Titan Medical Inc (TMDIF)

[66Mustang]

I thought I had read somewhere that the regulatory strategy Titan was using would not rely on the predicate device, in case there are issues or concerns with how the two systems correlate for performance. It sounded as though they were preparing for full blown PMA scenario but still hoping to use the predicate device for 510K could shortcut that. One more way that they could come in ahead of schedule, I suppose!



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At the end of the day, it all boils down to the fact that a major medical device player will NEED a robotic platform to compete with ISRG in the robotic Surgical space. We are seeing surgical robotic acquisitions go for 1B+ (Mazor for 1.7B, Auris 3.4B). Titan has a market cap right now of 75M, the opportunity is to make 10, 20, 30X current trading levels. The rest is noise, and should only concern you when you are trying to trade/short this stock. As someone who is in this space, someone who is seeing strategic robotic programs being set up by surgeons to drive patient volumes, TRUST me that a MAJOR medical device player would love to add SPORT to an existing surgical sales team and portfolio and go to market, compete and win business away from ISRG. MDT and JNJ are first to mind, but there are other med device players that would love to add SPORT and go to market. Once the technology is 510k approved it’s on, and remember ISRG got SP FDA approved, which means Titan only has to prove they have a predicate device, hence the 510k process vs full blown FDA approval. The heavy lifting is done, 510k is much easier, faster, and less costly.