InspireMD Reports Third Quarter 2026 Financial Results
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
InspireMD (Nasdaq: NSPR) reported third-quarter 2026 revenue of $2.242 million and received FDA approval for CGuard Prime in transcarotid procedures. Revenue fell 11.1% year over year, while net loss narrowed to $9.762 million, or $0.12 per share, from $12.708 million, or $0.17 per share. Gross margin fell to 10.7% from 34.2%. U.S. revenue declined following the May 2026 voluntary recall of the CGuard Prime delivery system for carotid artery stenting.
The company expects U.S. sales of CGuard Prime for transcarotid arterial revascularization to begin in fourth-quarter 2026. Its redesigned carotid artery stenting delivery system remains in final testing, with an FDA supplement submission expected in December 2026 and a potential relaunch in first-half 2027. Nine-month revenue rose 27.1% to $7.411 million. Cash and marketable securities totaled $19.246 million at September 30, versus $54.211 million at year-end 2025.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointFDA approval permits CGuard Prime use in transcarotid arterial revascularization procedures.
- Moderate point. Forward-looking: it has not happened yet and may not happen.U.S. TCAR sales are expected to commence in fourth-quarter 2026.
- Moderate point. Forward-looking: it has not happened yet and may not happen.CAS delivery-system design changes were implemented; InspireMD expects December 2026 submission and potential first-half 2027 relaunch.
- Moderate pointQ3 international revenue increased 9.1% year over year to $2.210 million from $2.026 million.
- Moderate pointQ3 net loss narrowed to $9.762 million, or $0.12 per share, from $12.708 million, or $0.17.
- Moderate pointNine-month revenue rose 27.1% year over year to $7.411 million from $5.830 million.
11 minor points
- Minor pointCGUARDIANS II demonstrated 100% acute device success; no death, stroke, myocardial infarction or stent thrombosis at 30 days.
- Minor pointCGUARDIANS III enrollment continued, evaluating SwitchGuard neuroprotection for use with CGuard Prime in TCAR procedures.
- Minor pointOriginal CGuard continued advancing through FDA review for carotid artery stenting.
- Minor point. Forward-looking: it has not happened yet and may not happen.Proprietary micro puncture kit introduction is anticipated to support vascular access.
- Minor pointQ3 research and development expenses fell to $3.273 million from $3.635 million a year earlier.
- Minor pointQ3 selling and marketing expenses fell to $2.394 million from $4.392 million a year earlier.
- Minor pointQ3 general and administrative expenses fell to $3.452 million from $5.888 million a year earlier.
- Minor pointNine-month U.S. revenue increased to $859,000 from $551,000 a year earlier.
- Minor pointNine-month international revenue increased 24.1% year over year to $6.552 million from $5.279 million.
- Minor pointNine-month general and administrative expenses fell to $12.329 million from $16.157 million a year earlier.
- Minor pointNine-month financial income, net increased to $601,000 from $505,000 a year earlier.
Negative
- Major pointNine-month net loss widened to $37.775 million from $37.025 million, despite per-share loss narrowing to $0.45 from $0.64.
- Moderate pointCash and marketable securities fell to $19.246 million at September 30, 2026, from $54.211 million at December 31, 2025.
- Moderate pointQ3 revenue declined 11.1% year over year to $2.242 million from $2.523 million.
- Moderate pointQ3 U.S. revenue fell to $32,000 from $497,000 a year earlier, reflecting the May 2026 voluntary recall.
- Moderate pointQ3 gross profit fell to $240,000 from $864,000; margin declined to 10.7% from 34.2% a year earlier.
- Moderate pointRestructuring and termination costs associated with workforce reduction totaled $1.074 million in Q3 2026. 2.9% of market cap
- Moderate pointNine-month gross profit fell to $153,000 from $1.469 million; margin declined to 2.1% from 25.2% a year earlier.
4 minor points
- Minor point. Forward-looking: it has not happened yet and may not happen.CAS delivery-system relaunch depends on final validation, performance testing and the planned FDA supplement submission.
- Minor pointQ3 financial income, net declined to $191,000 from $343,000 a year earlier.
- Minor pointNine-month research and development expenses rose to $12.331 million from $11.528 million a year earlier.
- Minor pointNine-month selling and marketing expenses rose to $12.795 million from $11.314 million a year earlier.
News Explained
FDA approval of InspireMD’s CGuard Prime for TCAR is in place, adding a U.S. use that the company says expands its addressable market by over 35,000 procedures annually and approximately doubles the U.S. opportunity.
