Study represents a significant step forward in Company’s mission to serve the broadest set of physician and patient needs with best-in-class CAS and TCAR solutions

Miami, Florida — December 9, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the first patient has been enrolled in the company’s CGUARDIANS II clinical trial evaluating its CGuard Prime Carotid Stent System in patients undergoing carotid artery stenting via the Transcarotid Artery Revascularization (TCAR) approach. The patient was enrolled by Dr. Patrick Muck at Good Samaritan Hospital, part of the TriHealth System in Cincinnati, Ohio. Dr. Muck serves as both the site principal investigator as well as a co-lead investigator of the CGUARDIANS II study.  

Marvin Slosman, Chief Executive Officer of InspireMD, commented, “As we approach potential FDA approval of CGuard Prime with a CAS indication in the first half of next year, we are thrilled to have initiated the CGUARDIANS II study that, if successful, will address an ever-expanding TCAR market of roughly 30,000 procedures performed in the U.S. this year. I would like to thank Dr. Muck for helping us achieve this initial and critical enrollment milestone, and I look forward to the efficient execution of this important study as we work to enable the use of CGuard Prime in the broadest application, offering patients and physicians this next generation stenting platform, which has demonstrated best-in-class clinical outcomes in rigorous clinical studies and with over 60,000 devices sold to date.”

Dr. Patrick Muck, program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, Ohio stated, “As we begin this study of CGuard Prime in a TCAR setting, we value tremendously the prior data from the C-GUARDIANS PMA, the real-world results of this implant and its potential to advance patient care through these unmatched clinical results. The protective qualities of the MicroNet mesh offer patients the sustainable protection which is so important in both short- and long-term outcomes of this procedure. We look forward to the efficient enrollment of this study, contribution from the team of investigators and working with InspireMD on this important program.”  

CGUARDIANS II is a prospective, multi-center, single arm pivotal study that aims to enroll a minimum of 50 evaluable patients. The objective of this study is to evaluate acute device success and technical success of the CGuard Prime when used in conjunction with an FDA-cleared TCAR neuro-protection system in patients at high risk for adverse events from carotid endarterectomy.

More information on the study can be found at: NCT06653387

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words.  Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s or directors’ expectations, hopes, beliefs, intentions or strategies regarding future events, future financial performance, strategies, expectations, competitive environment and regulation, including potential U.S. commercial launch. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently; actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute our stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com

– Submitted a Premarket Approval (PMA) application to the FDA seeking marketing approval of the CGuard Prime carotid stent system in the U.S. –

– Announced approval of an IDE application to initiate the CGUARDIANS II pivotal study of the CGuard Prime carotid stent system for use during TCAR procedures –

– Established its Headquarters in Miami, Florida, to optimally support the anticipated U.S. commercial launch of CGuard Prime in H1 2025, if approved –

Achieved another record high revenue and unit quarter of $1.81M and 3,121 respectively in served markets

—

Management to host investor conference call today, November 12^th, at 8:30am ET
—

Miami, FL — November 12, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating results for the third quarter ended September 30, 2024.

Third Quarter 2024 and Recent Developments:

• Announced that it has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) seeking marketing approval for the CGuard Prime carotid stent system in the U.S.
• Announced approval of its Investigational Device Exemption (IDE) application to initiate the CGUARDIANS II pivotal study of the CGuard Prime carotid stent system for use during TCAR procedures.
• Established its Headquarters in Miami, Florida, to optimally support the anticipated U.S. commercial launch of CGuard Prime in the first half of 2025, if approved.
• Announced completion of enrollment in the groundbreaking CREST-2 clinical trial, with 23 patients in the stenting arm treated with CGuard, the only investigational device allowed by FDA for inclusion in the trial.
• Generated record quarterly revenue of $1.81 million, an increase of 16.3% over the third quarter of 2023, on 3,129 CGuard stents sold, up nearly 14.4% over the third quarter of 2023.

Marvin Slosman, CEO of InspireMD, commented: “Since our last quarterly update, we have made significant progress advancing our best-in-class carotid implant, CGuard Prime, towards potential U.S. approval while also moving toward the initiation of a pivotal study of CGuard Prime for a TCAR indication, which represents a key component of our commercial strategy.”

