Item
8.01 Other Events.
NanoVibronix,
Inc. (the “Company”) will be relying on the Securities and Exchange Commission’s Order under Section 36 of the
Securities Exchange Act of 1934 Modifying Exemptions From Reporting and Proxy Delivery Requirements for Public Companies dated
March 25, 2020 (Release No. 34-88465) to delay the filing of its Annual Report on Form 10-K for the year ended December 31, 2019
(the “Report”) due to circumstances related to coronavirus, or COVID-19. The Company’s principal operating and
manufacturing facilities are located in Israel and most of its employees are residents of Israel. Israel has been impacted
by COVID-19 outbreak, resulting in authorities implementing numerous measures to try to contain the virus, such as travel bans
and restrictions, quarantines, shelter in place orders, and shutdowns. In particular, our office staff members responsible for
preparing and providing supporting materials and information to the third-party auditor and the Company’s third-party accountants
and tax professionals are located in Israel, and COVID-19 and the resulting government measures have caused disruptions in the
Company’s normal interactions with among such persons. Because of the Israeli government-mandated quarantine, the Company’s
staff and third-party audit personnel are now working remotely, leading to a significant delay in the Company’s ability
to provide relevant materials and other information to its third-party audit personnel to complete the audit for the year ended
December 31, 2019. The Company’s staff is in the process of providing the requisite information and working together with
the audit personnel to complete the audit, but the audit personnel will need additional time to conduct their review and request
any further information from the Company to complete the audit, which has delayed the Company’s ability to file the Report
prior to the due date. The Company expects to file the Report no later than May 14, 2020 (which is 45 days from the Report’s
original filing deadline of March 30, 2020).
In
light of the current COVID-19 pandemic, the Company will be including the following Risk Factor in its Report, as may be updated
to reflect subsequent events impacting the Company:
The
recent coronavirus outbreak may adversely affect our business.
In
December 2019, a strain of coronavirus was reported to have surfaced in Wuhan, China, and has reached multiple other countries,
resulting in government-imposed quarantines, travel restrictions and other public health safety measures in China, the U.S., Italy,
Israel and other affected countries. The continued outbreak and spreading of the coronavirus has and may continue to adversely
impact our business, as our operations are based in and rely on third parties located in countries affected by the outbreak. Our
third-party manufacturer, which is based in China, temporarily shut down for sixty days due to the outbreak and is slowly recovering,
leading to a significant delay in the production of goods needed to fulfill our sales orders. A critical component of our products
is manufactured in China, which production has been disrupted, and we are uncertain as to when sub-assembly production of such
components will be completed. Additionally, the product design firm we rely on to model our products to comply with the CE mark
in Europe is located in Italy and has been shut down for over a month, delaying our submission for CE mark approval for the year
2020. The various precautionary measures taken by many governmental authorities around the world in order to limit the spread
of the coronavirus has had and may continue to have an adverse effect on the global markets and global economy, including on the
availability and pricing of employees, resources, materials, manufacturing and delivery efforts and other aspects of the global
economy. The financial downturn has compelled us to furlough or reduce working hours for much of our operating staff, as well
as third-party contractors, and our clients may encounter cash-flow issues that will delay their payments to us. We also rely
on third-party professionals to provide services such as the preparation of our financial statements and to conduct audits, and
many of these parties have been affected by government-imposed precautionary measures, thereby delaying our receipt of these services.
Therefore, the coronavirus has and could continue to disrupt production and cause delays in the supply and delivery of our products,
may continue to affect our operation, may further divert the attention and efforts of the medical community to coping with the
coronavirus and disrupt the marketplace in which we operate and may have a material adverse effect on our operations. The extent
to which the coronavirus impacts our results will depend on future developments, which are highly uncertain and cannot be predicted,
including new information which may emerge concerning the severity of the coronavirus and the actions to contain the coronavirus
or treat its impact, among others. The development of the coronavirus outbreak could materially disrupt our business and operations,
hamper our ability to raise additional funds or sell or securities, continue to slow down the overall economy, curtail consumer
spending, interrupt our sources of supply, and make it hard to adequately staff our operations.
Cautionary
Note Regarding Forward-Looking Statements
Certain
of the statements contained in this report should be considered forward-looking statements within the meaning of the Securities
Act of 1933, as amended (the “Securities Act”), the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements may be identified by words
such as “may,” “will,” “expect,” “intend,” “anticipate,” “believe,”
“estimate,” “plan,” “project,” “could,” “should,” “would,”
“continue,” “seek,” “target,” “guidance,” “outlook,” “if current
trends continue,” “optimistic,” “forecast” and other similar words. Such statements include, but
are not limited to, statements about the Company’s plans, objectives, expectations, intentions, estimates and strategies
for the future, and other statements that are not historical facts. These forward-looking statements are based on the Company’s
current objectives, beliefs and expectations, and they are subject to significant risks and uncertainties that may cause actual
results and financial position and timing of certain events to differ materially from the information in the forward looking statements.
There may be other factors of which the Company is not currently aware that may affect matters discussed in the forward-looking
statements and may also cause actual results to differ materially from those discussed. In particular, the consequences of the
coronavirus outbreak to economic conditions and the industry in general and the financial position and operating results of our
company in particular have been material, are changing rapidly, and cannot be predicted. The Company does not assume any obligation
to publicly update or supplement any forward-looking statement to reflect actual results, changes in assumptions or changes in
other factors affecting these forward-looking statements other than as required by law. Any forward looking statements speak only
as of the date hereof or as of the dates indicated in the statement.