Development of SwitchGuard™ consistent with Company’s mission to uniquely support both Carotid Artery Stenting (CAS) and Transcarotid Artery Revascularization (TCAR) procedures with best-in-class carotid implant and platform

Tel Aviv, Israel, and Miami, FL — February 12, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Carotid Stent System (EPS) for the prevention of stroke, today announced that the Company has appointed principal investigators (PIs) for its upcoming C-GUARDIANS II clinical trial of the SwitchGuard™ Neuroprotection System (NPS). 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 enthusiastically agreed to act as lead PIs for the trial.

Additionally, 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, will act as an advisor to the Company. 

Marvin Slosman, chief executive officer of InspireMD, stated, “As the only company with a mission to develop solutions that support both CAS and TCAR carotid revascularization procedures with a best-in-class implant, we consider initiation of the C-GUARDIANS II clinical trial of our SwitchGuard™ Neuroprotection System as a very significant upcoming milestone for our company. We are very pleased that Drs. Geraghty and Muck, both recognized leaders in the field of vascular surgery, have agreed to lead the execution of this important trial, planned to start later this year. We also welcome William Gray, M.D., as an advisor to the Company and look forward to his contributions given his vast experience and knowledge in the field of carotid intervention.”

“We are very fortunate and grateful to have built an incredible a team of supporters and advocates for C-GUARDIANS II, as we did with the previously enrolled C-GUARDIANS trial, advancing our goal of establishing CGuard Prime as the leading carotid implant.”    

The C-GUARDIANS II study is intended to advance clearance of SwitchGuard™ NPS and associated tools, designed to allow the treating physician to reverse cerebral blood flow during a TCAR procedure, thus preventing embolic debris generated during the procedure from traveling to the brain, passing the blood through the filter housed within the SwitchGuard™ before returning it to the patient to minimize blood loss.

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 II trial, including the timing of its commencement. 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

Tel Aviv, Israel, and Miami, FL — January 31, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Carotid Stent System (EPS) for the prevention of stroke, today announced that it has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) regulatory framework. MDR replaced the previous MDD framework, which had governed the approval and marketing of medical devices in the EU until May of 2021.  

Marvin Slosman, chief executive officer of InspireMD, stated, “The transition from MDD to MDR has been challenging and has required us, and others in the medical device industry, to be comprehensive and persistent in our approach to addressing changes in requirements, timelines, and priorities during this process. We are very pleased to have now received formal recertification of our CE Mark under MDR, allowing us to continue to work to make CGuard EPS the standard of care for carotid artery revascularization in our existing commercial territories while also advancing our new product pipeline using the pathway provided under MDR.”     

“In parallel, our work on the Premarket Approval Application (PMA) for the C-GUARDIANS U.S. IDE trial continues to progress nicely, and we look forward to primary endpoint results in mid-2024, followed by submission of the final module of the PMA application to FDA in the second half of this year. We continue to aggressively work toward multiple value creating milestones, including the potential U.S. approval of the CGuard Prime EPS stent system in the first half of 2025,” 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 30-day results from such trial, as well as the timing and outcome of any subsequent results, the EFS, 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

Appointment brings more than 30 years of medical technology general management and commercial leadership experience to the InspireMD team

Reports inducement grant under NASDAQ listing rule 5635(c)(4)

Tel Aviv, Israel, and Miami, Florida — January 3, 2024 – InspireMD (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, announced today the appointment of medical technology executive Pete Ligotti as Executive Vice President and General Manager of North America. Mr. Ligotti brings more than 30 years of general management and commercial leadership experience to the InspireMD team.

Marvin Slosman, Chief Executive Officer of InspireMD, stated, “As we continue to scale our U.S. infrastructure ahead of potential approval of the CGuard EPS carotid stent platform, we are very pleased to welcome Pete to the team. With encouraging data emerging from our ongoing C-GUARDIANS Investigational Device Exemption (IDE) pivotal trial, notably positive 30-day follow up data that was recently presented at VIVA23 in November, we believe CGuard EPS has the potential to become the leading stent platform among carotid implants, enabling a shift toward an endovascular standard of care. The addition of Pete brings a track record of operating and commercial experience globally to bolster our talent and senior leadership as we build our U.S. base of operations.”

