InspireMD, Inc.

Previous wording

Our first product, the CGuard Carotid Embolic Prevention System (“CGuard EPS”), integrates a self-expanding nitinol stent with a MicroNet mesh sleeve as a single device for carotid artery revascularization. In January 2024, we received CE Mark recertification for CGuard EPS under the EU Medical Device Regulation (“MDR”). Our CGuard EPS previously held CE Mark approval under the former Medical Device Directive (“MDD”). CGuard EPS is marketed in over 30 countries outside the United States through a network of distributors. In the first quarter of 2026, we submitted a premarket approval for the CGuard EPS with a view to potential FDA approval in the in the third quarter of 2026.

Current wording

Our first product, the CGuard Carotid Embolic Prevention System (“CGuard EPS”), integrates a self-expanding nitinol stent with a MicroNet mesh sleeve as a single device for carotid artery revascularization. In January 2024, we received CE Mark recertification for CGuard EPS under the EU Medical Device Regulation (“MDR”). Our CGuard EPS previously held CE Mark approval under the former Medical Device Directive (“MDD”). CGuard EPS is marketed in over 30 countries outside the United States through a network of distributors. In the first quarter of 2026, we submitted a premarket approval for the CGuard EPS with a view to potential FDA approval in the second half of 2026.

Previous wording

Our second product, the CGuard Prime Carotid Stent System (“CGuard Prime”), uses the same stent and MicroNet mesh as the CGuard EPS with a differentiated deployment mechanism. CGuard Prime received premarket approval (“PMA”) by the U.S. Food and Drug Administration (“FDA”) on June 23, 2025, and is marketed exclusively in the United States through our direct salesforce. It also received MDR CE Mark approval on June 12, 2025.

Current wording

Our second product, the CGuard Prime Carotid Stent System (“CGuard Prime”), uses the same stent and MicroNet mesh as the CGuard EPS with a differentiated deployment mechanism. CGuard Prime received premarket approval (“PMA”) by the U.S. Food and Drug Administration (“FDA”) on June 23, 2025. In May 2026, we announced a voluntary recall in the U.S. of CGuard Prime, undertaken in consultation with the FDA after a controlled launch demonstrated that the technical success of its delivery system during CAS procedures did not meet performance expectations, with the voluntary action pertaining specifically to the delivery system and not to the CGuard stent implant. For additional information, see “FDA Matters” below. CGuard Prime also received MDR CE Mark approval on June 12, 2025.

Previous 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.

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, and in June 2026, we announced summary 30-day outcome data from the study, which showed acute device success of 100% with no major adverse events. 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, and in June 2026, we announced enrollment of the first patient.

Previous wording

In May 2026, we announced a voluntary recall in the U.S. of CGuard Prime, initiated in consultation with the FDA. The Company acted after determining during a controlled launch that the technical success of the delivery system during CAS procedures had not met performance expectations. The voluntary action pertained specifically to the CGuard Prime delivery system and did not include the CGuard stent implant. The action was voluntary with no implications for the safety of patients who had previously received the CGuard stent. The Company expects to establish a reserve for customer returns of approximately $700,000 and a reserve for inventory impairment and remediation costs of approximately $650,000.

Current wording

In May 2026, we announced a voluntary recall in the U.S. of CGuard Prime, initiated in consultation with the FDA. The Company acted after determining during a controlled launch that the technical success rate of the delivery system during CAS procedures had not met performance expectations. The voluntary action was limited to the CGuard Prime delivery system and did not involve the CGuard stent implant. The Company’s assessment did not identify new safety concerns for patients who had previously received a CGuard implant. We believe we have identified the root cause of the deployment resistance and are implementing design modifications intended to address the issue. We are currently performing verification and validation testing of these modifications in support of a PMA supplement to the FDA which we expect to submit in the fourth quarter of 2026. We cannot provide any assurance that the FDA will be satisfied with the corrective actions we are implementing in connection with the voluntary recall, or as to the timing of the resolution of such issues. Until these issues are resolved to the FDA’s satisfaction, we may be unable to resume commercialization of CGuard Prime in the United States. If the FDA determines that our corrective actions are inadequate or requires additional remediation, testing, validation or regulatory submissions, such requirements could increase costs, delay or prevent FDA acceptance or approval of our proposed PMA supplement, extend the duration of the voluntary recall, delay our ability to reintroduce CGuard Prime to the U.S. market or otherwise adversely affect our future commercialization plans, which could have a material adverse effect on our business, financial condition and results of operations. During the six months ended June 30, 2026, substantially all affected products were returned, and credits were issued to customers. We recorded approximately $734,000 as a reduction of revenue related to these returns and approximately $612,000 of inventory impairment associated with the recall.

