Vivos Inc Applies for Breakthrough Device Designation for Radiogel
Richland WA, Nov. 20, 2020 (GLOBE NEWSWIRE) -- Vivos Inc. (OTCQB: RDGL), Vivos Inc announced that it has completed its submission to the FDA seeking Breakthrough Device Designation for Radiogel.
This is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval or De Novo marketing authorization.
The Breakthrough Designation process takes priority over other FDA meetings, so we elected to submit this application prior to our planned our FDA Pre-Submission meeting. We intend to schedule the pre-submission meeting in the near future, with no impact to our overall IDE submission effort. It gives us time to gather more data to share with FDA.
Dr. Mike Korenko stated, “In our opinion RadioGel meets the criteria for Breakthrough Device Designation, but we cannot be presumptive about the FDA determination. If granted, this designation would give RadioGel priority review, opening up enhanced FDA communication channels and potentially saving months in the IDE approval process.”
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.