“The submission of our PMA application to FDA seeking U.S. approval of CGuard Prime is the result of years of tireless work by the entire InspireMD team and gives us line of sight to entry into the U.S. market in the first half of 2025, if approved. To support a robust launch, we’ve announced the opening of our new headquarters in Miami, Florida, that ideally positions us to support the world class commercial and operational infrastructure that we are assembling. South Florida has a rich history of medical device innovation, and we are pleased to be able to continue in that tradition.”    

“We also announced that the FDA has approved our IDE application allowing us to move forward with the initiation of a pivotal trial of CGuard Prime for use in TCAR procedures. This represents an important step in the advancement of our development pipeline and demonstrates our commitment to addressing the broadest set of physician and patient needs with tools for both CAS and TCAR procedures. I look forward to additional clinical and regulatory milestones in the months ahead, highlighted by the potential U.S. approval and commercial launch of CGuard Prime in the first half of next year,” Mr. Slosman concluded.

Financial Results for the Third Quarter Ended September 30, 2024

For the three months ended September 30, 2024, revenue increased by $254,000, or 16.3%, to $1,810,000, from $1,556,000 during the three months ended September 30, 2023. This increase was driven by growth in existing and new markets.

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 factor mentioned above.

Total operating expenses for the third quarter of 2024 were $8,876,000, an increase of $2,799,000, or 46.1%, compared to $6,077,000 for the third quarter of 2023. This increase was primarily due to an increase in compensation, clinical and development expenses in preparation for U.S. approval and launch.

Financial Income for the third quarter of 2024 was $572,000, an increase of $111,000, or 24.1%, compared to $461,000 for the third quarter of 2023. The increase in financial income primarily resulted from an increase in interest income from investments in marketable securities, money market funds and short-term bank deposits.

Net loss for the third quarter of 2024 totaled $7,890,000, or $0.16 per basic and diluted share, compared to a net loss of $5,178,000, or $0.15 per basic and diluted share, for the same period in 2023.

As of September 30, 2024, cash, cash equivalents and marketable securities were $40.4 million, compared to $39.0 million as of December 31, 2023.

Financial Results for the Nine Months Ended September 30, 2024

For the nine months ended September 30, 2024, revenue increased by $616,000, or 13.9%, to $5,060,000 from $4,444,000 during the nine months ended September 30, 2023. This sales increase was due to growth in existing and new markets, partially offset by a reduction in clinical trial revenue driven by the conclusion of C-GUARDIANS enrollment in June 2023.

For the nine months ended September 30, 2024, gross profit (revenue less cost of revenues) decreased by 20.4%, or $265,000, to $1,037,000, compared to $1,302,000 for the same period in 2023. This decrease in gross profit resulted from an increase in material and labor costs mainly due to compensation expense for new and current employees, higher sales volume, additional space to build capacity for anticipated increased volume requirements and additional training expenses. There were also additional costs related to facility downtime for maintenance and higher scrap due to increases in production levels.  This decrease was offset by an increase in revenue.

Total operating expenses for the nine months ended September 30, 2024, were $25,173,000, an increase of $8,536,000, or 51.3%, compared to $16,637,000 for the nine months ended September 30, 2023. This increase was primarily due to an increase in compensation and development expenses.

Financial Income for the nine months ended September 30, 2024 was $1,305,000, an increase of $481,000, or 58.4%, compared to $824,000 for the nine months ended September 30, 2023. The increase in financial income was driven primarily from a $478,000 increase in interest income from investments in marketable securities, money market funds and short-term bank deposits.

Net loss for the nine months ended September 30, 2024 totaled $22,831,000, or $0.58 per basic and diluted share, compared to a net loss of $14,511,000, or $0.69 per basic and diluted share, for the nine months ended September 30, 2023.

Conference Call and Webcast Details

Management will host a conference call at 8:30 am ET today, November 12^th, to review financial results and provide an update on corporate developments.  Following management’s formal remarks, there will be a question-and-answer session.  

