Item
8.01 Other Events.
NanoVibronix,
Inc. (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 Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2020
(the “Report”) due to circumstances related to coronavirus, or COVID-19.
The Company’s principal
operating facility is 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 Report. This issue 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 June 29, 2020 (which is the first business day 45 days from the original filing
deadline of May 15, 2020) in compliance with the exemptions granted under the Order.
In
light of the current COVID-19 pandemic, the Company will include 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 (“COVID-19”) 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 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 only recently
became fully operational which led to a significant delay in the production of goods needed to fulfill our sales orders. 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,
which delayed 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, and has forced remaining staff as well as third-party contractors, and our clients may
encounter cash-flow issues that will delay their payments to us. In addition, remaining staff members have been forced to operate
remotely from their homes resulting in delays in obtaining certain financial records. 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.