Vivos Inc (RDGL)

[bdvest]

Steps to treatment trials in Human
Jan-2018

https://globenewswire.com/news-release/2018/01/30/1314373/0/en/Vivos-Receives-FDA-Confirmation-of-RadioGel-Device-Classification-for-Animal-Skin-Cancer-Therapy.html

Step 1 finished:
After four months of dialog with the Center for Veterinary Medicine Product Classification Group we received a ruling that RadioGel is classified as a device for animal therapy of feline sarcomas and canine soft tissue sarcomas.

Step 2 finished

The Company’s feline sarcoma therapy series at Washington State University was completed in January. Those tests were designed to optimize our procedures and to determine the optimum dose. The tests demonstrated that RadioGel™ is safe and effective in killing cancer cells.

Step 3 ongoing with five dog serial:, 1 dog healed, one dog just dosed

In February, we plan to start recruiting canine skin cancer patients to be treated at the University of Missouri, incorporating lessons learned at WSU.

Step 4: communicate with FDA about the animal therapy data, ongoing when individual data available
The animal therapy data generated from these studies will also be used in the pre-clinical data required by the FDA as part of the testing required for treating skin cancer in humans.

Step 5: when all the test finished, permission to initiate human clinical trials will be approved soon
After all the pre-clinical testing is completed we will submit an Investigational Device Exemption to obtain permission to initiate human clinical trials.

other tests in animal started In April
we plan to begin therapy at University of California Davis on canine prostate and liver cancers. Later, we will continue our testing at the University of Missouri to treat equine sarcoids.
As we expand the indications for use of IsoPet™ we intend to communicate with the FDA to confirm the device designation applies. Having established a precedent for classification of skin cancer therapy as a device makes it highly likely that subsequent cancers will also be ruled similarly. Obtaining FDA approval in stages should increase the probability of success and provide the fastest path to commercializing our product in the animal sector.

We continue to communicate our progress with potential strategic partners.
In the future, we anticipate interacting with their technical review teams to assess the results of our animal therapies and endorse our product. We will then determine the optimum business relationship to sell IsoPet™, with the goal of leveraging the broad national presence of our strategic partner.

Dr. Mike Korenko stated “Obtaining this approval is an important step to set the stage for selling IsoPet to the private clinics for animal therapy. By being labeled a device there are no other regulatory approvals necessary for treating skin cancer, the most common cancer in animals. We chose a conservative path of obtaining FDA classification early with full and open communication on our intent in order to remove any future uncertainty in the regulatory space.”