NSPR

EX-99.1

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EX-99.1

Exhibit 99.1

InspireMD Reports Second Quarter 2026 Financial Results

- Company to host investor conference call today, August 17th, at 8:30am EDT -

Miami, FL — August 17, 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 six months ended June 30, 2026.

Recent Business Highlights:

●Generated revenue of $1.8 million in the second quarter of 2026, in line with the second quarter of 2025. Robust growth of 21% in international markets was driven by broad-based increases in demand across most countries, offset by the impact of the voluntary recall in the U.S. of the CGuard Prime 135 cm delivery system in May.

●Announced the appointment of carotid intervention commercial leader Kathleen Kennedy as Senior Vice President of Global Sales and Marketing to support the anticipated U.S. re-launch of the CGuard platform.

●Identified and implemented design changes to the CGuard Prime 135 cm delivery system to address the technical challenges identified following U.S. launch; design modifications now undergoing validation and performance testing ahead of FDA submission.

●Commenced patient enrollment activity in the Company’s CGUARDIANS III pivotal trial of its SwitchGuard neuroprotection system (“NPS”), for use with its CGuard Prime 80 cm stent platform, in TCAR procedures.

●Announced 30-day outcomes from the CGUARDIANS II clinical trial of the CGuard Prime 80 cm implant for use in TCAR procedures. Key highlights include:

○Acute device success was achieved in 100% (50/50) of patients;

○No deaths, strokes, or myocardial infarctions were reported within 30 days;

○No stent thrombosis was observed within 30 days;

○Complete stent patency observed at 30 days in evaluable subjects.

●Following the end of the second quarter of 2026, initiated savings actions designed to reduce the cost structure, improve operational efficiency, and better align the Company’s resources with its strategic priorities, expected to generate annual savings of approximately $9 million.

“Following the end of the second quarter, we executed a series of steps designed to consolidate resources and better align our global operations with our near-term commercial and regulatory priorities, including streamlining our commercial organization to more effectively support our anticipated U.S. platform re-launch,” stated Marvin Slosman, Chief Executive Officer. “We continue to engage in a productive dialogue with FDA regarding our pending regulatory submissions for our CGuard Prime 80 cm implant for TCAR procedures, as well as our original CGuard platform for traditional carotid stenting procedures. We continue to anticipate FDA decisions on both products later this year.”

“At the same time, the design improvements that we are making to the CGuard Prime 135 cm delivery system, which we voluntarily recalled last quarter, are progressing as planned, with an FDA submission anticipated before year-end,” continued Mr. Slosman. “Subject to receipt of the necessary regulatory approvals, we expect to return to the U.S. market with both TCAR and CAS delivery systems. We believe that this would strengthen our ability to compete in the carotid stenting market, and support increased adoption of the CGuard platform, expanded market penetration and future revenue growth, leveraging what we believe is a best-in-class implant in the carotid stenting space.”

Financial Results for the Second Quarter Ended June 30, 2026

For the second quarter of 2026, total revenue was $1,771,000, a decrease of $7,000, or 0.4%, compared to $1,778,000 for the second quarter of 2025.

U.S.

revenue for the second quarter of 2026 was $(351,000), compared to $27,000 for the second quarter of 2025. Net U.S. revenue was negative for the quarter, reflecting $734,000 of customer credits issued in connection with the voluntary recall of the CGuard Prime 135 cm delivery system, which exceeded gross U.S. product sales prior to the initiation of the recall. International revenue was $2,122,000, an increase of 21%, compared to $1,751,000 for the second quarter of 2025.

Gross loss (revenue less cost of revenues) for the second quarter of 2026 was $774,000, compared to gross profit of $313,000, or 17.6% of revenue, for the second quarter of 2025. Gross loss for the second quarter of 2026 included an inventory impairment of $612,000 and the aforementioned revenue credits of $734,000, both associated with the voluntary recall action. On a non-GAAP basis, which excludes the inventory impairment charge and revenue credits as calculated in the attached non-GAAP reconciliation table, adjusted gross profit for the second quarter of 2026 was $572,000.

Total operating expenses for the second quarter of 2026 were $13,671,000, an increase of $339,000, or 2.5%, compared to $13,332,000 for the second quarter of 2025.

EX-99.1

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EX-99.1

Exhibit 99.1

InspireMD 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 procedures -

- 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 -

Miami, 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.

Recent Business Highlights:

●Generated revenue of $3.4 million in the first quarter of 2026, up 122% year-over-year, with significant growth in demand for CGuard Prime in the U.S. and original CGuard in international markets.

●Supported over 625 cumulative carotid procedures utilizing CGuard Prime across over 100 leading U.S. hospitals and integrated delivery networks since launch.

●Filed for and anticipate FDA approval of the original, clinically proven CGuard stent delivery system in Q3 2026.

●Received Investigational Device Exemption (“IDE”) approval from the FDA to initiate the CGUARDIANS III clinical trial that will evaluate the Company’s next-generation SwitchGuard neuro protection system (“NPS”) with CGuard Prime 80 cm for use in transcarotid artery revascularization (“TCAR”) procedures.

●Initiated a voluntary recall of CGuard Prime 135 cm carotid stent delivery system to address the need for technical enhancements to improve user experience and delivery system performance.

“Our 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.”

“In 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.

Financial Results for the First Quarter Ended March 31, 2026

For 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 period of 2025.

U.S.

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.

Gross 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.

Total 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.

Financial income, net, for the first quarter of 2026 was $0.3 million, roughly flat with the first quarter of 2025.

Net 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.

The Company currently expects the financial impact of the U.S. recall

EX-99.1

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EX-99.1

Exhibit 99.1

InspireMD Reports Fourth Quarter and Full Year 2025 Financial Results

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Miami, 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.

Recent 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.

“We 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.”

Financial Results for the Fourth Quarter Ended December 31, 2025

For 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.

U.S.

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.

Gross 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.

Total 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.

Financial 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.

Net 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.

Financial Results for the Year Ended December 31, 2025

For 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.

U.S.

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 markets.

Gross 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.

Total 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.

Financial income, net for the full year 2025 was $0.9 million, a decreas