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

InspireMD to Report Second Quarter 2024 Financial Results and Provide Corporate Business Update on Tuesday, August 6^th 

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

 Tel Aviv, Israel, and Miami, FL — July 30, 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 second quarter 2024 financial results on Tuesday, August 6^th, 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

Series H warrants exercisable following release of positive outcomes results related to one-year follow-up from the Company’s C-GUARDIANS pivotal trial.

    Participating warrant holders include Marshall Wace, OrbiMed, Rosalind,
             Nantahala, Soleus, Velan, and certain InspireMD Board members.

     Represents first of four milestone-driven warrant tranches pursuant to private
            placement financing of up to $113.6 million announced in May 2023

Tel Aviv, Israel, and Westin, Florida — July 1, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced the completion of the full exercise of 12.9 million Series H warrants. The Series H warrants were converted primarily into pre-funded warrants. The gross proceeds to the company from the warrant exercise were $17.9 million, and $16.9 million after fees.  

The Series H warrants were issued as part of the transformational private placement financing of up to $113.6 million that InspireMD announced in May 2023. The Series H warrants became exercisable following the release of positive results related to one-year follow-up from the Company’s C-GUARDIANS pivotal trial of the CGuard Carotid Stent System. Participating warrant holders include Marshall Wace, OrbiMed, Rosalind, Nantahala, Soleus, Velan, and certain InspireMD Board members.

Marvin Slosman, chief executive officer of InspireMD, stated, “We are grateful for the continued support of these highly regarded healthcare investors, who have elected to exercise 100% of the available Series H warrants. This capital strengthens our business and helps fuel our growth, including advancing our CGuard Prime Carotid Stent System through to potential FDA approval and U.S. launch in the first half of next year.  CGuard is a highly differentiated stent implant that delivers superior short- and long-term patient outcomes, as reflected in the best-in-class evidence that was reported at both the VIVA 2023 and LINC 2024 conferences. Looking ahead, we are working to catalyze these milestones to continue building momentum toward commercialization, while advancing both our CAS and TCAR programs to address the broadest range of physicians and patient needs of any company within the field of carotid revascularization.”     

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, and statements relating to expectations regarding future warrant exercises or expected proceeds therefrom. 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

Data demonstrate lowest reported primary endpoint event rate of 1.95% through twelve months post-procedure for any carotid stent or embolic protection device pivotal trial

Study results to support a Premarket Approval (PMA) application to FDA in H2 2024

U.S. commercial launch of the CGuard™ Prime Carotid Stent System anticipated in H1 2025, if approved 

Tel Aviv, Israel, and Miami, Florida — May 28, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced the presentation of positive one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Carotid Stent System for the treatment of carotid artery stenosis at this year’s Leipzig Interventional Course (LINC) 2024, which is being held May 28-31, in Leipzig, Germany.

Marvin Slosman, chief executive officer of InspireMD, stated, “We are very pleased to have such a significant presence at this year’s LINC conference, highlighted by a presentation of the primary endpoint results from our C-GUARDIANS clinical study.  The independently adjudicated major adverse event rates through one-year are the lowest reported to date from any carotid stent or embolic protection device pivotal trial. With these data in-hand, we now have line of sight to a PMA application in the back half of this year, with preparation ongoing for a robust U.S. commercial launch in the first half of 2025, if approved. In addition to these results, we continue to be enthusiastic about our plans to introduce both CAS and TCAR solutions serving the broadest community of specialists serving the carotid revascularization market with the best implant in CGuard Prime.”

Dr. Chris Metzger, M.D., System Vascular Chief at OhioHealth, and lead investigator of the C-GUARDIANS trial, stated, “We are very excited that the one-year carefully adjudicated C-GUARDIANS data confirm the extremely low rates of stoke, death, myocardial infarction, and target vessel revascularization in this prospective trial of high-carotid endarterectomy (CEA) risk patients with obstructive carotid disease, including 25% who were symptomatic. These data confirm the potential ‘neuroprotective properties’ of this unique MicroNet technology, offering an outstanding front-line option to consider for each patient with obstructive carotid artery disease.”

