Full Press Release Details
Reports First Quarter 2026 Financial Results
Reports total Q1 2026 revenue of $3.4 million, representing year-over-year growth of 122% -
Received IDE approval from FDA to initiate the CGUARDIANS III clinical trial of its SwitchGuard neuro protection system for use in TCAR
FDA approval of the original CGuard delivery system anticipated in Q3 2026 -
On track for expected FDA approval of the CGuard Prime 80 cm for TCAR procedures in H2 2026, potentially doubling the Company's
addressable market -
FL - May 4, 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 first
quarter ended March 31, 2026.
Business Highlights:
first quarter results reflect strong underlying demand and consistent clinical outcomes for our CGuard carotid stent implant both in
the U.S. and internationally," stated Marvin Slosman, Chief Executive Officer of InspireMD. "While our decision to voluntarily
pause commercialization of CGuard Prime 135 cm in the U.S. will impact its availability in the short term, we are in the process of implementing
several enhancements to the delivery system that we are confident will elevate technical performance and accelerate rapid adoption. Importantly,
our TCAR program is unaffected by this voluntary action, and we were also pleased to have recently received FDA approval to initiate
the CGUARDIANS III clinical trial with our SwitchGuard NPS, which, if successful, would enable us to offer a full TCAR tool kit leveraging
our best-in-class implant."
parallel, we are pursuing FDA approval of our commercially-proven CGuard stent delivery system which we anticipate in the third quarter
of 2026. This delivery system was successfully used in over 70,000 implants globally. Having this additional delivery system available
in the U.S. will enable us to offer physicians multiple options to deliver the best implant to their patients," Mr. Slosman concluded.
Results for the First Quarter Ended March 31, 2026
the first quarter of 2026, total revenue was $3.4 million, representing an increase of 122%, as compared to $1.5 million during the same
revenue for the first quarter of 2026 was $1.2 million, representing a quarter-over-quarter increase of 36% as compared to $0.9 million
for the fourth quarter of 2025. International revenue was $2.2 million, representing a year-over-year increase of 48%, as compared to
$1.5 million for the first quarter of 2025.
profit for the first quarter of 2026 was $0.7 million, or 20.2% of revenue, compared to $0.3 million, or 19.1% of revenue, for the same
period of 2025. 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., offset by an inventory impairment charge of $0.5 million. On a non-GAAP basis,
which excludes the impact of the impairment charge as calculated in the attached non-GAAP reconciliation table, adjusted gross profit
was $1.2 million, or 34.1% of revenue.
operating expenses for the first quarter of 2026 were $14.7 million, an increase of $2.9 million, compared to $11.8 million for the first
quarter of 2025. 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 U.S. commercialization.
income, net, for the first quarter of 2026 was $0.3 million, roughly flat with the first quarter of 2025.
loss for the first quarter of 2026 was $13.7 million, or $0.16 per basic and diluted share, compared to a net loss of $11.2 million,
or $0.22 per basic and diluted share, for the same period in 2025.
Company currently expects the financial impact of the U.S. recall of CGuard Prime to include a reserve
for customer returns of approximately $700,000 and a reserve for inventory impairment and remediation costs of approximately $650,000.
Call and Webcast Details
will host a conference call at 4:30 pm ET today, May 4th, 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 here and 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 expectations regarding potential FDA approvals for original CGuard and the CGuard Prime 80 cm stent for TCAR procedures,
the Company's expectations regarding enhancements to the CGuard Prime 135 cm delivery system, the Company's beliefs regarding
the potential adoption of its products, statements relating to the Company's addressable markets and the Company's expectations
regarding reserves for customer returns and inventory impairment and remediation as result of the U.S. recall of CGuard Prime. 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
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 statements as a result of new information, future events or otherwise.
supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. Generally Accepted Accounting
Principles ("GAAP"), this press release and the accompanying tables include supplemental financial information, referred
to as non-GAAP financial measure, that have not been prepared in accordance GAAP, including adjusted gross profit. The Company believes
that the use of non-GAAP accounting measures is useful to its investors as an additional tool to enhance the overall understanding of