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. 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 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.

Previous wording

Our CGuard™ carotid embolic prevention system (“CGuard EPS”) combines MicroNet and a unique self-expandable nitinol stent in a single device for use in carotid artery revascularization. Our CGuard EPS originally received CE mark approval under Medical Device Directive 93/42/EEC (“MDD”) in the European Union (“EU”) in March 2013 and was fully launched in Europe in September 2015. Subsequently, we launched CGuard EPS in over 30 countries and on February 3, 2021, we executed a distribution agreement with Chinese partners for the purpose of expanding our presence in the Asian markets. In January 2024, we received CE mark recertification under the EU’s Medical Device Regulation regulatory framework.

Current wording

Our CGuard™ carotid embolic prevention system (“CGuard EPS”) combines MicroNet and a unique self-expandable nitinol stent in a single device for use in carotid artery revascularization. Our CGuard EPS originally received CE mark approval under Medical Device Directive 93/42/EEC (“MDD”) in the European Union (“EU”) in March 2013 and was fully launched in Europe in September 2015. Subsequently, we launched CGuard EPS in over 30 countries and on February 3, 2021, we executed a distribution agreement with Chinese partners for the purpose of expanding our presence in the Asian markets. In January 2024, we received CE mark recertification under the EU’s Medical Device Regulation (“MDR”) regulatory framework.

Previous wording

On September 8, 2020, we received approval from the U.S. Food and Drug Administration (“FDA”) of our Investigation Device Exemption (“IDE”), thereby allowing us to proceed with a pivotal study of our CGuard™ Carotid Stent System, C-GUARDIANS, for prevention of stroke in patients in the United States. C-GUARDIANS is a prospective, multicenter, single-arm, pivotal study to evaluate the safety and efficacy of the CGuard™ Carotid Stent System when used to treat symptomatic and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting (“CAS”). The study, which completed enrollment in June 2023, enrolled 316 patients across 24 trial sites in the U.S. and Europe and from April 2023 included deployment of the CGuard stent using CGuard Prime, our next generation CAS stent platform.

Current wording

On September 8, 2020, we received approval from the FDA of our Investigation Device Exemption (“IDE”), thereby allowing us to proceed with a pivotal study of our CGuard™ Carotid Stent System, C-GUARDIANS, for prevention of stroke in patients in the United States. C-GUARDIANS was a prospective, multicenter, single-arm, pivotal study to evaluate the safety and efficacy of the CGuard™ Carotid Stent System when used to treat symptomatic and asymptomatic carotid artery stenosis in patients undergoing CAS. The study, which completed enrollment in June 2023, enrolled 316 patients across 24 trial sites in the U.S. and Europe and from April 2023 included deployment of the CGuard stent using CGuard Prime, our next generation CAS stent platform.

Previous wording

Revenues. For the three months ended March 31, 2025, revenue increased by $18,000, or 1.2%, to $1,529,000, from $1,511,000 during the three months ended March 31, 2024. Growth in the quarter was driven by continued adoption of our CGuard technology, offset by the impact of foreign exchange and distributors managing CGuard inventory levels in anticipation of the potential CGuard Prime approval in Europe.

Current wording

Revenues. For the three months ended June 30, 2025, revenue increased by $39,000, or 2.3%, to $1,778,000, from $1,739,000 during the three months ended June 30, 2024. Growth in the quarter was driven by continued adoption of our CGuard technology, as well as positive impact of foreign exchange, offset by a decrease in revenues from Russia due to exchange rates implications and certain European distributors managing CGuard inventory levels in anticipation of the CGuard Prime launch in Europe.

Previous wording

General and Administrative Expenses. For the three months ended March 31, 2025, general and administrative expenses increased by $1,099,000, or 28.6%, to $4,943,000, from $3,844,000 during the three months ended March 31, 2024. The increase was primarily driven by a $757,000 increase in compensation expenses and related accruals, mainly due to new hires for our Miami headquarters, salary increases and expected severance payments accrued for as a result of our chief financial officer’s announced retirement, a $223,000 increase in employee headhunting fees, $98,000 for rent expenses, mainly related to our Miami headquarters, and an increase of $21,000 in miscellaneous expenses.

