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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 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): June 23, 2025
InspireMD,
Inc.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
(State
or Other Jurisdiction of Incorporation)
| 001-35731 |
|
26-2123838 |
(Commission
File Number) |
|
(IRS
Employer
Identification No.) |
4
Menorat Hamaor St.
Tel Aviv, Israel |
|
6744832 |
| (Address
of Principal Executive Offices) |
|
(Zip
Code) |
(888)
776-6804
(Registrant’s
Telephone Number, Including Area Code)
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, par value $0.0001 per share |
|
NSPR |
|
The
Nasdaq Capital Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in 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
7.01 Regulation FD Disclosure.
On
June 24, 2025, InspireMD, Inc. (the “Company”) issued a press release titled “InspireMD Announces FDA PMA Approval
for CGuard Prime Carotid Stent System for the Prevention of Stroke”. A copy of the press release is furnished herewith as Exhibit
99.1 to this Current Report on Form 8-K and is incorporated by reference in this Item 7.01. Additionally, on June 24, 2025, the Company
made available an updated investor presentation. A copy of the presentation is attached hereto as Exhibit 99.2 and incorporated by reference
in this Item 7.01. A copy of the presentation is also available on the Company’s website https://www.inspiremd.com/en/investors/investor-relations/.
In
accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K that is furnished pursuant to
this Item 7.01, including Exhibit 99.1 and Exhibit 99.2, shall not be deemed to be “filed” for the purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that
section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act
of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item
8.01 Other Events.
As
previously disclosed on September 16, 2024, the Company submitted a premarket approval (“PMA”) application for its the CGuard
Prime carotid stent system to the U.S. Food and Drug Administration (the “FDA”). On June 23, 2025, the Company received PMA
approval of the CGuard Prime Carotid Stent System in the United States from the FDA.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
| Exhibit
Number |
|
Description |
| 99.1 |
|
Press release, dated June 24, 2025 |
| 99.2 |
|
Investor Presentation June 2025 |
| 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 hereunto duly authorized.
| |
INSPIREMD,
INC. |
| |
|
| Date:
June 24, 2025 |
By: |
/s/
Marvin Slosman |
| |
Name: |
Marvin
Slosman |
| |
Title: |
Chief
Executive Officer |
