Form 8-K

8-K — Microbot Medical Inc.

Accession: 0001493152-26-025171

Filed: 2026-05-26

Period: 2026-05-26

CIK: 0000883975

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

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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)

the Securities Exchange Act of 1934

Date

of Report (Date of earliest event reported): May 26, 2026

MICROBOT

MEDICAL INC.

(Exact

name of registrant as specified in its charter)

Delaware

000-19871

94-3078125

(State

or other jurisdiction

incorporation)

(Commission

File

Number)

(IRS

Employer

Identification

No.)

175

Derby St., Bld. 27

Hingham,

MA 02043

(Address

of Principal Executive Offices) (Zip Code)

Registrant’s

telephone number, including area code: (781) 875-3605

(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(s)

Name

of each exchange on which registered

Common

Stock, $0.01 par value

MBOT

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 (17 CFR §230.405)

or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging

Growth Company ☐

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.

May 26, 2026, Microbot Medical Inc. (the “Company”) issued a press release announcing that it received regulatory approval

from the Israeli Ministry of Health’s AMAR Division, the authority responsible for medical device regulation in Israel, which allows

the Company to market and commercialize the LIBERTY® Endovascular Robotic System in Israel, and also enables the Company

to obtain a Free Sale Certificate to support submissions and commercial activities in additional jurisdictions.

The

press release, which is furnished as Exhibit 99.1 to this Current Report on Form 8-K, is incorporated herein by reference. The information

in this Item 7.01 and Exhibit 99.1 is being furnished and shall not be deemed to be “filed” for the purposes of Section 18

of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. This report will not be

deemed an admission as to the materiality of any information in this Item 7.01 or Exhibit 99.1.

Item

8.01 Other Events.

May 26, 2026, the Company announced that it received regulatory approval from the Israeli Ministry of Health’s AMAR Division, the

authority responsible for medical device regulation in Israel, which allows the Company to market and commercialize the LIBERTY®

Endovascular Robotic System in Israel, and also enables the Company to obtain a Free Sale Certificate to support submissions and commercial

activities in additional jurisdictions.

Forward

Looking Statements

This

Item 8.01 of this Current Report on Form 8-K may contain “forward-looking statements.” Such statements which are not purely

historical (including, but not limited to statements that contain words such as “will,” “believes,” “plans,”

“anticipates,” “expects,” “intends,” “would,” “could” and “estimates”)

are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future,

including but not limited to, regulatory milestones.

Actual

results could differ from those projected in any forward-looking statements due to numerous factors. These forward-looking statements

are made as of the date of this Form 8-K, and the Company assumes no obligation to update the forward-looking statements, or to update

the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Although

the Company believes that the beliefs, plans, expectations and intentions contained in this Form 8-K are reasonable, there can be no

assurance that such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information

set forth herein and should also refer to the risk factors disclosure outlined in the Company’s reports and statements filed from

time-to-time with the Securities and Exchange Commission.

Item

9.01. Financial Statements and Exhibits.

(d)

Exhibits

Exhibit

Number

Description

99.1

Press Release

104

Cover

Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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 thereunto duly authorized.

MICROBOT

MEDICAL INC.

By:

/s/

Harel Gadot

Name:

Harel

Gadot

Title:

Chief

Executive Officer, President and Chairman

Date:

May 26, 2026

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

Microbot

Medical® Receives Its First International Regulatory Approval for the Commercialization of the LIBERTY® Endovascular Robotic

System

Israel

becomes the second jurisdiction and the first outside of the U.S. to grant marketing clearance for the LIBERTY System

The

AMAR regulatory approval will enable the Company to obtain a Free Sale Certificate to support submissions and commercial activities in

additional jurisdictions

HINGHAM,

Mass., May 26, 2026 — Microbot Medical Inc. (Nasdaq: MBOT), developer and distributor of the innovative LIBERTY® Endovascular

Robotic System, announced that it has achieved a significant

regulatory milestone as Israel becomes the second jurisdiction — and

the first outside of the U.S. — to grant marketing clearance for the LIBERTY

System. The regulatory approval from the Israeli Ministry of Health’s AMAR Division, the authority responsible for medical device

regulation in Israel, allows the Company to market and commercialize the LIBERTY System in Israel, which also enables the Company to

obtain a Free Sale Certificate to support submissions and commercial activities in additional jurisdictions. The Company continues to

pursue CE Mark certification and is working toward completion by the end of 2026, in preparation for the next phase of commercial

expansion into the EU market.

The

expansion into international markets follows the successful launch of the LIBERTY System in the U.S. which continues to be the focused

territory for the Company. Multiple accounts and hospitals in Georgia, Florida, New York, Massachusetts, Michigan, and North Carolina

have already adopted the LIBERTY System.

“This

is an important regulatory milestone for the LIBERTY System and demonstrates that, as a Company, we are continuing

to execute on our growth strategies and making meaningful progress toward our overall commercial objectives,”

commented Harel Gadot, Chairman, CEO and President. “The AMAR approval gives us marketing clearance and supports commercialization

efforts in Israel, and we are already in advanced discussions to expedite the commercialization process and accelerate the adoption of

the system there, while leveraging this approval and experience to pursue additional relevant markets.”

LIBERTY

is the only FDA-cleared, single-use, remotely operated robotic system for peripheral endovascular procedures, and it is designed for

precise vascular navigation while aiming to reduce radiation exposure and physical strain.

About

Microbot Medical

Microbot

Medical Inc. (NASDAQ: MBOT) is a commercial stage medical device company focused on transforming endovascular procedures through advanced

robotic technology. Microbot’s LIBERTY® Endovascular Robotic System is the first single-use, remotely operated robotic

solution designed for precision, efficiency and safety. Backed by a strong intellectual property portfolio and a commitment to innovation,

Microbot is driving the future of endovascular care.

Learn

more at www.microbotmedical.com and connect on LinkedIn and X.

Safe

Harbor

Statements

to future financial and/or operating results, future adoption of products, future growth in research, technology, clinical development,

commercialization and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future

expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of

the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including,

but not limited to statements that contain words such as “contemplates,” “continues,” “could,” “forecasts,”

“intends,” “may,” “might,” “possible,” “potential,” “predicts,”

“projects,” “should,” “would,” “will,” “believes,” “plans,” “anticipates,”

“expects,” “estimates” and similar expressions) should also be considered to be forward-looking statements, but

the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements involve risks and uncertainties,

including, without limitation, market conditions, risks inherent in the commercialization of the LIBERTY® Endovascular

Robotic System, and in the development of future versions of or applications for the system, uncertainty in the results of regulatory

pathways and regulatory approvals, uncertainty resulting from political, social and geopolitical conditions, particularly any changes

in personnel or processes or procedures at the FDA and announcements of tariffs on imports into the U.S., disruptions resulting from

new and ongoing hostilities between Israel and the Palestinians, Iran and other neighboring countries, and maintenance of intellectual

property rights. Additional information on risks facing Microbot Medical® can be found under the heading “Risk Factors”

in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s

web site at www.sec.gov. Microbot Medical® disclaims any intent or obligation to update these forward-looking statements,

except as required by law.

Contacts:

IR@microbotmedical.com

Media@microbotmedical.com

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