Vivos Inc. Provides 2020 Recap and Outlines 2021 Objectives

January 28, 2021 9:30 AM EST

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Richland WA, Jan. 28, 2021 (GLOBE NEWSWIRE) --  Vivos Inc. (OTCQB: RDGL), provides 2020 recap and outlines future objectives. Vivos’ CEO, Dr. Mike Korenko stated, “as we begin 2021, I think it is important to review our progress during the past year and provide some insight on our goals and expectations for 2021 and beyond.”

We made significant progress in 2020 despite the impacts of the COVID-19 pandemic on our operations. Highlights for 2020 include the following:

  • ISOPET® THERAPY
    • The University of Missouri agreed to provide IsoPet therapy as a regional clinic.
    • Washington State University and the University of Missouri began an initiative to demonstrate treating solid tumors in horses. Both are still are on virus standdown, but we are optimistic that these initiatives will go live later this year.
    • We received expressions of Interest for IsoPet therapy for patients in eighteen states, Vancouver BC, and Montreal Canada.
    • Continued IsoPet treatments at Vista Veterinary Hospital. Most cases were advanced vs. early-stage cancers so we refined techniques for treating large primary tumors and tumor margins. In all cases the treatment was well tolerated and the patients experienced benefits from the therapy. 
  • RADIOGEL HUMAN THERAPY
    • Upgraded the Quality Management System necessary for the pedigree of all future testing to comply with the strict FDA guidelines.
    • Initiated the key contracts for pre-clinical testing.
    • Modified our initial Indication for Use to focus on non-resectable cancerous lymph nodes, particularly in the head and neck related to thyroid cancer.
    • Developed a strong working relationship with three doctors at Mayo Clinic.
    • Completed surrogate lymph node testing using mouse spleen injections to demonstrate uniform perfusion and stability to help obtain authorization from Mayo Clinic administration for a clinical trial.
    • Applied for Breakthrough Device Designation with the FDA. This would have accelerated FDA review, but was ultimately not granted. However, it opened a new communication link with the FDA and provided significant insights for the upcoming IDE submission. The FDA feedback and insight will save us considerable time by focusing the content of our application for the Investigational Device Exemption (IDE) and future clinical trials.  
  • PROCESS/PRODUCT IMPROVEMENT
    • Improved polymer production technique to increase yield and reduce production time.
    • Completed certification of a second veterinarian at Vista Veterinary Hospital for IsoPet therapy.
    • Refined clinical procedures improving efficiency, reducing IsoPet therapy time, and post-implant dosimetry.
    • Selected Eckert & Ziegler as our Y-90 supplier. 
  • INTELLECTUAL PROPERTY PROTECTION
    • Filed our particle production patent in the US and with the Patent Cooperation Treaty.
    • After two years of negotiation, we obtained the Grant of Protection in China. 
  • MARKETING/COMMUNICATION
    • Our paper in Cancer Biotherapy and Radiopharmaceuticals was the most-downloaded article published by that journal in 2020.
    • Published a peer-reviewed paper in the respected Health Physics journal on RadioGel safety.
    • Received expressions of interest in IsoPet from Japan, Australia, Russia, Italy, Germany, France, Turkey and Belgium. 
  • FINANCE/REPORTING
    • Achieved a clean balance sheet and capital structure with our financials with no toxic debt or derivatives.
    • Secured common stock funding necessary to complete all the pre-clinical testing needed for the IDE application.
    • Filed all SEC reports in a timely manner.

We are committed to pursuing our business plan in 2021 and beyond. Key future objectives include:

    • Perform additional IsoPet® therapies focusing on early-stage cancers.
    • Enroll additional regional clinics for IsoPet® therapy.
    • Complete the verification therapies on equine tumors.
    • Perform additional clinical studies in animals to enhance the acceptance of IsoPet® in the veterinary community
    • Establish a dedicated production center at our production site to set the stage for international production.
    • Complete the pre-clinical testing required by the FDA for the IDE with emphasis on an additional animal therapy.
    • Obtain formal authorization from Mayo Clinic to perform clinical trials after the IDE.
    • Execute formal collaboration and/or partnering agreements for Radiogel following receipt of the IDE.

In closing Dr. Korenko stated, “We have made steady and meaningful progress, which we have communicated through press releases and the social media. We have evolved to a stable financial structure and will continue to operate in a responsible manner for our shareholders and other stakeholders as we work to achieve our key objectives. We are committed to continuing to execute our plan.

We have clearly demonstrated that IsoPet®/RadioGel™ is safe for the therapist, the patient and their family with same day therapy and will be gathering new data to further demonstrate the efficacy. We have the highest therapeutic ratio of any other brachytherapy device. Our focus this year will be on increasing animal therapies, completing the pre-clinical testing and submitting the IDE needed for clinical trials in humans.”

About Vivos Inc. (OTCQB: RDGL)

Vivos Inc. has developed an Yttrium-90 based injectable brachytherapy device, for the treatment of tumors in animals (IsoPet®) and in humans (RadioGel™). Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area using the company’s proprietary hydrogel technology. The injection delivers therapeutic radiation from within the tumor without the entrance skin dose and associated side effects of treatment that characterize external-beam radiation therapy. This feature allows safe delivery of higher doses needed for treating both non-resectable and radiation-resistant cancers.

RadioGel™ is a hydrogel liquid containing tiny yttrium-90 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.

RadioGel™ also has a short half-life – delivering more than 90% of its therapeutic radiation within 10 days. This compares favorably to other available treatment options requiring up to six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an out-patient procedure and the patient may return home without subsequent concern for radiation dose to family members.

The IsoPet® Solutions division used university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. Testing on feline sarcoma at the Washington State University was completed in 2018 and testing on canine soft tissue sarcomas at the University of Missouri was completed in 2019.

In 2018 the Company obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a medical device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling which included canine and feline sarcomas as the initial indications for use. The FDA does not require pre-market approval for veterinary devices so no additional approval is required. Following the demonstration phase, Vivos is able to generate revenue through the sale of IsoPet® to University animal hospitals and private veterinary clinics.

IsoPet® for treating animals uses the same technology as RadioGel™ for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.

Safe Harbor Statement

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.

CONTACT:

Vivos Inc. Michael K. Korenko, Sc.D.President & CEOMKorenko@RadioGel.com

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Source: Vivos Inc.


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