Presentation details:

Title:             One-Year Follow-Up Results from the C-GUARDIANS Pivotal Trial of the
                       CGuard™ Carotid Stent System

Presenter:   Dr. D. Christopher Metzger, System Vascular Chief, OhioHealth

Date/time:  Tuesday, May 28^th at 2:53 pm CEST (8:53am EDT)

Presentation Highlights:

• From July 2021 to June 2023, 316 patients were prospectively enrolled in this single-arm carotid artery stenting study performed at 24 sites in the US and the EU.
• The primary endpoint is a composite of: (1) incidence of major adverse events including death (all-cause mortality), any stroke, or myocardial infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure.
• Stenting with the CGuard carotid stent system in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a primary endpoint event rate of 1.95%, from procedure through 1-year follow-up.
• The presentation is available on our website at: Clinical Presentations – InspireMD

About LINC
LINC, the Leipzig Interventional Course, is strongly committed to contributing to a systematic scientific evaluation and interdisciplinary discussion of new methods in the field of vascular medicine, allowing conclusions for daily interventional practice. LINC is an interdisciplinary live course, designed to provide a global platform, permitting the discussion of the “vascular patients” by integrating colleagues of different specialties from around the world who are performing endovascular interventions.

For more information, please visit: https://www.leipzig-interventional-course.com/.

About C-GUARDIANS
The C-GUARDIANS clinical trial evaluated the safety and efficacy of the CGuard™ Carotid Stent System for the treatment of carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in the U.S. and Europe.

The trial included both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS). The primary endpoint includes the composite of the following: incidence of the following major adverse events: death (all‐ cause mortality), all stroke, or myocardial infarction (DSMI) through 30‐days post‐index procedure, or ipsilateral stroke from 31‐365-day follow‐up, based on the Clinical Events Committee (CEC) independent adjudication. The performance goal will be considered to have been met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is <11.6% and the p-value is <0.025.

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

– Generated first quarter 2024 CGuard EPS revenue of $1.51 million, an increase of 22.0% over the first quarter of 2023 –

– Announced that an abstract detailing one-year outcomes from the C-GUARDIANS IDE clinical trial of CGuard™ Prime has been accepted for presentation at LINC 2024, to be held May 28-31 –

– Named Patrick Geraghty, M.D. and Patrick Muck, M.D. as lead principal investigators for the Company’s CGUARDIANS II clinical trial for Transcarotid Artery Revascularization (TCAR), as well as Dr. William Gray, as advisor to the company –

—

Management to host investor conference call today, May 14, at 8:30am ET
—

Tel Aviv, Israel and Miami, FL — May 14, 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 first quarter ended March 31, 2024.

First Quarter 2024 and Recent Developments:

• Generated CGuard revenue in the first quarter 2024 of $1.51 million, a 22.0% increase over the first quarter of 2023.
• Sold 2,553 CGuard EPS stent systems in the first quarter of 2024, as compared to 2,033 in the first quarter of 2023, an increase of 25.6%.
• Announced that an abstract of the one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Prime Carotid Stent System for the treatment of carotid artery stenosis has been accepted for presentation at the Leipzig Interventional Course (LINC) 2024, which is being held May 28-31, in Leipzig, Germany.
   
  • Presentation of one-year results follows an earlier abstract of 30-day results from C-GUARDIANS which were presented at the Vascular InterVentional Advances Annual Meeting (VIVA23) and the VEITH Symposium in November 2023.
  • The 30-day results demonstrated that patients with carotid artery stenosis and at high risk for carotid endarterectomy (CEA) had an overall major adverse event rate (death, stroke or myocardial infarction, or DSMI) of 0.95% from procedure through 30 day follow up when treated with carotid artery stenting (CAS) using CGuard.
  • The announcement of one-year results from C-GUARDIANS will potentially trigger the first of four $17.9 million financing tranches per the transformational private placement of up to $113.6 million that the company announced in May 2023.
• Named 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, as lead principal investigators for the Company’s CGUARDIANS II clinical trial of its SwitchGuard™ neuroprotection system for use with CGuard Prime in TCAR procedures.
• Announced recertification of the Company’s CE Mark under the European Union’s new Medical Device Regulation (MDR) regulatory framework.
• Announced the appointment of medical technology executive Pete Ligotti as Executive Vice President and General Manager of North America.

