential classification as a Class II medical device and allowing for the de Novo approval instead of the more extensive 510(K) as a Class III device. This is probably the biggest take-away from today's PR, that the FDA has preliminarily/unofficially assessed us as contenders for de Novo classification. A smooth pathway to regulatory clearance should make us that much more attractive as an acquisition, and possibly more attractive as an EARLIER acquisition because MDT would have an easier path walking Enos though de Novo, and maybe further leveraging some synergies along the way.
IMO, of course, as always...
