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

Rhea-AI Filing Summary

InspireMD, Inc. (NSPR) has filed a Form 8-K dated July 9, 2025 to furnish a Regulation FD disclosure.

Under Item 7.01, the company states that it has issued a press release entitled “InspireMD Announces U.S. Commercial Launch of CGuard® Prime Carotid Stent System for the Prevention of Stroke.” The full press release is included as Exhibit 99.1, but its text is not reproduced in the filing. Management emphasizes that the information is being furnished, not filed, meaning it is excluded from Exchange Act Section 18 liability and will not be incorporated into other SEC filings unless specifically referenced.

The filing contains no financial statements, guidance, or transaction details. The exhibit list consists of:

• 99.1 – Press Release (July 9, 2025)
• 104 – Cover Page Interactive Data File

Beyond the announcement of the U.S. commercial launch of CGuard Prime—InspireMD’s carotid stent designed to reduce stroke risk—no additional quantitative or strategic information is provided.

Insights

Medical Device Industry Specialist

TL;DR: U.S. launch of CGuard Prime signals a pivotal commercial milestone and potential revenue inflection for InspireMD.

The transition from development to full U.S. commercialization is typically a watershed moment for a medical-device company. CGuard Prime targets carotid artery disease, a sizable addressable market given stroke prevalence. FDA clearance had already been obtained; this 8-K confirms commercial readiness, which should unlock initial U.S. sales channels and reimbursement activities. Although the filing lacks sales projections, launching in the world’s largest med-tech market can materially accelerate topline growth and enhance competitive positioning against traditional bare-metal or covered stents. Success will hinge on physician adoption and payer coverage, but strategically this marks a positive catalyst.

Securities Analyst

TL;DR: Positive headline, but absence of financial or adoption data tempers near-term valuation impact.

The 8-K furnishes, rather than files, a press release—indicating management views the launch as noteworthy yet not requiring audited disclosure. Investors receive no revenue guidance, unit shipment targets, or margin implications, limiting the ability to model earnings impact. While the U.S. launch is intrinsically favorable, the materiality remains unquantified. Accordingly the market reaction may be modest until concrete sales metrics emerge in future earnings calls or 10-Q filings.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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): July 9, 2025

InspireMD, Inc.

(Exact name of registrant as specified in its charter)

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		6744832
(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.)

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. ☐

Item 7.01. Regulation FD Disclosure.

On July 9, 2025, the Company issued a press release titled “InspireMD Announces U.S. Commercial Launch of 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 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 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number		Description
99.1		Press Release, dated July 9, 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:	July 9, 2025	By:	/s/ Marvin Slosman
		Name:	Marvin Slosman
		Title:	Chief Executive Officer

FAQ

What did InspireMD (NSPR) announce in its July 9, 2025 Form 8-K?

The company disclosed the U.S. commercial launch of its CGuard® Prime Carotid Stent System via a furnished press release.

Does the 8-K include financial guidance related to the CGuard Prime launch?

No. The filing contains no revenue projections, earnings guidance, or financial statements.

Is the information in Item 7.01 considered "filed" with the SEC?

No. It is explicitly furnished, not filed, and is therefore not subject to Section 18 liabilities.

Where can investors find the full press release about CGuard Prime?

It is attached to the 8-K as Exhibit 99.1 dated July 9, 2025.

What exchange does InspireMD's common stock trade on and under what symbol?

InspireMD trades on the Nasdaq Capital Market under the ticker NSPR.