Marvin Slosman, CEO of InspireMD, commented: “Our first quarter results reflect continued momentum and share gains in our served CE Mark territories, including total revenue of $1.51 million that increased 22.0% year-over-year. We sold more than 2,500 stents during the quarter, up 25.6% year-over-year and bringing our real-world experience with the CGuard EPS stent platform to over 50,000 stents sold to date, a noteworthy milestone for our company.

“At the same time, we remain acutely focused on advancing our ongoing C-GUARDIANS PMA clinical trial through to completion for U.S. market approval. Recall that the 30-day results that were presented at last year’s VIVA23 and VEITH Symposium showed that stenting with CGuard in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%. These are best-in-class results from any carotid pivotal trial conducted to date and form the foundation of our ‘stent first’ strategy.

“We were very pleased to have recently announced that an abstract of the one-year results from C-GUARDIANS will be presented at the LINC conference in Germany later this month. This key milestone will potentially allow us to file a Premarket Approval (PMA) application with the FDA later this year and give us line-of-sight to potential approval in the first half of 2025.

“I am very pleased with our progress, including building our core business as well as advancing our clinical trials and new product pipeline, anticipating and preparing for a launch of our best-in-class carotid platforms in the U.S. in 2025,” Mr. Slosman concluded.  

Financial Results for the First Quarter Ended March 31, 2024

For the first quarter of 2024, total revenue increased 22.0%, to $1,511,000, from $1,239,000 during the first quarter of 2023. This increase was predominantly driven by growth in existing markets.

Gross profit for the first quarter of 2024 decreased by $81,000, or 21.6%, to $292,000, compared to a gross profit of $373,000 for the first quarter of 2023. This decrease resulted primarily from higher training costs of new hires to build capacity for anticipated increased volume requirements. Gross margin (gross profit as a percentage of revenue) decreased to 19.4% during the three months ended March 31, 2024, from 30.1% during the three months ended March 31, 2023.

Total operating expenses for the first quarter of 2024 were $7,706,000, an increase of $2,952,000, or 62.1% compared to $4,754,000 for the first quarter of 2023. This increase was primarily due to higher share-based compensation resulting from the recognition of grants made during the second quarter of 2023 and the first quarter of 2024.

Total financial income for the first quarter of 2024 was $382,000, an increase of $257,000 or 205.6% compared to $125,000 for the first quarter of 2023. This increase was primarily due to a $264,000 increase in interest income from investments in marketable securities, money market funds and short-term bank deposits.

Net loss for the first quarter of 2024 totaled $7,032,000, or $0.21 per basic and diluted share, compared to a net loss of $4,256,000, or $0.53 per basic and diluted share, for the same period in 2023.

As of March 31, 2024, cash, cash equivalents and marketable securities were $34.0 million compared to $39.0 million as of December 31, 2023.

Conference Call and Webcast Details

Management will host a conference call at 8:30AM ET today, May 14^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, May 14^th at 8:30 a.m. ET

Domestic:               1-877-407-4018
International:        1-201-689-8471
Conference ID:      13745786
Call me™                Link here
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 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 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

CONSOLIDATED STATEMENTS OF OPERATIONS⁽¹⁾

(U.S. dollars in thousands, except per share data)

(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 March 31, 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 and Exchange Commission.

