Tel Aviv, Israel— April 27, 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 first quarter 2023 financial results on Tuesday, May 9^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

– 2022 CGuard EPS revenue of $5.1 million increased 18.9% over 2021 –

– Resumed shipments of CGuard EPS to CE Mark territories under the pre-existing Medical Device Directive (MDD) regulatory framework; Company anticipates re-certification under new Medical Device Regulation (MRD) framework in coming weeks –

– Continued enrollment in the C-Guardian US IDE trial, with 20 sites currently enrolling patients; on track to complete enrollment by approximately end of Q2 2023 –

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

Tel Aviv, Israel— March 30, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for treatment of carotid artery disease (CAD) and prevention of stroke today announced financial and operating results for the fourth quarter ended December 31, 2022.

Fourth Quarter 2022 and Recent Developments:

• Generated CGuard revenues for the fourth quarter 2022 of $1,026,000, a 20.6% decrease from $1,291,000 for the fourth quarter of 2021. The decrease was caused by reduced shipments due to the temporary expiration of the Company’s CE Mark for the second half of the fourth quarter, due to delays in the European regulatory bodies in the Medical Device Regulation (MDR) recertification process.
• In mid-March 2023, resumed shipments of CGuard EPS to CE Mark territories on a temporary basis under the pre-existing Medical Device Directive (MDD) regulatory framework while awaiting final re-certification under MDR. 
• Hired medical device commercial veteran Shane Gleason as General Manager of North America and Vice President of Global Marketing to position InspireMD to capitalize on the US market upon expected FDA approval.
• Promoted the Company’s Vice President of Global Sales and Marketing, Andrea Tommasoli, to Chief Operating Officer to meet the Company’s increasing demand for CGuard.
• Delivered multiple presentations highlighting the superior safety of CGuard, and resulting positive patient outcomes, at the 2022 VEITH Symposium in November.
• Continued enrollment in the C-Guardian Investigational Device Exemption (IDE) Clinical Trial. The Company currently has 20 trial sites enrolling patients. The Company anticipates completing enrollment by approximately the end of Q2 2023.

Marvin Slosman, CEO of InspireMD, commented: “We are very pleased to have resumed shipments of CGuard to our major European markets under the existing MDD framework as we await final approval and CE Mark recertification under MDR. While revenues in Q4 of 2022 and Q1 of 2023 were impacted by the temporary lapse of our CE Mark, our team did an outstanding job converting backlog to revenue, and we anticipate that the remaining backlog will be shipped over the next two quarters.” 

“Our U.S. IDE trial continues to progress, and now has 20 sites enrolling patients. We anticipate having the trial fully enrolled by approximately the end of the second quarter, a critical step forward in our goal to gain eventual marketing approval of CGuard EPS in the U.S.”

“With the expectation of potentially obtaining CE Mark recertification under MDR in the next few weeks, we plan to work tirelessly to continue to gain share in our key European territories, further driven by conversion of existing endovascular carotid procedures to CGuard from other stent systems, and the potential introduction of two new delivery systems, our SwitchGuard Trans Carotid (TCAR) and CGuard Prime Transfemoral (TFEM) platforms, later this year, subject to regulatory approval. I believe we are well positioned for continued success as we progress through 2023,” Mr. Slosman concluded.  

Financial Results for the Fourth Quarter ended December 31, 2022

For the fourth quarter of 2022, total revenue decreased 25.7%, to $1,026,000, from $1,380,000 during the fourth quarter of 2021.  This decrease was predominantly driven by a 20.6% decrease in sales of CGuard EPS, to $1,026,000 in the fourth quarter of 2022 from $1,291,000 in the same period one year ago. This sales decrease was due to the temporary expiration of the CE Mark and resulting inability to ship to EU countries for the second half of the quarter, due to delays in the European regulatory bodies in the MDR recertification process, offset by an increase in US sales related to stents used in the C-Guardian U.S. Food and Drug Administration (FDA) clinical trial. 

