Titan Medical Inc (TMDIF)

[Endofanera]

I agree. I think 510(k) clearance is not out of the picture with no clinical data. Perhaps a clearance with requirement to perform a post-approval clinical follow-up study. It would be to Titan's advantage to run such a study regardless of FDA requirement or not. Not to mention they can collect hospital and economic data in these studies or perhaps a future registry study that supports the cost savings over time to the payers and hospital systems. This coupled with a low capital cost up front could be huge.

Training was one of Intuitive's weak point where lots of physicians (well known physicians) were getting their hands on robots and performing surgery without the proper training and of course resulting in poor results. The machine was blamed and this caused problems.

If Titan continues to implement a proper training program that select physicians to proctor others and ensure that they have performed X amount of procedures and X hours of training before they begin procedures it will be very beneficial.