We are pleased to share progress updates on the following projects.
We just reconstituted and strengthened our advisory boards. They provide us with valuable senior guidance.
Veterinary Medicine Advisory Board
Alice Villalobos, DVM our previous chairperson is retiring after many years of valuable consultation. She left us a legacy by referencing
IsoPet® several times in her textbook “Canine and Feline Geriatric Oncology.”
Richard Weller, DVM, DACVIM (internal medicine, oncology) is the new Board Chairperson.
John E. Hendrich, PhD, DVM, retired co-owner of the Ventana Animal Hospital and Riverside Animal Hospitals in NM is a new member.
The Phase Two 100Gy injections were completed. The focus was on treating margins of a complex tumor morphology tumor shape for future publications.
Next month the 400 Gy injections will be administered. CT imaging of tumor volume is being measured over time to track effectiveness. Histopathology analysis is also ongoing. The final
report is being outlined for the Phase One portion for submission to the FDA.
We presented to the FDA the case for the urgent benefit of RadioGel™ Precision Radionuclide Therapy (PRnT) over the current standard of care,
our proposed path forward to respond to their new comments on genotoxicity(1), the preliminary VX2 animal study results, and a summary data on the effectiveness of IsoPet in treating animals.
The post-meeting focus is now on completing the final VX2 report and responding to the new genotoxicity comments.
Our tactic is to continuously make progress toward achieving the final Investigational Device Exemption (IDE), by amending the previous draft IDE
submissions. Each time we address their written comments and add our new data. Our next amendment will address the recent new written comments and feedback from the meeting. This approach allows
us to harvest the progress over time.
1). Genotoxicity refers to the capability of a substance to damage the genetic information of cells (changes of the structure, sequence, and/or number of
Another surrogate session was conducted at Mayo Clinic to complete a requirement of our training plan for eventual human therapy. This was a
full-dress rehearsal injecting three regions of a warmed chicken breast to simulate three different-sized lymph nodes using the Injection Guidance Table and the new improved equipment.
The session went perfectly and we now are incorporating a new suggestion from the Mayo therapists to fill each dedicated syringe with the exact amount recommended
in the Guidance. This improves the precision of the administered activity. Our final surrogate training session will be at the activity concentration recommended to achieve the prescribed
dose for treating cancerous lymph nodes.
This month the state of New Hampshire regulators approved the Y-90 material handling license for Myhre Clinic. The final step is to complete the low-activity surrogate training session.
We recently added the domain www.isopetsolutions.com to our
This will be the new home for IsoPet® veterinary information. The focus of this website will supply
Veterinarian's with pet oncology information and the on going training section for treating animals with IsoPet® Precision Radionuclide Therapy (PRnT). This will allow our RadioGel™ website to
become more focused on information related to future Human Therapies. While under construction to the current website has limited information with links to RadioGel™.
The complete website is planned to be launched in May 2023.
Thank you for your continued support.
Mike Korenko, Sc. D
CEO & President Vivos, Inc.
Michael K. Korenko, Sc.D.
President & CEO