NSPR

- Company to host investor conference call today, August 17th, at 8:30am EDT - MIAMI, Aug. 17, 2026 (GLOBE NEWSWIRE) -- 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: 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. The increase was primarily due to greater headcount-related expenses for the U.S. commercial team, higher development, clinical and regulatory expenses related to SwitchGuard NPS and CGuard Prime 80 cm, partially offset by lower general and administrative compensation expenses. Financial income, net, for the second quarter of 2026 was $121,000, compared to financial expense, net, of $132,000 for the second quarter of 2025. Net loss for the second quarter of 2026 totaled $14,324,000, or $0.17 per basic and diluted share, compared to a net loss of $13,151,000, or $0.26 per basic and diluted share, for the same period in 2025. As of June 30, 2026, cash and cash equivalents and marketable securities were $30,421,000, compared to $54,211,000 as of December 31, 2025. Financial Results for the Six Months Ended June 30, 2026 For the first six months of 2026, total revenue increased by $1,862,000, or 56.3%, to $5,169,000, from $3,307,000 for the same period of 2025. U.S. revenue was $827,000, while international revenue was $4,342,000, representing a 33% year-over- year increase compared to the first six months of 2025. Gross loss (revenue less cost of revenues) for the six months ended June 30, 2026, was $87,000, compared to gross profit of $605,000, or 18.3% of revenue, for the same period of 2025. Gross loss for the six months ended June 30, 2026, included inventory-related charges totaling $1,085,000, consisting of a $612,000 inventory impairment charge associated with the voluntary recall action and a $473,000 charge associated with obsolete inventory, combined with the previously mentioned revenue credits of $734,000. 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 six months ended June 30, 2026, was $1,732,000. Total operating expenses for the six months ended June 30, 2026 were $28,336,000, an increase of $3,252,000, or 13.0%, compared to $25,084,000 for the six months ended June 30, 2025. The increase was primarily due to greater headcount-related expenses for the U.S. commercial team, higher clinical trial expenses, and increased compensation expenses due to the hiring of new employees in connection with our expansion in the United States, partially offset by lower general and administrative compensation expenses. Financial income, net, for the six months ended June 30, 2026 was $410,000, compared to $162,000 for the same period of 2025. Net loss for the six months ended June 30, 2026 totaled $28,013,000, or $0.33 per basic and diluted share, compared to a net loss of $24,317,000, or $0.48 per basic and diluted share, for the same period in 2025. Conference Call and Webcast Details Management will host a conference call at 8:30 am EDT today, August 17th, 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 email containing a link to the conference 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. 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 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 expectations regarding its ability to return to the U.S. market with both TCAR and CAS delivery systems; the Company's ability to compete effectively in the carotid stenting market and increase adoption of its products; expectations regarding market penetration, commercialization, revenue growth and future operating performance; the anticipated benefits of recent organizational and cost-saving initiatives, including expected annualized savings and improved operational efficiency; 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 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. Non-GAAP Financial Measures To 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 past financial performance and future prospects, and allow for greater transparency with respect to key measures used by management in its financial and operational decision making. The Company defines adjusted gross profit as gross profit excluding the impact of the inventory impairment charges and customer credits recognized during the periods. The non-GAAP financial data are not measures of the Company’s financial performance under GAAP and should not be considered as alternatives to gross margin or any other performance measures derived in accordance with GAAP. Non-GAAP financial measures may not provide information that is directly comparable to that provided by other companies in other industries or within InspireMD’s industry, as other companies may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. In addition, there are limitations in using non-GAAP financial measures because the non-GAAP financial measures are not prepared in accordance with GAAP, may be different from non-GAAP financial measures used by other companies and exclude expenses that may have a material impact on the Company’s reported financial results. Further, the reserve for inventory impairment recognized during the period is a significant item that affects gross profit and may obscure the Company’s underlying operating performance and comparability between periods. The presentation of non-GAAP financial information is not meant to be considered in isolation, as a substitute for, or superior to the directly comparable financial measures prepared in accordance with GAAP. In addition, non-GAAP measures should not be construed as an inference that the Company’s future results will be unaffected by unusual or non-recurring items. InspireMD urges investors to review the financial results calculated in accordance with GAAP and the reconciliation of the Company’s non-GAAP financial measures to the comparable GAAP financial measures included below, and not to rely on any single financial measure to evaluate the Company’s business. Investor Contacts: Jeff WarrenLifeSci [email protected] [email protected] (1) All 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 2025 financial information is derived from the Company’s 2025 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. (2) All June 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. Adjusted Gross Profit The following table reconciles Adjusted Gross Profit to Gross Profit, which we consider to be the most directly comparable GAAP financial measure. Amounts presented are in thousands of U.S. dollars.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributed the second quarter's flat revenue to the voluntary recall of the CGuard Prime 135 system, which necessitated $734,000 in customer credits that offset underlying U.S. sales growth. International business grew 21% year-over-year, serving as a strategic proof point for the CGuard implant's clinical efficacy and physician demand despite domestic regulatory setbacks. The company implemented a 20% workforce reduction to align its cost structure with near-term regulatory priorities, aiming to preserve cash while maintaining a lean commercial core for relaunch. Management emphasized that the CGuard implant itself remains the foundational value driver, with the recall being a 'well-defined and manageable' issue isolated to the delivery system rather than the stent technology. Operational focus has shifted to a dual-track U.S. strategy, preparing to address the entire 75,000-procedure stenting market by offering both TCAR and CAS platforms simultaneously. Strategic OUS efforts are pivoting toward margin expansion and pricing optimization to ensure the international segment contributes more effectively to the bottom line as it matures. Management anticipates potential FDA approval for both the CGuard Prime 80 (TCAR) and the original CGuard CAS platform in the fourth quarter of 2026. The redesigned CGuard Prime 135 delivery system is currently targeted for a first-half 2027 market reentry, though management is optimistic that an earlier approval is possible if the FDA grants an accelerated review. Cost-saving initiatives are expected to be fully realized by the fourth quarter of 2026, providing approximately $9 million in annual savings to extend the company's financial runway. The SwitchGuard neuroprotection system is tracking toward a back-half 2027 U.S. approval, with enrollment in the CGUARDIANS III pivotal study currently underway at high-volume sites. Guidance for the U.S. relaunch assumes a 'pent-up demand' scenario, leveraging a deliberate commercial playbook focused on high-volume territories identified through claims data. The voluntary recall resulted in a $612,000 impairment charge for CGuard Prime 135 inventory that was deemed no longer commercially viable. A restructuring charge between $900,000 and $1.2 million is expected in the third quarter of 2026 to cover severance and related costs from the 20% headcount reduction. Reported gross margin was negative 43.7% due to recall-related credits and impairments, though adjusted gross profit remained positive at $0.6 million when excluding these one-time items. Cash and equivalents decreased to $30.4 million as of June 30, 2026, down from $54.2 million at year-end 2025, reflecting increased R&D and commercial readiness spending. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management characterized the shift from Q3 to Q4 as a 'realistic' adjustment to accommodate FDA testing requirements and statutory review timeframes. Confirmed that all required testing is completed and the company is actively responding to FDA requests to ensure a smooth approval process. The 'long poles in the tent' for an earlier relaunch are biocompatibility testing and the FDA's statutory review process. Management has submitted an early pre-sub dossier to the FDA to argue for an accelerated review based on the minimal technical nature of the delivery system modifications. SwitchGuard is fundamental to the TCAR strategy as it allows InspireMD to capture both the implant and neuroprotection revenue for every procedure. The device includes proprietary features and functions that management believes address unmet needs compared to the current market predicate. Management reported 'palpable' and 'unanimous' physician enthusiasm for the product's return, noting that the sales team has been kept intact to maintain these relationships. The company is focusing on time-to-productivity for its field organization to ensure a rapid transition from approval to revenue generation.