Tuesday, November 12^th at 8:30 a.m. ET

     Domestic:                            1-800-225-9448

     International:                     1-203-518-9708

     Conference ID:                   IMD3Q24

     Webcast:                             Webcast Link – Click Here

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, future financial performance, strategies, expectations, competitive environment and regulation, including potential U.S. commercial launch. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities; substantial doubt about our ability to continue as a going concern; significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete  business objectives; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com

(1) All 2024 financial information is derived from the Company’s 2024 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2023 financial information is derived from the Company’s 2023 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

(2) All September 30, 2024, financial information is derived from the Company’s 2024 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2023 financial information is derived from the Company’s 2023 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2023 filed with the Securities

-Conference call and webcast to be held at 8:30 a.m. EDT-

 Tel Aviv, Israel, and Miami, FL — November 4, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today it will report third quarter 2024 financial results on Tuesday, November 12^th, 2024, before the financial markets open. 

Management will host a conference call and webcast with the investment community at
8:30 am (EDT) that same day to review financial results and provide an update on corporate developments. 

The webcast should be accessed 15 minutes prior to the conference call start time. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company’s website.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet^® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes.

Forward-looking Statements

 This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. For example, the company is using forward looking statements when it discusses the expansion of its portfolio and potential indications and that the CGuard Carotid stent provides a foundational advantage for improved patient outcomes and prevention of stroke.  Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com

Miami, Florida — October 15, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced the establishment of its global headquarters in Miami, Florida. The new facility will ideally position the Company to support the anticipated U.S. launch and commercialization of the CGuard Prime carotid stent system in the first half of 2025, if approved.  

Marvin Slosman, Chief Executive Officer of InspireMD, stated, “The establishment of our new headquarters location in the U.S. represents a significant step as we prepare for potential FDA approval of CGuard Prime in the first half of next year. Together with the ongoing build-out of world class commercial and operational teams and supporting infrastructure, our new U.S.-based headquarters will be key to driving long-term growth and serving the U.S. market while creating sustained shareholder value.”  

“Building our operational infrastructure in the South Florida market provides tremendous resources, as this area has a rich history of medical device innovation. This access to talent and capacity provides excellent capital to build our company as we ready for our U.S. launch,” said Peter Ligotti, General Manager of InspireMD’s U.S. Business.

Shane Gleason, Chief Commercial Officer, shared, “We’re building our marketing, training and sales operations teams in South Florida to form the foundation of a world-class US commercial organization and support our growing field sales and clinical support team.  It’s an exciting time as we prepare to build on our success outside of the US and serve the demand for CGuard Prime and SwitchGuard NPS upon their highly anticipated potential approval and clearance.”

On September 16^th, InspireMD announced that the company has submitted the final module of its Premarket Authorization (PMA) application to FDA for the CGuard Prime carotid stent system.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Examples of such statements include, but are not limited to, statements relating to the C-GUARDIANS U.S. IDE clinical trial, including one-year results from such trial presented at LINC 2024, as well as the timing and outcome of any subsequent results, potential FDA approval, or potential launch or commercialization in the U.S. or elsewhere. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently; actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute our stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com

Miami, Florida — October 7, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) Application to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80cm Carotid Stent System during transcarotid revascularization (TCAR) procedures.

In February 2024, InspireMD announced that Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, OH, have agreed to act as lead investigators for the trial.              

Marvin Slosman, Chief Executive Officer of InspireMD, stated, “The approval of our CGUARDIANS II IDE is an important milestone and a significant step forward in our mission to serve the broadest range of physician and patient needs with a comprehensive set of tools that can deliver our best-in-class carotid stent system, CGuard Prime, for both CAS and TCAR procedures. The CGUARDIANS II study is intended to facilitate approval of the use of CGuard Prime in an optimized TCAR version and indication.” 