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

 Tel Aviv, Israel, and Miami, FL — May 7, 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 first quarter 2024 financial results on Tuesday, May 14^th, 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

Tel Aviv, Israel, and Miami, Florida — April 3, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that Marvin Slosman, Chief Executive Officer, will deliver a company update presentation at the 23rd Annual Needham Virtual Healthcare Conference, which is being held April 8-11, 2024.

Presentation details:

Date:            Wednesday, April 10^th

Time:            8:00-8:40 AM ET

Webcast: https://wsw.com/webcast/needham138/nspr/2290730, or on the Events section of the company’s Investor Relations website at https://www.inspiremd.com/en/events/.

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.

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

Tel Aviv, Israel, and Miami, Florida — March 26, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that an abstract of the one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Prime Carotid Stent System for the treatment of carotid artery stenosis has been accepted for presentation at the Leipzig Interventional Course (LINC) 2024, which is being held May 28-31, in Leipzig, Germany.

Presentation details:

Title:             One-Year Follow-Up Results from the C-GUARDIANS Pivotal Trial of the CGuard™ Carotid Stent System

Presenter:      Chris Metzger, M.D., System Vascular Chief at Ohio Health, and lead investigator of the C-Guardians trial

Date/time:     To be announced

Marvin Slosman, chief executive officer of InspireMD, stated, “At last year’s VIVA and VEITH conferences in November, Dr. Metzger, principal investigator for the C-GUARDIANS trial, presented positive 30-day follow-up data from the trial which demonstrated a DSMI[1] rate of just 0.95% in the Intent-To-Treat (ITT) analysis population, and 0.63% in the per-protocol (PP) analysis population. We are very excited to announce today that an abstract of the 12-month outcomes data from this important trial has been accepted for presentation at the upcoming LINC 2024 conference, which is among the most influential and widely attended meetings focused on vascular intervention. We are optimistic that the results will show a similar level of neuroprotection, which may support a Premarket Approval Application (PMA) later this year and allow us to prepare for a commercial launch of CGuard Prime in the U.S. in the first half of 2025, if approved.”

About C-GUARDIANS

The C-GUARDIANS clinical trial evaluated the safety and efficacy of the CGuard™ Carotid Stent System for the treatment of carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in the U.S. and Europe.

The trial included both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS). The primary endpoint includes the composite of the following: incidence of the following major adverse events: death (all‐ cause mortality), all stroke, or myocardial infarction (DSMI) through 30‐days post‐index procedure, based on the Clinical Events Committee (CEC) adjudication or ipsilateral stroke from 31‐365-day follow‐up, based on CEC adjudication. The performance goal will be considered to have been met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is <11.6% and the p-value is <0.025.

About LINC

LINC, the Leipzig Interventional Course, is strongly committed to contribute to a systematic scientific evaluation and interdisciplinary discussion of new methods in the field of vascular medicine, allowing conclusions for daily interventional practice. LINC is an interdisciplinary live course, designed to provide a global platform, permitting the discussion of the “vascular patients” by integrating colleagues of different specialties from around the world who are performing endovascular interventions.

For more information, please visit: https://www.leipzig-interventional-course.com/

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 and that such results will be available to  be 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

[1] Death (all-cause mortality), stroke, or myocardial infarction

– Record fourth quarter 2023 CGuard EPS revenue of $1.76 million increased 71.6% over fourth quarter 2022 –

– Announced positive 30-day data from the Company’s ongoing U.S. Investigational Device Exemption (IDE) clinical trial, C-GUARDIANS, designed to support U.S. approval of CGuard Prime –

– Named Patrick Geraghty, M.D. and Patrick Muck, M.D. as lead principal investigators for the Company’s C-GUARDIANS II clinical trial of its SwitchGuard™ NPS for Transcarotid Artery Revascularization (TCAR), as well as Dr. William Gray, as advisor to the company –

—

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

Tel Aviv, Israel and Miami, FL — March 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 fourth quarter and full-year ended December 31, 2023.

