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): August 16, 2018
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))
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 August 16, 2018, NanoVibronix, Inc. (the “Company”) released a press release providing a business update for the quarter ended June 30, 2018. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is hereby incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. | Description | |
99.1 | Press release dated August 16, 2018 |
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: August 16, 2018 | By: | /s/ Stephen Brown | |
Name: Stephen Brown | |||
Title: Chief Financial Officer |
Exhibit 99.1
NanoVibronix
Provides Business Update
for the Second Quarter of 2018
Revenue increases 153% for the second quarter of 2018
ELMSFORD, NY – August 16, 2018 - NanoVibronix, Inc, (NASDAQ: NAOV), a medical device company utilizing the Company’s proprietary and patented low intensity surface acoustic wave (SAW) technology, today provided a business update for the second quarter ended June 30, 2018.
Brian Murphy, Chief Executive Officer of NanoVibronix, commented, “We believe our commercial strategy is beginning to take hold, as reflected by a 153% increase in sales, albeit off a small base, as our initial distributors have begun marketing our products in their respective markets. In June, we announced that we entered into another distribution agreement with M.D.S. Pharm Ltd. to market and distribute PainShield® and WoundShield® in Israel. We are in active discussions with a number of such distributors around the world. In entering these agreements, we strive to cautiously select a partner that we believe would be the best in each of the respective markets, with an established distribution network spanning insurance and health care providers, retail pharmacies, and other distribution points. At the same time, we are pursuing a number of larger strategic partnerships that may help further accelerate market adoption of our products.”
“We also continue to advance our clinical activities. Last month, we announced successful clinical trial results for our PainShield™ device in treating patients with Trigeminal Neuralgia. Trigeminal Neuralgia is considered one of the most, chronically painful conditions and is associated with a high suicide rate directly attributable to the condition. We saw a dramatic improvement in both pain scores and the use of pain medications such as opioids. We look forward to having these results published in a leading medical journal later this year and plan to aggressively market the device in order to help the millions of patients worldwide suffering from this painful and debilitating condition.”
The Company’s filed its Form 10-Q for the period ended June 30, 2018, with the Securities and Exchange Commission on August 14, 2018, which is available on the SEC’s website, www.sec.gov, or the Company’s website, www.nanovibronix.com.
About NanoVibronix
NanoVibronix Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York with research and development in Nesher, Israel, that is focused on developing medical devices utilizing its proprietary and patented low intensity surface acoustic wave technology. The company’s technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including the disruption of biofilms and bacteria colonization, as well as providing 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. Additional information about the company is available at: www.nanovibronix.com.
Investor Contact:
Crescendo Communications
naov@crescendo-ir.com
212-671-1021
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 and 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, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an 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 subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. 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.
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