Exhibit 99.1
InspireMD
Reports Third Quarter 2026 Financial Results
-
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,
FL — November 12, 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 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 of 9% 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 $2,242,000, a decrease of $281,000, or 11.1%, compared to $2,523,000 for the third quarter
of 2025.
International
revenue was $2,210,000, an increase of $184,000, or 9.1%, compared to $2,026,000 for the third quarter of 2025. U.S. revenue for the
third quarter of 2026 was $32,000, compared to $497,000 for the third quarter of 2025. The U.S. sales comparison reflects the impact
of the voluntary recall of the delivery system of the CGuard Prime for CAS in May 2026.
Gross
profit (revenue less cost of revenue) for the third quarter of 2026 was $240,000, or 10.7% of revenue, compared to gross profit of $864,000,
or 34.2% of revenue, for the third quarter of 2025. This decline reflects the impact of the U.S. recall action during the third quarter
of 2026 and the mix within international revenue to countries with a lower average sales price. Cost of revenues was $2,002,000 compared
with $1,659,000 in the prior-year period.
Total
operating expenses for the third quarter of 2026 were $10,193,000, a decrease of $3,722,000, or 26.7%, compared to $13,915,000 for the
third quarter of 2025. Third-quarter 2026 operating expenses included $1,074,000 in restructuring expenses and related termination costs
associated with the Company’s workforce reduction. Research and development expenses were $3,273,000, compared to $3,635,000, selling
and marketing expenses were $2,394,000, compared to $4,392,000, and general and administrative expenses were $3,452,000, compared to
$5,888,000.
Financial
income, net, for the third quarter of 2026 was $191,000, compared to financial income, net, of $343,000 for the third quarter of 2025.
Net
loss for the third quarter of 2026 totaled $9,762,000, or $0.12 per basic and diluted share, compared to a net loss of $12,708,000, or
$0.17 per basic and diluted share, for the same period in 2025.
As
of September 30, 2026, cash and cash equivalents and marketable securities totaled $19,246,000, compared to $54,211,000 as of December
31, 2025.
Financial
Results for the Nine Months Ended September 30, 2026
For
the first nine months of 2026, total revenue increased by $1,581,000, or 27.1%, to $7,411,000, from $5,830,000 for the same period of
2025. U.S. revenue was $859,000, compared with $551,000 in the prior-year period, while international revenue was $6,552,000, an increase
of $1,273,000, or 24.1%, from $5,279,000 for the first nine months of 2025.
Gross
profit (revenue less cost of revenue) for the nine months ended September 30, 2026 was $153,000, or 2.1% of revenue, compared to gross
profit of $1,469,000, or 25.2% of revenue, for the same period of 2025. This decline reflects the impact of the mix of revenue in the
nine months ended September 30, 2026 due to the U.S. recall action and the mix within international revenue to countries with a lower
average sales price. Cost of revenue was $7,258,000 compared with $4,361,000 for the prior year period.
Total
operating expenses for the nine months ended September 30, 2026 were $38,529,000, a decrease of $470,000, or 1.2%, compared to $38,999,000
for the nine months ended September 30, 2025. These expenses included $1,074,000 of restructuring and other expenses in 2026. Research
and development expenses were $12,331,000, compared to $11,528,000, selling and marketing expenses were $12,795,000, compared to $11,314,000,
and general and administrative expenses were $12,329,000, compared to $16,157,000.
Financial
income, net, for the nine months ended September 30, 2026 was $601,000, compared to $505,000 for the same period of 2025.
Net
loss for the nine months ended September 30, 2026 totaled $37,775,000, or $0.45 per basic and diluted share, compared to a net loss of
$37,025,000, or $0.64 per basic and diluted share, for the same period in 2025.
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 September 30, | | |
Nine months ended 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 $0.0001 per share; 250,000,000 and 150,000,000 shares authorized at September 30, 2026 and December 31, 2025; 47,119,438 and 43,532,281 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively | |
| 5 | | |
| 4 | |
Preferred C shares, par value $0.0001 per share;
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.
