Vivos Inc (RDGL)

[DreDiZzlE]

Lsdf is listed on the state of Washington's website under the pull down tab labeled "GOVERNMENT AGENCIES"

http://access.wa.gov/agency

This link on the LSDF site clearly states animal testing is a prelude to human clinical trials:

" LSDF funding will support preclinical testing of radiogel delivery, biodistribution, safety, and therapeutic efficacy as a precursor to clinical trials."

PRECURSOR TO CLINICAL TRIALS

https://www.lsdfa.org/profiles/fisher2

This email shows that the fda suggested animal AND human testing.





FDA DENIAL letter has a lot of quotes that says denovo won't work or even the product might not work at all with their risk/benefit assessment.

"Our determination that the benefits of your device do not outweigh the risks of your device "

"Our determination that your device presents an unreasonable risk of illness or injury "

"And our determination that your device IS NOT low to moderate risk. "

"Nor do we believe your device is of low to moderate risk and thus eligible for denovo "

"FDA has determined that RADIOGEL intended for radiation treatment of Non-resectable tumors that cannot be adequately treated by other methods and that can be accessed with a needle cannot be classified in class 1 or 2."