Advancing the CARENET-III study of CGuard System for Stroke Prevention
in the United States

Tel Aviv, Israel — September 10, 2020 – InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announced the addition of Dr. Christina Brennan as a strategic advisor to the company to assist with planning and execution of  a pivotal study of the CGuard™ Carotid Stent System, CARENET-III, for prevention of stroke in patients in the United States. The company recently announced that it had received approval from the FDA for the company to proceed with this pivotal study.

“We are pleased to have Dr. Brennan join the team as we advance our efforts of planning and execution of the CARENET -III pivotal trial. Dr. Brennan brings a wealth of experience to InspireMD with specific expertise in vascular and stent related research and clinical trial development and execution,” said Marvin Slosman, InspireMD’s CEO.  “Our expectations are to accelerate the planning and preparation efforts for our pivotal study with Dr. Brennan’s help.” 

Christina Brennan, M.D. has devoted her career to clinical research and currently serves as Northwell Health’s vice president of clinical research. Committed to the advancement of science and medicine, Dr. Brennan has more than 20 years of extensive clinical research experience, including over 15 years in management roles. She is on the board of trustees for the Association of Clinical Research Professionals. She is the immediate past president of the NY Metropolitan Chapter of the Association of Clinical Research Professionals and she is an active member of the Clinical Trial Transformation Initiative (CCTI), with Duke University and the FDA, where she actively sits on some of their committees.  She is on the leadership council for Society for Clinical Research Sites (SCRS), where she also sits on the oncology advisory board and technology site advocacy group.  She is an adjunct professor for a Masters of Science program with Yeshiva University teaching a clinical trial & research management class.  She is also an active member of the Women in Bio and the American College of Healthcare Executives.

Her clinical research interest is in carotid artery disease.  She began her clinical research career 20 years ago working at Lenox Hill Hospital in NY alongside the internationally renowned interventional cardiologist and the pioneer of carotid artery stenting – Dr. Gary Roubin.  For over 10 years she had the opportunity to have him as her mentor and work with him, Dr. Sriram Iyer and the late Dr. Jiri Vitek.  Together they worked on many important carotid artery trials, including the global NIH CREST trial where over 2,500 subjects were recruited.  They enrolled the first ACT I trial patient in which Abbott Vascular later went on to receive FDA approval of their X.ACT stent and embolic protection device.

Dr. Brennan also has authored chapters in textbooks, coauthored many manuscripts and abstracts, and has presented at numerous scientific and research meetings.

“We have an opportunity for CGuard EPS to create a paradigm shift in the field of carotid artery stenting, bringing it to the next level, and I look forward to bringing my years of expertise in the management and operations of carotid stent trials to the CARENET-III trial with InspireMD,” added Dr. Brennan.

About The CGuard® EPS

The CGuard® Embolic Protection System is an advanced platform solution designed to deliver the flexibility of the traditional open-cell stent with advanced protection from peri-procedural and post-procedural embolic events caused by plaque prolapse through the stent strut that can lead to stroke.  CGuard’s unique MicroNet™® technology mitigates the prolapse and associated embolization and has shown superior clinical outcomes for patients against alternative carotid stent types, conventional or next-generation double-layer stents, as well as invasive procedures such as endarterectomy, a major surgical procedure.  InspireMD’s CGuard™ has created a new dimension in the protected treatment of carotid artery disease with the potential to truly establish a new standard of care for the management of carotid artery disease and stroke prevention.

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 NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB.

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” 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) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) 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 (xiv) 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

IDE Approval to Pave the Way for Pivotal Study of CGuard System for
Carotid Artery Disease and Stroke Prevention in the United States

Tel Aviv, Israel — September 8, 2020 – InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announced the U.S. Food and Drug Administration (“FDA” or “the Agency”) has granted approval for the company to proceed with a pivotal study of the CGuard™ Carotid Stent System, CARENET-III, for prevention of stroke in patients in the United States. 

“This is a key milestone in the history of our company as it helps pave the way for us to initiate a clinical trial of CGuard EPS for addressing Carotid Artery Disease and preventing stroke in the United States market.  This will be the first U.S.-based study of CGuard which is a cornerstone of our global expansion plans,” said Marvin Slosman, InspireMD’s CEO. “A pivotal trial of this kind requires significant preparation and allocation of resources and we have already begun to move pieces into place in order to plan the initiation of our CARENET-III study. The FDA approval of the IDE represents an important step in enabling us to conduct a pivotal clinical trial to demonstrate the potential for CGuard EPS against carotid artery disease, which accounts for more than 6.2 million deaths worldwide, and a cost burden of more than $34 billion in the U.S. alone.”