This article first appeared on GuruFocus. Total Revenue: $1.8 million for Q2 2026, essentially flat compared to Q2 2025. International Revenue: $2.1 million, representing 21% year-over-year growth. Gross Profit: Loss of $0.8 million, or negative 43.7% of revenue, compared to a profit of $0.3 million (17.6% of revenue) in Q2 2025. Adjusted Gross Profit (non-GAAP): $0.6 million, excluding recall-related customer credits and impairment charges. Total Operating Expenses: $13.7 million, up from $13.3 million in Q2 2025. Net Loss: $14.3 million, or $0.17 per basic and diluted share, compared to a net loss of $13.2 million ($0.26 per share) in Q2 2025. Cash and Marketable Securities: $30.4 million as of June 30, 2026, down from $54.2 million at the end of 2025. Recall-Related Credit: $734,000 credit booked for the return of CGuard Prime 135 product. Inventory Impairment Charge: $612,000 impairment charge for CGuard Prime 135 inventory no longer commercially viable. Warning! GuruFocus has detected 3 Warning Signs with NSPR. Is NSPR fairly valued? Test your thesis with our free DCF calculator. Release Date: August 17, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. International revenue grew 21% year-over-year, driven by strong demand for the CGuard stent platform. The CGUARDIANS II trial for the CGuard Prime 80 platform reported outstanding 30-day results, with FDA approval expected in Q4 2026. The company is advancing multiple regulatory catalysts, including the original CGuard platform for CAS and the next-generation SwitchGuard neuroprotection system. The voluntary recall is being managed effectively, with a clear plan for design modifications and a potential earlier-than-expected market re-entry for the CGuard Prime 135 system. The company has taken decisive actions to reduce costs, including a 20% workforce reduction, saving approximately $9 million annually. Total revenue was flat year-over-year, with US revenue negatively impacted by customer credits and an inventory impairment charge related to the voluntary recall. Gross profit turned negative, with a gross margin of -43.7% due to recall-related credits and a $612,000 inventory impairment. Net loss widened to $14.3 million in Q2 2026, compared to $13.2 million in the same period last year. Cash and cash equivalents decreased significantly to $30.4 million from $54.2 million at the end of 2025, raising concerns about financial runway. The approval timeline for the original CGuard delivery system was pushed from Q3 to Q4 2026, reflecting regulatory delays. Q: What is the updated timeline for the original CGuard delivery system's FDA approval, and what is driving the shift from the previously mentioned Q3 to Q4?A: Marvin Slosman, CEO, explained that the shift to Q4 is about being realistic regarding regulatory timeframes and FDA workload. He noted that required testing is complete, but they want to allow adequate time for responses to FDA and the agency's feedback on the legacy system, emphasizing a cautious approach to the approval timeline. Q: What is left to do before submission for the CGuard Prime 135 delivery system, and how derisked is the first half of 2027 approval timeline?A: Marvin Slosman, CEO, stated that progress on the 135 Prime technical improvements is solid, with the delivery mechanism performing well in challenging anatomy. They are currently conducting design verification (DV) testing. The timeline remains first half of 2027, with long-pole items including biocompatibility testing and FDA's statutory review process. They have submitted a pre-sub dossier to FDA, and if they can eliminate some long-pole items, there is potential to pull the approval timeline in earlier. Q: Can you provide an update on the SwitchGuard enrollment progress and confirm the timeline for US approval and launch?A: Marvin Slosman, CEO, reported that enrollments are going well, with investigators pleased with the device's performance in its first human applications. The trial expansion will depend on available resources, but they are initiating high-volume sites enthusiastic about SwitchGuard. The timeline remains on track for the back half of 2027 for US approval and launch, though enrollment progress will ultimately determine the final timeline. Q: When will the cost-saving initiatives be fully realized, and where did the 20% headcount reduction occur within the organization?A: Michael Lawless, CFO, stated that the vast majority of actions are already in motion, with full impact expected in Q4 of this year. Q3 will see partial savings offset by restructuring costs. Marvin Slosman, CEO, added that the reduction was balanced to maintain commercial readiness for an aggressive relaunch, ensuring the field team remains strong to reestablish presence quickly. Q: What is the key variable that could change the CGuard Prime 135 timeline, and is it within the company's control?A: Marvin Slosman, CEO, identified two key testing scenarios: biocompatibility testing, which takes time and may not be necessary, and the statutory review process. They are seeking FDA's agreement on an accelerated review under the pre-sub scenario. If FDA agrees, timelines could be pulled in significantly, but they remain conservative with a first half of 2027 guidance. Q: How is the company thinking about the commercial strategy for the relaunch and subsequent launches, including VAT committee processes?A: Marvin Slosman, CEO, explained that they have optimized the field organization structure, focusing on high-performing territories and time-to-productivity. The new Head of Sales and Marketing has a clear playbook for the relaunch, and they are closely managing VAT committee approvals to ensure customers understand timelines. The voluntary recall provided an opportunity to refine and make the relaunch plan more efficient and aggressive. Q: What is driving the over 20% international growth, and is it sustainable?A: Marvin Slosman, CEO, attributed the growth to the device's world-class outcomes and established standard of care in OUS markets, with over 75,000 implants sold. While the business has grown significantly, they are now focusing on fine-tuning pricing and margins to improve bottom-line contribution, indicating a strategic pivot toward higher-margin opportunities in those markets. Q: Are physicians who used the recalled 135 delivery system still engaged, and will they re-adopt the product upon re-approval?A: Marvin Slosman, CEO, confirmed they are in touch with all customers, and the anticipation for the product's return is unanimous and palpable. The sales team has maintained relationships, and the expectation is that enthusiasm will quickly translate into revenue upon approval of both the 135 and the 80 for TCAR, with the sales organization preparing for a rapid relaunch. Q: How important is SwitchGuard to the long-term TCAR strategy, and how does it expand the addressable market versus just the CGuard 80?A: Marvin Slosman, CEO, emphasized that SwitchGuard is fundamental to the TCAR strategy, as every TCAR procedure uses both a stent and a neuroprotection device. SwitchGuard offers improved features over current predicates, and the associated sales dollars and margins are significant. Having both the implant and neuroprotection system allows them to address the entirety of the TCAR market, benefiting from better technology and higher revenue and margin opportunities. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

PMA supplement under FDA review with potential approval in H2 2026, potentially expanding the Company’s addressable market to include TCAR in addition to CAS carotid stenting procedures MIAMI, June 11, 2026 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced 30-day outcomes from the CGUARDIANS II clinical trial of the CGuard Prime 80cm implant for use in transcarotid artery revascularization (TCAR) procedures. InspireMD anticipates potential approval of the CGuard Prime 80 cm stent implant in the second half of this year. Key 30-day outcomes observed in the CGUARDIANS II trial 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. Dr. Patrick J. Geraghty, professor of surgery and radiology at Washington University School of Medicine in St. Louis and co-lead investigator of the CGUARDIANS II study, commented, “The 30-day results observed in the CGUARDIANS II trial suggest that the CGuard Prime 80 cm stent may deliver exceptional safety and efficacy when used with a TCAR approach. Notably, the 100% acute device success rate with zero major adverse events has the potential to make CGuard Prime the gold standard implant for high-risk patients undergoing TCAR procedures. I look forward to incorporating it into my own practice, if approved.” “We believe the 30-day CGUARDIANS II results represent a significant achievement in our quest to tap into the large and growing TCAR market,” said Marvin Slosman, CEO of InspireMD. “Together with our recently initiated CGUARDIANS III clinical trial of our proprietary SwitchGuard neuroprotection system, we potentially have line-of-sight to offering the full TCAR toolkit, subject to regulatory review and approval, leveraging our best-in-class CGuard Prime Carotid Stent System with its unmatched clinical outcomes, for the more than 35,000 TCAR procedures that are performed in the U.S. every year.” CGUARDIANS II is a prospective, multi-center, single-arm pivotal study that enrolled 50 patients across 11 trial sites. The objective of the study is to evaluate acute device success and technical success of the CGuard Prime 80 cm when used in conjunction with the FDA-cleared ENROUTE TCAR neuro-protection system in patients considered at high risk for adverse events from carotid endarterectomy. Regulatory Disclaimer: The CGuard Prime Carotid Stent System 80 cm is an investigational device in the United States and is limited by federal law to investigational use. InspireMD submitted a Premarket Approval (PMA) Supplement to the U.S. Food and Drug Administration (FDA) which is currently under review. 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 StatementsThis 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 expectations regarding potential FDA approvals for CGuard Prime Carotid Stent System 80 cm implant for use in TCAR procedures. 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 statements as a result of new information, future events or otherwise. Investor Contacts:Jeff WarrenLifeSci [email protected]@inspiremd.com

Management proactively paused CGuard Prime 135 commercialization in the U.S. following feedback from a controlled launch regarding the delivery system's technical performance. The pause is explicitly unrelated to the safety or efficacy of the CGuard stent implant itself, which has been used in over 70,000 cases globally. Performance attribution for the Q1 revenue growth of 122% was driven by the initial U.S. launch and 48% growth in international markets where the legacy delivery system is standardized. The company is prioritizing clinical excellence and physician confidence over commercial speed, believing that remediating delivery system issues now will strengthen long-term market leadership. Strategic positioning remains focused on the transition of the carotid market toward stenting, with management asserting they have the only 'best-in-class' mesh-covered stent to capture this shift. Operational focus has shifted to a dual-track regulatory strategy: seeking approval for the original CGuard system as a bridge and remediating the Prime 135 system for a 2027 re-entry. Management anticipates FDA approval of the original CGuard delivery system in the third quarter of 2026 (specifically the August window) to resume U.S. sales. The TCAR strategy remains on track with expected FDA approval of the CGuard Prime 80 system in the second half of 2026, which could potentially double the addressable market. Full-year 2026 revenue guidance has been withdrawn due to uncertainty regarding the exact timing of U.S. market re-entry and the duration of the commercial pause. The next-generation SwitchGuard neuroprotection system is entering the C-GUARDIANS III clinical trial, intended to eventually provide a complete TCAR toolkit. Management expects to resubmit the enhanced CGuard Prime 135 delivery system for approval with a target of early 2027 or sooner. A $700,000 reserve for customer returns and a $650,000 reserve for inventory impairment will be recognized in Q2 2026 due to the U.S. recall. Q1 gross margins were impacted by a $473,000 impairment charge for excess inventory and increased compensation for the Tel Aviv operations team during regional conflict. The company expects zero U.S. revenue from the date of the pause until the anticipated Q3 2026 approval of the legacy CGuard system. Operating expenses are expected to increase slightly due to R&D investments for the C-GUARDIANS III trial, while headcount growth is paused pending regulatory clarity. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management confirmed they have identified the root cause of the delivery system challenges and have already begun remediation and verification testing. It remains uncertain if the FDA will grant an expedited review or follow standard statutory timelines for the design changes. Management believes many hospitals will 'grandfather' the original CGuard system because the Value Analysis Committees (VAC) primarily approved the stent implant itself. The company expects to hit the ground running in August as the legacy product is already in high-volume production for international markets. Management clarified that the international business is unaffected as those markets already use the original delivery system which has a proven track record. The recall is limited to the 'Prime' delivery system used in the U.S. controlled launch, not the global CGuard implant technology. The CGuard Prime system had limited exposure in the PMA trial; issues only manifested when exposed to a broader range of 'real-world' accessory devices and user experiences. Management described the learning curve as 'unfortunate' but noted the controlled launch successfully allowed them to catch the issue early. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

