InspireMD, Inc. — Regulatory Filings 2024

Dec 9, 2024

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UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549

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FORM 8-K

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CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): December 9, 2024

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InspireMD, Inc.

(Exact name of registrant as specified in its charter)

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Delaware	001-35731	26-2123838
(State
or other jurisdiction of incorporation)	(Commission File
Number)	(IRS
Employer Identification No.)

| 6303

Waterford District Drive , Suite 215 Miami , Florida	33126
(Address
of principal executive offices)	(Zip
Code)

Registrant’s telephone number, including area code: (888) 776-6804

(Former name or former address, if changed since last report.)

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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, $0.0001 par value per share | NSPR | 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 (§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. ☐

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Item 7.01. Regulation FD Disclosure.

On December 9, 2024, InspireMD, Inc. (the “Company”) issued a press release titled “InspireMD Announces First Patient Enrolled in the CGUARDIANS II Pivotal Study of the CGuard Prime Carotid Stent System in Transcarotid Artery Revascularization Procedures (TCAR)”. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference in this Item 7.01.

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, 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.

On December 9, 2024, the Company announced that the first patient has been enrolled in the Company’s CGUARDIANS II clinical trial evaluating its CGuard Prime Carotid Stent System in patients undergoing carotid artery stenting via the Transcarotid Artery Revascularization (TCAR) approach.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

| Exhibit

Number	Description
99.1	Press
Release, dated December 9, 2024
104	Cover
Page Interactive Data File (embedded within the Inline XBRL document)

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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. — By: | /s/ Craig Shore | | --- | --- | | Name: | Craig Shore | | Title: | Chief Financial Officer |

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