The 4th Quarter was great, progress on all fronts.
February 01, 2024
Vivos Inc. Q4 2023 Update | IsoPet® - RadioGel™
Quarterly Progress Report – Q4 2023
Animal Business Sector
Marketing
Vivos Inc participated in seven conferences in 2023. This quarter we had booths in the Veterinary
Cancer Society, the American Association of Equine Practitioners, and the Wild West Vet Show.
Potential New Equine Market
Dr. Bill Bradly, owner of the New England Equine Practice, conducted an experiment to determine if
IsoPet is effective in treating caudal heel pain syndrome, sometimes called navicular syndrome. The
control test showed promise. In Q1, 2024 he will conduct a therapy on an equine patient that is in
pain. If IsoPet is effective this is a potential new and large market.
Medical Business Sector
Breakthrough Designation
The Food and Drug Administration has granted RadioGelTM Precision Radionuclide TherapyTM the
designation as a Breakthrough Device pursuant to the FDA’s Breakthrough Devices Program. Our Risk
Management Report and supporting data concludes that RadioGel™ is intrinsically safe and our animal
therapy data verifies its effectiveness. The FDA’s Breakthrough Devices program will enhance the
schedule priority for our upcoming IDE submission seeking authorization to begin human clinical trials.
Submittal of the IDE - (Q211938/S001)
The key ongoing activities for next IDE application are summarized below:
Mayo Clinic Protocol
We refined the Mayo Clinical Trial Protocol by integrating the previous comments from the FDA, the
comments from the gatekeeper to the Mayo Clinic Institutional Review Board, and from the lessons
learned from the Johns Hopkins VX2 Animal Study, which treated tumors in the same size range.
Next quarter we are planning to complete the final training certification steps for human therapy.
VX-2/Rabbit Animal Study
We completed the testing phase of the study and are now writing the report.
Genotoxicity
We participated in the Pre-Sub meeting with the FDA to gain a consensus on the Genotoxicity
Chemical Characterization Protocol. We have now completed the first phase of the testing.
Quality Management System
Before initiating human clinical trials, the FDA usually conducts a thorough audit of the quality
management system at the production site. Over the last three years we have strengthened our
Quality Management System. This quarter we conducted the required annual Design Review
Meeting to incorporate the 2023 improvements and created or amended 15 additional documents.
Intellectual Property
Intellectual property protection is always a priority and will become increasingly important, for
example, if we pursue international licensing our team with a major medical corporation.
This quarter we filed a utility patent for our Peltier Chiller and the support equipment. This proprietary.
equipment is being used by our regional animal therapy clinics and, in the future, by hospitals for
human therapy.
We previously patented our particles and our hydrogel, as well as potentiall new particles that
administer gamma and alpha radiation. We also have trademark protection for (IsoPet®, RadioGelTM
and Precision Radionuclide TherapyTM.