Image source: The Motley Fool. Nov. 4, 2025 at 8:30 a.m. ET Chief Executive Officer — Marvin Slosman Chief Financial Officer — Michael Lawless Chief Commercial Officer — Shane Gleason Need a quote from a Motley Fool analyst? Email [email protected] Marvin Slosman: Thank you, and good morning, everyone. I'm pleased to welcome you to today's call. Joining me on the line is Mike Lawless, our Chief Financial Officer; and Shane Gleason, our Chief Commercial Officer. We are dialed in live from VIVA, the Vascular InterVentional Advances Conference in Las Vegas, where we're hosting many conversations on the introduction of CGuard Prime following our approval in June. I will share more on our market traction shortly, but I want to start with a detailed overview of the results of the third quarter. I'm happy to share that our business is advancing with velocity and intention. In the third quarter, we reached $2.5 million in total revenue, representing year-over-year growth of 39% and sequential growth of over 40% since the last quarter. Our growth was driven by strong early momentum in the U.S. and continued demand for our CGuard stent platform internationally. Our strong performance was a result of months of significant internal preparation, which positioned us to hit the ground running upon the FDA approval. Following approval, which we received in late June, our team immediately activated our planned commercial efforts in the United States in July. When we say commercial activation, we mean a focused and deliberate effort to make sure that our device is accessible to U.S. providers and their patients who are at risk of stroke. Our team has been engaged with many physicians and hospital systems and are working through value analysis committee approvals, contract completions and case initiation. We are building traction methodically with the goal to drive sustainable penetration and growth in the market. Demand for CGuard Prime has been strong. As of today, we've completed more than 100 cases in the U.S., and many of these procedures were performed within some of the largest IDNs in the country. The demand and excitement for our technology reflects the foundational work we've done over the years, establishing value and awareness for our best-in-class clinical results. Globally, we are now approaching 70,000 stents sold to date as the carotid interventional market shifts to a stent-first approach. We believe the established CMS reimbursement, combined with our innovative protective mesh stent design, evidence and real-world experience provide a pathway for us to lead the carotid market. We are equipped with high-caliber sales leadership and clinical support, reflected in the remarkable progress our group has made in just a few months post FDA approval. Their deep experience in vascular market and established relationships with physicians and administrators combined with a best-in-class implant forms the backbone of our early and progressive success. The team is tasked with our commitment to expanding treatment to the vast patient population who could benefit from our technology. As a reminder, over 3 million people globally are diagnosed with carotid artery disease, yet only approximately 400,000 are treated annually. This massive gap in treatment leaves patients vulnerable to catastrophic stroke events. CGuard Prime aims to redefine success for these patients and their providers by lowering the risk of strokes and other major adverse events to levels never achieved with first-generation stenting or surgery, validated with rigorous evidence, proven clinical results, reimbursement and real-world outcomes. As I mentioned earlier, we are living the excitement of our technology firsthand here at VIVA. Today, we are here in Las Vegas with many members of our team and Board of Directors, engaging with our physician partners and champions as we continue to launch CGuard Prime in the U.S. The energy of our commercial-facing teams and the unmistakable momentum around endovascular intervention gives me incredible optimism for the future of our company. Before I provide a detailed update on our clinical trial work, I wanted to take a moment to welcome our new Chief Medical Officer, Dr. Peter Soukas. Dr. Soukas will oversee clinical and medical topics, further building on our best-in-class data as well as advancing awareness of our technology stent platform to the physician community. This transformational time for carotid intervention requires continually building a world-class team and support, and Dr. Soukas will be a tremendous contributor to our work ahead. We're thrilled to have Dr. Soukas join as our CMO. Now to the clinical pipeline, a critical piece of our long-term growth strategy. We continue to advance multiple programs in clinical studies as we work to expand our reach of our technology by building clinical evidence, potentially unlocking additional market opportunities. Starting in TCAR with C-GUARDIANS II, which evaluates a short TCAR-indicated version of CGuard Prime designed to be compatible with neuroprotection systems that are already in use in the field today. I'm pleased to report that we are on track to complete enrollment by the end of the year and potential approval anticipated in mid-2026. Simultaneously, we're advancing C-GUARDIANS III, the next phase of our TCAR strategy, evaluating our fully integrated TCAR solution, combining the CGuard Prime 80 stent with our proprietary SwitchGuard neuroprotection system. This study is designed to showcase the full potential of our purpose-built solution for TCAR, offering physicians a comprehensive streamlined option that we believe can set a new standard in the field. We currently expect FDA clearance and launch in mid-2027. The impact of these 2 studies highlights the versatility and clinical value of our platform and are expected to give us extremely competitive position in TCAR, a U.S. market that already exceeds 30,000 procedures annually. We also continue to make progress on our tandem lesion early feasibility study to expand the potential use of our technology in acute stroke care. The study is being conducted in partnership with Dr. Adnan Siddiqui and the Jacobs Institute in Buffalo, New York. This study evaluates the use of CGuard Prime in acute stroke patients with tandem lesions in conjunction with thrombectomy. I'm happy to share that enrollment is over 50% complete. It is inspiring to hear physicians' excitement for having an option to treat this critical need with our technology in a challenging patient population. Let me also mention our awareness of the upcoming CREST-2 data that's scheduled to be presented at the VIIF and SVIN meetings in the coming weeks. We believe the culmination and sharing of this data is another reminder of the advancement of awareness of carotid intervention and the importance of decoupling categories of therapy with specific implant-based performance to demonstrate the specificity and granularity of results. Clinical outcomes have been redefined with best-in-class evidence with CGuard implant across a large population sample of both symptomatic and asymptomatic patient cohorts measured in both short- and long-term outcomes. The baseline of nearly 70,000 implants sold and 2,000 patients studied and peer reviewed to date speaks volumes to the validation of our exceptional results. Our strong performance in the third quarter, combined with the establishment of a robust commercial foundation gives me tremendous confidence in our ability to deliver meaningful growth and value over the coming quarters and years. Now I'll turn the call over to Mike to walk us through the financials. Mike? Michael Lawless: Thanks, Marvin. For the third quarter of 2025, total revenue increased by 39% to $2.5 million. This increase was predominantly driven by the launch of CGuard Prime in the U.S., increased penetration of international markets with CGuard and the favorable impact of foreign exchange. U.S. revenue for the third quarter was $497,000, driven by the launch of CGuard Prime. This is the first quarter we recorded U.S. commercial revenue following the FDA approval in late June. International revenue for the third quarter was $2.0 million, an increase of $223,000 or 12% compared to $1.8 million for the third quarter of 2024, driven by increased usage in over 30 markets and the favorable impact of foreign exchange. Gross profit for the third quarter of 2025 increased by $450,000 or over 100% to $864,000 compared to gross profit of $414,000 for the third quarter of 2024. This increase in gross profit resulted from higher revenue and a favorable shift in sales mix towards higher-margin revenue from our commercial launch in the U.S., partially offset by higher production variances and training costs. Gross margin increased to 34.2% of revenue during the third quarter of 2025, up from 22.9% of revenue during the third quarter of 2024, driven primarily by the previously discussed favorable revenue mix and volume leverage of fixed operating costs. We expect continued expansion of gross margins in future quarters as our commercial sales ramp in the U.S. drives continued favorable mix and volume leverage. Total operating expenses for the third quarter of 2025 were $13.9 million, an increase of $5.0 million or 57% compared to $8.9 million for the third quarter of 2024. This increase was primarily due to higher headcount-related expenses as we continue to expand our U.S. personnel, particularly our commercial team to drive the U.S. commercial launch of CGuard Prime. A second driver of the increase in operating expenses was occupancy and infrastructure expense related to the establishment of our U.S. headquarters. Financial income decreased by $229,000 to $343,000 from $572,000 in the third quarter of 2024. This decrease was primarily due to $118,000 decrease in financial income from investments in marketable securities and money market funds and a $104,000 increase in financial expenses related to changes in exchange rates. Net loss for the third quarter of 2025 was $12.7 million or $0.17 per basic and diluted share compared to a net loss of $7.9 million or $0.16 per basic and diluted share for the same period in 2024. As of September 30, 2025, cash and cash equivalents and marketable securities were $63.4 million compared to $19.4 million as of June 30, 2025. The increase in cash resources is a result of 2 financing events with significant impact during Q3. First, we raised gross proceeds of $40.1 million through a PIPE offering with existing and new investors. Second, we raised gross proceeds of $17.9 million from the exercise of the second of 4 milestone-based financing tranches pursuant to our May 2023 equity private placement. The exercise of the warrants was triggered by the receipt of premarket approval from FDA for our CGuard Prime carotid stent. The 2 remaining tranches are triggered by future milestone events, including: first, the completion of 4 quarters of commercial sales of CGuard