Vivos Inc (OTCMKTS: RDGL) made an explosive move up earlier this year to $0.04 highs before coming back down the $0.01 mark where it has formed a new base. RDGL is one penny stock that knows how to market itself and has quickly attracted legions of shareholders who continue to bid up the price. 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.
Vivos Inc is developing RadioGelâ¢, 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. 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.
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.
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.
The Company recently obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet is classified as a device for skin cancer therapy in cats and dogs. The FDA also reviewed and approved the product labeling. FDA does not require pre-market approval for veterinary devices so no additional approval is required for treating skin cancer, which is the largest market sector. RDGL is positioning itself so that immediately following this demonstration phase, The Company can begin to generate revenues through the sale of IsoPet [TM] to University animal hospitals and private veterinary clinic consortiums. In July the Vivos announced they had obtained tradmark protection for IsoPet. According to the release the U.S. Patent and Trademark Office (“USPTO”) issued the Certificate of Registration for the mark ISOPET (Reg. No. 5,476,327) in Class 5.
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In October the Company reported the second dog in a five-dog series was successfully treated yesterday with Y-90 IsoPet® at the University of Missouri. Dr. Charlie Maitz, the University of Missouri veterinarian reported “The procedure today went really well. Because the tumor was oddly shaped, I ended up administering the remaining 0.02 ml in what looked to be the most underdosed region. I was happy with how the injections went. Our differential between the pre- and post- vial in the dose calibrator was 0.3 mCi, which fits well with our target injected dose. With the bandage on, our patient is already below our release criteria in terms of dose rate. He recovered well from anesthesia and will likely be discharging on Monday.”
On December 4 RDGL announced it has agreed to supply IsoPet® to treat a dog with advanced cancer at the University of Missouri. The procedure is scheduled to take place on December 6, 2018. The animal has a large tumor that weighs approximately one-half pound, which is well outside the parameters of our study plan for treatment of canine sarcomas. In addition, the patient has a growth in one lung indicating the cancer may have metastasized.
The dog’s owner was passionate about obtaining the treatment. We ultimately agreed on humanitarian grounds that the potential benefits of treatment with IsoPet® would outweigh the risks, even though the patient is likely to eventually succumb to metastatic disease. It will be the largest tumor treated with IsoPet to date, and offers the opportunity to evaluate the practical aspects of treating large tumors and help determine the parameters of effectiveness of the therapy. Additionally, there is evidence that a dying tumor can stimulate an animal’s immune system to recognize and destroy the cancerous cells, providing some encouragement for an outside chance that the metastatic cancer cells could be attacked well outside the tumor boundary. Effectively then, this treatment is being provided both for the hopeful benefit of the dog, as well as research.
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Currently trading at a $15 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 they have reached an agreement with debt holders big things could happen here. 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