[8-K] InspireMD, Inc. Reports Material Event

Rhea-AI Filing Summary

InspireMD has received FDA Premarket Approval (PMA) for its CGuard Prime Carotid Stent System on June 23, 2025, marking a significant regulatory milestone. This approval follows their PMA application submitted on September 16, 2024.

Key developments include:

• FDA PMA approval for stroke prevention device
• Release of updated investor presentation available on company website
• Trading on Nasdaq Capital Market under symbol NSPR

The company issued a press release on June 24, 2025, announcing the approval. The filing includes two key exhibits: the press release and an updated investor presentation. This regulatory achievement potentially opens up the U.S. market for InspireMD's carotid stent system, representing a material development for the company's commercial prospects.

Positive

• FDA granted PMA approval for CGuard Prime Carotid Stent System, enabling market access to the significant U.S. stroke prevention market
• Major regulatory milestone achieved with full PMA approval, representing the highest level of FDA device authorization

Negative

• None.

false 0001433607 0001433607 2025-06-23 2025-06-23 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

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

FAQ

What FDA approval did NSPR receive on June 23, 2025?

NSPR received FDA Premarket Approval (PMA) for its CGuard Prime Carotid Stent System in the United States. This approval follows their PMA application submitted on September 16, 2024.

When did NSPR file the PMA application for CGuard Prime Carotid Stent System?

InspireMD (NSPR) submitted the Premarket Approval (PMA) application for the CGuard Prime Carotid Stent System to the FDA on September 16, 2024.

What is the purpose of NSPR's CGuard Prime Carotid Stent System?

According to the press release title mentioned in the 8-K filing, the CGuard Prime Carotid Stent System is designed for the prevention of stroke.

What materials did NSPR include with their June 24, 2025 8-K filing?

NSPR included three exhibits with their 8-K filing: 1) A press release dated June 24, 2025, 2) An updated investor presentation for June 2025, and 3) A Cover Page Interactive Data File embedded within the Inline XBRL document.

Where is NSPR's stock traded and what is its trading symbol?

NSPR's common stock, with a par value of $0.0001 per share, trades under the symbol 'NSPR' on The Nasdaq Capital Market LLC.