Vivos Inc (RDGL)

[kayak_wench]

Kept digging, found some insight on percent EFS approved for the first few years of the programs existence. Its from 2013 through 2015 but the trend shows the intent and success of using EFS to bring more new devices to market in a timely manner. See figure 2B on page 21.

https://mdic.org/wp-content/uploads/2018/12/MDIC-EFS-Blueprint-for-EFS-Success-2016.pdf

The content is mostly identical to slides posted earlier but it is a document so provides more details.

Pages 41 through 44 discuss importance of site selection. RDGL only has one site in mind (Mayo clinic) but its a rock star so that will only add shine to the submission.

One thing I am a little confused about is whether RDGL has submitted the actual IDE, i.e last phase of EFS (phase 4 see page 25), as their PR states, or whether it is in the 3rd phase, a pre-submission followup (page 24). I ask this because the FDA suggests submitting the proposed nonclinical test protocols to be performed, the investigational plan, and the informed consent for the EFS for feedback for review. RDGL called out the submission of the Mayo Clinic test protocols. This document provides a timeline for phase 3 on page 25 (maximum of 2 months plus whatever time it takes for submitter to respond to meeting). Contrary to other information in my last post this document notes there is a 30 day review period once IDE is submitted. Perhaps both links are right in that the review period ends with acceptance or more input on how to continue (i.e thus continuing the interaction). It would be nice to have RDGS confirm it is the phase 4 of the EFS the actual IDE submission. If that is the case they have already done a lot of work prior to this submission.

What I have learned from this is the FDA is motivated to keep early testing of new devices in the U.S and the EFS path was developed to support that. They have a team at the FDA that is designed to make that new path succeed where possible so this path provides plenty of support/feedback in a timely manner.