InspireMD, Inc.

Previous wording

We are a medical device company focusing on the development and commercialization of products for the treatment of carotid artery disease and other vascular disease, including our proprietary CGuard™ stent platform. On June 23, 2025, CGuard Prime, our next generation carotid artery stenting (“CAS”) stent platform, was granted premarket application (“PMA”) approval the U.S. Food and Drug Administration (“FDA”). A stent is an expandable scaffold-like device, usually constructed of a metallic material, that is inserted into the lumen of an artery to create patency and improved blood flow. A sleeve of MicroNet™ mesh is attached over a stent to provide embolic protection both during and after stenting procedures.

Current wording

We are a medical device company specializing in the development and commercialization of products for the treatment of carotid artery disease and other vascular conditions. Our portfolio includes two commercial products based on our proprietary CGuard carotid stent technology, designed to provide market-leading embolic protection during and after stenting procedures. A stent is an expandable scaffold-like metallic device placed in an artery to widen the lumen and restore blood flow.

Previous wording

In October 2024, the FDA approved the Company’s IDE to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80cm Carotid Stent System during transcarotid revascularization (TCAR) procedures.

Current wording

In October 2024, the FDA approved the Company’s IDE to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80 cm carotid stent system during transcarotid revascularization (“TCAR”) procedures. In the first quarter of 2026, we completed enrollment in the CGUARDIANS II pivotal study. In May 2026, the FDA approved the Company’s IDE to initiate the CGUARDIANS III pivotal study of its CGuard Prime 80 cm carotid stent system during TCAR procedures.

Previous wording

In October 2023, the Centers for Medicare and Medicaid Service (“CMS”) issued its final National Coverage Determination (“NCD”), expanding coverage for both CAS and TCAR to include both asymptomatic and standard risk patients, significantly expanding and supporting the future growth of the U.S. CAS addressable market.

Current wording

In October 2023, the Centers for Medicare & Medicaid Services (“CMS”) issued its final National Coverage Determination (“NCD”), expanding coverage for both carotid artery stenting (“CAS”) and TCAR procedures to include both asymptomatic and standard risk patients, significantly expanding and supporting the future growth of the U.S. addressable market for CAS.

Previous wording

We consider our current addressable market for our CGuard Carotid Stent System and SwitchGuard NPS to be both symptomatic and asymptomatic individuals with diagnosed high-grade carotid artery stenosis for whom intervention is preferable to medical (drug) therapy. This group includes not only carotid artery stenting patients but also individuals undergoing carotid endarterectomy, as the two approaches compete for the same patient population. Assuming full penetration of the intervention caseload by CGuard, we estimate that the addressable market for CGuard Carotid Stent System and SwitchGuard NPS is approximately $1.3 billion (source: Health Research International Personal Medical Systems, Inc. September 13, 2021 Results of Update Report on Global Carotid Stenting Procedures and Markets by Major Geography and Addressable Markets and internal estimates). According to this same report and internal estimates, assuming full penetration of treatment for all individuals diagnosed with high-grade carotid artery stenosis, we estimate the total available market for CGuard Carotid Stent System and SwitchGuard NPS to be approximately $9.3 billion, which may grow over time if expanded treatment options such as CGuard Carotid Stent System and SwitchGuard NPS lead to increased patient screening for carotid artery disease.

Current wording

We consider our current addressable market for our CGuard EPS, CGuard Prime, and SwitchGuard NPS to be both symptomatic and asymptomatic individuals with diagnosed high-grade carotid artery stenosis for whom intervention is preferable to medical (drug) therapy. This group includes not only patients eligible for either CAS or TCAR procedures, but also individuals who are candidates for CEA, as all three approaches can be options to treat these patients. Assuming full penetration of the intervention caseload, we estimate that the addressable market for CGuard EPS, CGuard Prime, and SwitchGuard NPS is approximately $1.3 billion (source: Health Research International Personal Medical Systems, Inc. September 13, 2021 Results of Update Report on Global Carotid Stenting Procedures and Markets by Major Geography and Addressable Markets and internal estimates). According to this same report and internal estimates, assuming full penetration of treatment for all individuals diagnosed with high-grade carotid artery stenosis, we estimate the total available market for CGuard EPS, CGuard Prime, and SwitchGuard NPS to be approximately $9.3 billion, which may grow over time if expanded treatment options such as our products lead to increased patient screening for carotid artery disease.

