Titan Medical Inc (TMDIF)

[Facetrain]

Some posters question whether the FDA approval commands the timeline for a TMDI BO. There are indicators that CE Mark may have an earlier impact on what and when MDT might do in robotics.

In the conference on Januray 11th, Martha in his speech about RAS clearly stated that RAS in combination with AI has absolute priority.

CREATING & DISRUPTING BIG MARKETS HUGO™ SOFT-TISSUE ROBOTIC-ASSISTED SURGERY PLATFORM (https://investorrelations.medtronic.com/static-files/3c0a77bd-7651-41db-892a-7461733a0ee1)

Concerning the timeline his chart says:
"Embarking on global launch sequence; expect to file for CE Mark and U.S. IDE approval Q1 calendar year 2021"

66 Mustang (Post #122426) asked me whether I see a CE pathway that is substantially easier/quicker for the European market compared to the FDA. A simplified answer is: the FDA is a governmental institution whereas the CE mark regulation is based upon so called "Notified bodys". Notified bodys are privately owned companies; profit oriented and there are more than 50 of them competing in Europe. Your budget has an influence which speed and competence they may offer in a regulatory process. However most of them have absolut tight lips since secrecy violations can be very expensive.

My personal guess is 2nd Qu. 2021 things will culminate. There are rumors that Storz and Zeiss both early this year will come out with new robotics and the market is heating. Martha is not known for strolling.

Thanks Facetrain