Gross profit for the fourth quarter of 2022 decreased by $96,000, or 32.7%, to $198,000, compared to a gross profit of $294,000 for the fourth quarter of 2021. This decrease resulted from lower revenue offset by a decrease in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) decreased to 19.3% during the three months ended December 31, 2022, from 21.3% during the three months ended December 31, 2021.

Total operating expenses for the fourth quarter of 2022, were $5,134,000, an increase of $909,000, or 21.5% compared to $4,225,000 for the fourth quarter of 2021. This increase was primarily due to increases in expenses related to the commencement of the C-Guardians FDA study, sales and marketing expenses, and regulatory expenses.

Net loss for the fourth quarter of 2022 totaled $4,845,000, or $0.60 per basic and diluted share, compared to a net loss of $4,097,000, or $0.53 per basic and diluted share, for the same period in 2021.

As of December 31, 2022, cash, cash equivalents and short-term bank deposits were $17.8 million compared to $34.0 million as of December 31, 2021.

Financial Results for the full year ended Dec 31, 2022

For the twelve months ended December 31, 2022, total revenue increased by $676,000, or 15.0%, to $5,171,000, from $4,495,000 during the twelve months ended December 31, 2021. This increase was predominantly driven by a 18.9% increase in sales of CGuard EPS, to $5,123,000 during the twelve months ended December 31, 2022 from $4,309,000 during the twelve months ended December 31, 2021. This sales increase was mainly due to growth in existing and new markets and sales in the United States related to stents used in our C-Guardians FDA study as enrollment accelerated.

Gross profit for the twelve months ended December 31, 2022 increased by $363,000, or 48.1%, to $1,117,000, compared to a gross profit of $754,000 for the twelve months ended December 31, 2021. This increase in gross profit resulted from higher revenue, and a decrease of $177,000 in miscellaneous expenses. Gross margin increased to 21.6% during the twelve months ended December 31, 2022 from 16.8% during the twelve months ended December 31, 2021.

Total operating expenses for the twelve months ended December 31, 2022, were $19,830,000, an increase of $4,360,000, or 28.2% compared to $15,470 for the twelve months ended December 31, 2021.  This increase was primarily due to increases in expenses related to the commencement of the C-Guardians FDA study, share-based compensation, resumed activities in tradeshows and travel, regulatory expenses, and miscellaneous expenses.

Net loss for the twelve months ended December 31, 2022 totaled $18,491,000, or $2.35 per basic and diluted share, compared to a net loss of $14,918,000, or $2.03 per basic and diluted share, for the twelve months ended December 31, 2021.

Conference Call and Webcast Details

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

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

Domestic:                              1-877-407-4018

International:                       1-201-689-8471

Conference ID:                    13735869

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, 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) All financial information for the twelve months ended December 31, 2022 is derived from the Company’s 2022 audited financial statements and all financial information for the twelve months ended December 31, 2021 is derived from the Company’s 2021 audited financial statements, included in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2022 filed with the Securities and Exchange Commission.  All financial information for the three months ended December 31, 2022 and 2021 is derived from the Company’s unaudited, financial statements.

(2) All December 31, 2022 financial information is derived from the Company’s 2022 audited financial statements and all December 31, 2021 financial information is derived from the Company’s 2021 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 and Exchange Com

Mr. Tommasoli formerly served as the Company’s Senior Vice President of Global Sales & Marketing since 2020 and has significant prior commercial leadership experience at Integra LifeSciences and St. Jude Medical 

Tel Aviv, Israel — March 20, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has promoted Andrea Tommasoli to Chief Operating Officer. Mr. Tommasoli formerly served as the Company’s Senior Vice President of Global Sales & Marketing since joining InspireMD in November 2020.

“Andrea has been instrumental in expanding the footprint of CGuard EPS across our approved markets in the EU and, as we advance toward potential U.S. approval with our ongoing U.S. Investigational Device Exemption (IDE) clinical trial, and as our business requirements shift toward operational capacity to support our commercial growth, we believe his background and skill set make him an ideal candidate to assume the role of Chief Operating Officer of the Company at this important time.” Stated Marvin Slosman, Chief Executive Officer of InspireMD. “On behalf of the entire InspireMD team, I would like to congratulate Andrea on this promotion and look forward to his continued contributions.”

“I joined InspireMD because of the tremendous potential of the CGuard EPS stent platform in changing the standard of care for Carotid revascularization through our proprietary MicroNet™ technology,” stated Mr. Tommasoli. “As the needs of the business grow beyond European commercialization, I am pleased to be able to play a more significant leadership role with broader responsibilities to drive scalability and operational efficiency to meet our anticipated growth needs. I am highly confident in the Company’s ability to meet these ever-expanding drivers of growth and look forward to serving in this important role.” 

Mr. Tommasoli joined InspireMD from Integra LifeSciences (Nasdaq: IART), where he served in several senior commercial leadership roles, most recently as Senior Sales Director – Indirect Markets, where he led the commercial expansion and integration of Codman’s acquired portfolio in all OUS indirect countries. Before that, Mr. Tommasoli ran Integra’s Neurosurgery and Instruments business in direct sales countries in Europe. Prior to Integra, Mr. Tommasoli was the Director of St. Jude Medical’s (part of Abbott, NYSE: ABT) Neuromodulation division in France. Mr. Tommasoli received his B.A. in nuclear engineering from Bologna University, Italy and his M.B.A. from HEC Paris, France

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 Statement
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. 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

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

Tel Aviv, Israel— March 2, 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 fourth quarter and full-year 2022 financial results on Thursday, March 30, 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 for a limited time.

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

Seasoned veteran in vascular space adds significant expertise in U.S. commercial market readiness and global strategic marketing

Tel Aviv, Israel — February 14, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has hired medical device commercial veteran Shane Gleason as General Manager of North America and Vice President of Global Marketing. Mr. Gleason brings to InspireMD significant expertise in vascular interventions and a track record of successful go-to-market execution.

Marvin Slosman, chief executive officer of InspireMD, stated, “As we near completion of enrollment in our C-Guardian U.S. investigational device exemption (IDE) clinical trial and shift our focus to U.S. market readiness and infrastructure buildout, Shane brings the ideal experience and background to lead this critical transition. His knowledge of the carotid market, reputation with our key opinion leader (KOL) partners and track record of successfully executing new product launches globally add tremendous capabilities to our senior team. We are so pleased to have Shane join the company at this important time of growth and expansion.”

Shane Gleason, General Manager of North America and Vice President of Global Marketing at InspireMD, stated, “I was attracted to InspireMD as a company perfectly positioned to enable the ongoing shift to a carotid endovascular standard of care with a proven stent platform, CGuard EPS, that has demonstrated success in clinical outcomes and real-world performance. Leveraging this foundation for the U.S. market launch to include the new SwitchGuard trans carotid artery revascularization (TCAR) system and CGuard Prime, our next generation trans femoral delivery (TFEM) system, offering a complete set of options for all vascular interventionists, is a remarkable opportunity. There has never been a better time or better positioned company to fully leverage the market shift to an endovascular focus and I am excited to join the senior team.”

Shane Gleason joins InspireMD from Surmodics, where he served as Vice President of Sales, Vascular Interventions. Before that, he served as Senior Director, US Marketing at Edwards Life Sciences (NYSE: EW), a developer of artificial heart valve and hemodynamic monitoring technologies, and, before that, Chief Commercial Officer at Nuvaira, Inc., a privately held developer of COPD therapies that preserve patient lung health. Earlier in his career, Mr. Gleason held sales and marketing leadership roles at Cordis, a Cardinal Health company (NYSE: CAH), Trivascular Technologies (part of Endologix), and Abbott Vascular (NYSE: ABT), where he launched the second FDA approved carotid stent system.

About InspireMD, Inc.

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

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

Forward-looking Statements

This press release contains “forward-looking statements.” 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 (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 to feature leading experts discussing the current and future trends in the carotid treatment market  

Tel Aviv, Israel — November 28, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced a video series, “12 Days of Carotid Stenting,” which will feature leading multidisciplinary vascular specialists discussing the current and future trends in the carotid treatment market. The series will be available for viewing beginning on Monday, November 28, 2022.