Previous wording

We were organized in the State of Delaware on February 29, 2008. In October 2024, we established our global headquarters in Miami, Florida to support the anticipated U.S. launch and commercialization of the CGuard Prime carotid stent system.

Current wording

We were organized in the State of Delaware on February 29, 2008. In October 2024, we established our global headquarters in Miami, Florida to support the U.S. launch and commercialization of CGuard Prime.

Previous wording

Revenues. For the three months ended September 30, 2025, revenue increased by $713,000, or 39.4%, to $2,523,000, from $1,810,000 during the three months ended September 30, 2024. Growth in the quarter was driven mainly by the commercial launch of direct sales of the CGuard Prime product in the U.S. following FDA approval in June 2025, and continued growth in sales of the CGuard product through distributors in international markets.

Current wording

Revenues. For the three months ended March 31, 2026, revenue was $3,398,000, an increase of $1,869,000, or 122 %, compared to $1,529,000 during the three months ended March 31, 2025. Growth in the quarter was driven mainly by the commercial launch of direct sales of the CGuard Prime product in the U.S. following FDA approval in June 2025, and continued growth in sales of the CGuard product through distributors in international markets.

Previous wording

With respect to geographical regions, the increase in revenue was primarily attributable to a $490,000 increase in North America due to the official commercial launch of CGuard Prime in the U.S. following FDA approval in June 2025, and a $223,000 increase in international markets outside North America due to continued adoption of our CGuard technology.

Current wording

With respect to geographical regions, the increase in revenue was primarily attributable to a $1,151,000 increase in North America due to the commercial launch of CGuard Prime in the U.S. following FDA approval in June 2025, and a $718,000 increase in international markets outside North America due to continued adoption of our CGuard technology.

Previous wording

Research and Development Expenses. For the nine months ended September 30, 2025, research and development expenses increased by 16.0%, or $1,587,000 to $11,528,000, from $9,941,000 during the nine months ended September 30, 2024. This increase resulted primarily due to an increase in compensation and headcount related expenses due to higher staff levels in connection with our expansion in the United States, and higher development and regulatory expenses for of the SwitchGuard NPS and CGuard Prime 80cm Carotid Stent System, respectively. These increases were partially offset by a decrease of expenses for the C-GUARDIANS clinical study, which was completed prior to the approval by the FDA in June 2025.

Current wording

Research and Development Expenses. For the three months ended March 31, 2026, research and development expenses were $4,763,000, an increase of $704,000, or 17.4%, compared to $4,059,000 during the three months ended March 31, 2025. This increase resulted primarily due to higher staff levels in connection with our expansion in the U.S., an increase in regulatory activities expenses, and higher development and clinical expenses for the SwitchGuard NPS and CGuard Prime 80 cm carotid stent system, respectively. These increases were partially offset by a decrease in expenses for the C-GUARDIANS clinical study and related product preparation activity prior to the FDA approval of CGuard Prime in June 2025.

Previous wording

Selling and Marketing Expenses. For the three months ended September 30, 2025, selling and marketing expenses increased by $2,920,000, or 198.4%, to $4,392,000 from $1,472,000 during the three months ended September 30, 2024. This increase resulted primarily from an increase in compensation and headcount related expenses from higher commercial staffing levels in connection with the commercial launch of CGuard Prime in the U.S.

