The Sizzle on Vivos Inc.
Vivos Inc (OTCMKTS: RDGL) is an exciting Company with an intuitive product that could disrupt a major industry. The stock recently made a colossal move up.
This 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 (OTCMKTS: RDGL) is developing 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. The company is engaging the FDA for permission to use RadioGel for the treatment of advanced basal and squamous cell skin cancers. The brachytherapy market was worth $2 billion in 2016 in the US alone.
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. RadioGel 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 RadioGel 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.
On October 10 RDGL 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. As previously disclosed, under Path Forward Standstill Agreement, the remaining outstanding balance on all the secured debentures totaling approximately $2,500,000 automatically convert into Company stock at a fixed conversion price of $.004. These shares will be subject to a restriction on any sales below $.02 through December 31, 2018 and will have volume limitations on any sales below $.01 during the first six months of 2019. The private placement financing includes approximately $700,000 of new cash funding, as well as an approximate additional $900,000 from the conversion of bridge notes, conversion of past due compensation, and the conversion of a long-term loan held by the Company’s Chairman.
On October 22 Vivos reported its attendance and presentation at the annual meeting of the Veterinary Cancer Society in Louisville, Kentucky was very well received. A significant number of the attendees stopped by the company’s exhibit booth and learned about IsoPet® and the successful treatment of sarcomas in cats and dogs. On Saturday morning, Dr. Korenko had the honor of introducing the keynote speaker, and later that morning offered his own presentation on the efficacy of IsoPet® before several hundred veterinary professionals. It was the first time that Vivos has presented to leaders in the Veterinary cancer specialty since receiving FDA device classification clearing the way for commercial use of IsoPet® for veterinary applications. Dr. Korenko also announced at this conference that Vivos is now accepting expressions of interest from veterinary oncologists and radiologists interested in establishing regional treatment centers. Vivos Inc received strong interest from several clinics to become regional therapy centers for IsoPet. We will begin the next stage of the selection process by comparing the candidates against our target regions and then engage in a series of detailed discussions. We are targeting to sign Memorandums of Understanding with five clinics and to have them operational by mid- 2019.
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.
