Style Editor Docs
     
  • RadioGel™
    • Precision Radionuclide Therapy (PRnT)
    • Research (White Papers)
    • US FDA IDE Application Updates
    • US FDA IDE Pre-Submission Process
    • Human Clinical Trials
  • IsoPet®
    • Regional Clinics
      • IsoPet® Therapy Dog • Cat Application
      • IsoPet® Therapy Equine Application
    • IsoPet® Featured Therapy
    • Research (White Papers)
    • Survivor Stories
      • Brew (Dog)
    • Animal Studies
      • Canine Studies
      • Feline Studies
    • Our IsoPet® Mission
  • About
    • Management & Consultants
    • Advisory Boards
    • Contact - RadioGel™ | IsoPet®
  • Blog
  • Vivos Inc.
    • Press Releases
    • Board of Directors
    • SEC Filings
    • Contact - Investor Relations
   Contact Us
  • RadioGel™
    • Precision Radionuclide Therapy (PRnT)
    • Research (White Papers)
    • US FDA IDE Application Updates
    • US FDA IDE Pre-Submission Process
    • Human Clinical Trials
  • IsoPet®
    • Regional Clinics
      • IsoPet® Therapy Dog • Cat Application
      • IsoPet® Therapy Equine Application
    • IsoPet® Featured Therapy
    • Research (White Papers)
    • Survivor Stories
      • Brew (Dog)
    • Animal Studies
      • Canine Studies
      • Feline Studies
    • Our IsoPet® Mission
  • About
    • Management & Consultants
    • Advisory Boards
    • Contact - RadioGel™ | IsoPet®
  • Blog
  • Vivos Inc.
    • Press Releases
    • Board of Directors
    • SEC Filings
    • Contact - Investor Relations
    September 06, 2023

    RadioGel™ - FDA IDE Progress Update

    We've received numerous emails regarding where we are on our timeline in regards to our FDA IDE submission progress with RadioGel™ . 

     

    We have chosen to respond to the main inquiries in a 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 that we will not respond individually to any email that requests confidential information that has not been properly vetted and disclosed to the public.

     

    Retail investor questions and answers:

     

    When is the next FDA meeting or has Vivos already had it?

     

    • The next FDA Pre-Sub meeting is scheduled for Friday, September 29, 2023. 

     

    What is the status of the genotoxicity proposal - is it ready?  

     

    • Per the FDA recommendation, the proposed Genotoxicity Chemical Characterization Protocol was sent to the FDA for their comments on 7/23/23. Unfortunately, it has taken this long to get on their schedule. 

    • The FDA will give us written comments about a week before the meeting, which provides the basis for discussion.

    Are you planning on submitting the IDE after the genotoxicity (proposal/testing/protocol) testing is finished, or are you staying on the same path?

     

    • Our specific plan for the next IDE submission depends on the results of the feedback from the FDA at the next meeting scheduled for September 29, 2023.

    • Collectively we decided that our approach would be to submit an amendment to the previous IDE. Listing and then addressing all the FDA comments over the last five years, and then providing the answers - sometimes for the second time. This allows us to build on our progress and is the optimum way to communicate since 50% of the FDA reviewers are new. 

     

    Thank you for your continued support. 

     

    Mike Korenko, Sc. D

    CEO & President Vivos Inc.

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

    tagPlaceholderTags:

    Vivos, Inc.

    Precision Radionuclide Therapy (PRnT)

    OTCQB: RDGL

    contact: info@radiogel.com


    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 

    Contact

     

    Main colors
       bg-primary
       bg-primary-light
       bg-primary-dark
       bg-secondary
       bg-secondary-dark
    Template sections
       body
       top-header
       header
       content
    Footer Styles
       background
       text color
       link color
       horizontal line
    Buttons
       style 1
       style 2
       style 3
    Other elements
      social icons
      navigation color
      subnav background
    Mobile navigation
       background color
       navigation color
    Template configurations
    has-right-nav g-font
    navigation styles
    size-15 weight-400 snip-nav
    content styles
    form-white
    footer styles
    o-form color-white
    Typography
    Heading H1
    weight-600
    Heading H2
    weight-600
    Heading H3
    weight-600
    Buttons
    weight-600 is-uppercase
    Animations

    Note:
    All changes made here will be applied to your entire website.
    is-switcher admin-only

    RadioGel™ Logo

    Precision Radionuclide Therapy™ (PRnT)

    draggable-logo

    About | Privacy Policy | Cookie Policy | Sitemap
    © 2023 Vivos Inc. | RadioGel™ is a registered trademark | IsoPet® is a registered trademark
    Log out | Edit
    • Scroll to top