Current wording

Selling and Marketing Expenses. For the three months ended March 31, 2026, selling and marketing expenses were $5,180,000, an increase of $2,430,000, or 88.4%, compared to $2,750,000 during the three months ended March 31, 2025. This increase resulted primarily from higher commercial staffing levels in connection with the commercial launch of CGuard Prime in the U.S.

Previous wording

Net Loss. Our net loss increased by $4,818,000, or 61.1%, to $12,708,000, for the three months ended September 30, 2025, from $7,890,000 during the three months ended September 30, 2024. The increase in net loss resulted primarily from an increase of $5,039,000 in operating expenses.

Current wording

Net Loss. For the three months ended March 31, 2026, our net loss was $13,689,000, an increase of $2,523,000, or 22.6%, compared to $11,166,000 during the three months ended March 31, 2025. The increase in net loss resulted primarily from an increase of $2,913,000 in operating expenses.

Previous wording

We had an accumulated deficit as of September 30, 2025, of $291 million, as well as a net loss of $37.0 million for the nine months ended September 30, 2025 and negative operating cash flows. We expect to continue incurring losses and negative cash flows from operations until our product, CGuard Prime, reaches commercial profitability. As a result of these expected losses and negative cash flows from operations, along with our current cash position, we believe we do not have sufficient resources to fund operations for at least the next 12 months. Therefore, there is substantial doubt about our ability to continue as a going concern.

Current wording

We had an accumulated deficit as of March 31, 2026, of $316 million, as well as a net loss of $13.7 million for the three months ended March 31, 2026 and negative operating cash flows. We expect to continue incurring losses and negative cash flows from operations until we expand our commercial revenue to a scale that funds our commercial resources, development activities and support functions. As a result of these expected losses and negative cash flows from operations, along with our current cash position, we believe we do not have sufficient resources to fund operations for at least the next 12 months. Therefore, there is substantial doubt about our ability to continue as a going concern.

Previous wording

In May 2023, we closed a private placement offering of 10,266,270 shares of our common stock, pre-funded warrants to purchase up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting of Series H warrants to purchase up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to purchase up to 12,914,078 shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086 shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to 12,914,086 shares of common stock (the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “Warrants”), at an offering price of $1.6327 per Private Placement Share and associated Warrants and an offering price of $1.6326 per Pre-Funded Warrant and associated Warrants that resulted in aggregate gross proceeds of approximately $42.2 million, before deducting fees payable to the placement agent and other offering expenses payable by us. If the Warrants issued in the private placement offering are exercised in cash in full this would result in an additional $71.4 million of gross proceeds, of which $35.7 million have been received as of the date of this Quarterly Report on Form 10-Q.

Current wording

In May 2023, we closed a private placement offering that resulted in aggregate gross proceeds of approximately $42.2 million, before deducting fees payable to the placement agent and other offering expenses payable by us, pursuant to which we issued and sold 10,266,270 shares of our common stock, pre-funded warrants to purchase up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting of Series H warrants to purchase up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to purchase up to 12,914,078 shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086 shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to 12,914,078 shares of common stock (the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “May 2023 Warrants”), at an offering price of $1.6327 per Private Placement Share and associated May 2023 Warrants and an offering price of $1.6326 per pre-funded warrant and associated May 2023 Warrants. If the May 2023 Warrants are exercised in cash in full this would result in an additional $71.4 million of gross proceeds (of which approximately $33.8 million has been received as of the date of this Quarterly Report on Form 10-Q). There can be no assurance that we will achieve any of the remaining milestones set forth in the May 2023 Warrants or that the outstanding May 2023 Warrants will be exercised in cash in full.

Previous wording

During June 2024, Series H warrants to purchase 12,914,086 shares of common stock that were issued in the May 2023 private placement were exercised in full into 292,996 of shares of common stock and pre-funded warrants to purchase 12,621,090 shares of common stock. The net proceeds to the Company from the exercise of the Series H Warrants were $16.9 million after deducting placement agent fees.

