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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 24, 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
8.01 Other Events.
On
October 24, 2023, Microbot Medical Inc. (the “Company”) issued a press release announcing that it has received confirmation
for the commencement of the process to support its future CE Mark approval, and to ultimately allow the Company to market the LIBERTY®
Robotic Surgical System in Europe as well as other regions who accept the CE Mark.
According
to the confirmation, the Company will commence audits for ISO 13485 certification to ensure its compliance with the Quality Management
System (QMS) requirements of the EU Medical Devices Regulation (MDR 2017/745), during the first half of 2024. The Company had previously
taken the first step to advance its European program by engaging with a leading Notified Body, who recently confirmed dates for conducting
the required audits.
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.
(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:
October 24, 2023 |
|
Exhibit
99.1
Microbot
Medical Received Confirmation for the Commencement of Its CE Mark Approval Process During the First Half of 2024
The
Company’s designated Notified Body confirmed dates for conducting audits for ISO 13485 certification to ensure Microbot complies
with the QMS requirements of the EU MDR
The
Company expects that the full CE Mark approval process of obtaining clearance of sales in the European Union for the LIBERTY®
Robotic Surgical System, will be carried out in parallel with the FDA regulatory process
BRAINTREE,
Mass., October 24, 2023 – Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Robotic
Surgical System, today announces it has received confirmation for the commencement of the process to support its future CE Mark approval,
and to ultimately allow the Company to market the LIBERTY® Robotic Surgical System in Europe as well as other regions
who accept the CE Mark.
According
to the confirmation, the Company will commence audits for ISO 13485 certification to ensure its compliance with the Quality Management
System (QMS) requirements of the EU Medical Devices Regulation (MDR 2017/745), during the first half of 2024. The Company had previously
taken the first step to advance its European program by engaging with a leading Notified Body, who recently confirmed dates for conducting
the required audits.
The
audits for Microbot’s ISO 13485 certification will incorporate an off-site audit that includes a review of the Company’s
quality system and the LIBERTY® Robotic Surgical System Technical File, followed by an on-site audit at the Company’s
facilities.
“We
are confident that we have taken the right measures to successfully complete these audits, which will serve as the first step in our
commercial approval process for Europe as well as other regions across the globe which allow commercialization under the CE Mark,”
said Noa Ofer, Sr. Director QA/RA. “We intend that this process will be conducted in parallel with our FDA approval efforts, to
allow us to capture as many markets across the globe as we prepare for future commercialization.”
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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Microbot Medical (NASDAQ:MBOT)
過去 株価チャート
から 8 2024 まで 9 2024
Microbot Medical (NASDAQ:MBOT)
過去 株価チャート
から 9 2023 まで 9 2024