Previous wording

A critical accounting policy is one that is both important to the portrayal of our financial condition and results of operation and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Our critical accounting policies are more fully described in both (i) “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and (ii) Note 2 of the Notes to the Consolidated Financial Statements included in the Annual Report on Form 10-K for the year ended December 31, 2025. There have not been any material changes to such critical accounting policies since December 31, 2025.

Current wording

A critical accounting policy is one that is both important to the portrayal of our financial condition and results of operations and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Our critical accounting policies are more fully described in both (i) “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and (ii) Note 2 of the Notes to the Consolidated Financial Statements included in the Annual Report on Form 10-K for the year ended December 31, 2025. There have not been any material changes to such critical accounting policies since December 31, 2025.

Previous 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.

Current wording

Research and Development Expenses. For the three months ended June 30, 2026, research and development expenses were $4,295,000, an increase of $461,000, or 12%, compared to $3,834,000 during the three months ended June 30, 2025. This increase resulted primarily from higher development and clinical expenses for the SwitchGuard NPS and CGuard Prime 80 cm carotid stent system, regulatory activity related to the PMA for CGuard NPS, and redesign work for the CGuard Prime 135 cm.

Previous 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.

Current wording

Selling and Marketing Expenses. For the three months ended June 30, 2026, selling and marketing expenses were $5,221,000, an increase of $1,049,000, or 25.1%, compared to $4,172,000 during the three months ended June 30, 2025. This increase resulted primarily from higher commercial staffing levels following the commercial launch of CGuard Prime in the U.S. in July 2025.

Previous wording

General and Administrative Expenses. For the three months ended March 31, 2026, general and administrative expenses were $4,722,000, a decrease of $221,000, or 4.5%, compared to $4,943,000 during the three months ended March 31, 2025. The decrease was primarily driven by a reduction in share-based compensation expense resulting from forfeitures associated with executive employees who departed during the period.

Current wording

General and Administrative Expenses. For the three months ended June 30, 2026, general and administrative expenses were $4,155,000, a decrease of $1,171,000, or 22%, compared to $5,326,000 during the three months ended June 30, 2025. The decrease was primarily driven by lower compensation expenses, mainly due to severance costs related to our former chief financial officer’s retirement that were recognized in the three months ended June 30, 2025, and lower share-based compensation expense.

Previous 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.

Current wording

Net Loss. For the three months ended June 30, 2026, our net loss was $14,324,000, an increase of $1,173,000, or 8.9%, compared to $13,151,000 during the three months ended June 30, 2025. The increase in net loss resulted primarily from a decrease in gross profit of $1,087,000 and an increase in total operating expenses of $339,000, partially offset by an increase in financial income of $253,000 compared to the prior-year period.

Previous 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.

Current wording

Revenues. For the six months ended June 30, 2026, revenue was $5,169,000, an increase of $1,862,000, or 56.3%, compared to $3,307,000 during the six months ended June 30, 2025. The increase was driven mainly by direct sales of the CGuard Prime product in the U.S. and continued growth in sales of the CGuard product through distributors in international markets. The increase was partially offset by $734,000 of credits issued in connection with the voluntary recall of CGuard Prime products in the U.S. during the six months ended June 30, 2026.

Previous 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.