“In parallel, we continue to advance development of our comprehensive next generation TCAR Neuroprotection System, SwitchGuard NPS. Each of these initiatives helps pave the way, once approved, for us to initiate commercial sales and strive for market leadership in the United States. Our mission to improve stroke prevention and carotid disease management with our CGuard platforms continues as we build our company toward U.S. expansion and global success. Additionally, as we previously announced, we are thrilled to have Dr. Patrick Geraghty and Dr. Patrick Muck as co-principal investigators for the study, as well as a world class group of investigators committed to the trial’s success,” Mr. Slosman concluded.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Examples of such statements include, but are not limited to, statements relating to the C-GUARDIANS U.S. IDE clinical trial, including one-year results from such trial presented at LINC 2024, the C-GUARDIANS II trial, including the timing of its commencement, as well as the timing and outcome of any subsequent results, potential FDA approval, or potential launch or commercialization in the U.S. or elsewhere. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently; actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute our stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com

InspireMD Announces Submission of Premarket Approval Application to FDA Seeking U.S. Regulatory Approval of the CGuard™ Prime Carotid Stent System

PMA based on overwhelmingly positive results from the pivotal C-GUARDIANS clinical study that were first presented at LINC 2024 in May

U.S. commercial launch anticipated in H1 2025, if approved

Tel Aviv, Israel, and Miami, Florida — September 16, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) seeking marketing approval for the CGuard Prime carotid stent system in the U.S.

The PMA application is based on the overwhelmingly positive one-year data from the Company’s C-GUARDIANS pivotal clinical trial that were presented at the Leipzig Interventional Course (LINC) 2024 in May. The C-GUARDIANS clinical trial evaluated the safety and efficacy of CGuard for the treatment of carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in the U.S. and Europe.

The C-GUARDIANS results showed a primary endpoint[1] major adverse event rate of 1.95% through twelve months post-procedure, the lowest such event rate reported for any carotid stent or embolic protection device pivotal trial to date.

Marvin Slosman, chief executive officer of InspireMD, stated, “The submission of our PMA application to the FDA represents a significant step forward in our quest for U.S. approval of our next generation CGuard Prime stent to address carotid artery disease and stroke prevention with its best-in-class clinical outcomes. We look forward to the agency’s review of our application, which we have provided in a modular submission to facilitate the most efficient review process. Concurrently, we continue to build what I consider to be world class U.S. commercial and operational infrastructure to enter the U.S. market with as much momentum as possible to offer to this breakthrough technology.”  

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Examples of such statements include, but are not limited to, statements relating to the C-GUARDIANS U.S. IDE clinical trial, including one-year results from such trial presented at LINC 2024, as well as the timing and outcome of any subsequent results, PMA or potential launch. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently; actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute our stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com

[1] The primary endpoint was a composite of death, stroke or myocardial infarction (DSMI) through 30 days or ipsilateral stroke 31 – 365 days post-index procedure.

Dear Investors,

We are pleased to share with you an exciting development that highlights our continued success and promising future. Recently, Joe Mullings, Chairman & CEO of the Mullings Group and a med tech consultant, expert and recruiter, conducted an insightful interview with our CEO, Marvin Slosman, Chief Commercial Officer, Shane Gleason, and Executive VP and General Manager, Peter J. Ligotti.

During this interview, they discuss the significant achievements of InspireMD and outline our strategic vision, particularly focusing on our expansion and growth prospects in the U.S. market. This conversation provides a comprehensive understanding of our company’s direction and the innovative solutions we are bringing to the carotid intervention field.

We believe this interview will give you valuable insights into our operations and future plans. You can watch the full recording via the link below:

Watch the Interview

Thank you for your continued support and confidence in InspireMD, we look forward to sharing more updates with you as we progress on our journey.

Craig Shore,
Chief Financial Officer

– Announced positive outcomes from the C-GUARDIANS IDE clinical trial of the CGuard™ Prime carotid stent system demonstrating a one-year primary endpoint event rate of 1.95%, the lowest for any carotid stent or embolic protection device pivotal trial –

– On track to submit a Premarket Approval (PMA) application to the FDA this quarter –

– Raised gross proceeds of $17.9 million from full exercise of Series H warrants triggered by announcement of C-GUARDIANS data –  

—
Management to host investor conference call today, August 6^th, at 8:30am ET
—

Tel Aviv, Israel and Miami, FL — August 6, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating results for the second quarter ended June 30, 2024.

