NAOV NanoVibronix Inc

 

 

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 6, 2023

 

NanoVibronix, Inc.

(Exact name of registrant as specified in its charter)

 

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

 

525 Executive Blvd Elmsford, New York		10523
(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 September 6, 2023, NanoVibronix, Inc. (the “Company”), issued a press release announcing the presentation of positive independent testing results of UroShield at the International Continence Conference. 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 September 6, 2023 (furnished pursuant to Item 7.01)
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.
Date: September 6, 2023	By:	/s/ Stephen Brown
	Name:	Stephen Brown
	Title:	Chief Financial Officer

 

 

 

 

Exhibit 99.1

 

NanoVibronix Announces Presentation of Positive Independent Testing Results of UroShield at ICS Annual Meeting

 

Dr. Sandra Wilks to Present Findings from University of Southampton Study in Toronto

 

ELMSFORD, N.Y., September 6, 2023 (Business Wire) — NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that Dr. Sandra Wilks is scheduled to present the findings from her study of UroShield® at the International Continence Society (ICS) 2023 Conference in Toronto on Wednesday, September 27.

 

ICS 2023 is being held September 26-28 in Toronto. For additional information, please visit https://www.ics.org/2023.

 

The ICS annual conference brings together international experts in the research and treatment of bladder problems, pelvic floor disorders and Lower Urinary Tract Symptoms. It is multidisciplinary and welcomes urologists, gynaecologists, neurourologists, physiotherapists, nurses, midwives and research scientists. All ICS attendees will have the opportunity to learn about the UroShield® device and explore how the device can be introduced to their patients across the globe.

 

Brian Murphy, Chief Executive Officer of NanoVibronix, Inc., said, “Dr. Wilks’ independent research highlights the critical need for a medical device that improves outcomes for long-term catheter users. Incidences of catheter-associated urinary tract infections (CAUTI) continue to be a major clinical concern. Through this independent study, researchers witnessed positive outcomes from the use of UroShield both in the lab and with patients. Presentation of the study at ICS allows us to increase awareness of UroShield and the proven benefits from its use.”

 

The Southampton study data indicates that in addition to reducing infection and catheter blockages, UroShield® has the potential for developing a healthy urinary microbiome by use of low frequency ultrasound generated by the UroShield® device, thus avoiding long-term use of antibiotics and the risks associated with such strategies.

 

The full study, Understanding the Use of the NanoVibronix® UroShield® in Preventing Catheter-Associated Infections and Blockage was published by ScienceDirect and is available at https://www.sciencedirect.com/science/article/pii/S2772973723005647.

 

UroShield generates ultrasonic waves to create an acoustic shield on the surfaces of a catheter to interfere with the attachment of bacteria, prevent bacterial biofilm formation, the development of infections and may eliminate or reduce the need for antibiotics. It is designed to prevent biofilm formation, decrease bacteriuria/UTI, reduce catheter pain and discomfort and increase antibiotic efficacy.

 

 

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® and UroShield®, 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 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

brett@haydenir.com

(646) 536-7331

 

SOURCE: NanoVibronix, Inc.

 

 

 

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Cover	Sep. 06, 2023
Cover [Abstract]
Document Type	8-K
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Document Period End Date	Sep. 06, 2023
Entity File Number	001-36445
Entity Registrant Name	NanoVibronix, Inc.
Entity Central Index Key	0001326706
Entity Tax Identification Number	01-0801232
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	525 Executive Blvd
Entity Address, City or Town	Elmsford
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10523
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Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	NAOV
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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