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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): July 18, 2024
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
7.01 |
Regulation
FD Disclosure. |
On
July 18, 2024, Microbot Medical Inc. (the “Company”) issued a press release announcing that it completed the enrollment of
clinical sites in its pivotal human clinical trial with the addition of Memorial Sloan Kettering Cancer Center.
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.
The
Company completed the enrollment of clinical sites in its pivotal human clinical trial with the addition of Memorial Sloan Kettering
Cancer Center, New York. Memorial Sloan Kettering Cancer Center will conduct the clinical trial as part of the Investigational Device
Exemption for the Company’s LIBERTY® Endovascular Robotic Surgical System, and the Company expects its results will
support the future marketing submission to the Food and Drug Administration and subsequent commercialization.
Forward
Looking Statements
This
Item 8.01 of this Current Report on Form 8-K contains “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:
July 18, 2024
Exhibit
99.1
Microbot
Medical Completes the Enrollment of Clinical Sites in Its Pivotal Human Clinical Trial with the Addition of Memorial Sloan Kettering
Cancer Center
As
the third and final clinical site, Memorial Sloan Kettering Cancer Center joins Brigham Women’s Hospital and Baptist Hospital of
Miami as sites for the pivotal human clinical trial.
BRAINTREE,
Mass., July 18, 2024 — Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular
Robotic Surgical System, today announces it has received Institutional Review Board (IRB) approval and signed a clinical trial agreement
with Memorial Sloan Kettering Cancer Center, located in New York City, New York. Memorial Sloan Kettering Cancer Center will conduct
the clinical trial as part of the Investigational Device Exemption (“IDE”) for LIBERTY®, and the Company expects
its results will support the future marketing submission to the FDA and subsequent commercialization.
The
clinical trial at Memorial Sloan Kettering Cancer Center will be led by Francois Cornelis, MD, PhD. “I’m a great believer
in the future of robotics for interventional procedures and the value robotics can bring to physicians and our patients. I am excited
to participate in the LIBERTY clinical trial.” said Dr. Cornelis. Dr. Cornelis will also serve as principal investigator for the
overall LIBERTY clinical trial.
“We
are excited to have a hospital the caliber of Memorial Sloan Kettering Cancer Center partnering with us to complete the enrollment of
the clinical sites in our trial,” commented Harel Gadot, CEO, President and Chairman of Microbot Medical.
The
Company previously announced that Brigham and Women’s Hospital in Boston, and Baptist Hospital of Miami are both enrolled in the
trial and have performed clinical cases.
About
Microbot Medical
Microbot
Medical Inc. (NASDAQ: MBOT) is a clinical- stage 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
Investigational 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 the LIBERTY®
Endovascular Robotic Surgical System, the outcome of its studies to evaluate the LIBERTY® Endovascular Robotic Surgical
System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether
the Company’s pivotal study in humans is successful, 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, disruptions resulting from new
and ongoing hostilities between Israel and the Palestinians and other neighboring countries, 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
IR@microbotmedical.com
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