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
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.
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
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
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
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 The nylon screw is removed, and the patented hydrogel withdrawn by a syringe; once again serving as a radiation shield.
We reconstituted and strengthened our Veterinary Medicine and Medical advisory boards. They continue
to provide valuable senior guidance.
The 2nd Quarter 10-Q was been filed on schedule.
Thank you for your continued support.
Mike Korenko, Sc. D
CEO & President Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO