8-K
InspireMD, Inc. (NSPR)
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): November4, 2025
InspireMD, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
| 001-35731 | 26-2123838 |
|---|---|
| (Commission<br><br> <br>File Number) | (IRS Employer<br><br> <br>Identification No.) |
| 6303 Waterford District Drive, Suite 215<br><br> <br>Miami, Florida | 33126 |
| --- | --- |
| (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 2.02 Results of Operations and Financial Condition
On November 4, 2025, InspireMD, Inc. (the “Company”) issued a press release announcing its financial and operating results and recent highlights for the three and nine months ended September 30, 2025. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
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 2.02 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 7.01 Regulation FD Disclosure.
On November 4, 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/.
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 shall not be deemed to be “filed” for the purposes of Section 18 of 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 November 4, 2025 (furnished herewith pursuant to Item 2.02) |
| 99.2 | Investor Presentation November 2025 (furnished herewith pursuant to Item 7.01) |
| 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 4, 2025 | By: | /s/ Michael Lawless |
| Name: | Michael Lawless | |
| Title: | Chief Financial Officer |
Exhibit99.1
InspireMDReports Third Quarter 2025 Financial Results
—
Successfulinitial CGuard Prime U.S. commercial launch drives record quarterly revenue
—
Miami,FL — November 4, 2025 – InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced financial and operating results for the third quarter and nine months ended September 30, 2025.
RecentBusiness Highlights:
| ● | Initiated<br> U.S. commercial launch of the CGuard Prime carotid stent system |
|---|---|
| ● | Completed<br> over 100 U.S. carotid procedures across leading hospitals |
| ● | Strengthened<br> leadership team with the appointment of Peter A. Soukas, M.D., as Chief Medical Officer |
| ● | Appointed<br> Dan Dearen to the Board of Directors as audit committee chairman bringing valuable experience<br> to InspireMD |
MarvinSlosman, CEO of InspireMD, commented: “Our business demonstrated strong growth across all geographies in the third quarter of 2025. Over the last few months, our team executed our planned U.S. commercial launch of our CGuard Prime carotid stent system, which delivered measurable revenue in our initial commercial quarter in the United States. We continue to see strong demand for our solutions globally, validating our mission as we work to transform the carotid intervention market with a stent first approach.”
“Further, with the addition of $58 million in gross proceeds to our balance sheet, as announced in July, we are able to continue adding top-tier talent and executing our commercial rollout with intention, purpose, and stamina. We are entering a new era of growth, and I am confident that this team and technology can deliver immense value over the years ahead.”
FinancialResults for the Third Quarter Ended September 30, 2025
For the third quarter of 2025, total revenue increased by 39%, to $2.5 million as compared to $1.8 million during the same period of last year.
U.S. revenue for the third quarter was $497,000 and international revenue was $2.0 million. This increase was predominantly attributable to CGuard Prime revenue in the U.S., increased penetration of international markets with CGuard, and the favorable impact of changes in foreign exchange rates.
Gross profit (revenue less cost of revenues) for the third quarter of 2025 was $864,000 an increase of $450,000 compared to $414,000 for the third quarter of 2024. This increase in gross profit resulted from an increase in revenue and a favorable shift in sales mix towards higher margin revenue from the Company’s U.S. commercial launch, partially offset by higher production variances and training costs.
Total operating expenses for the third quarter of 2025 were $13.9 million an increase of 57% compared to $8.9 million for the third quarter of 2024. This increase was primarily due to increases in headcount-related expenses as the Company continued to expand its U.S. personnel, particularly its commercial team, to drive the U.S. commercial launch of CGuard Prime. A second driver of the increase in operating expenses was occupancy and related infrastructure expense related to the establishment of the Company’s U.S. headquarters.
Financial income, net for the third quarter of 2025 was $343,000, a decrease of 40% compared to financial income of $572,000 for the third quarter of 2024. This decrease was primarily due to a $118,000 decrease in financial income from investments in marketable securities and money market funds and a $104,000 increase in financial expenses related to changes in exchange rates.
