8-K
VIVOS INC (RDGL)
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): October 10, 2023
VIVOS
INC.
(Exact Name of Registrant as Specified in Charter)
| Delaware | 000-53497 | 80-0138937 |
|---|---|---|
| (State<br> or other jurisdiction<br><br> <br>of<br> incorporation) | (Commission<br><br> <br>File<br> Number) | (IRS<br> Employer<br><br> <br>Identification<br> No.) |
| 719 Jadwin Avenue, Richland, WA | 99352 | |
| --- | --- | |
| (Address<br> of principal executive offices) | (Zip<br> Code) |
Registrant’s telephone number, including area code: (509) 736-4000
| N/A |
|---|
| (Former<br> 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:
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title<br> of each class | Trading<br> Symbol | Name<br> of each exchange on which registered |
|---|---|---|
| N/A | N/A | N/A |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
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. ☐
| Item 8.01 | Other Events. |
|---|
On October 10, 2023, Vivos Inc. (the “Company”) posted to its website a new Quarterly Corporate Presentation Update (“Update”), providing an update on the Company’s intellectual property, production, marketing efforts, and on its medical business. A copy of the Update is attached to this Current Report on Form 8-K as Exhibit 99.1.
| Item9.01 | Financial Statements and Exhibits. |
|---|
(d) Exhibits
| Exhibit<br> No. | Description |
|---|---|
| 99.1 | Quarterly Corporate Presentation Update, dated October 2023 |
| 104 | Cover<br> Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
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 hereunto duly authorized.
| Date:<br> October 10, 2023 | VIVOS INC. | |
|---|---|---|
| By: | /s/ Michael Korenko | |
| Name: | Michael<br> Korenko | |
| Title: | Chief<br> Executive Officer |
Exhibit99.1
QuarterlyProgress Report
IntellectualProperty
Intellectual property remains a priority.
Patents
| ● | The<br> provisional patent on the chiller and related equipment expires on 12/30/23 so we authorized Indiano Law Group to file for a utility<br> patent based on the chiller, but including the combined shipping pig/vial holder and syringe shield. Chances are good that the patent<br> office will force us to split in early 2025. At that time, we can prosecute the two or three applications serially. |
|---|---|
| ● | We<br> received notification that Patent Number 2023/0263913 A1 Radiotherapy Gel and Method of Preparing the Same was published on 8/24/23. |
| ● | We<br> authorized our patent attorneys to file (nationalize) our hydrogel patent in each PCT country in February for Application: RADIOTHERAPY<br> GEL AND METHOD OF PREPARING THE SAME - International Application No. PCT/US2022/43274.This will cover more than ten patent offices<br> that collectively cover 63 countries throughout the world. |
Trademark
| ● | We<br> filed for a trademark on the term “Precision Radionuclide Therapy” so we can now use the TM mark. |
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QualityManagement System
We have created a robust Quality Management System. This includes documents, GLP validations, and GLP test plans and reports. This is necessary to prepare for FDA audits that occur when we initiate human clinic studies.
AlternateProduction Site
IsoTherapeutics is our primary manufacturing contractor for our hydrogel and particle components, but from a risk mitigation perspective we are to establishing an additional supplier. For almost two years we have been working with Jay Simon, the GM for North America, for Eckert & Ziegler to be our alternate. They engaged in detailed discussions of our proprietary procedures and have visited our production site, and we are confident a supply agreement can be established.
InjectionSystem Production
We finalized and patented our support equipment from shipping to therapy. We are currently focusing on developing an inventory of each item.
IsoPetPricing
We are continuously striving to reduce the production cost of IsoPet to enhance our potential profitability and to make it more affordable to the typical pet parent. This requires paying close attention to every production step and standardization, setting the stage for possible future automation.
