Vivos Inc Receives Feedback from FDA on Breakthrough Designation Request

Richland WA, Jan. 19, 2021 (GLOBE NEWSWIRE) — Vivos Inc. (OTCQB: RDGL), Although we were unable to secure a Breakthrough Device Designation from the FDA, this was a well-designed process that considerably benefited Vivos Inc and provided us substantive and constructive feedback.We can now hone our approach to our Investigational Device Exemption (IDE) application based on this feedback, which saves us from having costly iterations to that application. Specifically, we intend to complete additional animal testing to demonstrate the therapeutic benefits of Radiogel^™ compared to the current Standards of Care (SOC) for the thyroid tumor type prior to the IDE submission.A positive of this recent process was confirmation from the FDA that; “The FDA does believe that RadioGel™ meets criterion #2a: Device represents breakthrough technology. Your device does meet this criterion because it is a novel application of a brachytherapy device outside of the liver.”In our previous animal models, we treated feline and canine soft tissue sarcomas. In most cases these were advanced tumors of a cancer type that the literature indicates is very dendritic and prone to recurrence. In selecting this model, the primary goal was to demonstrate the safety of RadioGel^™. We clearly demonstrated that the Y-90 was safe; and more importantly, remains localized in the tumor.Dr. Mike Korenko stated, “The new animal testing is being defined and will be run in parallel with our ongoing pre-clinical testing. We are on target for early summer submission of our IDE for RadioGel^™.
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.CONTACT:Vivos Inc.
Michael K. Korenko, Sc.D.
President & CEO
[email protected]Safe Harbor StatementThis 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 & CEO
[email protected]

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