Second Quarter 2024 and Recent Developments:

• Announced one-year outcomes from the C-GUARDIANS IDE clinical trial of CGuard™ Prime demonstrating a primary endpoint event rate of 1.95% through one year, the lowest such event rate for any carotid stent or embolic protection device pivotal clinical trial.
• Announced the full exercise of 12.9 million Series H warrants issued pursuant to the transformational public financing of up to $113.6 million announced in May 2023. The Series H warrants were exercised primarily into pre-funded warrants and resulted in gross proceeds of $17.9 million, or $16.9 million after fees. 
• Generated second quarter 2024 CGuard EPS revenue of $1.74 million, an increase of 5.4% over the second quarter of 2023, on 2,969 CGuard stents sold, up nearly 6% over the second quarter of 2023.
• Engaged with a leading MedTech search firm, The Mullings Group, to accelerate build-out of world-class operations and commercial teams in the United States.
• Announced completion of enrollment in groundbreaking CREST-2 clinical trial, with 23 patients in the stenting arm treated with CGuard, the only investigational device allowed by FDA for inclusion in the trial.
• Advanced preparation activities for initiation of the CGUARDIANS II Transcarotid Arterial Revascularization (TCAR) clinical trial in the back half of 2024.

Marvin Slosman, CEO of InspireMD, commented: “The clear highlight since our last quarterly report was the announcement of best in class one-year outcomes data from our pivotal C-GUARDIANS clinical trial of the CGuard Carotid Stent System, which was designed to support a Premarket Approval (PMA) application to FDA later this year. The data demonstrated a primary endpoint event rate of 1.95% through one year, the lowest such rate for any carotid stent or embolic protection device pivotal clinical trial, thus adding to the significant body of data that we have compiled demonstrating the outstanding performance of CGuard both short- and long-term. With these results in hand, we intend to proceed with a PMA application this quarter while continuing to build out a world-class US commercial infrastructure in anticipation of FDA approval in the first half of 2025.

“In parallel, we continued to advance development of our pipeline of carotid intervention and stroke prevention tools, including our SwitchGuard NPS TCAR solution, and we remain on track to initiate our CGUARDIANS II clinical trial in the back half of this year. By uniquely developing solution sets for both CAS and TCAR utilizing our best-in-class CGuard Prime stent implant, we believe we are well positioned for the ongoing paradigm shift toward an endovascular ‘stent first’ approach. I am very pleased with our continued progress and look forward to a productive back half of the year,” Mr. Slosman concluded.  

Financial Results for the Second Quarter ended June 30, 2024

For the three months ended June 30, 2024, revenue increased by $90,000, or 5.4%, to $1,739,000, from $1,649,000 for the three months ended June 30, 2023. This increase was driven by growth in existing and new markets, partially offset by a reduction in clinical trial revenue driven by the conclusion of C-GUARDIANS enrollment in June 2023.

For the three months ended June 30, 2024, gross profit (revenue less cost of revenues) decreased by $160,000, or 32.6%, to $331,000, from $491,000 during the three months ended June 30, 2023. This decrease in gross profit resulted from an increase in material and labor costs mainly due to compensation expense for new and current employees, higher sales volume, additional space to build capacity for anticipated increased volume requirements and additional training expenses offset by an increase in revenues. Gross margin (gross profits as a percentage of revenue) decreased to 19.0% during the three months ended June 30, 2024, from 29.8% during the three months ended June 30, 2023, driven by the factors mentioned above.

Total operating expenses for the second quarter of 2024 were $8,591,000, an increase of $2,785,000, or 48.0%, compared to $5,806,000 for the second quarter of 2023. This increase was primarily due to an increase in compensation and development expenses with the vast majority being non-cash share-based compensation-related expenses.

Net loss for the second quarter of 2024 totaled $7,909,000, or $0.22 per basic and diluted share, compared to a net loss of $5,077,000, or $0.24 per basic and diluted share, for the same period in 2023.

As of June 30, 2024, cash, cash equivalents and marketable securities were $47.2 million compared to $39.0 million as of December 31, 2023. This includes the full exercise of Series H Warrants, raising gross proceeds of $17.9 million, related to the announcement of one-year follow up from the C-GUARDIANS pivotal trial.

