Current Report Filing (8-k)
January 27 2021 - 8:31AM
Edgar (US Regulatory)
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): January 27, 2021
MICROBOT
MEDICAL INC.
(Exact
name of registrant as specified in its charter)
Delaware
|
|
000-19871
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94-3078125
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(State
or other jurisdiction
of
incorporation)
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|
(Commission
File
Number)
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(IRS
Employer
Identification
No.)
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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:
[ ]
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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[ ]
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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[ ]
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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[ ]
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
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Trading
Symbol(s)
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Name
of each exchange on which registered
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Common
Stock, $0.01 par value
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MBOT
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NASDAQ
Capital Market
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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
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Regulation
FD Disclosure.
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On
January 27, 2021, Microbot Medical Inc. (the “Company”) issued a press release announcing the completion of successful
discussions with the U.S. Food and Drug Administration (FDA) for its Self-Cleaning Shunt (SCS). After review of the Company’s
existing pre-clinical data, the FDA’s feedback will allow the Company to apply for a limited clinical investigation known
as an Early Feasibility Study (EFS), which is designed for novel technologies such as the SCS. Consequently, the Company reiterates
its timeline for the First-in-Human (FIH) clinical trial under the EFS, expected to commence in the third quarter of 2022.
The
press release furnished as Exhibit 99.1 to this Current Report on Form 8-K is incorporated herein by reference. The information
in this report (including Exhibit 99.1) is being furnished pursuant to Item 7.01 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 herein (including Exhibit 99.1).
Item
9.01.
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Financial
Statements and Exhibits.
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(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.
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MICROBOT
MEDICAL INC.
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By:
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/s/
Harel Gadot
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Name:
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Harel
Gadot
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Title:
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Chief
Executive Officer, President and Chairman
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Date:
January 27, 2021
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