Current wording

General and Administrative Expenses. For the three months ended June 30, 2025, general and administrative expenses increased by $1,581,000, or 42.2%, to $5,326,000, from $3,745,000 during the three months ended June 30, 2024. The increase was primarily driven by a $1,119,000 increase in compensation expenses and related accruals, mainly due to new hires for our U.S. headquarters, salary increases and expected severance payments accrued as a result of our former chief financial officer’s announced retirement, a $98,000 increase for rent expenses, mainly related to our U.S. headquarters, and an increase of $364,000 in miscellaneous expenses.

Previous wording

Financial Income. For the three months ended March 31, 2025, financial income decreased by $88,000 or 23.0%, to $294,000, from $382,000 during the three months ended March 31, 2024. The decrease in financial income primarily resulted from a $90,000 decrease in interest income from investment in marketable securities, money market funds and short-term bank deposits.

Current wording

Financial Income (Expenses). For the three months ended June 30, 2025, financial income decreased by $483,000 to $132,000 of financial expenses, from $351,000 of financial income during the three months ended June 30, 2024. The decrease in financial income primarily resulted from a $313,000 increase in financial expenses related to changes in exchange rates and a $169,000 decrease in financial income from investment in marketable securities and money market funds.

Previous wording

Net Loss. Our net loss increased by $4,134,000, or 58.8%, to $11,166,000, for the three months ended March 31, 2025, from $7,032,000 during the three months ended March 31, 2024. The increase in net loss resulted primarily from an increase of $4,046,000 in operating expenses.

Current wording

Net Loss. Our net loss increased by $5,242,000, or 66.3%, to $13,151,000, for the three months ended June 30, 2025, from $7,909,000 during the three months ended June 30, 2024. The increase in net loss resulted primarily from an increase of $4,741,000 in operating expenses.

Previous wording

With respect to geographical regions, the increase in revenue was primarily attributable to a $50,000 increase in Latin America, a $21,000 increase in Asia due to continued adoption of our CGuard technology, and a $22,000 increase in North America due to sales in the United States related to stents used in our CGUARDIANS II pivotal study. This increase was offset by a $71,000 decrease in Europe driven by the impact of foreign exchange and distributors managing CGuard inventory levels in anticipation of the potential CGuard Prime approval in Europe and a $3,000 decrease in other territories.

Current wording

With respect to geographical regions, the increase in revenue was primarily attributable to a $163,000 increase in Latin America, a $60,000 increase in Asia, both due to continued adoption of our CGuard technology, and a $32,000 increase in North America due to sales in the United States related to stents used in our CGUARDIANS II pivotal study. This increase was offset by a $192,000 decrease in Europe driven by the impact of foreign exchange and distributors managing CGuard inventory levels in anticipation of the CGuard Prime launch in Europe, and a $6,000 decrease in other territories.

Previous wording

Research and Development Expenses. For the three months ended March 31, 2025, research and development expenses increased by 1,434,000, or 54.6%, to $4,059,000, from $2,625,000 during the three months ended March 31, 2024. This increase resulted primarily due to an increase of $670,000 of SwitchGuard NPS development and regulatory approval process including expenses related to the IDE application for the CGUARDIANS II pivotal study of the CGuard Prime 80cm Carotid Stent System, an increase in compensation expenses of $373,000, due to an increase of share-based compensation-related expenses and due to hiring of new employees in connection with our expansion in the United States, an increase of $282,000 related to CGuard Prime product preparation expenses for the anticipated U.S. commercial launch of CGuard Prime, and an increase of $109,000 in miscellaneous expenses.

Current wording

Research and Development Expenses. For the six months ended June 30, 2025, research and development expenses increased by 31.0%, or $1,867,000 to $7,893,000, from $6,026,000 during the six months ended June 30, 2024. This increase resulted primarily due to an increase of $932,000 of SwitchGuard NPS development and regulatory approval process including expenses related to CGUARDIANS II pivotal study of the CGuard Prime 80cm Carotid Stent System, an increase in compensation expenses of $786,000 due to hiring of new employees in connection with our expansion in the United States and due to an increase of share-based compensation-related expenses and an increase of $149,000 in miscellaneous expenses.

