Financial Data and Key Metrics Changes - For Q4 2025, total revenue was $3.1 million, a 62% increase from $1.9 million in Q4 2024, driven by the U.S. launch of CGuard Prime and increased international market penetration [10] - U.S. revenue for Q4 was $866,000, representing a 74% sequential growth compared to Q3 2025 [10] - International revenue for Q4 was $2.3 million, reflecting a 17% growth compared to $1.9 million in Q4 2024 [10] - Gross profit for Q4 2025 was $1.2 million, or 37.5% of revenue, up from $469,000 or 24.1% of revenue in Q4 2024, primarily due to a favorable shift in revenue mix towards U.S. sales [11] - Net loss for Q4 2025 was $11.8 million, or $0.14 per share, compared to a net loss of $9.2 million or $0.19 per share in Q4 2024 [13] Business Line Data and Key Metrics Changes - The company has completed over 500 cases and gained approvals in prominent Integrated Delivery Networks (IDNs) in the U.S. [6] - The CGuard stent has been used in over 70,000 cases across 30 international markets, providing valuable real-world experience for the U.S. launch [6] Market Data and Key Metrics Changes - The company anticipates revenue for the full year 2026 to be in the range of $13 million to $15 million, reflecting a growth of approximately 45% to 65% over 2025 [15] - The company expects increasing sequential revenue growth in the second half of 2026, driven by anticipated FDA label expansion for CGuard Prime in TCAR procedures [16] Company Strategy and Development Direction - The company aims to achieve market leadership through a stent-first strategy, focusing on operational expansion and establishing U.S.-based production to meet growing demand [4][5] - The company is committed to continuous improvement of its products and plans to introduce enhancements to the delivery system in Q4 2026 [7][25] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the company's impact on stroke prevention and the future of endovascular care, emphasizing the importance of operational and commercial excellence [4] - The management highlighted the positive trajectory of the U.S. launch and the anticipated progress in 2026 [10][15] Other Important Information - Cash and cash equivalents and marketable securities were $54.2 million as of December 31, 2025, compared to $34.6 million at the end of the previous year [14] - The company has two remaining milestone-based tranches from a private placement, each providing gross proceeds of $17.9 million if fully exercised [14] Q&A Session Summary Question: Guidance for FY 2026 - The management expects moderate growth in OUS sales and sustained controlled launch in the U.S. for the first half, with acceleration in the second half due to anticipated TCAR indication and enhanced clinical performance [19][20] Question: Account Standpoint in the U.S. - The company has completed cases in roughly 80 centers, with over 200 centers in the pipeline for VAC and evaluation stages [23] Question: Next Generation Delivery System - The next generation delivery system is targeted for Q4 2026, with minor regulatory changes expected to go through a 30-day FDA review [25][27] Question: Timing for CGUARDIANS II Data - The first reveal of CGUARDIANS II data is expected at the Charing Cross Symposium in April [30] Question: Account Adoption and Productivity Metrics - The company aims for CGuard to become the everyday stent for physicians, with a focus on increasing account adoption and productivity [34][35]

