# EDGAR Filing Document

**Accession Number:** 0001716166
**File Stem:** 0001493152-25-013953
**Filing Date:** 2025-9
**Character Count:** 13206
**Document Hash:** 49cc34d6f0cd0eb32ebaed993f620dc9
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-25-013953.hdr.sgml**: 20250918

**ACCESSION NUMBER**: 0001493152-25-013953

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20250917

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250918

**DATE AS OF CHANGE**: 20250917

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Vivos Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001716166
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 813224056
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39796
- **FILM NUMBER:** 251321563

**BUSINESS ADDRESS:**
- **STREET 1:** 7921 SOUTHPARK PLAZA,
- **STREET 2:** SUITE 210
- **CITY:** LITTLETON
- **STATE:** CO
- **ZIP:** 80120
- **BUSINESS PHONE:** (866)908-4867

**MAIL ADDRESS:**
- **STREET 1:** 7921 SOUTHPARK PLAZA,
- **STREET 2:** SUITE 210
- **CITY:** LITTLETON
- **STATE:** CO
- **ZIP:** 80120

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Vivos BioTechnologies, Inc.
- **DATE OF NAME CHANGE:** 20170901

?xml version='1.0' encoding='ASCII'?

**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 Therapeutics, Inc.**

**(Exact name of registrant as specified in its charter)**

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-39796** | **81-3224056** |
| **(State or other jurisdiction** | **(Commission** | **(I.R.S. Employer** |
| **of incorporation)** | **File Number)** | **Identification No.)** |

---

**7921 Southpark Plaza, Suite 210**

**Littleton, Colorado 80120**

**(Address of principal executive offices) (Zip Code)**

**(720) 399-9322**

**(Registrant's telephone number, including area code)**

**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(s)** | **Name of each exchange on which registered** |
| Common Stock, par value $0.0001 per share | VVOS | The NASDAQ Stock Market LLC |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in 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 Information**

On September 17, 2025, Vivos Therapeutics, Inc. (the "**Company**") issued a press release to announce first-time peer-reviewed data that confirms Vivos DNA (Daytime-Nighttime Appliance®) is both safe and efficacious in treating children suffering from obstructive sleep apnea. A copy of such press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.

**Item 9.01 Financial Statements and Exhibits.**

(d) Exhibits

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Press Release dated September 17, 2025](ex99-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |

---

**SIGNATURE**

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.

---

| | | |
|:---|:---|:---|
|  | **VIVOS THERAPEUTICS, INC.** | **VIVOS THERAPEUTICS, INC.** |
| Dated: September 17, 2025 | *By:* | */s/ Bradford Amman* |
|  | Name: | Bradford Amman |
|  | Title: | Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**Vivos Therapeutics Announces Landmark Clinical Trial Results in Pediatric Obstructive Sleep Apnea Treatment**

*The European Journal of Pediatrics publishes the first-ever multicenter clinical trial results demonstrating that the Vivos DNA appliance — part of the company's C.A.R.E. line of devices— is both safe and effective for children with OSA*

LITTLETON, Colo., Sept. 17, 2025 (GLOBE NEWSWIRE) **— Vivos Therapeutics, Inc. ("Vivos" or the "Company'') (NASDAQ: VVOS),** a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders, including obstructive sleep apnea (OSA), today announced first time, peer-reviewed published data confirming that the Vivos DNA (Daytime-Nighttime Appliance®) is both safe and efficacious in treating children suffering from OSA.

Results from a multicenter clinical trial, now published in the *European Journal of Pediatrics*, represent a significant milestone in the fight against one of the most underdiagnosed and undertreated pediatric health conditions. The DNA appliance is part of Vivos' Complete Airway Repositioning and Expansion ("C.A.R.E.") line of devices.

According to recent published research estimates, up to 20.4% of U.S. children — as many as 10 million — are living with pediatric OSA, a condition linked to ADHD behaviors, allergies, bedwetting, reduced IQ, aggressive behavior, and academic struggles. Alarmingly, up to 90% of these children remain undiagnosed. For those who are diagnosed, the current standard of care is adenotonsillectomy (AT) surgery, which is invasive, painful, and only effective for 20–40% of pediatric patients — with symptoms recurring in up to a quarter of cases.

Groundbreaking Results with the Vivos DNA Appliance

This new trial revealed remarkable outcomes in pediatric patients whose OSA was treated with the DNA appliance:

● 77% of participants experienced at least a 50% reduction in OSA severity.

● Among children with severe OSA, 93% reached a 50% reduction in OSA severity.

● 17% of patients in the study achieved complete resolution of their OSA.