HydrogelCost Reduction and Optimization
| ● | We<br> enhanced the polymer production process by eliminating a carbon filtering step. We also ran a dozen production runs to scale up the<br> polymer production volume and to understand and reduce variables for reproducibility. All changes were supported by validation testing. |
|---|---|
| ● | In<br> parallel, we were analyzing the PET data from the VX2 animal testing to determine if we can enhance the IsoPet characteristics while<br> remaining within specifications. We increased the standard polymer concentration in IsoPet hydrogel. The improved product has a lower<br> gelation initiation temperature and greater strength to help lock in the phosphate particles. |
Yttrium-90Cost Reductions
| ● | After<br> working with the Eckert & Ziegler senior management team in the US we will now obtain the Y-90 from their Wilmington MA plant<br> to reduce shipping costs. The new Y-90 price will result in an approximate $1,000 decrease per therapy. Germany will remain as an<br> alternate source of Y-90. |
|---|---|
| ● | Later<br> this year we intend to demonstrate our enhanced production flow and perform verification testing to qualify the new source of Y-90<br> as required by our quality management system. |
AnimalTherapy Marketing
Marketing to pet parents, clinic owners, veterinarians, and oncologists is complex. Aside from utilizing advertisements in key journals and the social media, the following activities are important:
| 1. | Open<br> new small animal and equine clinics that are reasonably close for pet parents to access. |
|---|---|
| a. | This<br> quarter we certified a new small animal clinic, Indian Creek Veterinary Hospital in Fort Wayne IN, and two new equine clinics, Myhre<br> Equine Clinic in Rochester NH and Hopkinton Animal Hospital in Weare NH. |
| --- | --- |
| b. | We<br> are currently in contact with several other clinics. |
| 2. | Participate<br> in conferences to interface with the animal therapy community |
| --- | --- |
| a. | Last<br> quarter |
| --- | --- |
| ○ | VSPA<br> Spring Conference in Saint Paul MN. |
| --- | --- |
| ○ | American<br> College of Veterinary Internal Medicine, ACVIM in Philadelphia PA |
| b. | This<br> quarter |
| --- | --- |
| ○ | 11^th^International Conference on Isotopes in Saskatoon Canada. |
| --- | --- |
| Nigel<br> Stevenson from Exubrion Therapeutics^®^ and management presented a joint paper entitled “Precision Radionuclide Therapy for Treating Veterinary Cancerous Tumors and Osteoarthritis.” | |
| ○ | Washington<br> State Veterinary Medical Association, WSVMA in Tacoma WA. |
| c. | Next<br> quarter |
| --- | --- |
| ○ | Veterinary<br> Cancer Society, VCS in Reno NV. |
| --- | --- |
| ○ | American<br> Association of Equine Practitioners, AAEP in San Diego CA. |
| d. | Next<br> year |
| --- | --- |
| ○ | American<br> College of Veterinary Internal Medicine, ACVIM in Minneapolis MN. |
| --- | --- |
| ○ | American<br> Association of Equine Practitioners, AAEP in Orlando FL. |
| ○ | International<br> Radiation Protection Association (IRPA) and IRPA 16^th^ International Congress and 69^th^Health Physics Society<br> Annual Meeting in Orlando FL. |
Dr. Darrell Fisher submitted an abstract: *“*Direct Interstitial Injection: An Approach to Optimizing Therapeutic Ratios for Safe and Effective Delivery of High-dose Radionuclide Therapy in Treating Solid Tumors” - Darrell R. Fisher, Versant Medical Physicsand Radiation Safety; Michael K. Korenko, Vivos, Inc.
| 3. | Perform<br> animal studies that result in publications in key journals. |
|---|---|
| a. | Next<br> quarter we will complete the VX2 tumor injection at Johns Hopkins Veterinary Clinical Trial Network within the approved IUCUC protocol.<br> This will result in two publications. |
| --- | --- |
| b. | Next<br> year we intend to follow-up with a new small animal study at JHU and an equine study at a university located near “equine territory.” |
| c. | Longer<br> term we will conduct other studies using mice models to support future indications for use, such as lung cancer. |
| 4. | Next<br> quarter Dr. Bill Bradly, owner of the New England Equine Practice, will conduct an experiment to determine if IsoPet is effective<br> in treating caudal heel pain syndrome, sometimes called navicular syndrome. This is a complex syndrome, but if IsoPet is effective,<br> this is a new and large market. |
| --- | --- |
MedicalBusiness Sector
Submittalof the IDE - (Q211938/S001)
| ● | Our<br> next IDE application will be an amendment to the previous submittal. We are systematically preparing the answers to the 60 previous<br> FDA comments. And as we near completion we felt it was worth the investment to redo a few studies to ensure that the FDA comments<br> are fully addressed. This includes the polymer and hydrogel shelf-lives, the effect of radiation on the hydrogel, and the effect<br> of polymer freeze-thaw cycles on the hydrogel properties. These tests will be completed next quarter. Important content is the VX2<br> Tumor Animal Study report and executing the Genotox protocol. |
|---|---|
| ○ | VX-2/Rabbit Animal Study - Dr. Rebecca Krimins has treated 12 rabbits. Next quarter she will treat the last nine rabbits, submit the data<br> to Pearl Pathways for independent review, and write the report. |
| --- | --- |
| ○ | Genotoxicity – Based on the FDA recommendation on September 29^th^ we participated in the Pre-Sub meeting to discuss the Genotoxicty<br> Chemical Characterization Protocol. We now feel sufficiently confident to initiate the genotox testing next month. |
MayoClinic Protocol and Institutional Review Board
After receiving FDA approval to conduct clinical trials we need formal approval from the Mayo Clinic IRB. In anticipation of this step and to help expedite the proccess we have submitted the Clinical Trial Protocol to their “gatekeeper” for comments. We have also been conducting certification training for Dr. Paz Fumagalli. Next quarter we are planning to complete the final training certification step using high activity RadioGel in a full-dress rehearsal operating theater.