Financial Data and Key Metrics Changes - For Q4 2025, total revenue was $3.1 million, a 62% increase from $1.9 million in Q4 2024, driven by the U.S. launch of CGuard Prime and increased international market penetration [10] - U.S. revenue for Q4 was $866,000, representing a 74% sequential growth compared to Q3 [10] - International revenue for Q4 was $2.3 million, reflecting a 17% growth compared to $1.9 million in Q4 2024 [10] - Gross profit for Q4 2025 was $1.2 million, or 37.5% of revenue, up from $469,000 or 24.1% of revenue in Q4 2024, primarily due to a favorable shift in revenue mix towards U.S. sales [11] - Net loss for Q4 2025 was $11.8 million, or $0.14 per share, compared to a net loss of $9.2 million or $0.19 per share in Q4 2024 [13] Business Line Data and Key Metrics Changes - The CGuard Prime stent platform has been launched in the U.S., with over 500 cases completed and approvals gained in prominent Integrated Delivery Networks (IDNs) [6] - The company has built a U.S. commercial team of over 30 people, focusing on operational expansion and increasing manufacturing capacity [5] Market Data and Key Metrics Changes - The company is focusing on expanding its market presence in the U.S. and international markets, with a strategy to dominate the carotid stenting space [4] - The anticipated FDA approval for TCAR indications is expected to boost market opportunities significantly [8] Company Strategy and Development Direction - The company aims to achieve market leadership through a stent-first strategy, focusing on operational excellence and customer support [4] - Plans include expanding the clinical pipeline and advancing indications for CGuard, with multiple programs and studies underway [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trajectory of U.S. sales and anticipates continued progress in 2026, with revenue expected to be between $13 million and $15 million, reflecting a growth of approximately 45%-65% over 2025 [15] - The company is committed to continuous improvement and exceeding customer expectations, with plans to introduce enhancements to the delivery system in Q4 2026 [26] Other Important Information - Cash and cash equivalents and marketable securities were $54.2 million as of December 31, 2025, compared to $34.6 million at the end of the previous year [14] - The company has two remaining milestone-based tranches from a private placement, each providing gross proceeds of $17.9 million if fully exercised [14] Q&A Session Summary Question: Guidance for FY 2026 - Management expects moderate growth in OUS sales and acceleration in U.S. growth in the second half of 2026 due to anticipated TCAR indication and enhanced clinical performance [19][20] Question: Account Standpoint in the U.S. - Cases have been performed in roughly 80 centers, with over 200 centers in the pipeline for VAC and evaluation stages [23] Question: Next Generation Delivery System - The next generation delivery system is targeted for Q4 2026, with minor regulatory changes expected to go through a 30-day FDA review [26] Question: Timing for CGUARDIANS II Data - CGUARDIANS II data will be first revealed at the Charing Cross Symposium in April, likely as an interim cut [30] Question: Account Adoption and Productivity Metrics - A growing number of physicians are using CGuard as their everyday stent, with an average of 15-20 cases per physician per year [35]

Financial Data and Key Metrics Changes - For Q4 2025, total revenue was $3.1 million, a 62% increase from $1.9 million in Q4 2024, driven by the U.S. launch of CGuard Prime and increased international market penetration [11] - U.S. revenue for Q4 was $866,000, representing a 74% sequential growth compared to Q3 [11] - International revenue for Q4 was $2.3 million, reflecting a 17% growth compared to $1.9 million in Q4 2024 [11] - Gross profit for Q4 2025 was $1.2 million, or 37.5% of revenue, up from $469,000 or 24.1% in Q4 2024, primarily due to a favorable revenue mix towards U.S. sales [12] - Net loss for Q4 2025 was $11.8 million, or $0.14 per share, compared to a net loss of $9.2 million or $0.19 per share in Q4 2024 [14] - Cash and cash equivalents were $54.2 million as of December 31, 2025, compared to $34.6 million at the end of the previous year [14] Business Line Data and Key Metrics Changes - The CGuard Prime stent platform is central to the company's strategy, with over 500 cases completed and approvals gained in prominent Integrated Delivery Networks (IDNs) in the U.S. [5][6] - The company has established a U.S. commercial team of over 30 people, focusing on operational expansion and increasing manufacturing capacity [5] Market Data and Key Metrics Changes - The company is focusing on expanding its market presence in the U.S. and internationally, with a controlled rollout strategy to ensure sustainable growth [49] - The anticipated FDA approval for TCAR indications is expected to significantly boost market opportunities, with over 35,000 TCAR procedures performed annually [8] Company Strategy and Development Direction - The company aims to achieve market leadership through a stent-first strategy, focusing on operational excellence and customer support [4] - Plans include expanding the clinical pipeline and advancing indications for CGuard, with a focus on TCAR procedures and enhancing the delivery system [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trajectory of U.S. sales growth and the potential for continued progress in 2026, with revenue expectations between $13 million and $15 million, reflecting a growth of approximately 45%-65% over 2025 [15][16] - The company is committed to continuous improvement and exceeding customer expectations, with plans to introduce enhancements to the delivery system in Q4 2026 [26] Other Important Information - The company has two remaining milestone-based tranches from a private placement, each providing gross proceeds of $17.9 million if fully exercised [14] - The company is leveraging real-world experience from over 70,000 cases in 30 international markets to inform its U.S. launch strategy [6] Q&A Session Summary Question: Guidance for FY 2026 - The CFO provided insights on U.S. versus international sales expectations, indicating moderate growth in OUS markets and anticipated acceleration in U.S. growth in the second half of 2026 due to TCAR indication and enhanced clinical performance [18][20] Question: Account Standpoint in the U.S. - The company has completed cases in approximately 80 centers, with over 200 centers in the pipeline for VAC and evaluation stages [21][23] Question: Next Generation Delivery System - The next generation delivery system is expected to be submitted for FDA review with minor changes, aiming for a 30-day review process [25][27] Question: Timing for CGUARDIANS II Data - The first reveal of CGUARDIANS II data is expected at the Charing Cross Symposium in late April, likely presenting interim data [30] Question: Account Adoption and Productivity Metrics - The company aims for CGuard to become the everyday stent for physicians, with a focus on increasing account productivity and support [34][35]

