Form 8-K - Current report
2023年10月11日 - 7:33PM
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2023-10-10
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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
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
719
Jadwin Avenue, Richland, WA |
|
99352 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (509) 736-4000
N/A |
(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:
☐ |
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)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol |
|
Name
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. ☐
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.
Item
9.01 |
Financial Statements and Exhibits. |
(d)
Exhibits
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:
October 10, 2023 |
VIVOS
INC. |
|
|
|
|
By: |
/s/
Michael Korenko |
|
Name: |
Michael
Korenko |
|
Title: |
Chief
Executive Officer |
Exhibit
99.1
Quarterly
Progress Report
Intellectual
Property
Intellectual
property remains a priority.
Patents
|
● |
The
provisional patent on the chiller and related equipment expires on 12/30/23 so we authorized Indiano Law Group to file for a utility
patent based on the chiller, but including the combined shipping pig/vial holder and syringe shield. Chances are good that the patent
office will force us to split in early 2025. At that time, we can prosecute the two or three applications serially. |
|
● |
We
received notification that Patent Number 2023/0263913 A1 Radiotherapy Gel and Method of Preparing the Same was published on 8/24/23. |
|
● |
We
authorized our patent attorneys to file (nationalize) our hydrogel patent in each PCT country in February for Application: RADIOTHERAPY
GEL AND METHOD OF PREPARING THE SAME - International Application No. PCT/US2022/43274.This will cover more than ten patent offices
that collectively cover 63 countries throughout the world. |
Trademark
|
● |
We
filed for a trademark on the term “Precision Radionuclide Therapy” so we can now use the TM mark. |
Quality
Management 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.
Alternate
Production 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.
Injection
System Production
We
finalized and patented our support equipment from shipping to therapy. We are currently focusing on developing an inventory of each item.
IsoPet
Pricing
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.
Hydrogel
Cost Reduction and Optimization
|
● |
We
enhanced the polymer production process by eliminating a carbon filtering step. We also ran a dozen production runs to scale up the
polymer production volume and to understand and reduce variables for reproducibility. All changes were supported by validation testing. |
|
● |
In
parallel, we were analyzing the PET data from the VX2 animal testing to determine if we can enhance the IsoPet characteristics while
remaining within specifications. We increased the standard polymer concentration in IsoPet hydrogel. The improved product has a lower
gelation initiation temperature and greater strength to help lock in the phosphate particles. |
Yttrium-90
Cost Reductions
|
● |
After
working with the Eckert & Ziegler senior management team in the US we will now obtain the Y-90 from their Wilmington MA plant
to reduce shipping costs. The new Y-90 price will result in an approximate $1,000 decrease per therapy. Germany will remain as an
alternate source of Y-90. |
|
● |
Later
this year we intend to demonstrate our enhanced production flow and perform verification testing to qualify the new source of Y-90
as required by our quality management system. |
Animal
Therapy 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
new small animal and equine clinics that are reasonably close for pet parents to access. |
|
a. |
This
quarter we certified a new small animal clinic, Indian Creek Veterinary Hospital in Fort Wayne IN, and two new equine clinics, Myhre
Equine Clinic in Rochester NH and Hopkinton Animal Hospital in Weare NH. |
|
b. |
We
are currently in contact with several other clinics. |
|
2. |
Participate
in conferences to interface with the animal therapy community |
|
○ |
VSPA
Spring Conference in Saint Paul MN. |
|
○ |
American
College of Veterinary Internal Medicine, ACVIM in Philadelphia PA |
|
○ |
11th
International Conference on Isotopes in Saskatoon Canada. |
|
|
Nigel
Stevenson from Exubrion Therapeutics® and management presented a joint paper entitled “Precision Radionuclide
Therapy for Treating Veterinary Cancerous Tumors and Osteoarthritis.” |
|
○ |
Washington
State Veterinary Medical Association, WSVMA in Tacoma WA. |
|
○ |
Veterinary
Cancer Society, VCS in Reno NV. |
|
○ |
American
Association of Equine Practitioners, AAEP in San Diego CA. |
|
○ |
American
College of Veterinary Internal Medicine, ACVIM in Minneapolis MN. |
|
○ |
American
Association of Equine Practitioners, AAEP in Orlando FL. |
|
○ |
International
Radiation Protection Association (IRPA) and IRPA 16th International Congress and 69th Health Physics Society
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 Physics
and Radiation Safety; Michael K. Korenko, Vivos, Inc.
|
3. |
Perform
animal studies that result in publications in key journals. |
|
a. |
Next
quarter we will complete the VX2 tumor injection at Johns Hopkins Veterinary Clinical Trial Network within the approved IUCUC protocol.
This will result in two publications. |
|
b. |
Next
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
term we will conduct other studies using mice models to support future indications for use, such as lung cancer. |
|
4. |
Next
quarter Dr. Bill Bradly, owner of the New England Equine Practice, will conduct an experiment to determine if IsoPet is effective
in treating caudal heel pain syndrome, sometimes called navicular syndrome. This is a complex syndrome, but if IsoPet is effective,
this is a new and large market. |
Medical
Business Sector
Submittal
of the IDE - (Q211938/S001)
|
● |
Our
next IDE application will be an amendment to the previous submittal. We are systematically preparing the answers to the 60 previous
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
are fully addressed. This includes the polymer and hydrogel shelf-lives, the effect of radiation on the hydrogel, and the effect
of polymer freeze-thaw cycles on the hydrogel properties. These tests will be completed next quarter. Important content is the VX2
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
to Pearl Pathways for independent review, and write the report. |
|
○ |
Genotoxicity
– Based on the FDA recommendation on September 29th we participated in the Pre-Sub meeting to discuss the Genotoxicty
Chemical Characterization Protocol. We now feel sufficiently confident to initiate the genotox testing next month. |
Mayo
Clinic 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.
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