UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): September 24, 2018
Vivos Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 00-53497 | 80-0138937 | ||
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
719 Jadwin Avenue
Richland, WA 99352
(Address of principal executive offices)
(509) 736-4000
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2) [ ]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act [ ]
TABLE OF CONTENTS
Item 1.01 - Entry Into a Material Definitive Agreement
Item 9.01 – Financial Statements and Exhibits
Item 1.01 Entry Into a Material Definitive Agreement
On September 24, 2018 the Vivos Inc issued a press release announcing a Standstill Agreement with Debt Holders to Halt the Toxic Selling and Eliminate the Secured Toxic Debt. Under terms of a path forward and restructuring agreement all secured note holders have agreed to refrain from “any market activity or conversion activity” for a period of ten trading days, which will run from September 26, 2018 until October 10, 2018. Further, upon completion of a financing of at least $500,000 and the repurchase by the company or sale to the company designees of at least $200,000 by the largest secured note holder, all of the company’s debt with current variable rated pricing will convert into common stock or common stock equivalents at a conversion price of $.004.
Item 9.01 Financial Statements and Exhibits
| Exhibit No. | Description | |
| (d) Exhibit 99.1 | Press Release dated September 24, 2018 |
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Vivos Inc. | ||
| Date: September 25, 2018 | By: | /s/ Michael K. Korenko |
| Michael K. Korenko | ||
| Chief Executive Officer | ||
| Exhibit No. | Description | |
| (d) Exhibit 99.1 | Press Release dated September 24, 2018 |
Exhibit 99.1
Vivos Inc Signs a Standstill Agreement with Debt Holders Designed to Halt the Toxic Selling and Eliminate the Secured Toxic Debt
(Richland WA – September 24, 2018) - Vivos, Inc . (OTC PINK: RDGL)
Vivos Inc is pleased to announce that all the debtholders of Vivos’ secured convertible debt have agreed to a ten trading day market standstill, during which time they agree to refrain from any conversions or to trade in our security. The market standstill will be in effect from Wednesday September 26 th through Wednesday October 10. Pursuant to the terms of the agreement, and subject to completion of a capital raise with proceeds of at least $500,000, the remaining outstanding balance on these secured debentures, which totals approximately $2,500,000 of principal and accrued interest, will automatically convert into common stock (or convertible preferred stock for conversions that would result in ownership in excess of 4.99% of the company’s common shares) 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 for the first six months of 2019.
Mike Korenko, Vivos Inc CEO, stated “It is our goal for the new capital to come in the form of common stock and warrants. In addition, we may consider additional financing in the form of convertible debt that automatically converts into a larger equity financing or converts at a fixed conversion price. Upon the successful completion of these transactions we plan to have a company free of convertible toxic debt moving forward. We are confident that we will be successful, but there is no guarantee that we will complete the transactions described above. We look forward to providing an update related to the financing in the next couple of weeks and we will continue to communicate developments related to Isopet® and Radiogel™.”
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 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.
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.
CONTACT:
Vivos Inc.
Michael K. Korenko, President & CEO
MKorenko@RadioGel.com