Marvin Slosman, chief executive officer of InspireMD, stated, “This truly unique video series featuring some of the most renowned thought leaders in the field of vascular interventions, and we are grateful that they have taken the time to participate in this important initiative. Topics that will be discussed include current market trends, momentum toward endovascular standard of care, technology differentiation and clinical results, delivery system topics including TCAR and TFEM approaches, and the overall progression of the landscape toward further conversion of surgical interventions to stenting. Importantly, the series will also highlight the distinct advantages of CGuard™ versus competing stent platforms for carotid revascularization and stroke prevention thus supporting our belief that CGuard™ can soon become the global standard of care for the treatment of carotid artery disease.”  

The video series will feature perspectives from the following thought leaders in the field of vascular interventions:

Chris Metzger, MD, System Chair of Clinical Research at Ballard Health and a practicing interventional cardiologist who serves as Director of Holston Valley Medical Center’s diagnostic catheterization and interventional labs

Sean Lyden, MD, Professor and Chairman of the Department of Vascular Surgery at Cleveland Clinic

Tommaso Castrucci, MD, Vascular, Endovascular and Emergency Vascular Surgery Unit, “S. Eugenio” Hospital, Rome, Italy

Adnan Siddiqui, MD, PhD, FACS, FAHA, FAANS, Director, Canon Stroke & Vascular Research Center at SUNY University at Buffalo, Professor of Neurosurgery & Radiology at University at Buffalo Neurosurgery (UBNS)

Kenneth Rosenfield, MD, Section Head, Vascular Medicine and Intervention at Massachusetts General Hospital and Chairman, ST-Elevation Myocardial Infarction (STEMI) & Acute Myocardial Infarction Quality Improvement Committee

The full Fireside Chat can be viewed at: www.inspiremd.com/en/fireside-chat-series/, along with brief sections on the company’s LinkedIn page.

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.” 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 (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 — November 15, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke, today announced that the company will deliver multiple presentations at the 2022 VEITH Symposium, which is being held November 15 – 19 in New York City.

Marvin Slosman, chief executive officer of InspireMD, stated, “We are very pleased to have such a notable presence at this year’s VEITH Symposium, which is among the most prestigious gatherings of vascular medicine specialists. There continues to be a growing body of clinical and safety data favoring CGuard EPS over competing stent platforms as well as open surgery, and gatherings such as VEITH are critical to raising awareness of this unique technology. We are grateful to all of the presenters who are participating on our behalf.”

Details of the presentations are as follows:

Wednesday, November 16, 2022

Title:              Clinical Results of a MicroNet™ Covered Carotid-Stent (CGUARD): Analysis of 145 Patients at Two Sites: Advantages and Disadvantages 
Presenter:   Christian Wissgott, MD, Christoph Kopetsch, MD and Reimer Andresen, MD
Time:            5:30 PM – 5:35 PM ET
Location:     Trianon Ballroom, 3rd Floor

Friday, November 18, 2022 – Session 77: New Developments in the Treatment of Carotid Stenosis with Mesh Covered Stents and TCAR (Transcervical Carotid Artery Revascularization)

Title:              Long-Term Results of Micromesh Stents Show Their Value in Carotid Artery Stenting (CAS): Are There Limitations: Do the Differences in the 3 Micromesh Stents Matter

Presenter:   Max Amor, MD
Time:            7:53 AM – 7:58 AM ET
Location:     Grand Ballroom East, 3rd Floor

Title:              Update on Carotid and Other Uses of MicroNet™-Covered Stents (C-Guard) in High-Risk Lesions and Aneurysms: What are the Long-Term Outcomes – and Are There Downsides

Presenter:   Piotr Musialek, MD, Dphil
Time:            7:59 AM – 8:04 AM ET
Location:     Grand Ballroom East, 3rd Floor

Title:              “New Multicenter Data Showing the Long-Term Value of the CGuard MicroNet™ Mesh Covered Stent for CAS in High-Risk Carotid Lesions (Thrombotic, Calcified and Symptomatic) From the FLOW-GUARD and Other Trials”