InspireMD, Inc. (NSPR) came out with a quarterly loss of $0.14 per share versus the Zacks Consensus Estimate of a loss of $0.22. This compares to a loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of +36.36%. A quarter ago, it was expected that this company would post a loss of $0.17 per share when it actually produced a loss of $0.17, delivering no surprise.Over the last four quarters, the company has surpassed cons ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR COMMISSION FILE NUMBER: 001-35731 InspireMD, Inc. (Exact name of registrant as specified in its charter) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (State or other jurisdiction of incorporation or organization) Delaware 26-2123838 (I.R.S. ...

Exhibit 99.1 InspireMD Reports Fourth Quarter and Full Year 2025 Financial Results — 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: "We continue to see robust early momentum in our U.S. business with CGuard Prime and growing demand internationally for ...

Core Insights - InspireMD, Inc. reported strong financial results for Q4 2025, with total revenue reaching $3.1 million, a 62% increase year-over-year, and a 25% sequential increase from Q3 2025 [4][11] - The company is experiencing robust growth in the U.S. market for its CGuard Prime carotid stent system and anticipates further market expansion with upcoming approvals for TCAR procedures [3][11] - InspireMD's net loss for Q4 2025 was $11.8 million, compared to a net loss of $9.2 million in Q4 2024, indicating increased operational expenses primarily due to the expansion of the U.S. commercial team [9][13] Financial Performance - Total revenue for the full year 2025 was $9.0 million, reflecting a 28% increase from $7.0 million in 2024 [10] - U.S. revenue for 2025 was $1.4 million, while international revenue was $7.6 million, an 8% increase from the previous year [10] - Gross profit for Q4 2025 was $1.2 million, representing 37.5% of revenue, up from 24.1% in Q4 2024, driven by higher margin sales in the U.S. [6][12] Operating Expenses - Total operating expenses for Q4 2025 were $13.3 million, an increase of $3.5 million compared to Q4 2024, mainly due to increased headcount and resources for the U.S. launch of CGuard Prime [7][13] - For the full year 2025, total operating expenses were $52.3 million, up from $35.0 million in 2024, reflecting ongoing investments in commercial operations [13] Future Outlook - The company expects revenue for 2026 to be between $13 million and $15 million, indicating anticipated growth of approximately 45% to 65% over 2025 [16] - InspireMD is focused on advancing its CGuard Prime product and expanding its market presence, with plans for further catalysts in 2026 to enhance adoption [3][11]

Core Viewpoint - InspireMD, Inc. is set to release its fourth quarter and full year 2025 financial results on March 18, 2026, and will host a conference call to discuss these results and recent highlights [1]. Group 1: Financial Results Announcement - The financial results for the fourth quarter and full year 2025 will be announced on March 18, 2026 [1]. - A conference call and webcast will take place at 8:30 a.m. Eastern Time on the same day to discuss the financial results [1]. Group 2: Company Overview - InspireMD, Inc. develops the CGuard Prime carotid stent system aimed at preventing strokes [1]. - The company utilizes proprietary MicroNet™ mesh technology to establish its products as the industry standard for carotid stenting, focusing on acute results and long-term stroke-free outcomes [3]. - InspireMD's common stock is traded on Nasdaq under the ticker symbol NSPR [3]. Group 3: Investor Information - A live audio webcast and an archive of the recording will be available on InspireMD's corporate website [2]. - Interested participants are encouraged to register more than 15 minutes before the start of the call [2].