Details
Market Reaction – NSPR
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Key Figures
- Additional annual TCAR procedures
- Over 35,000 procedures annually
- Addressable market opportunity from the approved TCAR indication
- Acute device success
- 100%
- CGUARDIANS II pivotal trial
- Reported events at 30 days
- Zero deaths, strokes, myocardial infarctions or stent thromboses
- CGUARDIANS II pivotal trial
- Q3 total revenue
- $2,242,000; down 11.1%
- Third quarter 2026 versus third quarter 2025
- Q3 international revenue
- $2,210,000; up 9.1%
- Third quarter 2026 versus third quarter 2025
- Q3 gross profit
- $240,000, or 10.7% of revenue
- Compared with $864,000, or 34.2% of revenue, in third quarter 2025
- Q3 net loss
- $9,762,000, or $0.12 per share
- Compared with a net loss of $12,708,000, or $0.17 per share, in third quarter 2025
- Cash and marketable securities
- $19,246,000
- As of September 30, 2026; compared with $54,211,000 as of December 31, 2025
Previous Earnings Reports
-
Recall credits and inventory impairment contributed to a gross loss and wider quarterly net loss.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
transcarotid arterial revascularization medical
myocardial infarction medical
stent thrombosis medical
premarket approval regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Received FDA approval of CGuard® Prime for Transcarotid Arterial Revascularization (TCAR) procedures, expected to approximately double the U.S. addressable market -
- Company to host investor conference call today, November 12th, at 4:30pm ET -
MIAMI, Nov. 12, 2026 (GLOBE NEWSWIRE) -- 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 three and nine months ended September 30, 2026.
Recent Business Highlights:
- Received U.S. Food and Drug Administration (“FDA”) approval of the CGuard® Prime TransCarotid Stent System (“CGuard Prime for TCAR”) for use in transcarotid arterial revascularization (“TCAR”) procedures, marking the return of the CGuard Prime platform to the U.S. market. The approval for the TCAR indication expands the Company’s addressable market opportunity by over 35,000 procedures annually and is supported by CGUARDIANS II pivotal trial data, which demonstrated
100% acute device success and zero death, stroke, myocardial infarction or stent thrombosis reported at 30 days. InspireMD expects to commence U.S. sales promptly in the fourth quarter of 2026. - Generated continued strong international performance with revenue of
$2.2 million in the third quarter of 2026, compared with$2.0 million in the third quarter of 2025, an increase of9% year over year. - Announced two upcoming scheduled talks featuring the CGuard and the CGuard Prime platforms at VEITH symposium 2026, to be held November 17-21, 2026, in New York.
- Successfully implemented design changes to the delivery system of the CGuard Prime Carotid Stent System (“CGuard Prime for CAS”), which is approved for use in carotid artery stenting (“CAS”) procedures. The enhanced CGuard Prime for CAS is currently undergoing final validation and performance testing in support of a premarket approval (“PMA”) supplement that the Company expects to submit to the FDA in December 2026, with potential re-launch expected during the first half of 2027.
- Announced the appointment of commercial leader Kathleen Kennedy as Senior Vice President of Global Sales and Marketing in advance of anticipated U.S. launch of the CGuard Prime for TCAR and the expected relaunch of CGuard Prime for CAS.
- Continued enrollment in the Company’s CGUARDIANS III pivotal trial of its SwitchGuard neuroprotection system, for use with its CGuard Prime for TCAR procedures.
- Continued to advance the original CGuard carotid stent system for CAS procedures through the FDA regulatory review process.
“FDA approval of CGuard Prime for TCAR procedures represents a transformative milestone for InspireMD, enabling the launch of our next-generation carotid implant that incorporates the latest carotid technology into a rapidly growing TCAR market,” stated Marvin Slosman, Chief Executive Officer of InspireMD. “We believe CGuard Prime for TCAR, supported by the results of our CGUARDIANS II pivotal trial, supports our mission to most effectively ‘treat the lesion’ with our advanced carotid implant, and, with its best-in-class evidence, paves the way for our return to the U.S. commercial market, strengthens our competitive position and advances our vision of establishing CGuard Prime as a leading platform for carotid intervention.”
“Building on this milestone, we remain focused on expanding our product portfolio and pipeline across both TCAR and CAS procedures. We continue to advance enhancements to our CGuard Prime for CAS delivery system, with submission of a PMA supplement to the FDA anticipated before year-end, while progressing our CGUARDIANS III pivotal trial evaluating our proprietary SwitchGuard neuroprotection system for TCAR procedures. We are also anticipating the introduction of a proprietary micro puncture kit, designed to support vascular access, a critical step in procedural success. Together, these initiatives reflect our commitment to building a comprehensive carotid intervention platform, with the goal of providing physicians with a broad range of solutions to address the diverse needs of patients undergoing carotid revascularization.”