Previous wording

Selling and Marketing Expenses. For the three months ended March 31, 2025, selling and marketing expenses increased by $1,513,000, or 122.3%, to $2,750,000 from $1,237,000 during the three months ended March 31, 2024. This increase resulted primarily from an increase in compensation expenses of $1,123,000 and related travel expenses of $129,000 as the Company build its U.S. commercial infrastructure to enter the U.S. market in anticipation of the potential FDA approval for CGuard Prime. In addition, there was an increase of $236,000 in promotional activities and an increase of $25,000 in miscellaneous expenses.

Current wording

Selling and Marketing Expenses. For the six months ended June 30, 2025, selling and marketing expenses increased by 158.1%, or $4,240,000, to $6,922,000, from $2,682,000 during the six months ended June 30, 2024. This increase resulted primarily from an increase in compensation expenses of $3,440,000 and related travel expenses of $396,000 as the Company continued to build its U.S. commercial infrastructure in connection with FDA approval for CGuard Prime and the commercial launch in the United States. In addition, there was an increase of $311,000 in promotional activities and an increase of $93,000 in miscellaneous expenses.

Previous wording

We had an accumulated deficit as of March 31, 2025, of $265 million, as well as a net loss of $11,166,000 and negative operating cash flows. We expect to continue incurring losses and negative cash flows from operations until our product, CGuard EPS, 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 June 30, 2025, of $278 million, as well as a net loss of $24.3 million 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.

Previous wording

In May 2023, we closed a private placement offering of 10,266,270 shares (the “Private Placement Shares”) of our common stock, pre-funded warrants (the “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.

Current 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.

Previous wording

During June 2024, Series H warrants to purchase 12,914,086 shares of common stock 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

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.

Previous wording

General. At March 31, 2025, we had cash and cash equivalents of $12,383,000 and marketable securities of $13,703,000, 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. At June 30, 2025, we had cash and cash equivalents of $11,509,000 and marketable securities of $7,865,000, 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.

Previous wording

For the three months ended March 31, 2025, net cash used in our operating activities increased by $3,728,000, or 73.6%, to $8,792,000, from $5,064,000 during the same period in 2024. The primary reason for the increase in cash used in our operating activities was an increase of $986,000 in payments for third party related expenses and for professional services, an increase of $2,151,000 in compensation costs paid during the three months ended March 31, 2025 (from $3,675,000 in the three months ended March 31, 2024 to $5,826,000 in the three months ended March 31, 2025), a decrease of $555,000 in payments received from customers during the three months ended March 31, 2025 (from $2,110,000 in the three months ended March 31, 2024 to $1,555,000 during the three months ended March 31, 2025) and a decrease of $36,000 in interest income received from money market funds and marketable securities.

Current wording

For the six months ended June 30, 2025, net cash used in our operating activities increased by $7,707,000, or 81.8%, to $17,125,000, from $9,418,000 during the same period in 2024. The primary reason for the increase in cash used in our operating activities was an increase of $1,826,000 in payments for third party related expenses and for professional services, an increase of $5,288,000 in compensation costs paid during the six months ended June 30, 2025 (from $6,186,000 in the six months ended June 30, 2024 to $11,474,000 in the six months ended June 30, 2025), a decrease of $346,000 in payments received from customers during the six months ended June 30, 2025 (from $3,726,000 in the six months ended June 30, 2024 to $3,380,000 during the six months ended June 30, 2025) and a decrease of $247,000 in interest income received from money market funds and marketable securities.

Previous wording

Cash provided by our investing activities was $1,702,000 during the three months ended March 31, 2025, compared to $4,817,000 during the three months ended March 31, 2024. The primary reason for the decrease in cash provided by our investing activities is withdrawal of $2,949,000, net of investment in marketable securities and an increase of $164,000 in payments made for purchase of property, plant and equipment during the three months ended March 31, 2025.

Current wording

Cash provided by our investing activities was $7,024,000 during the six months ended June 30, 2025, compared to $10,323,000 during the six months ended June 30, 2024. The primary reason for the decrease in cash provided by our investing activities is investment of $3,029,000, net of withdrawal in marketable securities and an increase of $265,000 in payments made for purchase of property, plant and equipment during the six months ended June 30, 2025.

Previous wording

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 our ATM Program. There was no cash provided by financing activities for the three months ended March 31, 2024.

Current wording

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. Cash provided by financing activities for the six months June 30, 2024, was $17,854,000. The source of the cash provided by financing activities during the six months ended June 30, 2024, were the proceeds from exercise of Series H warrants.

Previous wording

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

Current wording

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