Style Editor Docs
     
  • RadioGel™
    • Precision Radionuclide Therapy (PRnT)
    • Research (White Papers)
    • US FDA IDE Application
      • US FDA IDE Pre-Submission Process
    • Human Clinical Trials
  • IsoPet®
    • Regional Clinics
      • IsoPet® Therapy Dog • Cat Application
      • IsoPet® Therapy Equine Application
    • IsoPet® Therapy Pets
    • Veterinarians
    • Animal Studies
      • Canine Studies
      • Feline Studies
    • Our IsoPet® Mission
  • About Us
    • 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
      • US FDA IDE Pre-Submission Process
    • Human Clinical Trials
  • IsoPet®
    • Regional Clinics
      • IsoPet® Therapy Dog • Cat Application
      • IsoPet® Therapy Equine Application
    • IsoPet® Therapy Pets
    • Veterinarians
    • Animal Studies
      • Canine Studies
      • Feline Studies
    • Our IsoPet® Mission
  • About Us
    • Management & Consultants
    • Advisory Boards
    • Contact - RadioGel™ | IsoPet®
  • Blog
  • Vivos Inc.
    • Press Releases
    • Board of Directors
    • SEC Filings
    • Contact - Investor Relations
    November 01, 2022

    Vivos October Update

    These are two monthly highlights of our progress. 

     

    Veterinary Cancer Society Conference:

     

    • We were a Bronze Sponsor and had a booth at the VCS conference in Norfolk, VA. We made several contacts interested in IsoPet® therapy in the USA and internationally.

     

    • Dr. Darrell Fisher delivered a presentation on Precision Radionuclide Therapy, which was well-received as a new class of therapies to treat tumors.

     

     

    FDA Pre-Submission IDE process:

     

    • We had a Zoom meeting with the FDA on October 17. We submitted our Risk Management Report and a draft of the new VX-2/Rabbit Animal Study at Johns Hopkins University. 

     

    • Key investigators from Mayo Clinic and Johns Hopkins University participated in the meeting.

     

    • The Mayo Clinic doctors reiterated that RadioGel™ is needed to improve the current standard of care to treat neck lymphadenopathy (thyroid cancerous lymph nodes).

     

    • Since RadioGel™ delivers a large dose with a small amount of activity, it was necessary to fly a team member to JHU to determine if their PET and dose calibrators have adequate sensitivity to address the FDA expectations. 

     

    "We closed with a slide that illustrated the effectiveness of IsoPet® in treating equine sarcoids and stated, "currently, animals are receiving better cancer treatment than humans."

    (Mike Korenko, Sc.D • CEO • President – November 1, 2022)

     

    • The FDA provided feedback on the VX-2/Rabbit Animal Test Plan. We agreed to incorporate all the FDA suggestions: We increased the number of rabbits, defined the specific times for PET quantification measurements to demonstrate, once again, that the Y-90 remains at the point of injection, and agreed to hire an independent quality assurance consultant to meet the criteria of GLP-like testing. 

     

    • The FDA accepted the Risk Management Report. This analysis concluded that under the worst-case scenario of a missed injection, the dose to any significant organ was less than 1.4 Gy, which is insignificant. We also summarized the specific reasons that RadioGel™ is inherently safe. If the FDA accepts the draft meeting minutes, these safety conclusions will be in the permanent record and included in our application for the IDE for clinical testing.

     

    • We closed with a slide that illustrated the effectiveness of IsoPet® in treating equine sarcoids and stated, "Currently, animals are receiving better cancer treatment than humans."

     

    • Johns Hopkins University submitted The Institutional Animal Care and Use Committee request for animal testing. 
      • The IACUC is mandated by federal law to oversee the University's animal care and use program, facilities, and procedures and to ensure the appropriate care, use, and humane treatment of animals for research, testing, and education. 

    Financials:

     

    • As always, we filed the audited 10-Q on schedule.

     

    • We obtained a one-year extension from the SEC on our Reg A vehicle to bring in additional investment as required.

     

     

    Mike Korenko Sc. D

    President & CEO 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