Vivos Inc (RDGL)

[kayak_wench]

I think the major payoff for the company will be the expedited meetings (no more waiting 3 months to get on the calendar) and the clinical protocol agreement. I have read some articles that some wonder if there are downsides because of the possibility of getting 'extra' tests trials to do, but I think the benefit greatly outweighs the risks of not doing all the needed trials or not having the proper mix of people in the the trials.

The BDD is just the start of the journey to getting the device approved. Our next step is the IDE and after that human trials. The trials will be costly but the value of the company will greatly increase once we can start using the device in people. It will likely take a few years from the IDE being granted to getting device approval but the stock price will appreciate over that period, barring any bad trial results. Bad trial results are highly unlikely because of the number of animal treatments and tests to animals. Although I do not think a single live animal study/treatment (meaning an animal treated and with the purpose of extending its life versus killing it to see how things went) to date has involved treating an internal organ.

Something to keep in mind is that the BDD option was created in 2015. As of 6/0/2023 there had been
839 devices granted Breakthrough Device designation. Of these 839 BDD designations 81 Marketing Authorizations have been granted.

The length of time to market for breakthrough device is likely because they are something unlike and better than what is currently available. So its not a routine approval, they have to be properly vetted.

https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program#:~:text=As%20of%20June%2030%2C%202023,and%20CBER%20has%20granted%208.