Mr. Ligotti added, “Throughout my career, I have been fortunate to be able to contribute to the development, launch and growth of many groundbreaking medical technologies that drive improved patient outcomes, and I believe CGuard EPS, with its novel MicroNet® technology, is poised to be a leader not just among stenting alternatives, but in the conversion of carotid surgery to a ‘stent first’ approach. I am excited to join InspireMD at this opportune time and look forward to working to build our U.S. presence and make this technology broadly available to carotid artery disease patients, if approved.”     

Mr. Ligotti joins InspireMD from NuVasive (merged with Globus Medical, NYSE: GMED) where he served as Vice President and General Manager of NuVasive Specialized Orthopedics – NSO since January 2022. Before that, he served as Vice President of Global Commercial Strategy at Smith+Nephew (LSE: SN, NYSE: SNN), and, prior to that, in various roles of increasing responsibility at Integra LifeSciences (Nasdaq: IART), culminating with Senior Vice President and General Manager – Extremity Orthopedics. He began his career as Sales Manager at Clinical Neuro Systems (sold to Integra LifeSciences in December 1999). Mr. Ligotti earned his BA in Biology from Syracuse University, and a mini-MBA in Financial Essentials from Rutgers University.   

Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

In connection with the appointment of Mr. Ligotti as Executive Vice President and General Manager of North America, InspireMD has granted Mr. Ligotti 138,460 shares of restricted stock and stock options to purchase 46,150 shares of InspireMD’s common stock. The grant of restricted stock and stock options was approved by the Compensation Committee of InspireMD’s Board of Directors and was granted outside of InspireMD’s 2021 Equity Compensation Plan, with a grant date of January 2, 2024, as an inducement material to Mr. Ligotti entering into employment with InspireMD, in accordance with Nasdaq Listing Rule 5635(c)(4).

The restricted stock and stock options vest over three years, with one-third vesting on the first anniversary of the grant and the remainder vesting in two equal installments on the second and third anniversaries of the grant date, subject to Mr. Ligotti being continuously employed by InspireMD as of such vesting dates. The stock options have a ten-year term and an exercise price of $2.71, the closing sales price of InspireMD’s common stock on the grant date.

InspireMD is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

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 30-day results from such trial, as well as the timing and outcome of any subsequent results, the EFS, 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

Reflects continued focus on adding intellectual property to support the strategic direction of the Company to provide a complete solution set for the treatment of carotid artery disease and the prevention of stroke

Tel Aviv, Israel, and Miami, Florida — December 20, 2023 – InspireMD (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, announced today the issuance of U.S. Patent No. 11,844,893, titled, “Shunts with Blood Flow Indicators.”

The patent covers key aspects of the company’s SwitchGuard^TM Neuroprotection System (NPS) along with future features in development that are expected to enable the treating physician to visualize flow through the system. The SwitchGuard^TM NPS is designed to allow the physician to reverse blood flow to the brain during a carotid artery stenting procedure, including Transcarotid Artery Revascularization (TCAR) or other neurovascular procedures.  The SwitchGuard^TM NPS is designed to prevent embolic debris generated during the procedure from traveling to the brain, passing the blood through the filter housed within the SwitchGuard before returning it to the patient, to minimize blood loss during the procedure.

In October 2023, the Centers for Medicare and Medicaid Services (CMS) expanded coverage for carotid artery stenting (CAS) and TCAR to include both asymptomatic and standard risk patients at either high- or standard- risk for carotid endarterectomy (surgery).  The broader availability of these less invasive options should better enable physicians to tailor treatment plans to the needs of individual patients.