Prime in the U.S., which we anticipate in the back half of 2026; and second, receipt of FDA clearance for the SwitchGuard TCAR neuroprotection system, along with TCAR indicated CGuard Prime stent, which we expect during 2027. So turning to our financial outlook. We're encouraged by the initial traction for sales of CGuard Prime in the U.S. and the continuing solid performance of CGuard internationally. For the fourth quarter, we expect sequential growth in U.S. sales and steady demand trends internationally, resulting in revenue of approximately $2.5 million to $3.0 million in the fourth quarter. When we report our fourth quarter 2025 results, we will share our 2026 growth expectations informed by insights from an additional quarter of U.S. launch progress. This concludes our prepared remarks. We will now open the call for questions. For the Q&A segment, we will be joined by Shane Gleason, InspireMD's Chief Commercial Officer. Operator? Operator: [Operator Instructions] And we'll take our first question from Adam Maeder with Piper Sandler. Adam Maeder: Congrats on the progress. Can you hear me okay? Marvin Slosman: We can, Adam. Adam Maeder: Okay. Perfect. I was getting a little bit of feedback there. Maybe just to start, would love to hear a little bit more about the initial physician feedback that you're getting from U.S. customers that have started to use CGuard Prime? And then the second part of that is maybe it's a little bit early, but curious how CGuard is being used in the doctor's armamentarium. Is this kind of being used as kind of the workhorse carotid stent for customers? And then I had a couple of follow-ups. Marvin Slosman: Adam, thanks for the question. We're really enthusiastic in the response from physicians. I think that there has been a buildup to anticipating CGuard Prime's launch in the U.S. because of our baseline of experience outside of the U.S. And we purposefully launched this product over the many years outside the U.S. to build a very solid foundation of best-in-class clinical data and real-world experience. As you know, this world operates globally, and it was no secret anticipating this coming launch. So we're very enthusiastic about it. Frankly, we're trying to make sure that we follow a very deliberate controlled approach to things to get on top of all the opportunity that we see in front of us, but to do it the right way and deliver deliberately. We're following our playbook that was designed for a long view and leadership in this space with durability over time. But I think the early days, even though it's 1 quarter of data really give us a lot of enthusiasm and encouragement. I'm going to ask Shane to kind of jump into the second part of your question in terms of where this fits in the armamentarium of our customers across a pretty broad base of carotid users. Shane Gleason: Yes. Thanks for the question, Adam. The excitement has been really strong. And as we mentioned earlier, we're at the VIVA meeting. We're at the TCT conference last week. There are a number of other ones upcoming. And the team is in the field every day having these conversations. So the product has been very well received. And a lot of the discussion at the meeting has been exactly that. Where does this fit in to people's carotid toolkit. And up until now, there tended to be trade-offs between different stent platforms, a lot of advocacy for being comfortable with both an open cell stent and a closed cell stent for various anatomies. And one of the great things about CGuard Prime is that it really meets both of those. So we envision this to be a workhorse product. That's what the folks at the podium are saying as well. So that's our expectation going forward. Adam Maeder: Okay. Perfect. I appreciate all the color there, guys. And for the next question, I was hoping to just go a little bit deeper into U.S. launch and wanted to see if you could share some metrics, I guess, more specifically, device ASP versus volume in the quarter, number of accounts that have implanted CGuard at this point and visibility around that process for how we should think about onboarding accounts in Q4? Marvin Slosman: Thanks, Adam. I'm going to let Shane jump in on those topics. Again, early days and early data points, but I think thus far, the expectations across that spectrum that you just mentioned have been really encouraging and sort of above expectations. But Shane, do you want to add something on those. Shane Gleason: Yes. I'll say in terms of pricing, our approach has been that we are coming in at a premium to the market, but not a prohibitive one. The conversations that we have frequently are that our major adverse event rates are half or 1/3 of what the first-generation stents have. So we could have taken the approach that we're 2 or 3x as good, so we're going to charge you 2 or 3x as much. Price it like a drug-coated balloon or drug-coated stent newly into the market. But we know that while that may eventually get us on the shelf in some places, it would likely limit adoption certainly to being a workhorse product. So our communication is that we're requesting a, I'll call it, a modest premium, something versus the CAS and TCAR stents, something in the hundreds of dollars, not thousands of dollars. and saying that we want it to be a workhorse stent. We don't want it to be priced to the point where you only use it in case of emergency, you only use it in the worst of your worst cases, but we want to be used in all of their cases. So I'd say a more modest premium to the market, which has been well received by physicians and administrators as well. Adam Maeder: And just any color on accounts -- yes, sorry, go ahead, please. Shane Gleason: Yes. I was just going to clarify the other question. So we mentioned that we've done over 100 cases since launch. Obviously, that number is growing every day. And in terms of accounts open, are we -- yes. We've had about a dozen reps in the field until very recently. And I'll say that we on average opened several accounts per rep even in the first quarter, which we've outpaced expectations where you kind of think VACs and product committees tend to be measured in quarters to years, not weeks or months, but we've actually had a lot of approvals in months and not quarters. And we've done cases in a lot of the key IDNs around the U.S. So we've made a lot of traction there in terms of opening accounts. Marvin Slosman: Yes. Adam, I would just add that this is a foundational build for us. When we talk about activation, it's all of those things. But the benefit of having a team on the field at approval, thanks to our capital strategy was really important for us so that we could get into that activation mode quickly, and we'll obviously benefit as that continues to mature. Adam Maeder: Sure. Totally makes sense, and I appreciate the color. And just one last one, if I may sneak one more in. Just I think you just mentioned, Shane, 12 reps in the field in the U.S. until recently. Can you just remind us kind of how we should think about the sales force expansion plan as we get into this quarter, Q4 as well as 2026? I'll leave it there, guys. congrats again. Shane Gleason: Yes, absolutely. So what we communicated last time that we have a U.S. commercial organization that was north of 20 people with most of them in the field. I mentioned the number of reps just a minute ago, but then you add in the sales directors and clinical specialists. We were exiting this year with more than 30, again, with most of them in the field. And the additions that have all been territory manager, customer-facing sales roles. And then in terms of going forward, our plan has been to get to that point here as we exit the year, let them start to throw down some routes in their accounts and then scale accordingly as we get into and through 2026. Operator: [Operator Instructions] And we'll take our next question from Frank Takkinen with Lake Street Capital Markets. Frank Takkinen: Congrats on the solid initial launch. I was hoping to follow up on, I think there was a guide right at the end of $2.5 million to $3 million. I think I heard that was for total business. Can you maybe help us parse out OUS versus U.S. in that $2.5 million to $3 million? Apologies if I missed it. Michael Lawless: Yes, sure. Frank, this is Mike. Yes, the breakdown of the guidance really consists of stable international sales relative to Q3 with expectations for some growth in the U.S. market in Q4. Frank Takkinen: Perfect. Okay. That's helpful. And then maybe one, I know it's probably early days here, but any comments around those who have started to use it, how they are ordering product initially? Are they starting with a few units and then reordering? Are they putting half dozen units on the shelf? How are they, generally speaking, ordering product to start. Marvin Slosman: Yes. Frank, I'll jump in there and hand it off to Shane for the back half of that question. So far, patient outcomes are great. The stent performance is great. We're thrilled by the fact that expectations are certainly being met in those 2 parameters, which is what's most important and consistent with how we've done this globally and how the stent has performed globally. I'll let Shane kind of answer the general theme that we're following in terms of how we're stocking shelves, doing cases and most importantly, how the matrix of our products fits well into the size expectations that are on the shelves. Shane Gleason: Yes, our goal is to -- we want our team in the cases as we launch this product. One of the nice things about this space is that eventually, that won't be the requirement. We know that's a question of do you build a model where you need to be present in every single one of your cases. I'd say in the short term, as we launch the product, we want to be present in those cases. And then as we open things up going forward, we won't need to be. So what that tells is that we're not stocking shelves and running away and hoping they use it when we're not there, but primarily running the cases out of reps stock with reps present in the cases as we get started and we make sure that the users and the accounts that could use it are trained and familiar with it before we leave a bunch of products on customer shelves. Marvin Slosman: Yes, Frank, I think it's all about utilization at this point. We want to make sure that this is the go-to product and it's utilized effectively as such. Frank Takkinen: Got it. That's helpful. And then maybe if I can just sneak one last one in, gross margin commentary. How should we think about where gross margins can go with scale? Michael Lawless: Yes. Well, I think as I mentioned on the call, the clear driver of that is the increasing mix of U.S. sales as we go forward into the future. As our volumes grow, we'll get some scale leverage just from the higher revenue, but we'll also get the benefit of the much higher margin mix of sales in the U.S. market. And so I mean, I think at this point, I don't want to start giving forward guidance on margins, but suffice it to say that as U.S. becomes a larger and larger percentage of our revenue, we would expect that our margins would approach typical medical device type margins. Operator: At this time, we've reached our allotted time for questions. I will now turn the call back over to Marvin Slosman. Please go ahead. Marvin Slosman: I'd like to thank everyone for joining today's call and the continued support for our mission to lead and transform the carotid intervention market. We're really proud of the strong performance the team delivered globally in the third quarter and especially here in the U.S. and our first commercial quarter as we advance our activation efforts and accelerate momentum. If you happen to be here in Las Vegas at VIVA, stop by the booth, we'd be happy to see you and look forward to great progress on our business. Thank you. Before you buy stock in InspireMD, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and InspireMD wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $496,473!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,216,605!* Now, it’s worth noting Stock Advisor’s total average return is 968% — a market-crushing outperformance compared to 202% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 4, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. InspireMD (NSPR) Q3 2025 Earnings Transcript was originally published by The Motley Fool

