Titan Medical Inc (TMDIF)

[RockoTaco]

Anyone who truly wants this to succeed, study up on IDE. I’ve been researching a ton on it and it is fascinating.

Some facts to chew on:

1. In order for a foreign company to submit and receive approval they must have a US sponsor company

2. Once a company submits for IDE approval, the FDA has 30 days to respond - if they don’t the IDE request is approved and granted.

- What this means that once Titan submits their IDE application, the 30 day clock starts. If they submit it tomorrow, it will be approved by August 18.

3. Once approved, they can begin human clinical trials at approved sites.

4. Companies receiving IDE approval and having successful clinical trials, it will SIGNIFICANTLY reduce the regulatory approval process.

Also from what I’ve uncovered is that the end effectors supplier and the software supplier will need to be present for this clinical trials.