Marvin Slosman, Chief Executive Officer of InspireMD, stated, “The issuance of this patent demonstrates our continued priority to develop and build on our robust intellectual property to support our innovations, while expanding our product portfolio for optimal patient outcomes in the treatment of carotid artery disease with the utmost safety in mind. This coupled with our CGuard Prime Carotid Stent System should provide clinicians with innovation and safety during carotid revascularization procedures and minimize the risk of stroke.” 

InspireMD expects to submit an Investigational Device Exemption (IDE) to the FDA in 2024, which, if approved, would allow the company to initiate a clinical trial to support the clearance of the SwitchGuard^TM NPS coupled with CGuard Prime.

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 30-day results from such trial, as well as the timing and outcome of any subsequent results, the EFS, 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

Study to enroll 15 acute stroke patients across three U.S. sites.

Tel Aviv, Israel, and Miami, Florida — November 27, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the company has entered into 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.

Marvin Slosman, chief executive officer of InspireMD, stated, “This Early Feasibility Study provides the appropriate platform for our investment in this indication to address Carotid lesions in acute stroke settings and reinforces our commitment to the neuro community, as we aim to demonstrate that CGuard EPS is optimally designed with a low metal surface and MicroNet™ mesh covering for superior embolic protection during these acute events. We look forward to results from this study and view the tandem lesion indication as a critical component of our long-term growth strategy for the Cguard stent platform.”

Dr. Adnan Siddiqui added, “Tandem strokes with occlusion of both cervical and intracranial vessels are very common (~20%). To date, all clinical trials conducted in the U.S. for acute stroke from large vessel occlusions have specifically excluded them, resulting in a lack of guidelines and resultant great variability in the management of these lesions.  As a result, there are currently no FDA approved stents for this specific indication. The most dramatic part is that trials conducted outside the U.S. have shown the value of thrombectomy in this patient population is the most beneficial of any large vessel occlusion category. Retrospective analyses from large centers across the globe have suggested the safety and efficacy of stenting in conjunction with intracranial thrombectomy. There is strong evidence to suggest that stenting in these lesions is superior to not stenting.”

“I am delighted that InspireMD, with its C-Guard device, which has low metal surface area and therefore reduces thrombotic risk, as well as a MicroNet™ mesh that protects plaque prolapse intra- and post- procedure, have elected to investigate this critical indication.  I am also excited that this brings the carotid disease as it pertains to neurointerventionalists to the forefront.  This EFS will help lead to a design of the pivotal trial that can bring this large, neglected population into the standard practice of revascularization for stroke,” Dr. Siddiqui concluded.

The EFS is expected to enroll 15 patients across three U.S. trial sites and explore the safety and feasibility of using the CGuard EPS carotid stent, with its unique MicroNet™ mesh covering, to treat acute ischemic stroke patients with tandem lesions.  

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 30-day results from such trial, as well as the timing and outcome of any subsequent results, the EFS, 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 Reports Third Quarter 2023 Financial Results and Provides
Business Update

–

Presented positive 30-day follow-up results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) clinical trial demonstrating an overall major adverse events rate (DSMI) of 0.95% from procedure through 30 days at the Vascular InterVentional Advances Annual Meeting (VIVA23) –

– Announced support for CMS’ final decision expanding coverage of CAS to include both asymptomatic and standard risk patients, significantly expanding the U.S. CAS addressable market –

– Generated Q3 2023 CGuard EPS revenue of $1.56 million, an increase of nearly 9% over Q3 2022 – 

—

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

Tel Aviv, Israel, and Miami, FL — November 6, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for treatment of carotid artery disease and prevention of stroke today announced financial results and business updates for the third quarter ended September 30, 2023.