The CARENET-III study would be a 315-subject study with up to 40 U.S. institutions.  The company will provide additional details as plans advance.

About the CGuard® EPS
The CGuard® Embolic Protection System is an advanced platform solution designed to deliver the flexibility of the traditional open-cell stent with advanced protection from peri-procedural and post-procedural embolic events caused by plaque prolapse through the stent strut that can lead to stroke.  CGuard’s unique MicroNet™® technology mitigates the prolapse and associated embolization and has shown superior clinical outcomes for patients against alternative carotid stent types, conventional or next-generation double-layer stents, as well as invasive procedures such as endarterectomy, a major surgical procedure.  InspireMD’s CGuard™ has created a new dimension in the protected treatment of carotid artery disease with the potential to truly establish a new standard of care for the management of carotid artery disease and stroke prevention.

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 NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB.

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” 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) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy; (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) 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 (xiv) 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 

Tel Aviv, Israel — September 3, 2020 – InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announces the award for Best ESC Congress Poster for the  presentation of updated data from the large, long-term PARADIGM-EXTEND study of the CGuard™ Embolic Prevention System (EPS), as part of the European Society of Cardiology 2020 Carotid Update e-presentation at the European Society of Cardiology (ESC) Congress 2020. PARADIGM/EXTEND is an investigator-driven on-going study performed with CGuard Carotid stent for primary and secondary stroke prevention in a large, consecutive all-comers population, with 5 years (60 months) follow-up.

PARADIGM-EXTEND current results for 480 patients of the expected total of 550 that completed the 30-day follow-up were presented.  There were no peri-procedural major strokes or death. The total death/stroke /myocardial incidence at 30 days was 1.04% (5/480) due to two minor strokes, one myocardial infarction and two stent-unrelated deaths. In the study, 354/480 patients completed the 12-month follow-up with only 1 patient experiencing in-stent restenosis, 0.28% (1/354).  At the 12-month follow-up there were no other device-related adverse clinical events. Finally, 46/480 patients completed the 60-month follow-up period with one more case of in-stent restenosis and no additional cases of device-related stroke.

The lead investigator of the study and ESC Congress presenter was Prof Piotr Musialek, Jagiellonian University Department of Cardiac & Vascular Diseases John Paul II Hospital, Kraków, Poland. Prof Musialek stated, “In consecutive all-comer patients, CGuard EPS stent nearly abolished, in an unprecedented magnitude, stroke risk in relation to carotid restenosis.  Based on the PARADIGM-EXTEND and other accumulated clinical data on CGuard’s safety and efficacy, in our ESC 2020 Carotid Update Lecture we indicated that increasing the use of the MicroNet™-covered stent demonstrates a fundamental change in the carotid revascularization paradigm, with significantly larger proportions of patients now able to benefit from this technology and a percutaneous procedure rather than surgery.”

“The results from this investigator-driven initiative and resulting recognition of best poster, continue to demonstrate that CGuard provides extended safety and stroke prevention efficacy when added to optimized medical therapy.  We continue to prioritize patient care by focusing on measuring evidence that  confirms the superiority of CGuard EPS  in preventing neurovascular events. Recognition of this data through acknowledgement of this sort builds confidence and awareness within the physician community.  Our global expansion strategy and intention to bring CGuard to the United States builds on the foundation of real-world experience and results.  We believe the novel MicroNet™ technology, which is at the heart of the CGuard system, provides a clear differentiator in terms of prevention of additional ischemic events and restenosis,” said Marvin Slosman, InspireMD’s CEO. “We are grateful to Professor Musialek and Jagiellonian for their work on the PARADIGM-EXTEND study, and we look forward to sharing further results of this study and other key milestones as we continue to follow patients’ outcomes.”

The ESC Congress 2020 is being held digitally from August 29-September 2, 2020 and can be accessed via https://www.escardio.org/Congresses-&-Events/ESC-Congress.

About the PARADIGM-EXTEND Study

The PARADIGM-EXTEND study was designed to evaluate long-term clinical efficacy and safety of the CGuard system’s use in 550 consecutive carotid revascularization patients.  The study is an all-comer, all-referrals-tracked study with no exclusion criteria other than a lack of Neurovascular Team-determined indication. Clinically asymptomatic patients were to receive revascularization only in case of increased-stroke-risk characteristics.  Adverse events are independently adjudicated.  To date, 480 patients (39-87 years, 60% symptomatic, 142 women) with 514 arteries crossed the first follow-up window of 30 days.