Financial Results for the Third Quarter Ended September 30, 2026
For the third quarter of 2026, total revenue was
International revenue was
Gross profit (revenue less cost of revenue) for the third quarter of 2026 was
Total operating expenses for the third quarter of 2026 were
Financial income, net, for the third quarter of 2026 was
Net loss for the third quarter of 2026 totaled
As of September 30, 2026, cash and cash equivalents and marketable securities totaled
Financial Results for the Nine Months Ended September 30, 2026
For the first nine months of 2026, total revenue increased by
Gross profit (revenue less cost of revenue) for the nine months ended September 30, 2026 was
Total operating expenses for the nine months ended September 30, 2026 were
Financial income, net, for the nine months ended September 30, 2026 was
Net loss for the nine months ended September 30, 2026 totaled
Conference Call and Webcast Details
Management will host a conference call at 4:30 pm ET today, November 12th, to review financial results and provide an update on corporate developments. Following management’s formal remarks, there will be a question-and-answer session.
Parties interested in participating by phone should register using this online form. After registering for the webcast, dial-in details will be provided in an auto-generated e-mail containing a link to the conference phone number along with a personal pin.
A live audio webcast and an archive of the recording will be available here and through the Investors page of InspireMD’s corporate website at https://investors.inspiremd.com. Interested participants are encouraged to register more than 15 minutes before the start of the call.
About InspireMD, 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-looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, future financial 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. In particular, forward-looking statements in this press release include the Company’s expectations regarding the commencement and timing of U.S. sales of CGuard Prime for TCAR; the size of the addressable market opportunity for CGuard Prime for TCAR; the Company’s planned submission of a PMA supplement to the FDA for the enhanced CGuard Prime for CAS and the timing of the potential relaunch thereof; the continued enrollment and advancement of the CGUARDIANS III pivotal trial evaluating the Company’s SwitchGuard neuroprotection system; the advancement of the original CGuard carotid stent system through the FDA regulatory review process; the anticipated introduction of the Company’s proprietary micro puncture kit; the Company’s ability to compete effectively in the carotid intervention market and increase adoption of its products; the Company’s ability to establish CGuard Prime as a leading platform for carotid intervention; and the Company's strategic priorities, growth plans and future business prospects. 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’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with the voluntary U.S. recall of the CGuard Prime 135 cm delivery system, including current and future costs associated with the recall, including refunds or inventory write-off costs and other remediation costs, loss of sales and customers due to the recall or otherwise, our ability to effectively implement enhancements to CGuard Prime 135 cm delivery system, potential actions by regulators or other governmental entities associated with the recall, potential claims and lawsuits by customers and patients, including class action product liability lawsuits, other operational impacts and consequences of the recall, such as business disruption and distraction of management and other key employees; the Company’s history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of its liquidity to pursue its complete business objectives, and substantial doubt regarding its ability to continue as a going concern; the Company’s need to raise additional capital to meet its business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute our stockholders’ ownership interests; the clinical development, commercialization and market acceptance of the Company’s products; whether the clinical trial results for the Company’s products will be predictive of real-world results; an inability to secure and maintain regulatory approvals for the sale of the Company’s products; negative clinical trial results or lengthy product delays in key markets; the Company’s ability to 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 additional financing, including any unexpected costs or delays in the ongoing commercial launch of its products; the Company’s dependence on a single manufacturing facility and its ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from the Company’s current and planned clinical trials may not be sufficient to demonstrate that its technology is an attractive alternative to other procedures and products; intense competition in the Company’s industry, 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 potential technological 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 liability claims; product malfunctions; price increases for supplies and components; whether access to the Company’s products is achieved in 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 not be 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 in each jurisdiction; security, political and economic instability in the Middle East that could harm the Company’s business, including due to the current security situation in Israel; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; and changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements and the impact of such policies on the Company, its customers and suppliers, and the global economic environment. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Investor Contacts:
