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    • Precision Radionuclide Therapy (PRnT)
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      • US FDA IDE Pre-Submission Process
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  • Vivos Inc.
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    January 26, 2023

    Path to FDA IDE Submission

    Vivos Inc has dedicated several years to developing and strengthening our Quality Management System (QMS). This topic is low visibility but very important behind the scenes.

     

    Any future human therapies must be vital in this area, and we anticipate strict FDA audits on all aspects of the way we conduct our business. 

     

    Fred Swindler, our Manager of Quality and Regulatory Assurance, is leading this effort. Fred has more than thirty years of experience in this arena, working with several other companies throughout his career.  

    We are entering the final phase of validating our essential procedures. This process includes production to specification, sterility, shelf-life, and pre-mixing of our components. This data will be necessary to address critical sections of the subsequent IDE submittal.

    (Mike Korenko, Sc.D • CEO • President)

    Our technical and medical data collection for product implementation now has close to a hundred signed secure documents. Working with some of the best companies in this country has aided us in revising and improving more than once. This 'QMS' library defines all aspects of our specifications based on many months of optimization regarding our particle and polymer/hydrogel components. Some of this effort has resulted in crucial intellectual property, which we have protected with patents, but much remains proprietary. 

     

    We are entering the final phase of validating our essential procedures. This process includes production to specification, sterility, shelf-life, and pre-mixing of our components. This data will be necessary to address critical sections of the subsequent IDE submittal.

     

    Thank you.

     

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    Vivos, Inc.

    Precision Radionuclide Therapy (PRnT)

    OTCQB: RDGL

    contact: info@radiogel.com


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    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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