Image source: The Motley Fool. Wednesday, March 18, 2026 at 8:30 a.m. ET Chief Executive Officer — Marvin Slosman Chief Financial Officer — Michael Lawless Chief Commercial Officer — Shane Gleason Operator Marvin Slosman: Thank you, and good morning, everyone. As I reflect on our performance over the past several quarters, I'm extremely proud of our team here at InspireMD and enthusiastic about the impact we are having on stroke prevention and the future of an endovascular standard of care, catalyzed by our breakthrough CGuard Prime carotid stent platform. Through the CGUARDIANS FDA clinical trial, along with our numerous multiyear studies of our CGuard implant, we have demonstrated unmatched clinical evidence reflected in the lowest adverse event rates and most durable stroke prevention, enabling our continued focus on achieving market leadership through a stent-first strategy. Becoming #1 in this highly competitive market will require strong operational, commercial and customer-focused excellence throughout our organization. To this end, we are focusing on operational expansion, establishing U.S.-based production, increasing our manufacturing capacity to keep pace with this growing U.S. demand. On the commercial side, we're building our coverage capacity and procedural support bandwidth. Since our approval in June 2025, we have architected, implemented and now accelerated the foundational requirements to deliver commercial sales in the U.S. market through VAC initiations and approvals, contract implementation, case completions and reorders, all building in our mission to dominate this space with our next-generation stent. Thus far, we are pleased with the physician support and pace toward these fundamental operational milestones, getting products on shelves and available to meet market demand. We met our 2025 objectives of building our U.S. commercial team to north of 30 people with the majority in the field, as we previously shared. We have now completed over 500 cases, gained approvals in some of the most prominent IDNs in the United States and established ourselves as the go-to device for many physicians who now have access to CGuard Prime. We remain committed to supporting the success of every procedure with strong case support and continuous improvement with the ease of use of our products. As I've stated previously, we have real-world experience with the CGuard stent in over 70,000 cases in our 30 OUS markets to date, which we are leveraging in our launch. As we have executed on our controlled rollout, we have observed opportunities to improve our delivery systems' technical success and enhance ease of use. We understand what is required to exceed our customer expectations, and we plan to introduce these improvements beginning in the fourth quarter. Now to our clinical pipeline and advanced indications for our CGuard implant, a critical piece of our long-term growth strategy. We continue to build on multiple programs in clinical studies as we work to expand the reach of our technology by leveraging clinical evidence, potentially unlocking additional market opportunities. Starting in TCAR with C-GUARDIANS II, evaluating CGuard Prime in a shorter delivery system, purpose-built for use in TCAR procedures and designed to be compatible with neuroprotection systems that are already in use in the market. I'm pleased to report that we have completed enrollment in this trial and submitted the request for approval to FDA, anticipating potential approval in Q3. This indication will boost our market opportunity for stent sales into the more than 35,000 current TCAR procedures annually. Simultaneously, we are rapidly advancing CGUARDIANS III, the next phase of our TCAR strategy, evaluating our fully integrated TCAR solution, combining the CGuard Prime 80 stent with our proprietary SwitchGuard Neuroprotection System. This study is designed to showcase the full potential of our purpose-built solution for TCAR, offering physicians a comprehensive, streamlined option that we believe can set a new standard in the field. We plan to begin enrollment in this study in Q2 with expected FDA clearance and launch in the second half of 2027. To recap expectations for 2026, we will deliver extraordinary quality and exceed expectations for our growing range of customers, build a sustainable foundation from which we can expand stenting market, utilize the CGuard's stent-first strategy to differentiate superior outcomes, serve the entirety of the market for all specialists treating carotid disease, boldly build a market-leading company worthy of lofty expectations from our customers and patients who benefit from our breakthrough technology. Finally, I would like to thank our entire team for their extraordinary commitment to our success, and I look forward to continuing to build our organizational strength with deep talent and expertise to advance our mission to prevent strokes and save lives. I'm incredibly excited about our future and look forward to sharing our progress over the coming year. Now I'll turn the call over to Mike to walk us through the financials. Mike? Michael Lawless: Thanks, Marvin. For the fourth quarter of 2025, total revenue was $3.1 million, an increase of 62% compared to revenue of $1.9 million for the fourth quarter of 2024. This growth was driven by the launch of CGuard Prime in the U.S. and increased penetration of international markets with CGuard. U.S. revenue for the fourth quarter was $866,000, driven by the launch of CGuard Prime, representing 74% sequential growth versus the results of the third quarter. We are pleased with the trajectory of U.S. launch and anticipate continued progress in 2026. International revenue for the fourth quarter was $2.3 million, reflecting growth of 17% compared to $1.9 million for the fourth quarter of 2024. The majority of the international growth was driven by higher unit sales, while changes in foreign exchange rates contributed growth of about 7% to our international results. Gross profit for the fourth quarter of 2025 was $1.2 million or 37.5% of revenue compared to gross profit of $469,000 or 24.1% of revenue for the fourth quarter of 2024. This increase in gross margin resulted primarily from a favorable shift in revenue mix to U.S. sales, which carry a substantially higher margin than international sales. Our sales in the U.S. generated gross margins of about 70%, reflecting the strong pricing and value that we bring to our customers. Total operating expenses for the fourth quarter of 2025 were $13.3 million, an increase of $3.4 million compared to $9.8 million for the fourth quarter of 2024. This increase was primarily due to higher commercial staffing levels and marketing activities for the U.S. commercial launch of CGuard Prime. Financial income was $386,000, an increase of $134,000 compared to $252,000 for the fourth quarter of 2024, resulting from the increase in financial income from investments in marketable securities and money market funds. 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 of 2024. As of December 31, 2025, cash and cash equivalents and marketable securities were $54.2 million compared to $34.6 million at the end of the prior year. As a reminder, we have 2 remaining milestone-based tranches pursuant to the private placement we closed in May of 2023. Each tranche provides gross proceeds of $17.9 million if fully exercised, and the remaining tranches are triggered by future milestone events. First, the completion of 4 quarters of commercial sales of CGuard Prime in the U.S., which we anticipate in the second half of 2026; and second, the completion of both the receipt of FDA approval for the TCAR indicated CGuard Prime stent, which we expect in the third quarter of 2026, and the FDA clearance of the SwitchGuard TCAR Neuroprotection System, which we expect in the second half of 2027. Turning to our 2026 outlook. InspireMD expects revenue for the full year 2026 to be in the range of $13 million to $15 million, reflecting growth of approximately 45% to 65% over full year 2025. We expect increasing sequential revenue growth in the second half of 2026 as our business gains momentum and U.S. sales growth accelerates from the anticipated label expansion by the FDA for the use of CGuard Prime in TCAR procedures and the introduction of the enhanced delivery system for CGuard Prime for use in CAS procedures. This concludes our prepared remarks. We will now open the call for questions. For the Q&A segment, we will be joined by Shane Gleason, InspireMD's Chief Commercial Officer. Operator? Operator: [Operator Instructions] Our first question coming from the line of Adam Maeder with Piper Sandler. Adam Maeder: Congrats on all the progress. A couple for me today, if that's okay. And maybe we could start on the guidance front. Mike, just trying to get a better understanding of the construction of the guidance that you put out for FY '26. Maybe you could kind of double-click on that, help us think through U.S., the U.S. business versus OUS. And then with the CGuard Prime integration into the Boston Silk Road system, what's kind of contemplated in the guidance from that new product launch? And then I had a couple of follow-ups. Michael Lawless: Adam, thanks for the question. So first of all, for the OUS sales, we're continuing to expect sales that are in the range of what we've been able to perform in the last several quarters with some maybe some moderate growth there. So continued growing penetration of OUS markets. And then on the U.S. side, we're going to continue to sustain our controlled launch phase at this stage. So that would mean somewhat moderated growth in the U.S. for the first half. And then as we have those catalysts kicking in, in the second half, we would see some acceleration of the growth as a result of the anticipated TCAR indication, the anticipated enhanced clinical performance of the CGuard Prime for CAS, and then finally, just the maturing of approvals and contracts as we work through the VAC approval process. Adam Maeder: That's helpful. I appreciate the color. And maybe a good segue into the next question, which is hoping for an update on kind of exactly where you stand from an account standpoint in the U.S. So looking for metrics like number of accounts, number of VACs that are in process, just trying to kind of take the temperature there, even if it's not explicit, just hoping to get kind of some broad strokes color around how that's progressing. Marvin Slosman: Yes. Adam, it's Marvin. I might hand that one off to Shane just to provide a little bit of color on that topic. Shane, if you don't mind grabbing that question. Shane Gleason: Sure. So the questions around accounts and penetration, so we have done cases in -- and these are to date, not capped at Q4, but we've done cases in roughly 80 centers. And as we've mentioned, the VAC processes before, those are frequently not linear. So in some cases, there are evaluation cases before VAC approval. Sometimes the VAC approval has to happen before the first case can be performed. So that's kind of a mix of those, but 80-plus centers have done cases at this point, and tracking the number that are in our pipeline, there are north of 200 centers in the pipeline of -- between VAC and evaluation stage. So the team has been able to produce quite a lot of momentum. We have a lot in the funnel and the job is to drive them through the funnel and make them active ongoing customers from here. Adam Maeder: Great. Very helpful color, Shane. I appreciate all that. And sorry, I know I'm asking a bunch of questions today. Just wanted to tick through some of these. Next, on the next-gen delivery system and enhanced ease of use. It sounds like you're targeting that for Q4 of this year. My takeaway there is that this is kind of opportunistic. It's an opportunity to make a great product even better versus like a pressure point or consternation from docs. But I wanted to confirm that is correct. And then what is needed from a regulatory standpoint to get the next-gen delivery system across the goal line? Marvin Slosman: Yes, Adam, thanks for that question. You're absolutely correct in your assumption there. Our CGuard stent is performing extraordinarily well as anticipated and consistent with all the work that we've done with 70,000-plus implants to date. When we launched the CGuard Prime with this differentiated new delivery system, we did so in a controlled manner to ensure that we're able to manage first use of this device in a market with new users unfamiliar with the delivery system and platform. So we intentionally sought feedback looking for areas to discover and improve, like all good companies do, and we'll continue to iterate and improve off of that feedback