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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): December 7, 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 |
|
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
8.01 Other Events
On
December 7, 2023, Microbot Medical Inc. (the “Company”) issued a press release announcing the successful completion of its
GLP pivotal pre-clinical study, a critical milestone for the Company’s planned IDE submission to the U.S. Food and Drug Administration
to commence its human clinical study. The histopathology and lab report supplements previous positive Company findings.
The
study was conducted by three leading interventional radiologists that utilized the Company’s LIBERTY Endovascular Robotic Surgical
System to perform a total of 96 robotic navigations. Target vessels with surrounding tissue were examined and evaluated microscopically
after they were subjected to procedures using a range of commercially available intravascular catheterization devices controlled and
manipulated via the LIBERTY Endovascular Robotic Surgical System.
The
press release, which is filed as Exhibit 99.1 to this Current Report on Form 8-K, is incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits
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:
December 7, 2023
Exhibit
99.1
Microbot
Medical Announces the Successful Completion of Its GLP Pivotal Pre-Clinical Study, a Critical Milestone for Its IDE submission to Commence
Human Clinical Study
The
final histopathology and lab report supplements previous positive Company findings.
The results of the study will support the Company’s
IDE submission to the FDA to commence its human clinical study
BRAINTREE,
Mass., December 7, 2023 – Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular
Robotic Surgical System, today announces the successful completion of its GLP pivotal pre-clinical study, done under the guidelines of
FDA-required levels of planning, controlling, monitoring, and reporting, using a porcine model.
The
study was conducted by three leading interventional radiologists that utilized the LIBERTY Endovascular Robotic Surgical System to perform
a total of 96 robotic navigations. Target vessels with surrounding tissue were examined and evaluated microscopically after they were
subjected to procedures using a range of commercially available intravascular catheterization devices controlled and manipulated via
the LIBERTY Endovascular Robotic Surgical System.
“I
am very pleased with the positive outcomes of
the histopathology report and the completion of the GLP study,” said Juan Diaz Cartelle, Chief Medical Officer. “This
gives us confidence to move forward to the next stage of human clinical study.”
“Today’s
announcement marks another important milestone for the Company, as we continue our transition from R&D and pre-clinical phase into
the clinical, regulatory and pre-commercial phase” commented Harel Gadot, CEO. “We expect to submit our IDE application to
the FDA soon and commence our pivotal human clinical study, completing our transition to a clinically stage company.”
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® Endovascular 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® Endovascular 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 potential
products, including 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, disruptions resulting from new and ongoing hostilities between Israel and the
Palestinians, such as employees of Microbot and its vendors and business partners being called to active military duty, any 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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