Third Quarter 2023 and Recent Developments:

• Announced presentation of positive 30-day results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) clinical trial of CGuard EPS at the Vascular InterVentional Advances Annual Meeting (VIVA23). The results demonstrated that patients with obstructive carotid artery disease and at high risk for carotid endarterectomy (CEA) had an overall major adverse events rate (including cumulative death, stroke and myocardial infarction) of 0.95% from procedure through 30 days follow up when treated with carotid artery stenting (CAS) using the CGuard EPS.
• Implemented senior leadership additions and changes designed to support the Company’s commercial growth initiatives, including the hiring of Patrick Verta, MD, as Executive Vice President of Clinical and Medical Affairs and Cheryl Tal as Vice President of Quality Assurance and Regulatory Affairs. In addition, Shane Gleason, former General Manager of North America and Vice President of Global Marketing, has been promoted to Chief Commercial Officer.
• 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.
• Generated CGuard revenue for the third quarter 2023 of $1,556,072, an 8.8 % increase over the same period in 2022.
• Sold 2,734 CGuard EPS stent systems in the third quarter of 2023, as compared to 2,624 in the third quarter of 2022, an increase of 4.2 %.

Marvin Slosman, CEO of InspireMD, commented: “During the third quarter, we continued to grow revenue in our served markets outside the U.S., generating nearly 9% year-over-year revenue growth, while continuing our post-enrollment work toward a potential approval and launch of CGuard EPS in the U.S. in the first half of 2025.

“As previously announced, we were pleased to have presented very compelling 30-day safety data from C-GUARDIANS at VIVA23, one of the most important gatherings of endovascular specialists in the world. The results are consistent with eight previously completed clinical studies demonstrating extremely low rates of complications – death, stroke or myocardial infarction – as compared to historical data on competing first generation stents as well as conventional surgery (carotid endarterectomy, or CEA). The data emerging from C-GUARDIANS adds to the vast and growing body of evidence demonstrating the outstanding short- and long-term patient outcomes facilitated by CGuard EPS, which remains the cornerstone of our business.

“Subsequent to the end of the quarter, CMS issued its final National Coverage Determination (NCD), expanding coverage of CAS to include both asymptomatic and standard risk patients, significantly expanding the U.S. CAS addressable market. As we are focused on developing products for both CAS and TCAR approaches, we view this as very positive for our company, and a change that we believe will accelerate the ongoing shift toward an endovascular ‘stent first’ approach for all carotid interventions from the current more invasive surgery standard of care.     

“I am extremely pleased by our continued execution against our 2023 objectives and the transformational tailwind provided by the CMS coverage determination that will catalyze a stent-first approach to the treatment of carotid disease, a market we have invested to transform.”

Financial Results for the Third Quarter ended September 30, 2023

For the three months ended September 30, 2023, revenue increased by $125,000, or 8.7%, to $1,556,000, from $1,431,000 during the three months ended September 30, 2022. This increase was predominantly primarily driven by an increase in commercial sales of $166,000 of CGuard EPS to existing geographies, offset by a $41,000 decrease in the United States as the enrollment of all patients in the C-Guardians IDE clinical trial was completed in June 2023 and accordingly there were no further enrollments in the three months ended September 30, 2023.

For the three months ended September 30, 2023, gross profit (revenue less cost of revenues) increased by $72,000, or 19.7%, to $438,000, from $366,000 during the three months ended September 30, 2022. This increase in gross profit resulted from a $85,000 increase in revenues less the associated related material and labor offset by $13,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 28.1% during the three months ended September 30, 2023, from 25.6% during the three months ended September 30, 2022, driven by the factors mentioned above.

Total operating expenses for the third quarter of 2023 were $6,077,000, an increase of $1,101,000 or 22.1% compared to $4,976,000 for the third quarter of 2022. This increase was primarily due to an increase in compensation expenses.

Total financial income for the third quarter of 2023 was $461,000, an increase of $380,000 or 469% compared to $81,000 for the third quarter of 2022. This increase was primarily due to a $412,000 increase in interest income from investment in marketable securities, money market funds and short-term bank deposits.

