Current Report Filing (8-k)
08 September 2020 - 9:39PM
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): September 8, 2020
InspireMD,
Inc.
(Exact
name of registrant as specified in its charter)
Delaware
|
|
001-35731
|
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26-2123838
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(State
or other jurisdiction
of
incorporation)
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(Commission
File
Number)
|
|
(IRS
Employer
Identification
No.)
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4
Menorat Hamaor St.
Tel
Aviv, Israel
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6744832
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(Address
of principal executive offices)
|
|
(Zip
Code)
|
(888)
776-6804
(Registrant’s
telephone number, including area code)
N/A
(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 exchange on
which registered
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Common Stock, par value $0.0001 per share
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NSPR
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NYSE American
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Warrants, exercisable for one share of Common Stock
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NSPR.WS
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NYSE American
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Series B Warrants, exercisable for one share of Common Stock
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NSPR.WSB
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NYSE American
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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 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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
September 8, 2020, InspireMD, Inc. (the “Company”) issued a press release reporting that it has received approval
from the U.S. Food and Drug Administration (FDA) of its Investigation Device Exemption (IDE), thereby allowing the Company to
proceed with a pivotal study of its CGuard™ Carotid Stent System, CARENET-III, for prevention of stroke in patients in the
United States.
A
copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed
on its behalf by the undersigned hereunto duly authorized.
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InspireMD,
Inc.
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Date:
September 8, 2020
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By:
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/s/
Craig Shore
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Name:
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Craig
Shore
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Title:
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Chief
Financial Officer
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