UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Item 7.01 Regulation FD Disclosure.
On November 1, 2023, InspireMD, Inc. (the “Company”) issued a press release titled “InspireMD Presents Positive 30-Day Follow-Up Results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) Clinical Trial at VIVA23”. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. A copy of the presentation that the Company presented at the Vascular InterVentional Advances meeting (“VIVA23”) is attached hereto as Exhibit 99.2 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 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.
On November 1, 2023, the Company presented 30-day results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) clinical trial at VIVA23.
From July 2021 to June 2023, 316 patients were prospectively enrolled in a single-arm carotid artery stenting study performed at 24 sites in the United States and the European Union. The primary endpoint in the clinical trial was a composite of: (1) incidence of major adverse events including death (all-cause mortality), any stroke, or myocardial infarction (“DSMI”) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure. Stenting with the C-Guard carotid stent system in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, measured from the date of the procedure through 30 days follow-up post-procedure.
The Company anticipates reporting primary endpoint results from C-GUARDIANS U.S. Investigational Device Exemption (IDE) clinical trial in the second half of 2024 that may support a premarket approval application with the U.S. Food and Drug Administration.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description | |
| 99.1 | Press release, dated November 1, 2023 (furnished herewith pursuant to Item 7.01) | |
| 99.2 | InspireMD VIVA23 Presentation, November 2023 | |
| 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: November 1, 2023 | By: | /s/ Craig Shore |
| Name: | Craig Shore | |
| Title: | Chief Financial Officer | |