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run256

12/29/19 12:31 PM

#942 RE: flyonthewall #940

For a medical device to be approved by the FDA, time wise, this is generally shorter than for medications, that can take more than 10 years.

In this case, first, the FDA has to assign a medical device class to the SCS, this is yet unclear. What we do know, is that results from studies are soon to come and the presubmission phase is closer everyday.

Generally speaking the road to approval has 4 stages. We are at stage 1-2. Depending on the class the SCS is assigned maybe another 2 to 3 years. Or less, it will depend on the class.

Regarding Liberty, we are still far. I believe.


I.M.O. a buyout is possible. The technology around devices developed by Dr. Moshe Shoham is highly respected in the world. As an example Mazor Robotics. If SCS confirms its initial results, certainly this becomes even more possible. Again I.M.O.

But don't be surprised if results are good and yet another financing is announced. Developing medical devices is very expensive and management has expressed that having enough resources is a priority.

As you mentioned the team has vast experience, and definitely have a different vision of what robotics can do in the medical field.

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