to ensure we're delivering these world-class technical success results to meet these -- the leadership goals for the company. So I think you're absolutely correct about your assumptions. And these fall into that continuous improvement approach that we'll continue to take. As far as submission is concerned, these are relatively minor changes, and we'll go to FDA in a 30-day review. So I think we're always looking for those opportunities to build more confidence into the delivery side of the device itself, but the implant is performing exactly according to plan. Adam Maeder: Okay. Perfect. And if I could just ask one last one, I promise, I'll jump back in the queue. Just was hoping to better understand timing for the C-GUARDIANS II data specifically, when will we see that -- the data from that study as well as the CGuard cohort data from the CREST-2 trial. Just when should we expect those? Marvin Slosman: Yes, Shane, do you want to grab that one? I think you're probably latest up to date on the data. Shane Gleason: Sure. So we have a slot that's been accepted at the Charing Cross Congress in the back half of April. That will be the first reveal of C-GUARDIANS II data. That will likely be the interim cut of the data, but it will be the first time that we see any of the clinical data from that trial. Operator: Our next question coming from the line of Frank Takkinen with Lake Street Capital Markets. Frank Takkinen: Congrats on all the progress. I was hoping to start with a question around really account adoption and productivity metrics. So maybe first part of that, maybe any anecdotal patterns you can share when account does activate with CGuard, how are they first using the product? And have you seen any of your accounts really shift over to being an exclusive CGuard user? And then from a productivity standpoint, how should we think about how many accounts a rep can manage and maybe how many -- what peak productivity per account can look like over time? Marvin Slosman: Shane, do you want to grab that one, first part of it, and I can follow up? Shane Gleason: Sure. Yes. So we have seen adoption. And I think the one thing that's important to our strategy is we know we have a premium product. We have priced it at a premium, but not at such a premium that we want it relegated to only be used in the most challenging cases. So our goal is to be able to become the everyday stent of the people who use it. And of those docs who have made it through the evaluation stage, we do have a growing number who are using it as their everyday stent. So that's the goal. When you look at what physicians perform, "the average" if you look at the number of procedures being performed and the number of physicians performing them, the average is somewhere in the neighborhood of 15 to maybe approaching 20 cases a year. So we really look at it more as how many cases can a rep support versus how many doctors or accounts can they support. So if the average physician does, by those numbers, 1 or 2 a month, if they're on the same day, you can cover them more efficiently than if they're spread out on separate days. So there's 20-plus selling days most months and our reps' goals are to be in cases darn near every working day and hopefully multiple cases in the same day. So we've got a lot of room to expand. And from there, it's just logistics. Marvin Slosman: Yes, Frank, let me expand on that a little bit as well. So we're taking a very deliberate approach to measuring productivity in the field as we build our commercial organization. We use a lot of claims data to measure and monitor that. So I think it's safe to assume that we're going to continue to be present in these cases to make sure that the experiences are those that we expect, and we'll be prepared to expand as we get to a productivity curve that looks to be reasonable as we need to grow the organization and build it out. But so far, we've been very pleased with that productivity ramp and we'll continue to watch that closely. Frank Takkinen: Very helpful. And then maybe following up on some of the points made in there. Appreciating case support is extremely important in the early days. Do you envision over a longer period of time, this is a product that can be on the shelf and just be the de facto stent that is used and not necessarily requiring rep support in every single case at a more mature state of the company? Marvin Slosman: Absolutely. Yes, I think there are different -- there are slightly different expectations in the market for when we get into the TCAR space, a higher percentage of those cases are supported by industry representatives than there are for the CAS cases. So we have a kind of model by specialty of what our expectations are. But absolutely, the goal is once someone is comfortable with the device to be able to have them have it on their shelf and use it when we're not around. We still like to be there to provide support, but we don't need to be the rate-limiting item there once physicians gain comfort with the system. Frank Takkinen: Perfect. And then the last one, any refresher you guys can provide on sales force hiring cadence would be great color. Marvin Slosman: Shane, do you want to grab that? Shane Gleason: I can take it. So thanks, as the guys mentioned in the prepared remarks, we had last stated that our goal was to get to north of 30 people in the U.S. commercial organization by the end of the year with the majority in the field. We reached that. And at this point, our goal is to continue hiring opportunistically and selectively where we need increased penetration, where we need more support. But by and large, at this point, this is the group that's going to launch our first indication. Let this group kind of set down their roots, make their ways through those value analysis committees and processes. And then as we start to layer in additional indications when TCAR comes along, we expect that we'll probably pick that hiring back up. But our first goal was to get a somewhat uniform coverage of the major markets and let that group throw their roots down and climb that productivity curve that we've mentioned a few times now. Operator: Our next question in queue coming from the line of Jeremy Pearlman with Maxim Group. Jeremy Pearlman: First one regarding your limited or as you called it, the commercial rollout. Is that -- the 200 centers that you said are in the pipeline, is that still part of this controlled launch? Or does that already now bleed into a broader commercial U.S. launch? And then maybe talk about what time line could we expect for that broader U.S. commercial launch? Marvin Slosman: Yes, Jeremy, let me grab the first part of that, and then Shane can add. I just want to make sure we clarify the nomenclature. It's not a limited launch. It's a controlled launch. So we're being very prescriptive about how we go about doing it, but growth is still the driver. And we will continue to build our pipeline and support cases with the objective of growing the business. So that's a key differentiation. I just wanted to clarify there. We want to make sure that all these experiences that these physicians have with this new device are ones that build a sustainable model for the long term. So we will continue to build off of that, and we'll continue to grow the pipeline of opportunities. And with this new indication coming in the second half of the year with TCAR, we'll certainly launch that as aggressively as possible as well. Shane, I didn't know if you had any additional comments to that or not for Jeremy? Shane Gleason: Yes, that's really well said, Marvin. I think just a couple of additional points. One is when we look at the progress we've made, and I've mentioned the size of the sales organization, it's important to remember that roughly half of our territory managers started in Q4. So we had a group that was on board when we got approval last summer, but really half of our organization has been out there for a quarter. So we always talk about how these Value Analysis Committees tend to -- and contracts tend to measure their time lines in quarters, not months. So we don't work on things in serial or in series where you work on one until it's complete and then you start the next one. You get a whole lot of them moving at once in parallel, and they start to come to fruition on their own time schedules as we drive them through. So to your question of where does the controlled launch end and all systems go full bore launch pick up, many of those accounts that are in the pipeline now will be feeding into that full launch. So really well stated. Jeremy Pearlman: Okay. Understood. And then maybe any feedback you could share from the vascular surgeons? I know we've talked about in the past you have about shifting the whole market to a stent-first approach. The physicians that have adopted the CGuard Prime platform, have they echoed that sentiment that they see this as being now the first line of care? Marvin Slosman: Yes. Jeremy, let me grab the first part of that. Shane can jump in here as well. I think that the enthusiasm across the board, no matter what subspecialty, for a new innovative technology with these kinds of outcomes that are evidenced with the data that we have is just truly palpable. It's consistent across the board that this market has been looking for a new technology to advance an endovascular-first approach to carotid stenting regardless of specialty. But the feedback through the TCAR trial with the use of CGuard Prime has reiterated that to us, and we continue to have incredible enthusiasm on the part of all subspecialists, but in particular, the vascular surgeons are very keen on having an alternative to what up to this point has been only one device, 20-year-old device available to them. So it's really encouraging, and we're looking forward to taking advantage of the moment. Shane, anything from you there? Shane Gleason: No, nothing to add. Marvin Slosman: Thanks, Jeremy. I'd like to thank everyone for joining today's call and for the continued support of our mission to lead and transform the carotid intervention market. CGuard is redefining outcomes for patients and their providers by lowering risk of stroke and other major adverse events to levels never achieved with first-generation stenting surgery or medical therapy alone, validated with rigorous evidence, proven clinical results, reimbursement and real-world outcomes. We're very excited for what the future has to hold for InspireMD. Thanks for joining the call today. Operator: This concludes today's conference call. Thank you for your participation, and you may now disconnect. Before you buy stock in InspireMD, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and InspireMD wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $496,473!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,216,605!* Now, it’s worth noting Stock Advisor’s total average return is 968% — a market-crushing outperformance compared to 202% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 4, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. InspireMD (NSPR) Q4 2025 Earnings Transcript was originally published by The Motley Fool

