In our previous meeting this past May with the FDA, it was recommended that we perform additional animal testing to confirm RadioGel™ remained at the point of injection. The FDA suggested before we initiate any testing, we send them a copy of the proposed animal test plan to review in our next IDE Pre-Submission meeting.

A strength of our patented Precision Radionuclide Therapy device is that the Y-90 stays at the injection site. We believe the data already presented to the FDA provided enough evidence in our previous animal studies that our product was safe and effective. We appreciate the FDA’s guidance and as we are the company seeking IDE approval; following their suggestions and guidelines is the preferred strategy.



RadioGel™ is very efficient and delivers a significant dose of radiation by injecting a small amount of activity. This efficient low activity represents a challenge in measurement sensitivity to the degree of accuracy requested by the FDA. Therefore, it was necessary to send a member of our team to Johns Hopkins University to run a surrogate radioactive injection into an equivalent rabbit tumor model to determine if their PET could measure this small injected activity, and then remeasure it after ten days of 2.7-day half-life decay.



In addition, the injections are to be in VX-2 tumors in rabbits. These types of tumors can be difficult to grow, but Johns Hopkins University has succeeded in growing a currently pea size tumor. The tumor size must be at least 1 cc in diameter before further testing can be performed. Laboratory tests such as these must be well planned and validated to give our team confidence in the test results prior to proposing them to the FDA. 

We have just formally requested the next FDA meeting and attached our proposed Animal Test Plan. They agreed to schedule the meeting within an accelerated timeframe per their policies and procedures. 

We also included with our test plan the RadioGel™ Risk Management Report. This report considers all the plausible scenarios for risks related to Precision Radionuclide Therapy. It concludes in all scenarios that our product is safe, the patient risks are insignificant, and RadioGel™ has the highest Therapeutic Ratio of any product currently on the market. 



Ultimately, the FDA’s role is to balance risk versus benefit in approving a clinical trial.  As I previously stated, “Considering we have not yet been approved to begin a clinical trial, the actual risk is—people fighting a life-threatening illness are being delayed therapy by a safe product."

Thank you.

Michael K. Korenko, Sc.D. – President & CEO

CONTACT:
Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
MKorenko@RadioGel.com

RadioGel™ is intrinsically safe. Even if a significant amount of it activity migrated, which we know does not happen, the risk to the patient would be very low. We pointed out that the FDA has approved other brachytherapy products with much higher activity that is not fully contained. One of the side effects listed on the product label is occasional death.

We believe that RadioGel™ should have a broad indication for use as a device that allows administering precision radionuclides to any tumor. It is our intent to demonstrate the safety and effectiveness of RadioGel™ in thyroid cancer therapy and then follow up with additional data to expand the indications for use to other tumor types and anatomic locations.