Presenter:   D. Christopher Metzger, MD, Piotr Musialek, MD, Dphil
Time:            8:05 AM – 8:10 AM ET
Location:     Grand Ballroom East, 3rd Floor

Title:              Results from a Multicenter Italian Study of the C-Guard Micromesh Stent for CAS: Advantages and Complications

Presenter:   Francesco Speziale, MD, Gianmarco de Donato, MD, Ashraf Mansour, MD, Pasqualino Sirignano, MD, Carlo Setacci, MD
Time:            8:11 AM – 8:16 AM ET
Location:     Grand Ballroom East, 3rd Floor

Title:              Value of a Mesh Covered Stent with TCAR: Is It the Best of All Worlds: Limitations

Presenter:   Ralf R. Kolvenbach, MD
Time:            10:48 AM – 10:53 AM ET
Location:     Grand Ballroom East, 3rd Floor

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.” 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 (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

– Generated 38.8% growth in CGuard™ revenue year-over-year –

– Continued enrollment in the C-Guardian US IDE trial, with 24 sites currently enrolling patients; on track to complete enrollment by approximately end of Q1 2023 –

– Announced strategic partnership with NAMSA, a med tech contract research organization (CRO), to accelerate new medical device development and commercialization –

—

Management to Host Investor Conference Call Today, November 8^th, at 8:30am ET
—

Tel Aviv, Israel— November 8, 2022 – 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 third quarter ended September 30, 2022.

Third Quarter 2022 and Recent Highlights:

• CGuard revenues for the third quarter 2022 were $1,430,836, a 38.8 % increase over the same period in 2021, on 2,624 stent systems sold, as compared to 1,709 stents sold in the same period in 2021.  
• Continued enrollment in the C-Guardian Investigational Device Exemption (IDE) Clinical Trial. The company currently has 24 trial sites enrolling patients (19 US, 5 EU) and anticipates adding two more US sites by the end of the year. The company anticipates completing enrollment by approximately end of Q1 2023, consistent with prior guidance.

• Professor Piotr Musialek presented at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) Conference long term patient results from the ongoing CGuard Optima study establishing a new baseline of carotid stent performance.
• Announced strategic outsourcing partnership with NAMSA, a med tech contract research organization (CRO), to accelerate new medical device development and commercialization.

Marvin Slosman, CEO of InspireMD, commented: “During the third quarter, we continued to gain share in our key European markets, contributing to nearly 40% CGuard revenue growth over the prior year period. We continue to work with our Notified Body to secure our CE Mark certification under the MDR, which currently expires November 12, while preparing our customers and distributors with sufficient inventory to mitigate as best as possible any potential delay in the recertification process.

“At the same time, our U.S. IDE trial now has 24 sites enrolling patients. We continue to anticipate having the trial fully enrolled by approximately end of Q1 of next year, a critical step forward in our goal to gain eventual marketing approval in the U.S.”

“We believe we have set the stage for a catalyst-rich 2023, driven by continued share gains in our established markets, ongoing progress with our U.S. IDE trial, conversion of existing endovascular CAD procedures to CGuard from other stent systems, and the introduction of two new delivery systems, our SwitchGuard Trans Carotid (TCAR) , and CGuard Prime Transfemoral (TFEM) platforms which will allow us to continue to address the comprehensive needs for all vascular specialist treating Carotid disease and stroke, including vascular surgeons who continue to treat a significant percentage of Carotid patients,” Mr. Slosman concluded.     

Financial Results for the Third Quarter ended September 30, 2022

For the third quarter of 2022, total revenue increased 33.6%, to $1,431,000, from $1,071,000 during the third quarter of 2021.  This increase was predominantly driven by a 38.8% increase in sales of CGuard EPS, to $1,431,000 in the third quarter of 2022 from $1,031,000 in the same period one year ago. This sales increase was due to growth in existing markets as well as US sales related to stents used in the C-Guardian U.S. Food and Drug Administration (FDA) clinical trial. 

