Vivos Inc (OTCMKTS: RDGL) is making an explosive move up the charts after the Company met with the US FDA on May 20 on its IDE process for Radiogel to clarify #Yttrium particle containment and the Company dosimetry calculation technique. According to Vivos, early indications are that the FDA is satisfied with the Company’s health physics dosimetry calculations; but may request an additional animal test that proves once again that the Y-90 stays at the injection site captured by the hydrogel. The company’s relationship with prestigious Oncology research institutions, such as the Mayo Clinic and John Hopkins speaks volumes. If approved, the market for treating Basil Cell and Squamous Cell carcinomas alone with this new technology is enormous. 

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Biotech stocks are easily the most explosive opportunities in small caps and RDGL is one such opportunity. Currently debt free, with no dilution, and a low OS with only 296 million free trading shares the Company has a large and growing shareholder base who believe in the Company and their products and their ability to disrupt billion-dollar markets. Microcapdaily has been reporting on this one for years starting back when it was Advanced Medical Isotope Corp. and trading as ADMD. 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. 

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.

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. The global brachytherapy market size was valued at USD 788.5 million in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 7.1% from 2021 to 2028.

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.

Vivos has also formed a 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.

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.

$RDGL interesting volume spike on FDA meet day.. GS was on it last year too. 340M OS. Nice accumulation too. https://t.co/K1M51aNPah pic.twitter.com/4hm0K65xos

— FighterJet (@_FighterJet_) May 20, 2022

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RDGL skyrocketed from the $0.025 range to highs over $0.30 per share after the Company had its first meeting with the FDA. During that meeting 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. 

More recently Vivos conducted a Pre-Submission Zoom meeting with the FDA to obtain interim comments on its draft IDE. They used the equivalent of the rapid breakthrough review process to give the RadioGel review a priority. The Company just completed a second meeting with the FDA on May 20 where they discussed details of the dosimetry calculations and demonstrated has addressed their previous suggestions. The final IDE application will be submitted after the biocompatibility testing is complete. Management stated that early indications are that the US FDA is satisfied with the Company’s health physics dosimetry calculations; but may request an additional animal test that proves once again that the Y-90 stays at the injection site captured by the hydrogel.

On May 10 Vivos reported it has expanded its intellectual property protection on several fronts. The Company’s patent team filed its particle patent in more than ten patent offices that collectively cover 63 countries throughout the world. This year Vivos also filed a provisional patent number 63-299,930 giving us broader protection on recent and projected developments on both our hydrogel and our particle components. This week the Company filed a continuation-in-part applications number 1774054 in the USA to expand the claims on our particle patent. 

Vivos is nearing completion on additional development work and intend to file expanded particle claims internationally using the Patent Cooperation Treaty, PCT, process. Additionally, building on the substantial refinements to its hydrogel during the past two years, the Company also plans to file a new utility patent to protect these proprietary developments. RDGL anticipates the filings will be completed during the third quarter. 

Vivos Inc. may be who we are. This is what we do.#extendinglives #cancertreatment #CancerResearch #savinglives $RDGL https://t.co/yEKs0QowCM

— Vivos Inc. (@VivosIncCo) May 17, 2022

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RDGL is making an explosive move up the charts after the Company met with the US FDA on May 20 on its IDE process for Radiogel to clarify #Yttrium particle containment and the Company dosimetry calculation technique. According to Vivos, early indications are that the FDA is satisfied with the Company’s health physics dosimetry calculations; but may request an additional animal test that proves once again that the Y-90 stays at the injection site captured by the hydrogel. The company’s relationship with prestigious Oncology research institutions, such as the Mayo Clinic and John Hopkins speaks volumes. If approved, the market for treating Basil Cell and Squamous Cell carcinomas alone with this new technology is enormous. 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. RDGL is debt free, with a low OS of  only 296 million free trading shares and is one biotech to watch here that could disrupt several billion dollar industries.  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.