Net loss for the third quarter of 2025 was $12.7 million or $0.17 per basic and diluted share, compared to a net loss of $7.9 million or $0.16 per basic and diluted share, for the same period in 2024.
As of September 30, 2025, cash and cash equivalents and marketable securities were $63.4 million compared to $34.6 million as of December 31, 2024.
ConferenceCall and Webcast Details
Management will host a conference call at 8:30 am ET today, November 4^th^, to review financial results and provide an update on corporate developments. Following management’s formal remarks, there will be a question-and-answer session.
Tuesday,November 4^th^ at 8:30 a.m. ET
| Domestic: | 1-800-579-2543 |
|---|---|
| International: | 1-785-424-1789 |
| Conference ID: | IMD3Q25 |
| Webcast: | Webcast Link – Click<br> Here |
AboutInspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet ™ mesh 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 Nasdaq under the ticker symbol NSPR. We routinely post information that may be important to investors on the Company’s website. For more information, please visit www.inspiremd.com.
Forward-lookingStatements
Thispress release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statementsregarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, futurefinancial performance, strategies, expectations, competitive environment and regulation. 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 guarantees of future performance,are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’scontrol, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or impliedby such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated withthe Company’s history of recurring losses and negative cash flows from operating activities, significant future commitments andthe uncertainty regarding the adequacy of its liquidity to pursue its complete business objectives, and substantial doubt regarding itsability to continue as a going concern; the Company’s need to raise additional capital to meet its business requirements in thefuture and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; theclinical development, commercialization and market acceptance of the Company’s products; whether the clinical trial results forthe Company’s products will be predictive of real-world results; an inability to secure and maintain regulatory approvals for thesale of the Company’s products; negative clinical trial results or lengthy product delays in key markets; the Company’s abilityto maintain compliance with the Nasdaq listing standards; the Company’s ability to generate significant revenues from its products;estimates of the Company’s expenses, future revenues, capital requirements and its needs for and ability to access sufficient additionalfinancing, including any unexpected costs or delays in the ongoing commercial launch of its products; the Company’s dependenceon a single manufacturing facility and its ability to comply with stringent manufacturing quality standards and to increase productionas necessary; the risk that the data collected from the Company’s current and planned clinical trials may not be sufficient todemonstrate that its technology is an attractive alternative to other procedures and products; intense competition in the Company’sindustry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical,manufacturing, marketing and sales, distribution and personnel resources than it does; entry of new competitors and products and potentialtechnological obsolescence of the Company’s products; inability to carry out research, development and commercialization plans;loss of a key customer or supplier; technical problems with the Company’s research and products and potential product liabilityclaims; product malfunctions; price increases for supplies and components; whether access to the Company’s products is achievedin a commercially viable manner and whether its products receive adequate reimbursement by governmental and other third-party payers;the Company’s efforts to successfully obtain and maintain intellectual property protection covering its products, which may notbe successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions;the fact that the Company conducts business in multiple foreign jurisdictions, exposing it to foreign currency exchange rate fluctuations,logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability ineach jurisdiction; security, political and economic instability in the Middle East that could harm the Company’s business, includingdue to the current security situation in Israel; current or future unfavorable economic and market conditions and adverse developmentswith respect to financial institutions and associated liquidity risk; and changes in tariffs, trade barriers, price and exchange controlsand other regulatory requirements and the impact of such policies on the Company, its customers and suppliers, and the global economicenvironment. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statementsis set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Reporton Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of chargeon the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-lookingstatements as a result of new information, future events or otherwise.
