# EDGAR Filing Document

**Accession Number:** 0001326706
**File Stem:** 0001493152-23-008323
**Filing Date:** 2023-3
**Character Count:** 10864
**Document Hash:** 525295f268e5a88aa0a7e0e69aa414c8
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-23-008323.hdr.sgml**: 20230321

**ACCESSION NUMBER**: 0001493152-23-008323

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20230321

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230321

**DATE AS OF CHANGE**: 20230321

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** NanoVibronix, Inc.
- **CENTRAL INDEX KEY:** 0001326706
- **STANDARD INDUSTRIAL CLASSIFICATION:** ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES [3842]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36445
- **FILM NUMBER:** 23747914

**BUSINESS ADDRESS:**
- **STREET 1:** 525 EXECUTIVE BLVD
- **CITY:** ELMSFORD
- **STATE:** NY
- **ZIP:** 10523
- **BUSINESS PHONE:** (914) 233-3004

**MAIL ADDRESS:**
- **STREET 1:** 525 EXECUTIVE BLVD
- **CITY:** ELMSFORD
- **STATE:** NY
- **ZIP:** 10523

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Nano Vibronix, Inc.
- **DATE OF NAME CHANGE:** 20111206

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Nano Vibronix Inc
- **DATE OF NAME CHANGE:** 20050510

?xml version="1.0" encoding="utf-8"?

**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): March 21, 2023

**<u>NanoVibronix, Inc.</u>**

(Exact name of registrant as specified in its charter)

<u>Delaware</u> <u>001-36445</u> <u>01-0801232</u> <br> (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.)

<u>525 Executive Blvd Elmsford, New York</u> <u>10523</u> <br> (Address of principal executive offices) (Zip Code)

Registrant's telephone number, including area code: (914) 233-3004

(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** |
| Common Stock, par value $0.001 per share | NAOV | Nasdaq Capital Market |

---

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 7.01. Regulation FD Disclosure.**

On March 21, 2023, NanoVibronix, Inc. (the "Company"), issued a press release announcing the filing of a new provisional patent application for UroShield Ultra. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. The Company undertakes no obligation to update, supplement or amend the materials attached hereto.

The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is being furnished pursuant to Item 7.01 and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise be subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and regardless of any general incorporation language in such filing.

**Item 9.01 Financial Statements and Exhibits.**

(d) Exhibits

---

| | |
|:---|:---|
| **Exhibit Number** | **Description** |
| 99.1 | [Press Release dated March 21, 2023 (furnished pursuant to Item 7.01)](ex99-1.htm) |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) |

---

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **NanoVibronix, Inc.** | **NanoVibronix, Inc.** |
| Date: March 21, 2023 | By: | */s/ Stephen Brown* |
|  | Name: | Stephen Brown |
|  | Title: | Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**NanoVibronix Files Provisional U.S. Patent Application for UroShield Ultra**

***Next Generation Device Configured with Multiple Frequencies to Enhance Product Performance and Effectiveness***

 ****

ELMSFORD, N.Y., March 21, 2023 (Business Wire) -- **<u>NanoVibronix, Inc</u>**., (NASDAQ: NAOV) (the "Company"), a medical device company utilizing the Company's proprietary and patented low intensity surface acoustic wave ("SAW") technology, today announced it has filed a new provisional patent application with the United States Patent and Trademark Office ("USPTO") entitled "Multiple Frequency Surface Acoustic Waves for Internal Medical Device" (the "Patent Application") related to its UroShield.

The Patent Application covers a recently developed enhancement to the UroShield product, UroShield "Ultra", which incorporates improvements to the Company's original UroShield. The next generation UroShield Ultra includes modified housing that is designed to improve catheter coupling and incorporates multiple actuators that work in sequence to discourage bacterial docking by delivering SAWs at multiple frequencies directly to indwelling catheters.

"UroShield is, to our knowledge, the only proven, effective solution for the prevention of Catheter Associated Urinary Tract Infections ("CAUTI"), the single highest source of hospital acquired infections," stated Brian Murphy, Chief Executive Officer of NanoVibronix. "This new filing expands our portfolio of intellectual property assets and reinforces our competitive position. UroShield has been proven to be instrumental in improving outcomes for hospital patients suffering from CAUTI. We are continually seeking opportunities to improve our products and by employing cutting edge technology."

**About NanoVibronix, Inc.**

NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, focused on developing medical devices utilizing its patented low intensity surface acoustic wave (SAW) technology. The proprietary technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including for disruption of biofilms and bacterial colonization, as well as for pain relief. The devices can be administered at home without the assistance of medical professionals. The Company's primary products include PainShield®, UroShield® and WoundShield®, all of which are portable devices suitable for administration at home without assistance of medical professionals. Additional information about NanoVibronix is available at: www.nanovibronix.com.

**Forward-looking Statements**

This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with: (i) market acceptance of our existing and new products or lengthy product delays in key markets; (ii) negative or unreliable clinical trial results; (iii) inability to secure regulatory approvals for the sale of our products; (iv) intense competition in the medical device industry from much larger, multinational companies; (v) product liability claims; (vi) product malfunctions; (vii) our limited manufacturing capabilities and reliance on subcontractor assistance; (viii) insufficient or inadequate reimbursements by governmental and/or other third party payers for our products; (ix) our ability to successfully obtain and maintain intellectual property protection covering our products; (x) legislative or regulatory reform impacting the healthcare system in the U.S. or in foreign jurisdictions; (xi) our reliance on single suppliers for certain product components; (xii) the need to raise additional capital to meet our future business requirements and obligations, given the fact that such capital may not be available, or may be costly, dilutive or difficult to obtain; (xiii) our conducting business in foreign jurisdictions exposing us to additional challenges, such as, e.g., foreign currency exchange rate fluctuations, logistical and communications challenges, the burden and cost of compliance with foreign laws, and political and/or economic instabilities in specific jurisdictions; and (xiv) market and other conditions. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's web site at: http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events, or otherwise, except as required by law.

**Investor Contacts:**

Brett Maas, Managing Principal, Hayden IR, LLC

<u>brett@haydenir.com</u>

(646) 536-7331

SOURCE: NanoVibronix, Inc.