● Airway volume increased by an average of 67.8%, a primary endpoint of the study.

● Pediatric Sleep Questionnaire (PSQ) symptom scores decreased by 31%, a statistically significant improvement.

"We believe this data signals a new era in pediatric OSA treatment," said Kirk Huntsman, Chairman and CEO of Vivos Therapeutics. "For over a century, surgery has been the go-to treatment for children with OSA. With these results, parents and providers now have strong evidence supporting our DNA appliance as a safe, non-surgical alternative. No child should face invasive surgery without first considering our FDA cleared appliance available through Vivos-trained healthcare providers."

**Mounting Clinical Data in Support of Non-Surgical Alternatives**

This latest study adds to a growing body of evidence supporting Vivos' oral appliance therapies for pediatric patients. Since publication, certain authors of the study have been invited to present the findings of this and other Vivos research to medical and dental audiences around the world. Recently, lead author Clete A. Kushida, MD, PhD, Director of the Stanford Center for Human Sleep Research at Stanford University, presented the results of a separate new study highlighting the safety and efficacy of Vivos C.A.R.E device technology at the World Sleep Congress 2025 in Singapore. Dr. Kushida chairs Vivos' Medical Advisory Board and has co-authored a number of papers on Vivos device technology.

In addition to the DNA appliance and other C.A.R.E devices, Vivos also offers Vivos Guides — specialized devices designed for guided jaw growth and development in children. These appliances are intended to support proper craniofacial growth at an early age, which may help children avoid the need for obstructive sleep apnea treatment later in life. Clinical data also shows that Vivos Guides can help alleviate symptoms associated with underdeveloped jaw growth, including ADHD behaviors and nocturnal enuresis (bedwetting).

● In one study, Vivos Guides virtually eliminated bedwetting in children, with 50% seeing results within two weeks and 97.4% resolving within 60 days.

● Another study showed that 61% of children with OSA reported their ADHD symptoms were completely resolved or rarely occurred after just seven months of treatment.

● A third study found that 90% of children had their OSA symptoms completely resolved after a similar treatment period.

Healthcare providers trained in the Vivos Method also integrate FDA 510(k)-cleared adjunctive therapies, including laser treatments to address swollen tonsils, which may provide near-term relief alongside long-term airway development.

**About Vivos Therapeutics**

Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as obstructive sleep apnea (OSA) and snoring in adults. Vivos' devices have been cleared by the U.S. Food and Drug Administration (FDA) for adult patients diagnosed with all severity levels of OSA and moderate-to-severe OSA in children ages 6 to 17. Vivos' groundbreaking Complete Airway Repositioning and Expansion (CARE) devices are the only FDA 510(k) cleared technology for treating severe OSA in adults and the first to receive clearance for treating moderate to severe OSA in children.

OSA affects over 1 billion people worldwide, yet 90% remain undiagnosed and unaware of their condition. This chronic disorder is not just a sleep issue—it's closely linked to many serious chronic health conditions. While the medical community has made strides in treating sleep disorders, breathing and sleep health remain areas that are still not fully understood. As a result, legacy OSA treatments like CPAP are often mechanistic and fail to address the root causes of OSA.

Founded in 2016 and based in Littleton, CO, Vivos is working to change this. Through innovative technology, education, and acquisitions of, or commercial collaborations with, sleep healthcare providers, Vivos is empowering healthcare providers to more thoroughly address the complex needs of OSA patients.

Vivos calls the use of its appliances and protocols to treat OSA The Vivos Method, which offers a proprietary, clinically effective solution that is nonsurgical, noninvasive, and nonpharmaceutical, providing hope to allow patients to *Breathe New Life*.

For more information, visit www.vivos.com.

**Cautionary Note Regarding Forward-Looking Statements**

This press release and the statements of the Company's management and other parties made in connection therewith, contain "forward-looking statements" (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events. Words such as "may", "would", "should", "expects", "projects," "potential," "intends", "plans", "believes", "anticipates", "hopes", "estimates", "goal". "aim" and variations of such words and similar expressions are intended to identify forward-looking statements. In this press release, forward-looking statements include, without limitation, those relating to the actual future impact of the clinical trial results described herein on general patient outcomes and Vivos' future revenues and results of operations. These statements involve significant known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos' control. Vivos' filings can be obtained free of charge on the SEC's website at www.sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos' expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based.

**Media Inquiries:**

Karla Jo Helms<br> JOTO PR™<br> 727-777-4629<br> <u>jotopr.com</u>

**Investor Inquiries:**

R. Kirk Huntsman<br> Chief Executive Officer<br> investors@vivoslife.com