Financial Results for the Six Months ended June 30, 2024

For the six months ended June 30, 2024, revenue increased by $362,000, or 12.5%, to $3,250,000, from $2,888,000 for the six months ended June 30, 2023. This sales increase was due to growth in existing and new markets, partially offset by a reduction in clinical trial revenue due to the completion of C-GUARDIANS enrollment in June 2023.

For the six months ended June 30, 2024, gross profit (revenue less cost of revenues) decreased by 27.9%, or $241,000, to $623,000, compared to $864,000 for the same period in 2023. This decrease in gross profit resulted from an increase in material and labor costs mainly due to compensation expense for new and current employees, higher sales volume, additional space to build capacity for anticipated increased volume requirements and additional training expenses offset by an increase of the revenues.

 Total operating expenses for the six months ended June 30, 2024, were $16,297,000, an increase of $5,737,000, or 54.3% compared to $10,560,000 for the six months ended June 30, 2023. This increase was primarily due to an increase in compensation and development expenses with the vast majority being non-cash share-based compensation-related expenses.

Net loss for the six months ended June 30, 2024, totaled $14,941,000, or $0.43 per basic and diluted share, compared to a net loss of $9,333,000, or $0.64 per basic and diluted share, for the six months ended June 30, 2023.

Conference Call and Webcast Details

Management will host a conference call at 8:30AM ET today, August 6, to review financial results and provide an update on corporate developments.  Following management’s formal remarks, there will be a question-and-answer session.  

Tuesday, August 6^th at 8:30 a.m. ET

Domestic:                              1-800-445-7795

International:                       1-785-424-1699

Conference ID:                    IMD2Q24

Webcast:                               Webcast Link – Click Here

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, future financial performance, strategies, expectations, competitive environment and regulation, including revenue growth. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities; significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete  business objectives; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com

(1) All 2024 financial information is derived from the Company’s 2024 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2023 financial information is derived from the Company’s 2023 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

(2) All June 30, 2024, financial information is derived from the Company’s 2024 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2023 financial information is derived from the Company’s 2023 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2023 filed with the Securities

CGuard was the only investigational carotid stent approved by FDA for inclusion in the trials

CREST-2 included 23 cases implanted with CGuard

Tel Aviv, Israel, and Miami, Florida — Augst 5, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today congratulated the lead investigators on the completion of enrollment in the CREST-2 (Carotid Revascularization Endarterectomy or Stenting Trial) clinical trials. The CGuard carotid stent, utilizing its proprietary MicroNet™ mesh, was included as a device option for stenting in the CREST-2 trials following FDA approval of InspireMD’s Investigational Device Exemption (IDE) supplement application in February 2022. CREST-2 included 23 cases implanted with CGuard.

Marvin Slosman, chief executive officer of InspireMD, stated, “We would like to thank Dr. Lal and the other investigators who are executing this landmark trial, a remarkable achievement in the field of carotid revascularization and stroke prevention. We are proud to have been the only second-generation investigational device option approved by FDA for inclusion in the stenting arm of the trial, which we believe reflects the desire of the CREST-2 committee to offer the latest stenting technology. It has been our honor to contribute to this important work.”  

Brajesh Kumar Lal, MD, Professor of Vascular Surgery at the University of Maryland School of Medicine, and co-principal investigator of the CREST-2 trial, stated, “There continue to be significant advancements in the field of carotid revascularization and stroke prevention, and information from this study will help determine the optimal treatment for carotid stenosis patients without stroke symptoms. This trial, when complete, will ensure that we remain current with state-of-the-art innovation to achieve the best possible short- and long-term patient outcomes. Along with my fellow investigators, we eagerly await topline results from this important study.”

Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial randomized patients in a 1:1 ratio to carotid endarterectomy versus no endarterectomy and another randomized patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management is uniform for all randomized treatment groups and is centrally directed.

For additional information please visit: https://clinicaltrials.gov/study/NCT02089217

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Examples of such statements include, but are not limited to, statements relating to the C-Guardians U.S. IDE clinical trial, including one-year results from such trial presented at LINC 2024, as well as the timing and outcome of any subsequent results, PMA or potential launch. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com