InspireMD, Inc.

Previous wording

We are a medical device company focusing on the development and commercialization of our proprietary MicroNet™ stent platform for the treatment of carotid artery disease and other vascular disease. A stent is an expandable “scaffold-like” device, usually constructed of a metallic material, that is inserted into the lumen of the artery to create patency and revascularization of blood flow. MicroNet, a micron mesh sleeve, 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. 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. Currently, we are seeking strategic partners for a potential launch of CGuard EPS in Japan and other Asian countries.

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 regulatory framework.

Previous wording

On May 28, 2024, we announced positive one-year follow up results from the C-GUARDIANS trial in which stenting with the CGuard Carotid Stent System in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a 30-day DSMI and Ipsilateral stroke between 31 and 365 days rate of 1.95% measured from procedure to 1-year follow-up.

Current wording

In May 2023, we announced positive 30-day follow up results from the C-GUARDIANS trial in which stenting with the CGuard Carotid Stent System in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, measured from the date of the procedure through 30 days follow-up post-procedure. In May 2024, we announced positive one-year follow up results from the C-GUARDIANS trial, with a rate of 30-day DSMI and ipsilateral stroke between 31 and 365 days of 1.95%.

Previous wording

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

Current 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.

Previous wording

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 anticipated U.S. launch and commercialization of the CGuard Prime carotid stent system.

Previous wording

Gross Profit. For the three months ended September 30, 2024, gross profit (revenue less cost of revenues) decreased by $24,000, or 5.6%, to $414,000, from $438,000 during the three months ended September 30, 2023. This decrease in gross profit resulted from a $24,000 increase in miscellaneous expense. Gross margin (gross profits as a percentage of revenue) decreased to 22.9% during the three months ended September 30, 2024, from 28.1% during the three months ended September 30, 2023, driven by the factors mentioned above.

Current wording

Gross Profit. For the three months ended March 31, 2025, our gross profit was $292,000, no change in our gross profit compared to the three months ended March 31, 2024. Gross margin (gross profits as a percentage of revenue) decreased to 19.1% during the three months ended March 31, 2025, from 19.3% during the three months ended March 31, 2024.

Previous wording

Research and Development Expenses. For the three months ended September 30, 2024, research and development expenses increased by $1,805,000, or 85.5%, to $3,915,000, from $2,110,000 during the three months ended September 30, 2023. This increase resulted primarily due to an increase of $1,016,000 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 $670,000, mainly due to an increase of share-based compensation-related expenses and due to the hiring of the Executive Vice President and General Manager of North America in connection with our expansion plans in the United States, an increase of $140,000 related to an early feasibility study of CGuard Prime for the treatment of acute stroke patients with tandem lesions and an increase of $224,000 in miscellaneous expenses. These increases were offset by a decrease of $245,000 in expenses associated with the C-Guardians FDA Study as the one-year follow-up finalized in the second quarter of 2024 and the submission this quarter of the PMA application to the FDA.

Current 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.

Previous wording

Selling and Marketing Expenses. For the three months ended September 30, 2024, selling and marketing expenses increased by $596,000, or 68.0%, to $1,472,000, from $876,000 during the three months ended September 30, 2023. This increase resulted primarily from an increase in compensation expenses of $524,000 as the Company build its U.S. commercial infrastructure to enter the U.S. market and an increase of $72,000 in miscellaneous expenses.

Current 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.

Previous wording

Financial Income. For the three months ended September 30, 2024, financial income increased by $111,000 or 24.1%, to $572,000, from $461,000 during the three months ended September 30, 2023. The increase in financial income primarily resulted from a $91,000 increase in interest income from investment in marketable securities, money market funds and short-term bank deposits.

Current 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.

Previous wording

Net Loss. Our net loss increased by $2,712,000, or 52.4%, to $7,890,000, for the three months ended September 30, 2024, from $5,178,000 during the three months ended September 30, 2023. The increase in net loss resulted primarily from an increase of $2,799,000 in operating expenses.

Current 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.

Previous wording

We had an accumulated deficit as of September 30, 2024, of $244 million, as well as a net loss of $22,831,000 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 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.

Previous wording

In May 2024, we entered intoan Equity Distribution Agreement with Piper Sandler & Co., as sales agent (“Piper Sandler) to which we may offer and sell, from time to time, at our option, through or to Piper Sandler up to $17,000,000 shares of our common stock (the “ATM Program”). As of the issuance date of this report, we have sold 134,316 shares of our common stock for total gross proceeds of approximately $341 thousands under the ATM program.

Current 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 $2,396 thousands under the ATM Program.

Previous wording

General. At September 30, 2024, we had cash and cash equivalents of $15,818,000 and marketable securities of $24,584,000, as compared to cash and cash equivalents of $9,640,000 and marketable securities of $29,383,000 as of December 31, 2023. 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 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.

Previous wording

For the nine months ended September 30, 2024, net cash used in our operating activities increased by $2,919,000, or 23.9%, to $15,118,000, from $12,199,000 during the same period in 2023. The primary reason for the increase in cash used in our operating activities was an increase of $2,276,000 in payments for third party related expenses and for professional services, an increase of $1,506,000 in compensation costs paid during the nine months ended September 30, 2024, from $7,332,000 in the nine months ended September 30, 2023 to $8,838,000, a decrease of $99,000 in interest income received from money market funds, marketable securities and bank deposits, offset in part by an increase of $933,000 in payments received from customers.

Current 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.

Previous wording

Cash provided in our investing activities was $4,399,000 during the nine months ended September 30, 2024, compared to cash used of $16,056,000 during the nine months ended September 30, 2023. The primary reason for the increase in cash provided by our investing activities is proceeds from matured marketable securities of $5,556,000, net of investment in marketable securities in the nine months ended September 30, 2024, compared to an investment in marketable securities of $28,838,000, offset by a withdrawal from short-term bank deposits, net of investment in short-term deposits, of $18,500,000 in the nine months ended September 30, 2023 and by an increase of $925,000 in payments made for purchase of property, plant and equipment during the nine months ended September 30, 2024.

Current 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.

Previous wording

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. Cash provided by financing activities for the nine months September 30, 2023, was $37,534,000. The source of the cash provided by financing activities during the nine months ended September 30, 2023, were the proceeds from the Private Placement Offering in May 2023 that resulted in approximately $37,534,000 of aggregate net proceeds.

Current 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.

Previous wording

During the nine months ended September 30, 2024, there were no material changes to our contractual obligations and commitments since the year ended December 31, 2023.

Current 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.