Vivos Inc (OTCMKTS: RDGL) is skyrocketing up the charts after the Company stated on twitter that it has received word that its application for Breakthrough Device Designation has been accpeted and is now being processed. This comes just a week and half since the Company reported it has completed its submission to the FDA seeking Breakthrough Device Designation for Radiogel™.  Dr. Mike Korenko, the Compnay’s CEO 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.”

RDGL has a history of big moves and used to trade at much higher prices. A break over a dime and its blue skies ahead. Microcapdaily has been reporting on this one for years starting back when it was Advanced Medical Isotope Corp. and trading as ADMD. RDGL has a large shareholder base who believe in the Company and their products and their ability to disrupt a billion-dollar market.

Vivos Inc (OTCMKTS: RDGL) operating out of Richland, Washington 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.

The strategic market sector of Vivos Inc.  is therapeutic isotope applications.  Currently, the Company is engaged in the development of RadioGel™, a Yttrium-90 based brachytherapy device, for the treatment of tumors. Brachytherapy uses radiation to destroy cancerous tumors by placing a radioactive isotope inside the treatment area.

Currently there is nothing on the market like the Y-90 RadioGelä device which the Company holds 8 patents on and trademarks in about 40 different countries. The devices design features make it suitable for use in a broad range of solid tumors and the company has highlighted potential opportunities in pancreatic and brain tumors. The Company is engaging the FDA for clearance to market RadioGel [TM] for the treatment of advanced basal and squamous cell skin cancers in humans. Vivos Is also developing IsoPet(R) for treating animals which uses the same technology as RadioGel [TM] for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.

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RadioGel™ is a hydrogel liquid containing tiny Yttrium-90 phosphate particles to be injected into a tumor.  This hydrogel is a liquid at temperatures below body temperature but begins to gel, harden, upon injection as the temperature increases to normal body temperature, thereby locking the particles in place. The particles emit a very high concentrated and contained beta irradiation to kill the tumor. The beta radiation has a short penetration distance so there is minimal collateral damage to healthy tissues outside of the injected area.

According to Global Industry Analysts, by 2016 the U.S. brachytherapy market will reach $2 billion.  It is estimated that the U.S. market represents approximately half of the global market.  Vivos believes there are significant opportunities in prostate, breast, liver, pancreatic, head and neck cancers.

The Company has also formed a new, wholly-owned subsidiary, IsoPet Solutions Corporation, to focus on the vibrant and expanding veterinary oncology market. The IsoPet™ Veterinary Solutions division is focued on bringing RadioGel™ yttrium-90 brachytherapy products to veterinary oncologists to treat dogs and cats suffering from tumor cancers.

On November 20 RDGL reported 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, the Compnay’s CEO 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.”

We're pleased to announce that we've received word that our application for Breakthrough Device Designation has been accepted, and is now being processed. #FDA #Cancer #CancerResearch #Breakthough #SavingLives $RDGL pic.twitter.com/W6uzINpEUi

— RadioGel™ (@radiogel) November 30, 2020

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RDGL is skyrocketing up the charts after the Company stated on twitter that it has received word that its application for Breakthrough Device Designation has been accpeted and is now being processed. This comes just a week and half since the Company reported it has completed its submission to the FDA seeking Breakthrough Device Designation for Radiogel™.  Dr. Mike Korenko, the Compnay’s CEO 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.” RDGL has a history of big moves and used to trade at much higher prices. A break over a dime and its blue skies ahead from here. Microcapdaily has been reporting on this one for years starting back when it was Advanced Medical Isotope Corp. and trading as ADMD. RDGL has a large shareholder base who believe in the Company and their products and their ability to disrupt a billion-dollar market. We will be updating on RDGL when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with RDGL.