Vivos Inc Obtains Feedback from the FDA on Clinical Testing of RadioGel™

Rhea-AI Summary

Vivos Inc. (OTCQB: RDGL) recently met with the FDA to discuss the Investigational Device Exemption for its RadioGel™ treatment for recurrent thyroid cancer. The FDA provided beneficial guidance, suggesting a Q-Submission path for expedited review and offering insights on clinical testing protocols. Vivos's representatives from Mayo Clinic effectively communicated the medical necessity for RadioGel™. CEO Mike Korenko noted that this pivotal meeting could prevent a rejected IDE submittal, emphasizing the company's readiness to cover costs for final IDE submission.

Positive

• FDA meeting indicates strong support for RadioGel™ clinical testing.
• Helpful FDA suggestions may streamline the Investigational Device Exemption process.
• CEO affirms sufficient funding is available for final IDE submission.

Negative

• None.

Richland WA, Dec. 02, 2021 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), on November 30 Vivos Inc met with the Food and Drug Administration to obtain suggestions on improving the current draft of the Investigational Device Exemption, which is necessary to initiate clinical testing in humans. Two physicians from Mayo Clinic, Dr. Paz Fumagalli and Dr. Beau Toskich did an excellent job presenting the need for Radiogel^™ to treat recurrent thyroid cancer and to answer a range of questions from the new FDA review team.

The FDA was very supportive and had suggested this Q-Submission path for rapid turnaround and dialog. The FDA provided many helpful suggestions on a range of subjects from labeling to dosimetry to the Mayo protocol for clinical testing, and the need for some additional specific testing. They suggested having another Q-Sub Review and conference call dedicated to the details of the dosimetry calculations.

Mike Korenko stated “Obtaining FDA approval is challenging, but we made significant progress with this meeting. This was the first time the Mayo Clinic Doctors met with the FDA regarding RadioGel. They were able to communicate the unmet medical need that RadioGel could address and successfully fielded several key questions from the FDA reviewers. If we did not take this interim step our IDE submittal would likely have been rejected and it would have cost us significantly more effort and time to recover. We already have sufficient funding in hand to complete all the scope necessary to submit the final IDE.”

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 is using 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 was required for treating skin cancer, which is the largest market sector. 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

FAQ

What was discussed in the recent FDA meeting regarding RDGL?

Vivos Inc. discussed the Investigational Device Exemption for RadioGel™ treatment and received supportive feedback from the FDA.

How does RadioGel™ work for treating cancer?

RadioGel™ is an injectable brachytherapy device that delivers localized radiation directly into tumors, minimizing damage to surrounding tissues.

What is the next step for RDGL after the FDA meeting?

The next step involves submitting the final Investigational Device Exemption (IDE) based on FDA feedback.

Who represented Vivos Inc. in the FDA meeting?

Two physicians from the Mayo Clinic presented for Vivos Inc. during the meeting with the FDA.

What is the significance of the Q-Submission path suggested by the FDA for RDGL?

The Q-Submission path allows for a faster review and ongoing dialogue with the FDA, potentially accelerating the clinical trial process.