Net loss for the third quarter of 2023 totaled $5,178,000 or $0.15 per basic and diluted share, compared to a net loss of $4,529,000, or $0.58 per basic and diluted share, for the same period in 2022.

As of September 30, 2023, cash, cash equivalents and short-term investments and bank deposits were $43.0 million compared to $17.8 million as of December 31, 2022.

Financial Results for the Nine Months ended September 30, 2023

For the nine months ended September 30, 2023, revenue increased by $299,000, or 7.2%, to $4,444,000, from $4,145,000 during the nine months ended September 30, 2022. This increase was predominantly driven by a $347,000 increase in sales volume of CGuard EPS from $4,097,000 during the nine months ended September 30, 2022, to $4,444,000 during the nine months ended September 30, 2023.

For the nine months ended September 30, 2023, gross profit (revenue less cost of revenues) increased by 41.7%, or $383,000, to $1,302,000, compared to a $919,000 for the same period in 2022. This increase in gross profit resulted from a $246,000 increase in revenues less the associated related material and labor costs and a decrease in write-offs of $199,000. This increase was partially offset by an increase of $62,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 29.3% during the nine months ended September 30, 2023, from 22.2% during the nine months ended September 30, 2022, driven by the reasons mentioned above.

Total operating expenses for the nine months ended September 30, 2023, were $16,637,000, an increase of $1,941,000, or 13.2% compared to $14,696,000 for the nine months ended September 30, 2022. This increase was primarily due to an increase in compensation and other general and administrative expenses.

Total financial income for the nine months ended September 2023, was $824,000, an increase of $693,000 or 529% compared to $131,000 for the nine months ended September 30, 2022. This increase was primarily due to a $689,000 increase in interest income from investment in marketable securities, money market funds and short-term bank deposits.

Net loss for the nine months ended September 30, 2023 totaled $14,511,000, or $0.69 per basic and diluted share, compared to a net loss of $13,646,000, or $1.75 per basic and diluted share, for the nine months ended September 30, 2022.

Conference Call and Webcast Details

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

Monday, November 6^th, at 8:30 a.m. ET

               Domestic:                            1-877-407-4018
               International:                     1-201-689-8471
               Conference ID:                   13741842
               Call me™                             Link here
               Webcast:                             Link 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 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; all 2022 financial information is derived from the Company’s 2022 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, 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. 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, 2022 filed with the Securities

Tel Aviv, Israel, and Miami, FL — November 2, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for treatment of carotid artery disease and prevention of stroke, today announced that the Marvin Slosman, Chief Executive Officer, will participate in three upcoming investor conferences in November:

Wolfe Research Healthcare Conference

Wednesday, November 15, 2023

Fireside chat: 12:30pm ET

Canaccord Genuity MedTech, Diagnostics, Digital Health & Services Forum

Thursday, November 16, 2023

Investor one-on-one meetings only

Piper 35th Annual Healthcare Conference

Wednesday, November 29, 2023

Fireside chat: 8:00am ET

A live webcast of the presentations will be available in the News and Events section of the Company’s website at www.inspiremd.com/en/events/. Replays will be available on the website for 30 days.

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

Data demonstrate a low major adverse event rate of 0.95% through 30 days post-procedure.

Tel Aviv, Israel, and Miami, Florida — November 1, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today presented 30-day results from the C-GUARDIANS U.S. Investigational Device Exemption (IDE) clinical trial at the Vascular InterVentional Advances (VIVA) meeting, which is being held October 30 through November 2 in Las Vegas, NV. The presentation, which was accepted as a late-breaking abstract, was delivered by Dr. Chris Metzger, System Vascular Chief at OhioHealth in Columbus, OH and principal investigator of the C-GUARDIANS trial.

C-GUARDIANS is a pivotal trial designed to evaluate the safety and efficacy of the CGuard™ Carotid Stent System when used to treat symptomatic and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting (CAS) and at a high risk for carotid endarterectomy (CEA).

