8-K
InspireMD, Inc. (NSPR)
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): June 13, 2025
InspireMD,Inc.
(Exactname of registrant as specified in its charter)
| Delaware | 001-35731 | 26-2123838 |
|---|---|---|
| (State or other jurisdiction of incorporation) | (Commission<br><br> <br>File Number) | (IRS Employer Identification No.) |
| 6303 Waterford District Drive, Suite 215<br><br> <br>Miami, Florida 33126 | 6744832 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (888) 776-6804
(Formername 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br>material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br>communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br>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<br> Stock, $0.0001 par value per share | NSPR | The<br> 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 June 13, 2025, the Company issued a press release titled “InspireMD Announces CE Mark Approval for CGuard^®^ Prime Embolic Prevention System (EPS) Under European MDR 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 8.01 Other Events
On June 13, 2025, the Company announced that it received CE Mark approval under the European Medical Device Regulation (MDR) for the CGuard^®^ Prime EPS.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| ExhibitNumber | Description |
|---|---|
| 99.1 | Press Release, dated June 13, 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 13, 2025 | By: | /s/ Marvin Slosman |
| Name:<br><br> <br>Title: | Marvin Slosman <br><br>Chief Executive Officer |
Exhibit 99.1
InspireMD Announces CE Mark Approval for CGuard^®^Prime Embolic Prevention System (EPS) Under European MDR for the Prevention of Stroke
Miami, Florida — June 13, 2025 (GLOBE NEWSWIRE) – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard^®^ Prime carotid stent system for the prevention of stroke, today announced the company has received CE Mark approval under the European Medical Device Regulation (MDR) for the CGuard^®^Prime EPS.
CGuard Prime^®^ was developed incorporating extensive user feedback and optimizes deliverability and deployment of the proven CGuard stent. With its proprietary MicroNet™ mesh, CGuard is designed to reduce both early and late embolic events by trapping debris against the vessel wall, preventing plaque prolapse and embolization that can cause stroke.
“Securing CE Mark certification under the EU MDR is a major milestone that demonstrates InspireMD’s commitment to advancing our next generation platforms, regulatory rigor, and execution,” said Marvin Slosman, CEO of InspireMD. “This approval clears the path for the commercial launch of CGuard^™^Prime EPS across our current CE marked served markets, taking a pivotal step forward in our growth as a commercial-stage company and further strengthening our leadership in carotid stenting innovation. Additionally, this is the same platform that we intend to launch in the United States later this year, subject to FDA approval, enabling greater scale as we move towards offering a unified platform across our served markets”
About CGuard
The CGuard Embolic Prevention System (EPS) is a novel mesh-covered carotid stent designed to widen narrowed carotid arteries in patients who are at high risk for complications from surgery and need a less invasive treatment and to improve patient safety through sustained embolic protection. CGuard combines the largest open-cell frame of available carotid stents with the smallest mesh pore size, preventing plaque prolapse and embolization through the stent, for lasting protection demonstrated beyond five years.
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet^™^technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.
We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.
Forward-looking Statements
This press releasecontains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMDor its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, future financial performance,strategies, expectations, competitive environment and regulation, including potential FDA approval and potential U.S. commercial launch.Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,”“anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,”“hopes,” “potential”, “scheduled” or similar words. Forward-looking statements are not guaranteesof future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many ofwhich are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materiallyfrom those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks anduncertainties associated with our history of recurring losses and negative cash flows from operating activities; substantial doubt aboutour ability to continue as a going concern; significant future commitments and the uncertainty regarding the adequacy of our liquidityto pursue our complete business objectives; our need to raise additional capital to meet our business requirements in the future and suchcapital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance ofour products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results orlengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenuesfrom our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property;our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increaseproduction as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstratethat our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitorshaving substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing andsales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescenceof our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technicalproblems with our research and products and potential product liability claims; product malfunctions; price increases for supplies andcomponents; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfullyobtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and localgovernment regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multipleforeign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens andcosts of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel,which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adversedevelopments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and therisk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securitiesand Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investorsand security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumesno obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Investor Contact:
Webb Campbell
Gilmartin Group LLC
webb@gilmartinir.com
investor-relations@inspiremd.com