InvestorContacts:
Webb Campbell
Gilmartin Group LLC
Webb@gilmartinir.com
investor-relations@inspiremd.com
CONDENSEDCONSOLIDATED STATEMENTS OF OPERATIONS ^(1)^
(Unaudited)
(U.S. dollars in thousands, except share and per share data)
| Three months ended | Nine months ended | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| September 30, | September 30, | |||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||
| Revenues | $ | 2,523 | $ | 1,810 | $ | 5,830 | $ | 5,060 | ||||
| Cost of revenues | 1,659 | 1,396 | 4,361 | 4,023 | ||||||||
| Gross Profit | 864 | 414 | 1,469 | 1,037 | ||||||||
| Operating Expenses: | ||||||||||||
| Research and development | 3,635 | 3,915 | 11,528 | 9,941 | ||||||||
| Selling and marketing | 4,392 | 1,472 | 11,314 | 4,154 | ||||||||
| General and administrative | 5,888 | 3,489 | 16,157 | 11,078 | ||||||||
| Total operating expenses | 13,915 | 8,876 | 38,999 | 25,173 | ||||||||
| Loss from operations | (13,051 | ) | (8,462 | ) | (37,530 | ) | (24,136 | ) | ||||
| Financial income, net | 343 | 572 | 505 | 1,305 | ||||||||
| Net Loss | $ | (12,708 | ) | $ | (7,890 | ) | $ | (37,025 | ) | $ | (22,831 | ) |
| Net loss per share – basic and diluted | $ | (0.17 | ) | $ | (0.16 | ) | $ | (0.64 | ) | $ | (0.58 | ) |
| WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic and diluted | 73,466,501 | 48,369,412 | 58,245,368 | 39,413,004 |
CONDENSEDCONSOLIDATED BALANCE SHEETS ^(1)^
(Unaudited)
(U.S. dollars in thousands, except share and per share data)
| September 30, 2025 | December 31, 2024 | |||
|---|---|---|---|---|
| ASSETS | ||||
| Current Assets: | ||||
| Cash and cash equivalents | $ | 63,403 | $ | 18,916 |
| Marketable securities | - | 15,721 | ||
| Accounts receivable: | ||||
| Trade, net | 1,961 | 1,572 | ||
| Other | 475 | 682 | ||
| Prepaid expenses | 945 | 1,060 | ||
| Inventory | 3,607 | 2,570 | ||
| Total current assets | 70,391 | 40,521 | ||
| Non-current assets: | ||||
| Long term deposit | 438 | 426 | ||
| Property, plant and equipment, net | 3,403 | 2,371 | ||
| Operating lease right of use assets | 2,915 | 2,360 | ||
| Funds in respect of employee rights upon retirement | 1,325 | 1,129 | ||
| Total non-current assets | 8,081 | 6,286 | ||
| Total assets | $ | 78,472 | $ | 46,807 |
CONDENSEDCONSOLIDATED BALANCE SHEETS ^(1)^
(Unaudited)
(U.S. dollars in thousands, except share and per share data)
| September 30, 2025 | December 31, 2024 | ||||
|---|---|---|---|---|---|
| LIABILITIES AND EQUITY | |||||
| Current liabilities: | |||||
| Accounts payable and accruals: | |||||
| Trade | 1,753 | $ | 1,254 | ||
| Other | 9,063 | 6,424 | |||
| Total current liabilities | 10,816 | 7,678 | |||
| Long-term liabilities: | |||||
| Operating lease liabilities net of current maturities | 2,367 | 1,796 | |||
| Liability for employee rights upon retirement and others | 1,175 | 1,247 | |||
| Total long-term liabilities | 3,542 | 3,043 | |||
| Total liabilities | 14,358 | $ | 10,721 | ||
| Equity: | |||||
| Common stock, par value 0.0001 per share; 150,000,000 shares authorized at September 30, 2025, and December 31, 2024; 41,919,141 and 26,611,033 shares issued and outstanding on September 30, 2025, and December 31, 2024, respectively | 4 | 3 | |||
| Preferred C shares, par value 0.0001 per share; 1,172,000 shares authorized at September 30, 2025, and December 31, 2024;<br> 1,718 shares issued and outstanding at September 30, 2025, and December 31, 2024, respectively | * | * | |||
| Additional paid-in capital | 354,641 | 289,589 | |||
| Accumulated deficit | (290,531 | ) | (253,506 | ) | |
| Total equity | 64,114 | 36,086 | |||
| Total liabilities and equity | 78,472 | $ | 46,807 |
All values are in US Dollars.
(1) All September 30, 2025, financial information is derived from the Company’s 2025 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on November 10, 2025. All December 31, 2024, financial information is derived from the Company’s 2024 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2024, filed with the Securities and Exchange Commission on March 12, 2025.
Exhibit99.2
