Full Press Release Details
Reports Fourth Quarter and Full Year 2025 Financial Results
FL - March 18, 2026 - 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 fourth
quarter and year ended December 31, 2025.
Business Highlights:
| Generated revenue of $3.1 million in the fourth quarter of 2025, up 62% year-over-year. | ||
| Sustained strong commercial traction in the U.S. with the launch of CGuard Prime and continued growth in international demand for CGuard. | ||
| Supported over 500 cumulative carotid procedures utilizing CGuard Prime across leading hospitals and integrated delivery networks since launch. | ||
| Completed enrollment in CGUARDIANS II pivotal trial evaluating the safety and performance of CGuard Prime designed for use in transcarotid artery revascularization ("TCAR") procedures. | ||
| Submitted a PMA-S to the U.S. Food and Drug Administration ("FDA") seeking an approval for indications of use of CGuard Prime in TCAR procedures. | ||
| Published C-GUARDIANS manuscript of pivotal trial results in the Journal of the American College of Cardiology. |
continue to see robust early momentum in our U.S. business with CGuard Prime and growing demand internationally for CGuard as we build
a platform designed to position us to be a global leader in the treatment of carotid artery disease and the prevention of stroke,"
said Marvin Slosman, CEO of InspireMD. "In addition, we are committed to advancing CGuard Prime for use in TCAR procedures. Once
approved, this will potentially double our addressable U.S. market opportunity. We expect more catalysts in 2026 that may accelerate
the adoption of our next-generation stent platform and the growth of our business."
Results for the Fourth Quarter Ended December 31, 2025
the fourth quarter of 2025, total revenue was $3.1 million, representing an increase of 62%, as
compared to $1.9 million during the same period of 2024 and a sequential increase of 25% over the third quarter of 2025.
revenue for the fourth quarter of 2025 was $0.9 million, representing sequential growth of 74% during the Company's second quarter
of launch of CGuard Prime. International revenue was $2.3 million, a 17% increase over the fourth quarter of 2024, reflecting increased
penetration of international markets with CGuard.
profit for the fourth quarter of 2025 was $1.2 million, or 37.5% of revenue, compared to $0.5 million, or 24.1% of revenue, for the same
period of 2024. The increase in gross margin (gross profit as a percentage of revenue) was driven by a favorable shift in sales mix towards
significantly higher margin revenue from sales in the U.S.
operating expenses for the fourth quarter of 2025 were $13.3 million, an increase of $3.5 million, compared to $9.8 for the fourth quarter
of 2024. This increase was primarily due to greater headcount-related expenses for the U.S. commercial team, as well as additional investment
in resources and infrastructure to support the U.S. commercial launch of CGuard Prime.
income, net for the fourth quarter of 2025 was $0.4 million, an increase of $0.1 million, compared to financial income of $0.3 million
for the fourth quarter of 2024. This increase was primarily due to an increase in financial income from investments in marketable securities
and money market funds, partially offset by an increase in financial expenses related to changes in exchange rates.
loss for the fourth quarter of 2025 was $11.8 million or $0.14 per basic and diluted share, compared to a net loss of $9.2 million or
$0.19 per basic and diluted share, for the same period in 2024.
Results for the Year Ended December 31, 2025
the full year 2025, total revenue was $9.0 million, representing an
increase of 28%, as compared to $7.0 million during the full year 2024.
revenue for the full year 2025 was $1.4 million, representing the first two quarters of launch of CGuard Prime in the U.S. International
revenue was $7.6 million, an 8% increase over the full year 2024 driven by increasing sales of CGuard through distributors in key international
profit for the full year 2025 was $2.7 million, or 29.5% of revenue, compared to $1.5 million, or 21.5% of revenue, for the full year
2024. Gross margin was driven by a favorable shift in sales mix towards significantly higher margin revenue from sales in the U.S.
operating expenses for the full year 2025 were $52.3 million, an increase of $17.3 million, compared to $35.0 million for the full year
2024. This increase was primarily due to greater headcount-related expenses for the U.S. commercial team, as well as additional resources
and infrastructure to support the U.S. commercial launch of CGuard Prime.
income, net for the full year 2025 was $0.9 million, a decrease of $0.7 million compared to financial income of $1.6 million for the
full year 2024. This decrease was primarily due to a decrease in financial income from investments in marketable securities and money
market funds and an increase in financial expenses related to changes in exchange rates.
loss for the full year 2025 was $48.8 million or $0.76 per basic and diluted share, compared to a net loss of $32.0 million or $0.76
per basic and diluted share, for the full year 2024.
of December 31, 2025, cash and cash equivalents and marketable securities were $54.2 million compared to $34.6 million as of December
Company is providing its initial expectations for full year 2026. Management currently expects revenue for the full year 2026 to be
in the range of $13 million to $15 million, reflecting expected revenue growth of approximately 45% to 65% over 2025.
revenue guidance provided above constitutes forward-looking statements and actual results may differ materially. Refer to the
"Forward-looking Statements" safe harbor section below for information on the factors that could cause the
Company's actual results to differ materially from these forward-looking statements, as well as our Form 10-K for the fiscal year ended December 31,
2025, including in "Management's Discussion and Analysis of Financial Condition and Results of Operations Liquidity
and Capital Resources" and "Risk Factors", for further context.
Call and Webcast Details
will host a conference call at 8:30 am ET today, March 18th, to review financial results and provide an update on corporate
developments. Following management's formal remarks, there will be a question-and-answer session. A live audio webcast and an archive
of the recording will be available through the Investors page of InspireMD's corporate website at https://investors.inspiremd.com.
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.
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 anticipated revenues and other results for the full year 2026. 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 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 out 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