Vivos Inc (RDGL)

[DreDiZzlE]

" If the de novo is declined and if we obtain funding to permit us to continue operations, we will explore steps toward seeking approval for the device as a Class III medical device. Generally, the time period and cost of seeking approval as a Class III medical device is materially greater than the time period and cost of seeking approval as a Class II medical device.  If the Company seeks approval as a Class III device, human clinical trials will be necessary.  Generally, human trials for Class III products are larger, of longer duration and more costly than those for Class II devices.  If human clinical trials are necessary, there will be additional cost and time to reach marketing clearance or approval.  Unless we obtain sufficient funding we will be unable to do the foregoing activities."


This was from a PR while waiting on the denovo decision from the fda.
Jim said if the denovo is declined it should go to class 3. DENOVO WONT WORK ! HAS TO BE CLASS 3!