One stock you may have overlooked in covering the micro-cap space that has shown some very interesting action in recent weeks is Vivos Inc (OTCMKTS:RDGL). The stock exploded higher in mid-September on a big stand taken by management and the board against toxic debt in the form of a sharp clean-up effort on the balance sheet and cap table.
Last week, that story was further developed by means of the company’s latest announcement that it has successfully raised enough funding to eliminate toxic debt through the activation of the Path Forward Standstill Agreement announced on September 24, 2018. According to the release, “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.”
Vivos Inc (OTCMKTS:RDGL) has developed an Yttrium-90 based brachytherapy injectable 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 formulation.
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.
IsoPet for treating animals uses the same technology as RadioGelTM for treating humans. The Food and Drug Administration advised using different product names in order to avoid confusion and cross-use.
IsoPet is a hydrogel liquid containing tiny yttrium-90 phosphate particles that may be administered directly into a tumor. This hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial space after injection to keep the radiation source safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
IsoPet 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 six weeks or more to deliver a full course of radiation therapy. Therapy can be safely administered as an out-patient procedure and the patient may return home without subsequent concern for radiation dose to the family.
The IsoPet Solutions division 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. Following this demonstration phase, Vivos can begin to generate revenues through the sale of IsoPet to University animal hospitals and private veterinary clinic consortiums.
The Company is also engaging the FDA for clearance to market RadioGel for the treatment of advanced basal and squamous cell skin cancers in humans.
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As noted above, RDGL just announced that the company has successfully raised enough funding to eliminate toxic debt through the activation of the Path Forward Standstill Agreement announced on September 24, 2018. The chart shows 560% piled on for shareholders of the company during the trailing month, but that move comes in the context of a larger bearish trend.
Mike Korenko, Vivos, Inc. CEO, stated “This funding is crucial for our efforts to accelerate development and begin initial commercialization of IsoPet and develop RadioGel, a treatment for human cancer. Vivos will be now free of convertible toxic debt and will have a dramatically improved our balance sheet. This sets the stage to pursue a substantial funding package to focus on expanding our 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 and to more aggressively pursue development and commercial sales in the animal health sector with IsoPet.”
At this time, carrying a capital value in the market of $13.9M, RDGL has virtually no cash on the books, which compares with about $10.7M in total current liabilities. One should also note that debt has been growing over recent quarters. RDGL is pre-revenue at this stage. You can bet we will update this one again as new information comes into view. Sign-up for continuing coverage on shares of $RDGL stock, as well as other hot stock picks, get our free newsletter today and get our next breakout pick!
Disclosure: we hold no position in $RDGL, either long or short, and we have not been compensated for this article.