- 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, May 04, 2026 (GLOBE NEWSWIRE) -- 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 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. Conference Call and Webcast Details Management 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. 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 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. Non-GAAP Financial Measures To 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 past financial performance and future prospects, and allow for greater transparency with respect to key measures used by management in its financial and operational decision making. The Company defines adjusted gross profit as gross profit excluding the impact of the reserve for inventory impairment recognized during the period. The non-GAAP financial data are not measures of the Company’s financial performance under GAAP and should not be considered as alternatives to gross margin or any other performance measures derived in accordance with GAAP. Non-GAAP financial measures may not provide information that is directly comparable to that provided by other companies in other industries or within InspireMD’s industry, as other companies may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. In addition, there are limitations in using non-GAAP financial measures because the non-GAAP financial measures are not prepared in accordance with GAAP, may be different from non-GAAP financial measures used by other companies and exclude expenses that may have a material impact on the Company’s reported financial results. Further, the reserve for inventory impairment recognized during the period is a significant item that affects gross profit and may obscure the Company’s underlying operating performance and comparability between periods. The presentation of non-GAAP financial information is not meant to be considered in isolation, as a substitute for, or superior to the directly comparable financial measures prepared in accordance with GAAP. In addition, non-GAAP measures should not be construed as an inference that the Company’s future results will be unaffected by unusual or non-recurring items. InspireMD urges investors to review the financial results calculated in accordance with GAAP and the reconciliation of the Company’s non-GAAP financial measures to the comparable GAAP financial measures included below, and not to rely on any single financial measure to evaluate the Company’s business. Investor Contacts: Jeff Warren LifeSci Advisors [email protected] [email protected] CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(1) (Unaudited) (U.S. dollars in thousands, except share and per share data) (1) All 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 2025 financial information is derived from the Company’s 2025 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. (2) All March 31, 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. Adjusted Gross Profit The following table reconciles Adjusted Gross Profit to Gross Profit, which we consider to be the most directly comparable GAAP financial measure

Image source: The Motley Fool. Tuesday, Aug. 5, 2025 at 8:30 a.m. ET Chief Executive Officer — Marvin L. Slosman Chief Financial Officer — Michael A. Lawless Chief Commercial Officer — Shane Thomas Gleason Need a quote from a Motley Fool analyst? Email [email protected] Marvin L. Slosman: Thank you, and good morning, everyone. We're happy to welcome you to today's call at this exciting and transformative moment for our company. Before we review our recent progress and second quarter results, I'd like to take a moment to formally welcome Mike Lawless, our new Chief Financial Officer. Mike brings decades of financial leadership and deep expertise to InspireMD as well as a clear commitment to our mission and to the patients we serve. I'd also like to thank Craig Shore for his contribution and dedication over the past 15 years. His impact on the company's foundation and trajectory has been invaluable and is a big part of why we are here today. Turning to our recent progress as a business. Today's call comes just about a month after we received FDA premarket approval for our CGuard Prime Carotid Stent System, the most significant milestone in our company's history to date. We are now commencing on our U.S. commercial launch, leveraging our wealth of experience from over 30 OUS markets with over 60,000 patients treated to date to take the first step toward our mission of leading the U.S. carotid interventional market. I want to take a moment to reiterate what sets us apart as we step into this immense opportunity. Our mission is clear: to transform the carotid intervention market and deliver best-in-class patient outcomes through a stent-first approach. Over 3 million people globally have been diagnosed with carotid artery disease with countless others remaining undiagnosed, while only 155,000 are treated annually in the United States. These patients are at risk of stroke with deadly and profound debilitating outcomes. We've invested years of effort and expertise to build an innovative stent platform, CGuard Prime, that redefines success for these patients and their providers by lowering the risk of strokes and other major adverse events to levels never achieved with stenting or surgery as validated with rigorous evidence, proven clinical results and real-world experience. We are the first company to invest in the broadest toolkit of carotid procedures supporting both carotid artery stenting known as CAS and transcarotid artery revascularization known as TCAR with an implant-first procedure-agnostic strategy. Our approach has resonated strongly with physicians who are eager for innovation to improve outcomes and practice performance while addressing the full scope of carotid intervention. In 2023, a CMS shift further catalyzed this opportunity, positioning stenting as the emerging go-to treatment. We've built a strong foundation to capitalize on this shift with a world-class team, solid infrastructure and a sizable balance sheet, all fueling our momentum. Thanks to our investors' confidence in our strategy and plan, we were funded and well prepared to commercialize at approval. We're now building traction and velocity to create and capture market demand. At the core of our business, we have a stent platform delivering next-level outcomes ready to transform the vascular market. With the assets we've built, the evidence we've generated and the team we've assembled, we are now well positioned to execute our U.S. launch with excellence to drive growth, expansion and shareholder value. Turning to our launch progress. In recent weeks, we've begun to strategically execute our commercial playbook in many U.S. centers. Our sales team is taking a methodical approach, leveraging claims and market data to target accounts. Early interest has been strong as we navigate value analysis committee approvals and educate providers about our differentiated stent system. As of today, we've successfully completed approvals, orders and commercial procedures in numerous accounts and hospital systems, a reflection of the enthusiasm and demand. We are not simply executing a product launch. We are laying the foundation to redefine the carotid intervention market. A successful launch starts with the right team, and we are proud of the exceptional group we've assembled. Our sales and clinical support specialists bring deep experience in the vascular markets, established relationships with physicians and administrators and a proven ability to launch innovative products successfully. Their expertise and understanding of account dynamics are already driving engagement and establishing our presence nationwide. We continue to receive overwhelming interest from highly experienced professionals eager to join our team. This is a testament to the demand and awareness of CGuard Prime in the field, the promise of the talent we've already attracted and the sizable opportunity in a stent-first carotid intervention. Our team experienced the enthusiasm of our technology firsthand just a few weeks ago at the Society of NeuroInterventional Surgery's Annual Meeting. The energy surrounding CGuard Prime was unmistakable. Our booth was the constant hub of activity, drawing the attention of many prominent U.S. physicians eager to learn more about how our innovation can transform carotid care. Time and again, we are hearing from doctors who are genuinely excited to offer this technology to elevate the standard of care and improve the lives of their patients. Moments like this reinforce our conviction in our technology and in our mission. We have built the infrastructure, assembled the team and developed the operational readiness to execute this launch with excellence, and we look forward to updating you all on our progress as we move through foundation building toward more robust commercial scale over the coming quarters. Turning now to our clinical pipeline, a critical component of our long-term growth strategy. We continue to make steady progress on multiple fronts as we work to expand the reach of our technology, build clinical evidence and unlock additional market opportunities. First, I'll update you on our pivotal studies in TCAR. In C-GUARDIANS II, we are evaluating CGuard Prime in a catheter designed for TCAR procedures used with neuroprotection systems that are already used commercially today. This study is designed to demonstrate the safety and effectiveness of CGuard Prime in TCAR procedures and to open this important segment of the market to our platform. We received the FDA IDE approval to initiate the study in late 2024, and I'm pleased to report that enrollment continues at a good pace as we continue to work toward first half of '26 approval. At the same time, we're advancing the next phase of our TCAR strategy with C-GUARDIANS III, which evaluates our fully integrated TCAR solution, combining a CGuard Prime 80 stent with our proprietary SwitchGuard neuroprotection system. This study is designed to showcase the full potential of our purpose-built solution for TCAR, offering physicians a comprehensive streamlined option that we believe can set a new standard in the field. Given the variability of time lines surrounding clinical enrollment and FDA review, we now anticipate clearance and launch in 2027. Together, these 2 pivotal studies are designed to strengthen our competitive position in TCAR, a U.S. market that already exceeds 30,000 procedures annually and to demonstrate the versatility and clinical value of our differentiated platform. We're also making progress in expanding the potential use of our technology into acute stroke care, particularly our tandem lesion early feasibility study, which we're conducting in partnership with Dr. Adnan Siddiqui at the Jacobs Institute in Buffalo, New York. This study evaluates the use of CGuard Prime in acute stroke patients with tandem lesions in conjunction with thrombectomy. These are highly complex, high- risk cases where embolic protection is critical, and we believe our proprietary MicroNet mesh technology is uniquely suited to deliver superior outcomes in this setting. To date, enrollment is roughly halfway complete. Initial physician interest underscores the unmet need and potential impact of our technology in this challenging patient population. Each of these clinical initiatives reflect our commitment to advancing the standard of care in carotid and neurovascular disease, building evidence to support our differentiated portfolio and unlocking new pathways for growth. We believe our dual focus on CAS and TCAR positions us to serve the broadest space of physicians while leading the shift toward a stent first standard of care. Before I turn the line to Mike to review our Q2 performance, I want to highlight 2 major recent achievements that strengthen our balance sheet. Last week, we successfully entered into a securities purchase agreement with a group of leading institutional investors, raising $40.1 million in gross proceeds through a private placement. In addition, we raised $17.9 million for the exercise of warrants that were triggered by FDA approval of CGuard Prime. This is the second tranche of warrants that were originally issued as a part of the company's milestone-based financing announced in May of 2023. These transactions achieved several important objectives in support of our growth strategy as we launch CGuard Prime in the U.S. market. First, they deepen the commitment of several of our largest existing shareholders while expanding our investor base with the addition of high-quality investors. Second, they significantly strengthened our cash position collectively bolstering our resources by over $58 million in proceeds, allowing us to invest in the commercial scale necessary to achieve key growth milestones and execute toward long-term profitability. Now we are even more confident in our ability to scale U.S. commercial operations effectively and position InspireMD to deliver meaningful growth and value over the coming quarters and years. Now I'll turn the call over to Mike to walk us through the financials. Mike? Michael A. Lawless: Thanks, Marvin. Before I begin, I'd like to briefly say how excited I am to join InspireMD at such a pivotal moment in the company's trajectory. It's a tremendous opportunity to contribute to a team that's driving meaningful progress, and I look forward to supporting our continued growth and success. With that, let's turn to the second quarter results. For the second quarter of 2025, total revenue increased by 2% to $1.8 million. This increase was predominantly driven by increased usage in our international markets from the continued adoption of CGuard technology and the positive impact of foreign exchange, partially offset by decreased revenue from Russia and European distributors managing CGuard inventory levels in anticipation of the CGuard Prime launch in Europe. As expected, we