Current wording

Following the announcement of the one year follow up study results from the Company’s C-GUARDIANS trial, the Series H Warrants were exercised in full into 292,996 shares of common stock and pre-funded warrants to purchase 12,621,090 shares of common stock. The net proceeds from the exercise of the Series H Warrants were $16.9 million after deducting placement agent fees.

Previous wording

During June and July 2025, Series I warrants to purchase 12,914,078 shares of common stock that were issued in the May 2023 private placement were exercised in full into 2,352,393 shares of common stock and pre-funded warrants to purchase 10,561,685 shares of common stock. The net proceeds to the Company from the exercise of the Series I Warrants were $16.9 million after deducting placement agent fees.

Current wording

Following the announcement of the PMA approval of the CGuard Prime carotid stent system in the United States, the Series I warrants were exercised in full into 2,352,393 shares of common stock and pre-funded warrants to purchase 10,561,685 shares of common stock during June and July 2025. The net proceeds from the exercise of the Series I Warrants were $16.9 million after deducting placement agent fees.

Previous wording

In May 2024, we entered into an Equity Distribution Agreement with Piper Sandler & Co., as sales agent (“Piper Sandler), pursuant to which we may offer and sell, from time to time, at our option, through or to Piper Sandler up to $75,000,000 of our common stock (the “ATM Program”). As of the issuance date of this report, we have sold 920,898 shares of our common stock for total gross proceeds of approximately $2.4 million under the ATM Program.

Current wording

In May 2024, we entered into an Equity Distribution Agreement (the “2024 Distribution Agreement”) with Piper Sandler & Co., as sales agent (“Piper Sandler”). Pursuant to the 2024 Distribution Agreement, we were able offer and sell from time to time, at our option, through or to Piper Sandler shares of our common stock having an aggregate offering price of up to $75 million. Wepaid Piper Sandler a commission at a fixed rate of 3.0% of the aggregate gross proceeds from each sale of the shares under the 2024 Distribution Agreement. On April 3, 2026, we terminated the 2024 Distribution Agreement in connection with our entry into the 2026 Distribution Agreement (as defined below) with BTIG (as defined below). During the first quarter of 2026, we did not sell any shares pursuant to the 2024 Distribution Agreement.

Previous wording

On August 1, 2025, we closed the Private Placement Offering that resulted in aggregate gross proceeds of approximately $40.1 million, before deducting fees payable to the placement agent and other offering expenses payable by the Company.

Current wording

In August 2025, we closed the private placement offering that resulted in aggregate gross proceeds of approximately $40.1 million, before deducting fees payable to the placement agent and other offering expenses payable by us.

Previous wording

General. At September 30, 2025, we had cash and cash equivalents of $63,403,000, as compared to cash and cash equivalents of $18,916,000 and marketable securities of $15,721,000 as of December 31, 2024. We have historically met our cash needs through a combination of issuing new shares, borrowing activities and product sales. Our cash requirements are generally for research and development, marketing and sales activities, finance and administrative costs, capital expenditures and general working capital.

Current wording

General. As of March 31, 2026, we had cash and cash equivalents of $11,362,000 and marketable securities of $30,208,000, as compared to cash and cash equivalents of $8,939,000 and marketable securities of $45,272,000 as of December 31, 2025. We have historically met our cash needs through a combination of issuing new shares, borrowing activities and product sales. Our cash requirements are generally for research and development, marketing and sales activities, finance and administrative costs, capital expenditures and general working capital.

Previous wording

For the nine months ended September 30, 2025, net cash used in our operating activities increased by $10,640,000, or 70.4%, to $25,758,000, from $15,118,000 during the same period in 2024. The primary reasons for the increase in cash used in our operating activities were an increase of $9,005,000 in compensation costs paid during the nine months ended September 30, 2025 (from $8,838,000 in the nine months ended September 30, 2024 to $17,843,000 in the nine months ended September 30, 2025) and an increase of $1,709,000 in payments for third party related expenses and for professional services.