Current wording

We had an accumulated deficit as of June 30, 2026, of $330 million, as well as a net loss of $28 million for the six months ended June 30, 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 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.

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 outstanding May 2023 Warrants or that the outstanding May 2023 Warrants will be exercised in cash in full. The exercise price of the outstanding May 2023 Warrants is $1.3827 per share. The Series J Warrants expire 20 trading days after FDA approval of SwitchGuard and CGuard Prime 80 cm, while the Series K Warrants expire on October 28, 2026, which is 20 trading days after the end of the fourth fiscal quarter following the commencement of first U.S. commercial sales of CGuard Prime in July 2025. The last reported sale price of our shares of common stock on August 13, 2026 was $0.8401 per share. We believe that the likelihood that warrant holders will exercise their outstanding May 2023 Warrants, and therefore the amount of cash proceeds we would receive, is dependent upon the trading price of our shares of common stock. If the trading price of our shares of common stock is less than $1.3827 per share, we believe that warrant holders will be unlikely to exercise their outstanding May 2023 Warrants.

Previous 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.

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 to 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. We paid 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 half of 2026, we did not sell any shares pursuant to the 2024 Distribution Agreement.

Previous wording

In April 2026, we entered into an Equity Distribution Agreement (the “2026 Distribution Agreement”) with BTIG, LLC, as sales agent (“BTIG”). Pursuant to the 2026 Distribution Agreement, we may offer and sell from time to time, at our option, through or to BTIG shares of our common stock having an aggregate offering price of up to $75 million. Wewill pay BTIG a commission at a fixed rate of up to 3.0% of the aggregate gross proceeds from each sale of the shares under the 2026 Distribution Agreement. As of the date hereof, we have not sold any shares pursuant to the 2026 Distribution Agreement.

Current wording

In April 2026, we entered into an Equity Distribution Agreement (the “2026 Distribution Agreement”) with BTIG, LLC, as sales agent (“BTIG”). Pursuant to the 2026 Distribution Agreement, we may offer and sell from time to time, at our option, through or to BTIG shares of our common stock having an aggregate offering price of up to $75 million. We will pay BTIG a commission at a fixed rate of up to 3.0% of the aggregate gross proceeds from each sale of the shares under the 2026 Distribution Agreement. As of the date hereof, we have not sold any shares pursuant to the 2026 Distribution Agreement.

Previous 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.

Current wording

General. As of June 30, 2026, we had cash and cash equivalents of $15,149,000 and marketable securities of $15,272,000 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 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).

Current wording

For the six months ended June 30, 2026, net cash used in our operating activities increased by $6,107,000, or 35.7%, to $23,232,000, from $17,125,000 during the same period in 2025. The primary reasons for the increase in cash used in our operating activities were an increase of $6,741,000 in compensation costs paid during the six months ended June 30, 2026 (from $11,474,000 in the six months ended June 30, 2025 to $18,215,000 in the six months ended June 30, 2026), an increase of $1,937,000 in payments to vendors, clinical service providers and other professional service providers, offset by an increase of $2,617,000 in payments received from customers during the six months ended June 30, 2026 (from $3,380,000 in the six months ended June 30, 2025 to $5,997,000 during the six months ended June 30, 2026).

Previous 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.

Current wording

Cash provided by our investing activities was $29,432,000 during the six months ended June 30, 2026, compared to $7,024,000 during the six months ended June 30, 2025. The primary reason for the increase in cash provided by our investing activities is withdrawal of $30,000,000 from our investment in marketable securities.

Previous 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.

Current wording

There was no cash provided by financing activities for the six months ended June 30, 2026. Cash provided by financing activities for the six months ended June 30, 2025, was $2,643,000. The source of the cash provided by financing activities during the six months ended June 30, 2025, were the proceeds from exercise of Series I warrants of $1,947,000, and proceeds from issuance of shares of $696,000, net of issuance costs, received from our ATM Program.

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, 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.

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

Current wording

During the six months ended June 30, 2026, there were no material changes to our contractual obligations and commitments since the year ended December 31, 2025.