Core Insights - The CGuard Prime Carotid Stent System has demonstrated the lowest 30-day and 1-year major adverse event rates in pivotal studies of carotid stenting [1][2][3] Group 1: Clinical Trial Results - The C-GUARDIANS pivotal trial published in the Journal of the American College of Cardiology (JACC) shows a 30-day disabling stroke or myocardial infarction (DSMI) rate of 0.95% and a one-year ipsilateral stroke rate of 1.93%, the lowest reported for high-risk patients [2][3] - The trial included 316 patients across 24 sites in the U.S. and Europe, with 25% of participants being symptomatic, indicating a favorable comparison to other carotid revascularization methods [4][2] - The primary endpoint of the trial was met, with the upper bound of the two-sided 95% confidence interval for the observed primary endpoint rate being less than 11.6% [4] Group 2: Technology and Market Position - The MicroNet™ technology used in the CGuard Prime is positioned as a potential next-generation standard of care for carotid artery stenting, expanding patient eligibility without compromising outcomes [3][4] - The publication in JACC is expected to enhance physician awareness and engagement, driving adoption of the CGuard Prime technology [3][4] - InspireMD aims to establish its MicroNet™ mesh technology as the industry standard for carotid stenting, focusing on achieving outstanding acute results and durable, stroke-free long-term outcomes [5]

InspireMD FY Conference Summary Company Overview - **Company**: InspireMD (NasdaqCM:NSPR) - **Event**: 2025 Piper Sandler Healthcare Conference - **Date**: December 03, 2025 Key Industry Insights - **Industry**: Carotid artery disease treatment and intervention - **Recent Trial**: CREST-2 trial results were favorable for intervention, specifically TFCAS, showing statistically significant benefits over medical management [4][11][12] Core Points and Arguments 1. **Market Transition**: The transition from open surgery to endovascular procedures is accelerating, supported by the favorable CREST-2 trial results and prior CMS approval for stenting-first approaches [8][14] 2. **Interventionalist Perspective**: The CREST-2 trial results encourage interventionalists to treat more patients with stenting, expanding the patient base for carotid disease treatment [12][20] 3. **Surgical Interventionalist Perspective**: Surgical interventionalists are likely to shift towards TCAR (Transcarotid Artery Revascularization) as a preferred method due to the positive outcomes of stenting in the CREST-2 trial [13][14] 4. **Patient Demographics**: CREST-2 included 70% asymptomatic patients, indicating a potential increase in early treatment for carotid artery disease [19][20] 5. **Market Size**: Approximately two-thirds of diagnosed patients in the U.S. with carotid artery disease are currently treated with medical management alone, indicating a significant opportunity for intervention [21][22] 6. **Stent Technology**: The stents used in CREST-2 were older generation, while InspireMD's CGuard stent is a newer, closed-cell design that has shown better outcomes in previous studies [24][28] 7. **Commercial Launch**: InspireMD's commercial launch in the U.S. began in Q3 2025, with a focus on controlled growth and physician training [38][39] 8. **Revenue Guidance**: For Q4 2025, InspireMD provided a revenue guidance of $2.5-$3 million, based on strong international performance and early U.S. launch results [46][48][50] Additional Important Insights 1. **Referral Pathway Changes**: The CREST-2 results are expected to influence referral patterns, with more vascular surgeons considering TCAR and interventionalists seeing increased patient referrals [33][34] 2. **Pipeline Products**: InspireMD is working on integrating the CGuard stent with Boston Scientific's Enroute neuroprotection device, with FDA submission expected in the first half of 2026 [53][54] 3. **Tandem Lesions Study**: An early feasibility study is underway to demonstrate the protective value of CGuard in acute stroke settings, with over 50% enrollment achieved [75][79] 4. **Market Dynamics**: The carotid intervention market is expected to grow not by increasing the number of operators but by enabling existing operators to treat more patients effectively [35][36] This summary encapsulates the key points discussed during the InspireMD FY Conference, highlighting the company's strategic direction, market opportunities, and ongoing clinical developments.