did not recognize commercial revenue in the U.S. in Q2 as our FDA approval came in the last week of the quarter. However, we have begun to recognize U.S. commercial sales this quarter, positioning us for sequential revenue growth in Q3 and beyond. Our Q2 volumes add to the growing body of real-world experience. Globally, we have sold more than 60,000 implants to date. This track record reinforces our expertise, validates our innovative platform and highlights the strength of our global commercial infrastructure, all of which position us well as we shift our focus to the significant U.S. opportunity. Gross profit for the second quarter of 2025 decreased by $18,000 or 5.7% to $313,000 compared to a gross profit of $331,000 for the second quarter of 2024. This decrease in gross profit resulted from an increase in some production variances, partially offset by lower material and labor costs. Gross margin decreased to 17.6% during the 3 months ended June 30 from 19.0% during the 3 months ending June 30, 2024, driven by the above factors. Total operating expenses for the second quarter of 2025 were $13.3 million, an increase of $4.7 million or 55% compared to $8.6 million for the second quarter of 2024. This increase was primarily due to increases in headcount-related expenses as we continue to expand our U.S. personnel, particularly our commercial team to support the commercial launch of CGuard Prime in the United States. A second driver of our OpEx increase was occupancy and related expenses related to the establishment of our U.S. headquarters. Financial income decreased by $483,000 to $132,000 of financial expense from $351,000 of financial income for the second quarter of 2024. This decrease was primarily due to a $313,000 increase in financial expense related to changes in exchange rates and a $169,000 decrease in financial income from investments in marketable securities and money market funds. Net loss for the second quarter of 2025 totaled $13.2 million or $0.26 per basic and diluted share compared with a net loss of $7.9 million or $0.22 per basic and diluted share for the same period in 2024. As of June 30, 2025, cash and cash equivalents and marketable securities were $19.4 million compared to $26.1 million as of March 31, 2025. The June 30 cash balance does not include the $58 million in gross proceeds from our previously mentioned financing events. As mentioned above, the receipt of premarket approval from the FDA triggered the second of 4 milestone-based financing tranches pursuant to the transformational private placement of up to $113.6 million that we originally announced in May 2023. The remaining 2 milestones would each trigger additional tranche financings, including: one, the completion of 4 quarters of commercial sales of CGuard Prime in the United States, which we anticipate in the back half of 2026; and two, receipt of FDA clearance for the SwitchGuard TCAR neuroprotection system, along with the TCAR indicated CGuard Prime stent. While we are not providing guidance at this stage for our commercial launch, we look forward to sharing more about our progress and outlook when we report our Q3 results. Please keep in mind that while we are excited about the opportunity ahead, we know that a strong adoption trajectory will not be achieved overnight. We are executing a methodical launch to Marvin's earlier comments and we'll spend the next few months laying the foundation for robust future expansion. This concludes our prepared remarks. We will now open the call for questions. For the Q&A segment, we will be joined by Shane Gleason, InspireMD's Chief Commercial Officer. Operator? Operator: [Operator Instructions] We'll take our first question from Adam Maeder with Piper Sandler. Adam Carl Maeder: Congrats on the progress. And to you, Mike, welcome and Craig, wishing you the best in the future. Two for me, and I guess I'll start with the first one, which is a little bit of a myopic question, but I just wanted to see if there's any more detail that you can share regarding your progress with U.S. account openings since FDA approval for CGuard Prime in late June? And as we think about subsequent quarters and even 2026 for that matter, are there any targets or framework that you want to provide for The Street as we think about kind of initial launch, whether that's revenue, market share, number of accounts, et cetera? And then I did have one follow-up. Shane Thomas Gleason: Adam, this is Shane. I'll go ahead and start that one off and then maybe hand it off to Marvin for the second part of that. So we got approval about 6 weeks ago this week, and we're really excited about the progress that we've made. As we've noted previously, we have a commercial organization in the U.S. of around 20 people with a great majority of them in the field. We plan to continue scaling that and we're planning on adding roughly 10 people to that number by the end of the year. Having that group onboard at the time of approval, let us hit the ground running, I think it's common to see 6 weeks into an approval that very little, if anything, has occurred in the way of cases. We've actually done procedures with double-digit physicians, and we've even reached the point of beginning to secure shelf space with stocking orders in a number of those accounts. So I'd say the early reception has been exactly what we'd expected and hoped it to be, and we're off to a healthy start. Marvin L. Slosman: Adam, yes, this is Marvin. I think Shane framed it perfectly. I think that the opportunity for us was in our May 2023 financing. We were able to fuel a commercial team, a game plan and a playbook that allowed us to hit the road when we had approval, and we will continue to build off that momentum. We certainly understand that there's headwinds involved with building administrative approvals and all the things associated with readiness, and we have to have some patience in that regard. But I think overall, we've hired to the standard of being able to build access to these facilities and physicians. And so far, as Shane said, the reception has been overwhelming, and we really appreciate the fact that the market is receiving CGuard Prime as well as they have. Adam Carl Maeder: Okay. Perfect. That's great color there. And for the follow-up, I did want to ask about C-GUARDIANS III and SwitchGuard, your proprietary TCAR device, if I heard correctly in the prepared remarks, now expect clearance and launch in '27, a little bit of a wiggle from late '26, which I think was the prior expectation. Just wanted to, I guess, kind of better understand kind of what's driving the change in expected time lines? Is it related to device design? Is it pinning down clinical strategy and trial construction? Is it something else? And yes, just trying to kind of better understand the change in timing there and the confidence in getting clearance in '27. Marvin L. Slosman: Sure, Adam. Thanks. So just let's go back as a reminder of our overall TCAR strategy. It was built around the entry into the market with a TCAR indicated catheter first to unlock the potential of the implant first, which is most sought after by the physicians and remains Phase I, which is in line with our prior time lines. SwitchGuard was designed as a next-generation platform for neuroprotection and as such, requires the entirety of the development process from design through production build. And in parallel, we've also considered the clinical enrollment aspect, FDA regulatory requirements, statutory time lines, all those kinds of things. So we're progressing exceptionally well in all of these areas, but just believe that the time line should reflect a broader window to clearance. There's variability in all of these aspects of bringing new products to market, and we're just trying to expand the window to give us room to deal with the uncertainties of those aspects of all of these launch parameters, but nothing other than that trying to be realistic and compensate for that. As you've seen in the past, we've previously demonstrated that we'll continue to find passive lease resistance and deliver accordingly and time lines in our world remain as aggressive as we can in hopes that we can beat expectations. Operator: We'll take our next question from Frank Takkinen with Lake Street Capital Markets. Frank James Takkinen: Congrats on all the progress. I was hoping you could refresh us on some account metrics. I know we've talked about it in the past, how many high potential accounts do you see out there? How many do you intend to target with the initial sales footprint? And then how does that kind of roll out progress as you bring on more reps? Shane Thomas Gleason: Yes. Thanks, Frank. This is Shane again. So one of the nice things here is that carotid stenting is an established market. We have claims data that shows we know that there are roughly 60,000 annualized procedures and growing. They're performed by 4,000 physicians in the U.S. We have claims data showing who they are, where they are, where they practice and what their volumes are. So in terms of the old fish where the fish are, we're putting -- we're hiring our team selectively in locations that have the highest density of procedures. We're targeting the physicians that do above average number of procedures, obviously, in the busier accounts. So what we're tracking early on, the obvious one is revenue. The other ones are just physicians in every stage of our sales funnel who's expressed interest, who's in their value analysis committee who is evaluating the product and where have we secured business. So we're tracking all of those metrics in the early stages, and they're tracking in the direction that we expected them to do. Frank James Takkinen: Got it. That's helpful. And then maybe also partially a refresher and just a kind of update on the broader market. The 60,000 procedures you talked about, my understanding is that's transfemoral as well as TCAR in that number. And then there's approximately another 100,000 or so that are still being completed open. What are kind of the latest trends in that mix? And then how do you think about that trend towards an endovascular first mindset progresses over the next few years? Shane Thomas Gleason: Yes, that's exactly right. We see the trend where it used to be 70% plus surgery, that gap is closed to where it's now less than 60% surgery. And with the 40% plus being stent-based, which, to your point, could be transfemoral, could be transradial, could be TCAR. And we see those lines continuing to converge. So we expect within the next year or so that we'll likely reach a 50-50 point for the first time. And then in the coming years for carotid intervention to look just like every other vascular intervention in the U.S. where there are products, there's reimbursement and an endo first standard of care. So between CAS and TCAR, we -- that is -- there is a mix there. It's about 50-50. And really, what we do with the claims is we can tell who's doing cases. We choose not to assume which approach they're going to take. Not all surgeons prefer TCAR, not all interventionalists prefer CAS. So we don't assume what they're doing, but then with our long-term strategy, we'll be able to serve all approaches. But in the short term, the goal is to find those that have a use for our CAS indicated stents and target those in the early stages here. Operator: We have reached the end of our question-and-answer session. I will turn the program back over to Marvin Slosman for any additional or closing remarks. Marvin L. Slosman: Great. I'd like to thank everyone for joining the call today and your continued support of our mission to lead and transform the carotid intervention market. We're proud of the strong execution we delivered in the second quarter of '25 and even more excited about the milestones ahead as we enter the critical first quarters of our U.S. commercial launch of CGuard Prime. With a differentiated technology, strong clinical foundation and a clear strategy to expand the market and improve outcomes, we believe InspireMD is uniquely positioned to reshape stroke prevention in the United States. As we execute on this launch and build momentum, our focus remains on driving meaningful impact for patients, physicians and shareholders alike. We're confident in our path forward and energized about the opportunity ahead to expand provider treatment options, advance patient care and establish CGuard Prime as the standard of carotid intervention. Thanks for joining today. Operator: Thank you. 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