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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): October 31, 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.) |
25
Recreation Park Drive, Unit 108
Hingham,
Massachusetts 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 ☐
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
October 31, 2023, Microbot Medical Inc. (the “Company”) issued a press release announcing additional updates regarding positive
outcomes of its previously announced pivotal pre-clinical study using the LIBERTY Robotic Surgical System. Follow up visual examination
three days after the procedures using the LIBERTY Robotic Surgical System, confirms 100% success rate in reaching the targets with no
visual evidence of vascular injury or any other visual adverse event.
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.
On
October 31, 2023, the Company announced additional updates regarding positive outcomes of its previously announced pivotal pre-clinical
study using the LIBERTY Robotic Surgical System. Follow up visual examination three days after the procedures using the LIBERTY Robotic
Surgical System, confirms 100% success rate in reaching the targets with no visual evidence of vascular injury or any other visual adverse
event.
The
Company expects to receive the comprehensive final report later this quarter. Subject to the final report, and the completion of the
verification and validation process, the Company plans on submitting the Investigational Device Exemption (IDE) application to the U.S.
Food and Drug Administration, in order to commence its pivotal clinical trial in humans.
Cautionary
Statements Regarding Forward-Looking Statements
This
Current Report on Form 8-K includes “forward-looking statements” within the meaning of the safe harbor provisions of the
United States Private Securities Litigation Reform Act of 1995. Certain of these forward-looking statements can be identified by the
use of words such as “believes,” “expects,” “intends,” “plans,” “estimates,”
“assumes,” “may,” “should,” “will,” “seeks,” or other similar expressions.
These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially
from the expected results, including those under “Risk Factors” in the Company’s Annual Report on Form 10-K for the
fiscal year ended December 31, 2022 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2023. Most of these factors
are outside the Company’s control and are difficult to predict. The Company cautions readers not to place undue reliance upon any
forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking
to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change
in events, conditions or circumstances on which any such statement is based, except as may be required by law.
Item
9.01. Financial Statements and Exhibits.
(d)
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: October 31, 2023 |
|
|
Exhibit
99.1
Microbot
Medical Reveals Successful Short Term Follow Up Outcomes from its Pivotal Pre-Clinical Study
Follow
up visual examination three days after the procedures using the LIBERTY Robotic Surgical System, confirms 100% success rate in reaching
the targets with no adverse events.
BRAINTREE,
Mass., October 31, 2023 – Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Robotic
Surgical System, today announces additional updates regarding positive outcomes of its previously announced pivotal pre-clinical study
using the LIBERTY Robotic Surgical System.
The
pivotal study was conducted by three leading interventional radiologists that utilized the LIBERTY Robotic Surgical System to reach a
total of 48 animal targets. In a series of visual testing, preformed 72 hours following each procedure, examination of the animals treated
with the LIBERTY Robotic Surgical System showed no visual evidence of vascular injury or any other visual adverse event.
This
new data follows the recently announced successful initial outcomes from the pivotal pre-clinical study. A total of 6 LIBERTY Systems
were used in the study, each was used to reach a total of 8 targets. All 6 LIBERTY Systems performed flawlessly based on the initial
outcomes, with 100% usability and technical success. No acute adverse events or complications were visually observed intra-operative.
The
Company expects to receive the comprehensive final report later this quarter. Subject to the final report, and the completion of the
verification and validation (V&V) process, the Company plans on submitting the Investigational Device Exemption (IDE) application
to the FDA, in order to commence its pivotal clinical trial in humans.
“
We are excited to share additional positive outcomes of our pivotal pre-clinical study. The absence of any visual evidence of vascular
injury in the follow-up examination after 72 hours continues to reaffirm the safety and effectiveness of our technology. This milestone,
together with the advancement of the verification and validation process, bring us one step closer to the submission of the IDE and commencing
our pivotal clinical trial in humans.” said Simon Sharon, Microbot’s GM & CTO.
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 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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