Fourth Quarter 2023 and Recent Developments:

• Generated record CGuard revenue in the fourth quarter 2023 of $1.76 million, a 71.6% increase over the fourth quarter of 2022.
• Sold 3,107 CGuard EPS stent systems in the fourth quarter of 2023, as compared to 1,781 in the fourth quarter of 2022, an increase of 74.5%.
• Announced presentation of positive 30-day results from the C-GUARDIANS U.S. clinical trial of CGuard EPS at the Vascular InterVentional Advances Annual Meeting (VIVA23) and the VEITH Symposium. The results demonstrated that patients with carotid artery stenosis and at high risk for carotid endarterectomy (CEA) had an overall major adverse event rate (death, stroke or myocardial infarction, or DSMI) of 0.95% from procedure through 30 day follow up when treated with carotid artery stenting (CAS) using the CGuard EPS.
• Announced re-certification of the Company’s CE Mark under the European Union’s new Medical Device Regulation (MDR) regulatory framework.
• Named 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, as lead principal investigators for the Company’s C-GUARDIANS II clinical trial of its SwitchGuard™ neuroprotection system for use with CGuard Prime in TCAR procedures.
• Appointed William Gray, M.D., system chief of the cardiovascular division at Main Line Health in Wynnewood, PA and professor of medicine at Thomas Jefferson University in Philadelphia, PA, as an advisor to the Company.
• Announced a strategic agreement with the Jacobs Institute at the State University of New York at Buffalo, and Dr. Adnan Siddiqui, Vice-Chairman and Professor of Neurosurgery, to execute an Early Feasibility Study (EFS) evaluating the CGuard EPS carotid stent to treat severe carotid stenosis or occlusion, in conjunction with thrombectomy, in patients presenting with acute ischemic stroke and tandem lesions.
• Announced support for the Centers for Medicare and Medicaid Services’ (CMS) final National Coverage Determination expanding coverage for CAS to include both asymptomatic and standard risk patients, significantly expanding the U.S. CAS addressable market.
• Announced the appointment of medical technology executive Pete Ligotti as Executive Vice President and General Manager of North America.

Marvin Slosman, CEO of InspireMD, commented: “We delivered another strong quarter of sales growth in our approved CE Mark territories while at the same time advancing our U.S. clinical trial and product development pipeline. Our total revenue of $1.76 million represents a record quarter and an increase of nearly 72% over the comparable period in 2022. Notably, we sold over 3,100 stents, up more than 74% year-over-year and bringing our real-world experience to more than 48,000 stents sold to date. The receipt of formal recertification of our CE Mark under the EU’s new Medical Device Regulation (MDR) regulatory framework just a few weeks ago allows us to now leverage the new product development pathway and the latest regulatory certification provided under MDR.

“Also during the quarter, we were extremely pleased to report 30-day follow-up data from our C-GUARDIANS clinical trial at VIVA23 and the VEITH Symposium, which are among the most important annual gatherings of specialists who treat vascular disease. The data showed that stenting with CGuard in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95% from procedure through 30 days, which compares favorably to both surgery and alternative stenting options and represents best in class results to date of any pivotal trial of carotid intervention. We remain on track to report 12-month follow-up data mid-year, followed by the submission of our Premarket Approval (PMA) application.

“Finally, we made progress advancing our new product pipeline by announcing the lead PIs for our upcoming C-GUARDIANS II clinical trial of our SwitchGuard NPS for use with CGuard Prime in TCAR procedures. We also announced an agreement with Jacobs Institute to conduct an early feasibility study of CGuard Prime to treat patients with acute ischemic stroke and tandem lesions.

“We believe InspireMD is uniquely positioned with a best-in-class implant and solutions to support both CAS and TCAR procedures, with line-of-sight to significant clinical and regulatory catalysts this year and next,” Mr. Slosman concluded.  

Financial Results for the Fourth Quarter Ended December 31, 2023

For the fourth quarter of 2023, total revenue increased 71.6%, to $1,761,000, from $1,026,000 during the fourth quarter of 2022.  This increase was predominantly driven by the CE Mark recertification which occurred subsequent to the end of the fourth quarter 2022.

