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FORM
CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
On May 1, 2026, InspireMD, Inc. (the “Company”) issued press releases announcing the events described in Item 8.01 of this Current Report on Form 8-K (“Form 8-K”). A copy of each of the press releases is furnished herewith as Exhibit 99.1 and Exhibit 99.2, respectively, to this Form 8-K and is incorporated by reference in this Item 7.01.
In accordance with General Instruction B.2 of Form 8-K, the information in this 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 May 1, 2026, the Company announced that it initiated a voluntary recall in the United States of its CGuard® Prime 135 cm carotid stent delivery system after determining during a controlled launch that the technical success of the delivery system during carotid artery stenting (“CAS”) procedures has not met performance expectations. The voluntary recall pertains specifically to the CGuard Prime 135 cm delivery system and does not include the CGuard stent implant.
On May 1, 2026, the Company announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (“IDE”) Application to initiate the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system (“NPS”), including next generation enhancements from the prior IDE approval, for use with its CGuard Prime 80 cm stent platform, in transcarotid artery revascularization (“TCAR”) procedures.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number | Description | |
| 99.1 | Press Release, dated May 1, 2026 | |
| 99.2 | Press Release, dated May 1, 2026 | |
| 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: May 1, 2026 | By: | /s/ Marvin Slosman |
| Name: | Marvin Slosman | |
| Title: | Chief Executive Officer |