Gross profit for the third quarter of 2022 increased by $274,000, or 297.8%, to $366,000, compared to a gross profit of $92,000 for the third quarter of 2021. This increase resulted from higher revenue and a reduction in write offs of $64,000, training expenses of $64,000 and miscellaneous expenses of $51,000. Gross margin (gross profits as a percentage of revenue) increased to 25.6% during the three months ended September 30, 2022, from 8.6% during the three months ended September 30, 2021.

Total operating expenses for the third quarter of 2022, were $4,976,000, an increase of $853,000, or 20.7% compared to $4,123,000 for the third quarter of 2021.  This increase was primarily due to increases in expenses related to the commencement of the C-Guardians FDA study and share-based compensation expenses.

Net loss for the third quarter of 2022 totaled $4,529,000, or $0.58 per basic and diluted share, compared to a net loss of $4,071,000, or $0.53 per basic and diluted share, for the same period in 2021.

As of September 30, 2022, cash, cash equivalents and short-term bank deposits were $21.0 million compared to $34.0 million as of December 31, 2021.

Financial Results for the Nine Months ended September 30, 2022

For the nine months ended September 30, 2022, total revenue increased by $1,030,000, or 33.1%, to $4,145,000, from $3,115,000 during the nine months ended September 30, 2021. This increase was predominantly driven by a 35.7% increase in sales of CGuard EPS, to $4,097,000 during the nine months ended September 30, 2022 from $3,018,000 during the nine months ended September 30, 2021. This sales increase was mainly due to growth in existing and new markets and sales in the United States related to stents used in our C-Guardians FDA study as enrollment accelerated.

Gross profit for the nine months ended September 30, 2022 increased by $459,000, or 99.8%, to $919,000, compared to a gross profit of $460,000 for the nine months ended September 30, 2021. This increase in gross profit resulted from higher revenue, partially offset by a decrease of $141,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 22.2% during the nine months ended September 30, 2022 from 14.8% during the nine months ended September 30, 2021.

Total operating expenses for the nine months ended September 30, 2022, were $14,696,000, an increase of $3,451,000, or 30.7% compared to $11,245,000 for the nine months ended September 30, 2021.  This increase was primarily due to increases in expenses related to the commencement of the C-Guardians FDA study, share-based compensation, resumed activities in tradeshows and travel, directors’ and officers’ liability insurance and miscellaneous expenses.

Net loss for the nine months ended September 30, 2022 totaled $13,646,000, or $1.75 per basic and diluted share, compared to a net loss of $10,821,000, or $1.50 per basic and diluted share, for the nine months ended September 30, 2021.

Conference Call and Webcast Details

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

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

Domestic:                              1-877-407-4018
International:                       1-201-689-8471
Conference ID:                    13733319
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.

For more information, please visit www.inspiremd.com.

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. 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, including the changing regulatory environment in Europe and the timing of the renewal of certificate to continue to sell CGuard under the new MDR rule structure, (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

(1) 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; all 2021 financial information is derived from the Company’s 2021 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, 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. All December 31, 2021 financial information is derived from the Company’s 2021 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2021 filed with the Securities and Exchange Commission.

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

Tel Aviv, Israel— October 25, 2022 – 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 2022 financial results on Tuesday, November 8^th, 2022, 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 — September 13, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke, today announced that the company will deliver a presentation at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) Conference, which is being held September 16-19, 2022, at the Boston Convention and Exhibition Center in Boston, MA.

Details of the presentation are as follows:

Title:             Endovascular Sequestration of High-Risk Carotid Lesions Using the MicroNet™-Covered Embolic Prevention Stent in Consecutive Patients with Symptoms or Signs of Carotid Stenosis-Related Cerebral Injury: An Investigator-Initiated, Intravascular, Ultrasound-Controlled, Multinational, Multispecialty Trial (CGuard OPTIMA)

Presenter:   Prof. Piotr Musialek, Associate Professor of Cardiovascular Medicine, Jagiellonian University Department of Cardiac & Vascular Diseases, Krakow, Poland

Date:             Saturday, September 17, 2022

Time:            4:15 pm ET

Location:     Clinical Science & Endovascular Theatre, Exhibition Level, Hall C

For more information: TCT2022

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.” 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 (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