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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 27, 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 27, 2023, NanoVibronix, Inc. (the “Company”), issued a press release announcing the approval for inclusion of its
UroShield products in the National Health Service’s Prescription Services’ Drug Tariff. 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
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 27, 2023 |
By: |
/s/ Stephen
Brown |
|
Name: |
Stephen Brown |
|
Title: |
Chief Financial Officer |
Exhibit
99.1
NanoVibronix
Gains Approval for Inclusion of UroShield Products in
NHS
Prescription Services’ Drug Tariff
Establishes
Reimbursement for UroShield Actuators Enabling Increased Distribution to NHS Patients
NHS
Supply Chain Contract Extended for Complete UroShield System
ELMSFORD,
N.Y., Sept. 27, 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 its application for UroShield actuators to be available on NHS Prescription Services’ Drug Tariff has been approved.
The
company also confirmed that the contract with NHS Supply Chain for the supply of UroShield through the company’s U.K. distribution
partner, Peak Medical Limited, has been extended for up to four years.
Drug
Tariff provides for full reimbursement of UroShield actuators by the NHS. Clinicians in the U.K. will be able to prescribe the products,
which are used in conjunction with the UroShield device, beginning November 1, 2023. Both hospital and community clinicians will have
the option of prescribing UroShield either through the prescription process or through the NHS contract. Importantly, wherever a patient
is treated, they can now receive the full UroShield system with the NHS paying the cost and not the patient.
Brian
Murphy, Chief Executive Officer of NanoVibronix, Inc., said, “Receiving reimbursement approval is a vitally important advancement
in our efforts to increase access to and distribution of UroShield. Approval for clinicians to prescribe alongside the NHS procurement
contract greatly eases a patient’s ability to access the UroShield device through their healthcare providers, wherever they are
being treated. Across the health system, the cost of UroShield actuators will no longer be a limiting factor for patients. We are pleased
that the NHS recognizes the value of the UroShield technology and the patient benefits that the device can deliver, whilst also addressing
the resource and financial challenges in the healthcare system.”
Murphy
continued, “Achieving reimbursement status had been a critical missing piece to advancing distribution in the NHS and now with
this hurdle cleared, we are better positioned to increase unit sales throughout the country. Through our partnership with Peak Medical
Limited, we have an established distribution channel and a robust team of sales and marketing professionals with vast experience in urological
medicine. Furthermore, we are increasing production to meet the upsurge in demand that we believe will be generated from this new development.”
Auriol
Lawson, Managing Director of Peak Medical Limited, commented, “With the Drug Tariff listing, health care professionals now have
the option of prescribing UroShield actuators to help prevent Catheter-Associated Urinary Tract Infections (C-AUTIs) for patients with
indwelling catheters. At Peak Medical, we are committed to delivering innovative products that can have a positive impact on patient
outcomes, and UroShield has been proven and recognized by the NHS as an effective solution for preventing infection. We are delighted
to be working with NanoVibronix to increase product awareness and channel the preventative devices to all patients who will benefit from
its use.”
About
NanoVibronix
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 to 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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Grafico Azioni NanoVibronix (NASDAQ:NAOV)
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