Gross profit for the fourth quarter of 2023 increased by $307,000, or 155.1%, to $505,000, compared to a gross profit of $198,000 for the fourth quarter of 2022. This increase resulted from higher revenue and a decrease in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 28.7% during the three months ended December 31, 2023, from 19.3% during the three months ended December 31, 2022.

Total operating expenses for the fourth quarter of 2023 were $6,313,000, an increase of $1,179,000, or 23.0% compared to $5,134,000 for the fourth quarter of 2022. This increase was primarily due to increases in expenses related to the salaries and share-based compensation offset by a reduction in clinical trial expenses as we near completion of the C-GUARDIANS trial.

Total financial income for the fourth quarter of 2023 was $468,000, an increase of $349,000 or 293% compared to $119,000 for the third quarter of 2022. This increase was primarily due to a $349,000 increase in interest income from investment in marketable securities, money market funds and short-term bank deposits.

Net loss for the fourth quarter of 2023 totaled $5,405,000, or $0.16 per basic and diluted share, compared to a net loss of $4,845,000, or $0.60 per basic and diluted share, for the same period in 2022.

As of December 31, 2023, cash, cash equivalents, short-term bank deposits and marketable securities were $39.0 million compared to $17.8 million as of December 31, 2022.

Financial Results for the full year ended Dec 31, 2023

For the twelve months ended December 31, 2023, total revenue increased by $1,034,000, or 20.0%, to $6,205,000, from $5,171,000 during the twelve months ended December 31, 2022. This increase was driven by a 21.1% increase in sales of CGuard EPS, to $6,205,000 during the twelve months ended December 31, 2023, from $5,123,000 during the twelve months ended December 31, 2022. This sales increase was mainly due to growth in existing and new markets.

Gross profit for the twelve months ended December 31, 2023, increased by $690,000, or 61.8%, to $1,807,000, compared to a gross profit of $1,117,000 for the twelve months ended December 31, 2022. This increase in gross profit resulted from higher revenue and a decrease in write-off and miscellaneous expenses. Gross margin increased to 29.1% during the twelve months ended December 31, 2023, from 21.6% during the twelve months ended December 31, 2022.

Total operating expenses for the twelve months ended December 31, 2023 were $22,950,000, an increase of $3,120,000, or 15.7% compared to $19,830,000 for the twelve months ended December 31, 2022. This increase was primarily due to increases in expenses related to salaries and share-based compensation offset by a reduction in clinical and product development expenses.

Total financial income for the twelve months ended December 2023, was $1,292,000, an increase of $1,042,000 or 417% compared to $250,000 for the twelve months ended December 31, 2022. This increase was primarily due to a $1,152,000 increase in interest income from investment in marketable securities, money market funds and short-term bank deposits.

Net loss for the twelve months ended December 31, 2023 totaled $19,916,000, or $0.82 per basic and diluted share, compared to a net loss of $18,491,000, or $2.35 per basic and diluted share, for the twelve months ended December 31, 2022.

Conference Call and Webcast Details

Management will host a conference call at 8:30AM ET today, March 6^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.  

Wednesday, March 6^th at 8:30 a.m. ET

Domestic:                              1-877-407-4018
International:                       1-201-689-8471
Conference ID:                    13744173
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 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 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 financial information for the twelve months ended December 31, 2023 is derived from the Company’s 2023 audited financial statements and all financial information for the twelve months ended December 31, 2022 is derived from the Company’s 2022 audited financial statements, included in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2023 filed with the Securities and Exchange Commission.  All financial information for the three months ended December 31, 2023 and 2022 is derived from the Company’s unaudited, financial statements.

(2) All December 31, 2023 financial information is derived from the Company’s 2023 audited financial statements and all December 31, 2022 financial information is derived from the Company’s 2022 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 and Exchange Commission.

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

Tel Aviv, Israel, and Miami, FL — February 28, 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 fourth quarter and full-year 2023 financial results on Wednesday, March 6^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