Vivos Inc. (RDGL) creates Vivos Scientific India LLP for manufacturing, trials

Rhea-AI Filing Summary

Vivos Inc. reported that its Board of Directors approved the creation of Vivos Scientific India LLP, a wholly owned legal entity based in India. This new subsidiary is intended to establish a manufacturing center, expand the company’s human therapies, and pursue commercialization of those therapies in the Indian market.

The company also plans to use Vivos Scientific India to generate additional human clinical trial data to support its process with the U.S. Food and Drug Administration. This step reflects a strategic focus on both international expansion and building a stronger evidence base for regulatory review.

Insights

Biotech and global strategy analyst

Vivos forms an India subsidiary to support manufacturing, trials, and future FDA process.

Vivos Inc. has approved Vivos Scientific India LLP as a wholly owned entity in India. The stated goals include building a manufacturing center, expanding human therapies, and commercializing these therapies locally, which shifts part of the company’s operational footprint to an international hub.

The entity is also intended to generate additional human trial data to support the company’s process with the FDA. This connects the Indian operations directly to the U.S. regulatory pathway, but the scale, timing, and cost of these activities are not detailed in the excerpt.

Actual impact will depend on how quickly Vivos India can establish manufacturing capability and advance human trials. Subsequent company filings may provide more detail on investment levels, trial design, and any resulting FDA interactions.

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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): September 17, 2025

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.)

1030 N Center Parkway Kennewick, 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. ☐

Item 8.01 Other Events.

On September 17, 2025, the Board of Directors of Vivos Inc. (the “Company”) approved the creation of Vivos Scientific India LLP (“Vivos India”), a wholly owned separate legal entity in India. Vivos India expands the Company’s strategic initiatives, with the objective of establishing a manufacturing center, expanding human therapies and pursuing commercialization of therapies in India. In addition, we will generate additional human trial data to support our process with the Food and Drug Administration (“FDA”).

SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) 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 18, 2025	By:	/s/ Michael K. Korenko
	Name:	Michael K. Korenko
	Title:	Chief Executive Officer

FAQ

What did Vivos Inc. (RDGL) announce regarding its operations in India?

Vivos Inc. announced Board approval to create Vivos Scientific India LLP, a wholly owned legal entity in India. The subsidiary is intended to house a manufacturing center, expand human therapies, and support commercialization efforts specifically focused on the Indian market and related activities.

What is the purpose of Vivos Scientific India LLP for Vivos Inc. (RDGL)?

Vivos Scientific India LLP is designed to establish a manufacturing center, expand human therapies, and pursue commercialization of those therapies in India. It also serves as a platform to generate additional human trial data that can support the company’s process with the U.S. Food and Drug Administration.

How will Vivos Scientific India LLP support Vivos Inc.’s FDA process?

Vivos plans to use Vivos Scientific India LLP to generate additional human trial data that will support its process with the FDA. This means clinical information gathered in India is intended to strengthen the company’s evidence package for U.S. regulatory review of its therapies.

Is Vivos Scientific India LLP a wholly owned entity of Vivos Inc. (RDGL)?

Yes, Vivos Scientific India LLP is described as a wholly owned separate legal entity in India. This indicates Vivos Inc. retains full ownership and control over the new subsidiary, aligning its Indian manufacturing and clinical activities with the company’s broader strategic objectives.

What strategic initiatives does Vivos Inc. (RDGL) aim to expand through Vivos India?

Through Vivos Scientific India LLP, the company aims to expand strategic initiatives around building a manufacturing center, broadening human therapies, and pursuing commercialization in India. These initiatives are also linked to generating human trial data to support its regulatory process with the FDA.