Current wording

For the three months ended March 31, 2026, net cash used in our operating activities increased by $3,545,000, or 40.3%, to $12,337,000, from $8,792,000 during the same period in 2025. The primary reasons for the increase in cash used in our operating activities were an increase of $5,038,000 in compensation costs paid during the three months ended March 31, 2026 (from $6,132,000 in the three months ended March 31, 2025 to $11,170,000 in the three months ended March 31, 2026) offset by an increase of $1,561,000 in payments received from customers during the three months ended March 31, 2026 (from $1,555,000 in the three months ended March 31, 2025 to $3,116,000 during the three months ended March 31, 2026).

Previous wording

Cash provided by our investing activities was $14,575,000 during the nine months ended September 30, 2025, compared to $4,399,000 during the nine months ended September 30, 2024. The primary reason for the increase in cash provided by our investing activities is withdrawal of $10,343,000, net of investment in marketable securities.

Current wording

Cash provided by our investing activities was $14,779,000 during the three months ended March 31, 2026, compared to $1,702,000 during the three months ended March 31, 2025. The primary reason for the increase in cash provided by our investing activities is withdrawal of $15,000,000 from our investment in marketable securities.

Previous wording

Cash provided by financing activities for the nine months ended September 30, 2025, was $55,569,000. The source of the cash provided by financing activities during the nine months ended September 30, 2025, were the proceeds from the Private Placement Offering in July 2025 as well as proceeds from issuance of shares received from our ATM Program that resulted in approximately $38,714,000 of aggregate net proceeds and proceeds from exercise of Series I warrants of $16,855,000. Cash provided by financing activities for the nine months September 30, 2024, was $16,889,000. The source of the cash provided by financing activities during the nine months ended September 30, 2024, were the proceeds from exercise of Series H warrants.

Current wording

There was no cash provided by financing activities for the three months ended March 31, 2026. Cash provided by financing activities for the three months ended March 31, 2025, was $506,000. The source of the cash provided by financing activities during the three months ended March 31, 2025, were the proceeds from issuance of shares of $506,000, net of issuance costs, received from the 2024 Distribution Agreement.

Previous wording

We believe that our future operating results will continue to be subject to quarterly variations based upon a wide variety of factors, including the market acceptance of the U.S. commercial launch, cyclical nature of the ordering patterns of our distributors, timing of regulatory approvals, the implementation of various phases of our clinical trials and manufacturing efficiencies due to the learning curve of utilizing new materials and equipment. Our operating results could also be impacted by a weakening of the Euro and strengthening of the NIS, both against the U.S. dollar. Lastly, other economic conditions we cannot foresee may affect customer demand, such as individual country reimbursement policies pertaining to our products.

Current wording

We believe that our future operating results will continue to be subject to quarterly variations based upon a wide variety of factors, including the market acceptance of the U.S. commercial launch, cyclical nature of the ordering patterns of our distributors, timing of regulatory approvals, the implementation of various phases of our clinical trials, manufacturing efficiencies due to the learning curve of utilizing new materials and equipment and the costs or other consequences associated with any current or future product recall that may occur. Product recalls in particular may adversely affect our operating results through the direct costs of executing a recall, lost revenues resulting from the removal of affected products from the market and the interruption of sales during any remediation period, costs associated with redesigning and remanufacturing affected products, potential regulatory, litigation and other legal costs, and longer-term reputational harm that may reduce market acceptance of our current and future products. Our operating results could also be impacted by a weakening of the Euro and strengthening of the NIS, both against the U.S. dollar. Lastly, other economic conditions we cannot foresee may affect customer demand, such as individual country reimbursement policies pertaining to our products.

Previous wording

During the nine months ended September 30, 2025, there were no material changes to our contractual obligations and commitments since the year ended December 31, 2024.

Current wording

During the three months ended March 31, 2026, there were no material changes to our contractual obligations and commitments since the year ended December 31, 2025.