October 10, 2023
Our next IDE submission will be an amendment to the previous application. We are systematically preparing the answers to the 60 previous FDA comments over the last five years. Most of these have been addressed previously, but the members of the review team have changed. When we critiqued our responses, we felt it was worth the investment to redo a few studies to ensure that the FDA comments were fully addressed...
September 08, 2023
We are pleased to announce the notice of official publication of our patent application: Radiotherapy Gel and Method Preparing the same.
September 06, 2023
We've received numerous emails regarding where we are currently in regard to our FDA progress with RadioGel our FDA IDE submission.
We have chosen to answer the main inquiiries in this question-and-answer format which will allow us to disseminate the information to our entire shareholder base, and not one particular shareholder or potential investor. Please note we will not respond to any email that requests confidential information that has not been properly vetted and disclosed.
July 06, 2023
We engaged IUVO Bioscience to perform scoping studies and to write the genotoxicity testing protocol. Next week we will submit the protocol to the FDA for review at a 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.
May 09, 2023
Beloved dogs and cats are part of the family, and finding out that our four-legged friends have cancer is never easy. After getting the news, the natural next step is exploring treatment options.
May 01, 2023
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.
April 03, 2023
Phase One testing has been completed. The data is now being analyzed and histopathology specimens have been submitted for analysis. Based on the activity decay curves, the objectives were met, and the Yttrium-90 was contained. The therapeutic ratios and activity delivered to the target volume were as high as 18,000. This is unprecedentedly high, which confirms the importance of precision radionuclide therapy.
February 28, 2023
After several months of planning, preparation, and FDA review the first VX-2 tumors were injected with low-activity IsoPet® to deliver a very high 800 Gy dose. The local activity is now being measured over time using PET-CT to demonstrate that the IsoPet® will kill the VX-2 tumors and that the hydrogel effectively keeps the Yttrium-90 at the point of injection, thus limiting the migration to other areas of the body.
February 10, 2023
Last year we developed two alternate suppliers for the polymer that is used to produce the hydrogel component. This year we are focusing on the more difficult task of locating a second supplier for our yttrium-90 phosphate particles.
February 01, 2023
The first month of 2023 has come to a close, and we're pleased to share our business recap and updates for the end of January.
Home Page Cover Image:
Veterinarian Dr. Michelle Myer from Vista Veterinarian Hospital in Kennewick, WA.
Seen here administering IsoPet® therapy to a feline suffering from a sarcoma.
RadioGel™ is a hydrogel liquid containing tiny yttrium-90 (90Y) phosphate particles that may be administered directly into a tumor. The hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
IsoPet® Therapy Application(s)
Precision Radionuclide Therapy (PRnT)
Vivos Inc. - (OTCQB: RDGL) Investor Relations
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Precision Radionuclide Therapy™ (PRnT)
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