Item 8.01 Other Events.
On April 3, 2020, NanoVibronix,
Inc. (the “Company”) filed with the Securities and Exchange Commission (the “SEC”) an Amendment No. 1 to
its Current Report on Form 8-K (as amended, the “April 3 Form 8-K”) reporting that the Company will be relying on the
SEC’s Order (the “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.
Further to the April 3
Form 8-K, the Company will be relying on the Order to delay the filing of its Definitive Proxy Statement (the “Proxy Statement”)
relating to its Annual Meeting, including the information to be omitted from the Report, pursuant to General Instruction G(3) of
Form 10-K (“Part III Information”), which the Company expects to include in the Proxy Statement, due to circumstances
related to 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 the 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. Because of the Israeli government-mandated quarantine,
the Company’s office staff members are now working remotely, and management has had to devote significant time and attention
to assess the impact of COVID-19 and related events on the Company’s operations and financial position and to develop operational
and financial plans to address those matters, leading to a significant delay in the Company’s ability to complete tasks necessary
to file the Proxy Statement. This issue has delayed the Company’s ability to file Part III Information prior to the due date.
The Company expects to file the Definitive Proxy Statement, including Part III Information, no later than June 15, 2020 (which
is the first business day 45 days from the original 120-day filing deadline of April 29, 2020, for incorporation by reference in
the Report of the Part III Information) in compliance with the exemptions granted under the Order.
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 following Risk Factor supersedes the Risk Factor previously disclosed in the April 3 Form 8-K.
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 notified regulatory body we rely on to obtain European CE approval 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.