Vivos Inc (RDGL)

[Big Al T]

All the pre-clinical testing is completed, except for the VX-2/rabbit study, so we submitted a draft IDE. It is prudent to obtain continuous FDA feedback to expedite the final submittal. It is anticipated that the FDA comments will be received in early April. After the animal study is completed the final draft of the IDE will be submitted.

We have now demonstrated that our standardized procedures and support equipment can be used to treat tumors ranging from these small sizes to very large (up to a pound) equine tumors.

This exact technique will be used by Mayo Clinic to eventually treat cancerous lymph nodes. Mayo is scheduled to conduct its own surrogate tissue training exercise in April.

I say submittal mid May to early June.