Richland WA, Oct. 10, 2018 (GLOBE NEWSWIRE) -- Vivos, Inc. (OTC PINK: RDGL) Vivos, Inc. a pharmaceutical company researching and developing minimally invasive treatments to combat cancer in humans and animals, announced today, 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. 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.
All shares to be issued in the private placement are restricted securities. Under the terms of the private placement, the per share purchase price is $.005 per share. The private placement purchasers are also to be issued warrants in an amount equal to 50% of the common shares purchased. The warrants have a two-year term and an exercise price of $.01
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™.”
Vivos advisor, George Sharp, commented, “I am encouraged that Vivos will soon be able to fund its entire 2019 program at terms more beneficial to Vivos and its shareholders. I truly believe that management is on the cusp of bringing great things into the world cancer treatments and to the investors standing behind it.”
About Vivos Inc. (OTC: RDGL)
Vivos, Inc. 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 RadioGel™ 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.
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.