Jeff Warren
LifeSci Advisors
jwarren@lifesciadvisors.com
investor-relations@inspiremd.com
| CONDENSED CONSOLIDATED 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, | ||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||
| REVENUES | $ | 2,242 | $ | 2,523 | $ | 7,411 | $ | 5,830 | |||||
| COST OF REVENUES | 2,002 | 1,659 | 7,258 | 4,361 | |||||||||
| GROSS PROFIT | 240 | 864 | 153 | 1,469 | |||||||||
| OPERATING EXPENSES: | |||||||||||||
| Research and development | 3,273 | 3,635 | 12,331 | 11,528 | |||||||||
| Selling and marketing | 2,394 | 4,392 | 12,795 | 11,314 | |||||||||
| General and administrative | 3,452 | 5,888 | 12,329 | 16,157 | |||||||||
| Restructuring and other | 1,074 | - | 1,074 | - | |||||||||
| Total operating expenses | 10,193 | 13,915 | 38,529 | 38,999 | |||||||||
| LOSS FROM OPERATIONS | (9,953) | (13,051) | (38,376) | (37,530) | |||||||||
| FINANCIAL INCOME, net: | 191 | 343 | 601 | 505 | |||||||||
| NET LOSS | $ | (9,762) | $ | (12,708) | $ | (37,775) | $ | (37,025) | |||||
| NET LOSS PER SHARE - basic and diluted | $ | (0.12) | $ | (0.17) | $ | (0.45) | $ | (0.64) | |||||
| WEIGHTED AVERAGE NUMBER OF COMMON STOCK USED IN COMPUTING NET LOSS PER SHARE - basic and diluted | 85,616,203 | 73,466,501 | 84,701,615 | 58,245,368 | |||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS (2) | |||||||
| (Unaudited) | |||||||
| (U.S. dollars in thousands, except share and per share data) | |||||||
| September 30, | December 31, | ||||||
| 2026 | 2025 | ||||||
| ASSETS | |||||||
| CURRENT ASSETS: | |||||||
| Cash and cash equivalents | $ | 19,246 | $ | 8,939 | |||
| Marketable securities | - | 45,272 | |||||
| Accounts receivable: | |||||||
| Trade, net | 1,895 | 2,168 | |||||
| Other | 444 | 400 | |||||
| Prepaid expenses | 1,077 | 1,296 | |||||
| Inventory | 2,991 | 3,396 | |||||
| TOTAL CURRENT ASSETS | 25,653 | 61,471 | |||||
| NON-CURRENT ASSETS: | |||||||
| Long term deposit | 455 | 442 | |||||
| Property, plant and equipment, net | 3,947 | 3,584 | |||||
| Operating lease right of use assets | 2,254 | 2,758 | |||||
| Fund in respect of employee rights upon retirement | 1,259 | 1,149 | |||||
| TOTAL NON-CURRENT ASSETS | 7,915 | 7,933 | |||||
| TOTAL ASSETS | $ | 33,568 | $ | 69,404 | |||
| September 30, | December 31, | ||||||
| 2026 | 2025 | ||||||
| LIABILITIES AND EQUITY | |||||||
| CURRENT LIABILITIES: | |||||||
| Accounts payable and accruals: | |||||||
| Trade | 1,562 | 1,255 | |||||
| Other | 7,007 | 9,457 | |||||
| TOTAL CURRENT LIABILITIES | 8,569 | 10,712 | |||||
| LONG-TERM LIABILITIES- | |||||||
| Operating lease liabilities net of current maturities | 1,711 | 2,224 | |||||
| Liability for employee rights upon retirement and others | 1,536 | 1,267 | |||||
| TOTAL LONG-TERM LIABILITIES | 3,247 | 3,491 | |||||
| TOTAL LIABILITIES | 11,816 | 14,203 | |||||
| COMMITMENTS AND CONTINGENT LIABILITIES | |||||||
| EQUITY: | |||||||
| Common stock, par value | 5 | 4 | |||||
| Preferred C shares, par value 1,172,000 shares authorized at September 30, 2026 and December 31, 2025; 1,718 shares issued and outstanding at September 30, 2026 and December 31 2025 | * | * | |||||
| Additional paid-in capital | 361,814 | 357,489 | |||||
| Accumulated deficit | (340,067) | (302,292) | |||||
| Total equity | 21,752 | 55,201 | |||||
| Total liabilities and equity | $ | 33,568 | $ | 69,404 | |||
(1) All 2026 financial information is derived from the Company’s unaudited financial statements for the three and nine months ended September 30, 2026, included in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2025 financial information is derived from the Company’s unaudited financial statements for the three and nine months ended September 30, 2025, included in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.
(2) All September 30, 2026 financial information is derived from the Company’s 2026 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2025 financial information is derived from the Company’s 2025 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2025 filed with the Securities and Exchange Commission.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were InspireMD's third-quarter 2026 financial results?
InspireMD reported $2.242 million in revenue, down 11.1% year over year, and a net loss of $9.762 million, or $0.12 per basic and diluted share. The prior-year quarter had revenue of $2.523 million and a net loss of $12.708 million, or $0.17 per basic and diluted share.
When does InspireMD expect to launch CGuard Prime for TCAR in the United States?
InspireMD expects to commence U.S. sales of CGuard Prime for TCAR in fourth-quarter 2026. FDA approval covers use in transcarotid arterial revascularization procedures and marks the platform's return to the U.S. market.
What did InspireMD's CGUARDIANS II trial show?
CGUARDIANS II demonstrated 100% acute device success, with zero death, stroke, myocardial infarction or stent thrombosis reported at 30 days. The pivotal trial data supported FDA approval of CGuard Prime for TCAR.
Why did InspireMD's gross margin decline in 2026?
The gross-margin decline reflected the U.S. recall action and an international revenue mix involving countries with lower average selling prices. Third-quarter margin fell to 10.7% from 34.2% a year earlier; nine-month margin fell to 2.1% from 25.2%.