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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
MICROBOT
MEDICAL INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
000-19871 |
|
94-3078125 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File Number) |
|
(IRS
Employer
Identification
No.) |
288
Grove Street, Suite 388
Braintree,
MA 02184
(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 |
|
The
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 ☐
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, Microbot Medical Inc. (the “Company”) issued a press release announcing its partnership with a Contract
Research Organization (CRO) in the U.S. The engagement is an additional step in the Company’s path towards marketing clearance
with the FDA.
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
9.01. Financial Statements and Exhibits.
(d)
Exhibits
Exhibit
No. |
|
Description |
|
|
|
99.1 |
|
Press Release |
104 |
|
Cover
Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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. |
|
|
|
/s/
Harel Gadot |
|
Harel
Gadot |
|
Chairman,
President and Chief Executive Officer |
|
|
Date:
September 27, 2023 |
|
Exhibit
99.1
Microbot
Medical Engages CRO to Support its Upcoming U.S. Pivotal Clinical Trial
The
engagement is an additional step in the Company’s path towards marketing clearance with the FDA
BRAINTREE,
Mass., September 27, 2023 – Microbot Medical Inc. (Nasdaq: MBOT), the developer of the LIBERTY® Robotic
Surgical System, the first single-use endovascular robotic system, announced today its partnership with a Contract Research Organization
(CRO) in the U.S. This is an additional step in the preparations to the commencement of the Company’s planned upcoming clinical
trial.
The
CRO will provide an array of comprehensive research management services, leveraging their expertise and resources to bolster Microbot’s
clinical trial initiatives. The CRO will also furnish guidance throughout the clinical trial process, along with essential functional
support and resources, to ensure a seamless execution of the Company’s U.S. pivotal clinical trial.
This
engagement is expected to support Microbot as it seeks to navigate the regulatory landscape and achieve necessary compliances with the
Food and Drug Administration (FDA). The Company’s upcoming U.S. pivotal clinical trial has been designed to evaluate the safety
and efficacy of the LIBERTY® Robotic Surgical System in endovascular procedures.
“Our
new CRO partner has distinguished themselves with an exceptional track record of excellence in the very niche sector of cardiovascular
and peripheral vascular device trials and has paved the way for successful FDA approvals in the past,” commented Jason Lewen, Director
of Clinical Affairs at Microbot Medical. “Their clinical team is comprised of individuals with an extensive background in the clinical
domain, many of whom are former hospital employees with vast amounts of clinical trial functional experiences. We believe that they will
be able to effectively expand our clinical trial capabilities with expert guidance and functional support while maintaining the highest
standards of quality and regulatory compliance. We view this significant development as an important milestone in our clinical trial
roadmap for FDA market approval and beyond.”
About
Microbot Medical
Microbot
Medical Inc. (NASDAQ: MBOT) is a pre-clinical medical device company that specializes in transformational micro-robotic technologies,
with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within
the human body.
The
LIBERTY® Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating
the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company
believes the LIBERTY® Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular
interventional procedures.
Further
information about Microbot Medical is available at http://www.microbotmedical.com.
Safe
Harbor
Statements
to future financial and/or operating results, future growth in research, technology, clinical development, 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 “will,” “believes,” “plans,” “anticipates,” “expects”
and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and
uncertainties, including, without limitation, market conditions, risks inherent in the development and/or commercialization of LIBERTY,
the outcome of its studies to evaluate LIBERTY, whether the Company’s core business focus program and cost reduction plan are sufficient
to enable the Company to continue to focus on its LIBERTY technology while it stabilizes its financial condition and seeks additional
working capital, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory
studies which could adversely affect or delay such studies, uncertainty in the results of pre-clinical and clinical trials or regulatory
pathways and regulatory approvals, lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital,
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.
Investor
Contact:
Michal
Efraty
+972-(0)52-3044404
IR@microbotmedical.com
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