Vivos Inc. Files Early Feasibility IDE Application with FDA for Radiogel™
Vivos Inc. (OTCQB: RDGL) announced the submission of its Investigational Device Exemption (IDE) for the Early Feasibility Medical Device Study of Y-90 RadioGel™ to the FDA. This marks a significant milestone, encouraging enhanced communication and an efficient review process. The IDE includes the Mayo Clinic's Clinical Trial Protocol. Dr. Mike Korenko noted FDA support for the project. RadioGel™ aims to treat tumors using localized radiation, reducing side effects associated with traditional therapies. This IDE submission signals Vivos's progress in cancer treatment innovation.
- Submission of IDE for Y-90 RadioGel™ could accelerate FDA review process.
- Inclusion of Mayo Clinic's Clinical Trial Protocol may enhance credibility and support.
- None.
Richland WA, Sept. 20, 2021 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc. is pleased to announce that it has submitted the IDE, Investigational Device Exemption for The Early Feasibility Medical Device Study, First in Human Study for Y-90 RadioGel™, to the Food and Drug Administration as part of a pre-submission meeting process. The FDA recommended this path to facilitate enhanced ongoing communication with Vivos and to increase the efficiency of the review process. This review typically takes several iterations and we will continue with biocompatibility testing in parallel.
This filing is an important milestone for Vivos and reflects the efforts of numerous parties. In particular, we are pleased that this IDE filing included the Mayo Clinic Clinical Trial Protocol for Radiogel™, which is currently being reviewed by Mayo’s Independent Review Team.
Dr. Mike Korenko stated, “We were encouraged that the FDA was supportive and we expect them to provide valuable insight to ultimately gain final approval.”
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
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
MKorenko@RadioGel.com
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 & CEO
MKorenko@RadioGel.com
FAQ
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