We are pleased to share quarterly progress updates on the following items:

Food and Drug Administration Path to an IDE Submittal

• We completed the VX2/Rabbit Animal Study and are now writing the comprehensive report, which will be included in the final IDE(1) submission.

• As previously mentioned we met with the FDA in an IDE Pre-Sub meeting this past April 10th. They now want us to focus on genotoxicity(2).

• We engaged IUVO Bioscience(3) to perform scoping studies and to write the genotoxicity(2) testing protocol.
  
  The week of July 14th we will submit the protocol request to the FDA; for review at a future Pre-Sub meeting as they recommended. In addition we will request a review of our comprehensive Risk Management report, which concludes that RadioGel™ is intrinsically safe.

• 1). FDA approval of an IDE is required for human study of a significant risk device which is not approved for the indication being studied.

• 2). Genotoxicity refers to the capability of a substance to damage the genetic information of cells (changes of the structure, sequence, and/or number of genes) 

• 3). About: iuvo is headquartered in Rush, NY and maintains a 30,000-square-foot preclinical laboratory testing facility that offers an on-site AAALAC accredited vivarium and specialty testing services for the medical device and pharmaceutical industries. iuvo has a talented team whose breadth of testing and consulting expertise spans multiple disciplines including Analytical Chemistry, Microbiology, Toxicology, and Sterilization Validation.  Our experience is particularly deep serving the ophthalmics industry, including OTCs, drugs, devices, and combination products.

New Regional Clinics

• We completed certification of the Myhre Equine Clinic in Rochester NH. June 23, 2023 they treated their first patient for a large melanoma on its tail. We have added them to our list of regional clinics.

Marketing

• Chad Smith from F.X. Massé presented at the Delaware Society for Radiation Safety, DVSRS, annual health physics meeting in Philadelphia. Chad is contracted to help with the required licensing at the regional clinics and provides the on-line certification training modules.

• Dave Swanberg, our Chief Technology Manager, presented at the VSPA Spring Conference in St. Louis.

• We had a booth at the American College of Veterinary Internal Medicine Conference in Philadelphia, which is the largest small animal conference of the year. Fred Swindler, our Quality Assurance Manager and I attended. There was strong interest in the Precision Radionuclide Therapy (PRnT) and we obtained many new contacts. 

• I am presenting a paper at the 11th International Conference on Isotopes in July in Saskatoon Canada in July.

• We have booths at the Washington State Veterinary Medical Association in Tacoma, WA in September, the Veterinary Cancer Society in Reno, NV in October and at the American Association of Equine Practitioners in San Diego, CA in December.

Therapy Support System Equipment

• We completed the patented design on our therapy support system equipment and are now in production to send them to all our current and future regional clinics.

• We refined the IsoPet® Instructions for Use, Injection Guidance Table, and its Training Guide to incorporate the latest equipment design and recommendations for process improvement, including recommending room temperature injections. This will go to all future human applications as well.

Peltier Chiller | Mixer

The pig/vial containers are transparent acrylic. They are designed to ship the IsoPet® solution, and stay in the container. All shown with nylon lid threaded shoulder screw. The nylon screw is removed, and the patented hydrogel withdrawn by a syringe; once again serving as a radiation shield. 

Advisory Boards

We reconstituted and strengthened our Veterinary Medicine and Medical advisory boards. They continue to provide valuable senior guidance. 

Financial

The 2nd Quarter 10-Q was been filed on schedule.

Thank you for your continued support. 

Mike Korenko, Sc. D

CEO & President Vivos Inc.

CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO