Vivos Inc (OTCMKTS: RDGL) has been moving up steadily in recent days since briefly dipping below the $0.005 mark last week. Vivos skyrocketed in early October of last year after the Company announced they have successfully raised enough funding to eliminate toxic debt through the activation of the Path Forward Standstill Agreement announced on September 24, 2018.
On July 11 Vivos announced the device classification obtained from the FDA Center for Veterinary Medicine (CVM) is not limited to canine and feline sarcomas, and can be extended to a much broader population of veterinary cancers, essentially all solid tumors in animals. A review by the international law firm, Hogan-Lovells, who are premier experts on FDA matters, confirmed the broader application of the FDA’s veterinary device classification. While the FDA does not have premarket authority over veterinary devices (i.e., products classified as a device can be brought to market without first being reviewed by the FDA) the manufacturer is responsible for assuring that the product is safe, effective, properly labeled, and otherwise in compliance with all applicable laws and regulations.
Vivos Inc (OTCMKTS: RDGL) is engaged in the development of RadioGelâ¢, an 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. The company is engaging the FDA for permission to use RadioGelâ¢ for the treatment of advanced basal and squamous cell skin cancers. The brachytherapy market was worth $2 billion in 2016 in the US alone. Microcapdaily has been reporting on this one for years like back when it was Advanced Medical Isotope Corp. and trading as ADMD. The stock is a runner and has a long history of highly explosive moves.
RadioGelâ ¢ 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. RadioGelâ¢ 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 6 weeks or more to deliver a full course of radiation therapy. This is an outpatient treatment much safer to the personnel treating the patient than competing brands and the patient can go home immediately with no risk to family members.
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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.
The IsoPet(R) Solutions division of RDGL is using university veterinary hospitals to demonstrate the safety and therapeutic effectiveness for different animal cancers. The testing on feline sarcoma at the Washington State University is completed and the testing on canine soft tissue sarcomas at University of Missouri will begin in the near future.
Vivos commercialization plan is to first pilot with a local clinic and then to partner with several regional clinics across the United States: Signed a Memorandum of Understanding with Vista Veterinary Hospital to become the pilot clinic for commercial IsoPet® therapy. We are currently working with them on certification training and to obtain their Radioactive Material Handling license.
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Currently trading at a $7.7 million market valuation RDGL has no cash, no revenues and a significant debt. But RDGL is an exciting story developing in small caps; the Company is focused on expanding animal testing and the pre-clinical testing required for the Investigational Device Exemption required by the FDA to initiate clinical trials for human skin cancer therapy as well as pursuing development and commercial sales in the animal health sector with IsoPet™.” RDGL has a large shareholder base who believe in the Company and their products and their ability to disrupt a billion-dollar market. There is huge demand for RDGL here, more than most penny stocks could dream of, now that the stock is on the rise again big things could happen. 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.
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Disclosure: we hold no position in RDGL either long or short and we have not been compensated for this article