Richland WA, Feb. 01, 2019 (GLOBE NEWSWIRE) -- Vivos, Inc. (OTC PINK: RDGL). The Board of Directors of Vivos Inc. (OTCPINK: RDGL), a pharmaceutical company in the process of researching and developing minimally invasive treatments to combat cancer in animals and humans, addresses its shareholders through this press release.
2018 was very challenging and yet a year full of accomplishments, which have been detailed in previous press releases. Specifically, we are looking forward to the opening of our pilot vet clinic in Kennewick, Washington this coming April, now that we have the FDA classification to use IsoPet® to treat solid tumors in animals. We expect the opening of the treatment center at Vista Clinic to be covered by significant press which should result in good publicity.
Unfortunately, the company is not where it needs to be financially in order to proceed with further studies, ramp up new vet clinics, and eventually proceed to human trials. As many shareholders know, our financial troubles were due to the legacy toxic debt created before Dr. Korenko became CEO. Since last autumn, we worked tirelessly to negotiate our way out of this debt and obtain enough equity financing to get out from under the mercy of the debt holders. That we were able to accomplish this goal is a tribute to the skill and hard work of our officers, especially our CEO, Dr. Mike Korenko and our Corporate Advisor, George Sharp.
Unfortunately, the conversion of our debt to equity has made our current share structure untenable. Currently there are funders looking to help raise the $5 million required for our continued progress through equity financing. However, these funders are concerned about the current share structure. There is still much stock for sale from our converted toxic debt, even though the rate of selling is controlled by agreement. Vivos has always resisted executing a reverse split, as it has no desire to dilute or wipe out the retail shareholders or recent equity financiers.
After much discussion, deliberation and hand wringing, we have decided on a course of action that includes a gentle reverse split of one new share for eight old shares coupled with a reduction in the number of authorized shares. This decision has received the approval of the recent equity funders who supplied the necessary funds to make Vivos a viable company again. We believe that under the proposed reverse split ratio, the current shareholders will not only maintain a strong position in Vivos, but that they will benefit for the following reasons;
- Shareholder holdings will not be diluted or wiped out under a one for eight split
- Selling by those who hold shares converted from debt will be tempered
- Equity funding can be obtained under much more favorable terms now that there are fewer shares to sell
- The reduced number of shares for sale will enable the share price to rise since a massive number of shares will not be offered by the lenders who convert their debt
- The ability of the company to perform with new financing will increase shareholder value
Under the proposed reverse split, the number of shares outstanding on a fully diluted basis will be reduced to about 250 million shares and the overhang of converted debt to shares will be reduced to about 60 million shares. Under the previously announced Path Forward Agreement negotiated with the toxic lenders last autumn, those shares cannot be sold at a rate of more than 15% per month. Also, the authorized number of shares will be reduced to 950 million, although we do not expect it to be necessary to issue that many new shares in the foreseeable future.
Reducing the number of new shares to be sold every month should reduce the selling pressure. This should allow the price to rise. Of course, there are no guarantees. Still, there is a tremendous amount of interest in Vivos shares as is evidenced by the absorption of the large number of shares sold by the toxic lenders over the last year. Vivos is now committed to avoiding toxic debt financing.
The management of Vivos thanks its loyal shareholders for their support. We are trying to increase shareholder value and to build a legacy with a viable treatment for cancerous tumors with little residual effect. We strongly feel that we are at the cusp of great things.
On behalf of the Board of Directors,
Carlton M. Cadwell, D.D.S.
Chairman of the Board
About Vivos Inc. (OTC: RDGL)
Vivos, Inc. is a pharmaceutical company researching and developing minimally invasive treatments to combat cancer in humans and animals. It 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 the University of Missouri is currently underway.
The Company recently obtained confirmation from the FDA Center for Veterinary Medicine that IsoPet® is classified as a device according to its intended use and means by which it achieves its intended purpose. The FDA also reviewed the product labeling which included canine and feline sarcomas as the initial indications for use. 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 premarket 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.
Michael K. Korenko, President & CEO