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 C-Guard carotid stent system 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 follow-up.

Marvin Slosman, chief executive officer of InspireMD, stated, “The follow-up data from C-GUARDIANS once again supports the safety of the C-Guard EPS stent, with its novel MicroNet™ technology, as reflected in the low rate of major adverse events observed through 30 days. We believe the neuroprotective qualities of C-Guard set it apart from competing stents on the market and should help accelerate the ongoing shift in carotid revascularizations from ‘surgery first’ to an endovascular ‘stent first’ approach. We look forward to reporting 12-month results as we continue to advance CGuard EPS toward potential FDA approval in the first half of 2025.”         

InspireMD anticipates reporting primary endpoint results from C-GUARDIANS in the second half of 2024 that may support a Premarket Approval (PMA) application.

About C-GUARDIANS

The C-GUARDIANS clinical trial is evaluating the safety and efficacy of the CGuard™ Carotid Stent System for the treatment of carotid artery stenosis. The study, which completed enrollment in June 2023, enrolled 316 patients across 24 trial sites in the U.S. and Europe.

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

The company anticipates primary endpoint results from the study in H2 2024.

About VIVA

VIVA (Vascular InterVentional Advances) is a global educational event for specialists caring for patients with vascular disease. VIVA brings together attendees and faculty specializing in vascular surgery, interventional cardiology, interventional radiology, vascular medicine, neurointervention/neurosurgery, and cardiothoracic surgery, offering a uniquely comprehensive educational experience with access to some of the best minds in endovascular care.

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 30-day results from such trial, 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

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

Tel Aviv, Israel, and Miami, FL — October 30, 2023 – 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 2023 financial results on Monday, November 6^th, 2023, 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

  Provides additional treatment options for patients and treating physicians; likely expands CAS addressable market
Potentially accelerates conversion of carotid interventions from surgery (carotid endarterectomy) to minimally invasive CAS and TCAR procedures
InspireMD advancing both CAS and TCAR stent delivery platforms along U.S. and E.U. regulatory pathways leveraging proven CGuard EPS stent system

Tel Aviv, Israel, and Miami, Florida — October 12, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced its support for the Centers for Medicare and Medicaid Services (CMS) final National Coverage Determination (NCD) which expands coverage of carotid artery stenting (CAS) and transcarotid artery revascularization (TCAR) to include both asymptomatic and standard risk patients.

Marvin Slosman, Chief Executive Officer of InspireMD, stated, “We support CMS’s final decision on the expansion of coverage of CAS to include both symptomatic and asymptomatic carotid artery disease patients considered to be either standard or high risk for surgery. This decision offers a new treatment alternative to patients and their treating physicians and, we believe, will accelerate the ongoing shift toward an endovascular ‘stent first’ approach and away from more invasive surgery, the current standard of care.

“Importantly, at InspireMD, we continue to advance our mission, focusing on the importance of the implant first in both our CAS and TCAR programs, which are advancing through regulatory pathways in the U.S. and E.U. These programs both feature our next-generation CGuard EPS stent that has demonstrated unmatched clinical outcomes across nine clinical trials that have enrolled more than 1,850 patients, as well as over 40,000 real-world procedures performed to date. The CGuard EPS stent remains the cornerstone of our business, and this decision by CMS will broaden access to what we regard as this best-in-class technology, with anticipated FDA approval.”

In June 2023, InspireMD announced completion of enrollment in the C-GUARDIANS investigational device exemption (IDE) clinical trial of its CGuard™ EPS stent system. Thirty-day safety results from the trial will be presented as a Late Breaking Clinical Trial at the VIVA (Vascular InterVentional Advances) conference on November 1, 2023, in Las Vegas. The company anticipates filing for Premarket Approval (PMA) in the second half of 2024 when one-year follow up has been completed.          

InspireMD will provide further updates on this and other recent developments during its regularly scheduled third quarter 2023 conference call in November.

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, 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