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): July 7, 2020
NanoVibronix, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
001-36445 | 01-0801232 | |
(Commission File Number) | (IRS Employer Identification No.) |
525 Executive Blvd., Elmsford, NY 10523
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (914) 233-3004
Not Applicable
(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 communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
[ ] | Pre-commencement communication 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 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company [X]
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. [ ]
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 $0.001 per share | NAOV | Nasdaq Capital Market |
Item 8.01 Other Events.
On July 7, 2020, NanoVibronix, Inc. (the “Company”) issued a press release announcing that effective June 22, 2020, it has entered into a two-year exclusive agreement with Ultra Pain Products, Inc. for the distribution of the Company’s proprietary PainShield™ devices and components through and by Durable Medical Equipment (DME) Distributors throughout the United States. 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.
As previously reported, the Company recently experienced a cybersecurity incident. Specifically, the Company believes that one or two unauthorized third parties were able to use an email domain similar to the Company’s to convince two of the Company’s vendors to send payments in the aggregate amount of approximately $308,000 to unauthorized bank accounts that should have been sent to the Company. One of the vendors successfully reclaimed $78,000 of the fraudulent transfers and has deposited such amount into the Company’s account, while the other vendor recently informed the Company that it has recovered the remaining $230,000 of the fraudulent transfers and expects to deposit such amount into the Company’s account.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit
No. |
Description | |
99.1 | Press release, dated July 7, 2020 |
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.
NANOVIBRONIX, INC. | ||
Date: July 8, 2020 | By: | /s/ Brian Murphy |
Name: | Brian Murphy | |
Title: | Chief Executive Officer |
Exhibit 99.1
NanoVibronix Signs Two Year, Exclusive
Distribution Agreement for PainShield
Ultra Pain Products, Inc. to Distribute Products Throughout the United States
Initial Order Completed
ELMSFORD, N.Y., July 7, 2020 (PR NEWSWIRE) — NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield®, and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that effective June 22, 2020, it has entered into a two-year exclusive agreement with Ultra Pain Products, Inc. (“UPPI”) for the distribution of NanoVibronix’s proprietary PainShield™ devices and components through and by Durable Medical Equipment (DME) Distributors throughout the United States.
“Teaming with Ultra Pain Products provides us with a solid, proven distribution channel that further supports our growth objectives and facilitates the smooth delivery of products and management of relationships with both local and regional Durable Medical Equipment (DME) suppliers,” said Brian Murphy, CEO of NanoVibronix. “With an established pipeline, Ultra Pain Products will play a critical role in delivering our opioid-free pain management solution to healthcare providers and their patients at a time when social distancing is critical. Ultra’s established billing capabilities in workers’ compensation, private insurance and motor vehicle insurance will enable quality customer service for buyers and more predictable management of working capital for us.”
“Our agreement comes at a critical time amidst the COVID-19 pandemic, providing us with a unique opportunity to apply our strengths in sales, marketing and reimbursement to bring the PainShield product to the U.S. and further advance the treatment of patients in a safe, remote setting,” said Ari Alayev, President of Ultra Pain Products, Inc. “We are committed to providing solutions that enable healthcare providers to meet patients’ pain management needs, regardless of the setting and partnering with NanoVibronix reinforces this commitment. Through our agreement we are equipped to deliver what we believe is one of the greatest and most admirable contributions to the medical community for targeting the opioid crisis.”
Under the terms of the two-year agreement, the Company granted exclusive distribution rights to UPPI to sell the newest model of PainShield MD and components, including the new ergonomic design and single-use custom daily dressing or adhesive through DME distributors. In exchange, the Company received an initial purchase order and minimum annual quantities, which must be achieved. The agreement is subject to minimum unit pricing restrictions and bi-monthly order quantity minimums in the first year that increase and shift to quarterly order minimums in year two. Distribution rights expressly exclude sales to Veteran’s Facilities under the Federal Supply Schedule (FSS).
PainShield is an ultrasound device, consisting of a reusable driver unit and disposables, which includes a proprietary therapeutic transducer and cover adhesive. PainShield delivers a localized ultrasound effect to treat pain and induce soft tissue healing in a targeted area, while keeping the level of ultrasound energy at a safe and consistent level. Its range of applications includes acute and chronic pain resolution through its many mechanisms of action. PainShield can be used by patients at home or work or in a clinical setting and can be used even while the patient is sleeping. Patient benefits include ease of application and use, faster recovery time, high compliance, and increased safety and efficacy over existing devices that rely on higher-frequency ultrasound.
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) the geographic, social and economic impact of COVID-19 on the Company’s ability
to conduct its business and raise capital in the future when needed, (ii) market acceptance of our existing and new products or
lengthy product delays in key markets; (iii) negative or unreliable clinical trial results; (iv) inability to secure regulatory
approvals for the sale of our products; (v) intense competition in the medical device industry from much larger,
multinational companies,; (vi) product liability claims; (vii) product malfunctions; (viii) our limited manufacturing
capabilities and reliance on subcontractor assistance; (ix) insufficient or inadequate reimbursements by governmental and/or other
third party payers for our products; (x) our ability to successfully obtain and maintain intellectual property protection covering
our products; (xi) legislative or regulatory reform impacting the healthcare system in the U.S. or in foreign jurisdictions; (xii)
our reliance on single suppliers for certain product components, (xiii) 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; and (xiv) 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. 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.
Investor Contacts:
Nanovibronix Inc
bmurphy@nanovibronix.com
(630) 338-5022
Or:
Brett Maas, Managing Principal, Hayden IR, LLC
brett@haydenir.com
(646) 536-7331
SOURCE: NanoVibronix, Inc.