Richland WA, Sept. 21, 2018 (GLOBE NEWSWIRE) -- Vivos, Inc. (OTC PINK: RDGL)
Vivos Inc is pleased to announce that all the debtholders of Vivos convertible debt have agreed to a 10 day standstill, during which time they agree not to convert any more debt into common stock as well as not trade in our security. The purpose of the standstill agreement is to give Vivos time to raise new capital. As part of the standstill agreement, the debtholders will agree to remove the variable rate convertible features from their debt upon the successful completion of the capital raise and convert the balance of their debt into common stock and preferred stock at a fixed price. The new capital coming in would also be common stock, not variable rate convertible debt. Upon the successful completion of these transactions we plan to have a company that is debt free moving forward. We are confident that we will be successful but there is no guarantee that we will complete the transactions. We look forward to providing updates in the next couple of weeks.
About Vivos Inc. (OTC: RDGL)
Currently, the Company has developed an Yttrium-90 based brachytherapy device, for the treatment of tumors in animals and humans. Brachytherapy uses highly localized radiation to destroy cancerous tumors by placing a radioactive isotope directly inside the treatment area. The product 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 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 IsoPetTM to University animal hospitals and private veterinary clinic consortiums.
The Company is also engaging the FDA for clearance to market RadioGelTM for the treatment of advanced basal and squamous cell skin cancers in humans.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by the use of the words "may," "will," "should," "plans," "expects," "anticipates," "continue," "estimates," "projects," "intends," and similar expressions. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those projected or anticipated. These risks and uncertainties include, but are not limited to, the Company's ability to successfully execute its expanded business strategy, including by entering into definitive agreements with suppliers, commercial partners and customers; general economic and business conditions, effects of continued geopolitical unrest and regional conflicts, competition, changes in technology and methods of marketing, delays in completing various engineering and manufacturing programs, changes in customer order patterns, changes in product mix, continued success in technical advances and delivering technological innovations, shortages in components, production delays due to performance quality issues with outsourced components, regulatory requirements and the ability to meet them, government agency rules and changes, and various other factors beyond the Company's control.