About The CGuard® EPS
The CGuard® Embolic Protection System is an advanced platform solution designed to deliver the flexibility of the traditional open-cell stent with advanced protection from peri-procedural and post-procedural embolic events caused by plaque prolapse through the stent strut that can lead to stroke.  CGuard’s unique MicroNet™® technology mitigates the prolapse and associated embolization and has shown superior clinical outcomes for patients against alternative carotid stent types, conventional or next-generation double-layer stents, as well as invasive procedures such as endarterectomy, a major surgical procedure.  InspireMD’s CGuard™ has created a new dimension in the protected treatment of carotid artery disease with the potential to truly establish a new standard of care for the management of carotid artery disease and stroke prevention.

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 NYSE American under the ticker symbol NSPR, and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB.

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” 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) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy; (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) 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 (xiv) 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  

Tel Aviv, Israel — August 25, 2020 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today  announced that Marvin Slosman, President and Chief Executive Officer, will give a virtual corporate presentation at the LD Micro 500 taking place online on Thursday, September 3, 2020 at 4:20 PM EST followed by a live Q&A session with registered investors and other conference attendees.

Webcast link: https://www.webcaster4.com/Webcast/Page/2019/36847

In addition, Mr. Slosman will be available for virtual one-on-one meetings from September 1-4, 2020.  To schedule a meeting please contact Eric Lahiji at eric@ldmicro.com.

About InspireMD, Inc.

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

InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB.

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” 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) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy; (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) 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 (xiv) 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 

CORE IR
investor-relations@inspiremd.com

Tel Aviv, Israel — August 10, 2020 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced that as of August 7, 2020, the Company has regained compliance with the NYSE American’s continued listing standards.

As previously disclosed, on August 14, 2019, the Company received a Deficiency Letter from the NYSE American stating that InspireMD was not in compliance with certain NYSE American continued listing standards relating to stockholders’ equity. Specifically, InspireMD was not in compliance with Part 10, Section 1003(a)(iii) of the NYSE American Company Guide, due to the fact the Company had reported stockholders’ equity of less than $6 million as of June 30, 2019 and had net losses in its five most recent fiscal years ended December 31, 2018. Following the recently announced funding transaction in which the Company raised net proceeds after offering expenses of approximately $10.7 million, the Company has successfully solved the non-compliance issue.

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 NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB.

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” 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) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy; (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) 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 (xiv) 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 

CORE IR
investor-relations@inspiremd.com

 In the second quarter the Company was granted approval to market its CGuard™ MicroNet™ stent in Brazil and completed an $11.5 million capital raise; reported outstanding results in studies treating patients with the CGuard™ MicroNet™ stent 

Management to host investor conference call today, August 5, 2020 at 8:30am ET

Tel Aviv, Israel— August 5, 2020 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of Carotid Artery Disease (CAD), today announced financial and operating results for the second quarter ended June 30, 2020.

Second Quarter 2020 and recent highlights: 

• Received approval from the Brazilian registration authority (ANVISA), to market the CGuard™ MicroNet™®- covered stent, effectively clearing it for sale and distribution in Brazil. SUPRI Artigos Médicos Hospitalares Ltda. will serve as distribution partner.

• Completed an $11.5 million follow-on underwritten public offering, which included $1.5 million from the exercise by the underwriter of its full over-allotment option for the offering.

• On June 25, 2020, the U.S. Food and Drug Administration (FDA) granted InspireMD conditional approval of its Investigational Device Exemption (IDE) application to initiate a pivotal study of CGuard™ EPS. We are in the process of addressing the Agency’s remaining requests, specifically related to the stent-embolic protection device (EPD) compatibility performance testing that was previously conducted.

• Published 12-month PARDIGM trial results in the journal, EuroIntervention, a prestigious peer-reviewed publication covering the latest advancements in vascular intervention. The paper, titled “Routine MicroNet™” details the results of 101 unselected consecutive real-life patients treated with the CGuard™ MicroNet™ covered stent for carotid stenosis and the 12-month prevention of post-procedural neurologic events. The results indicate that 12 months following carotid intervention the CGuard EPS MicroNet™-covered stent delivers sustained protection against postprocedural neurologic events.

• Announced early results from the investigator-initiated SIBERIA randomized clinical trial of CGuard™ compared to Acculink™, evaluating 30-day silent brain infarcts in 100 patients who qualified for carotid revascularization with high risk for surgery. The results indicated that significantly fewer silent brain infarcts were associated with CGuard™ EPS versus Acculink™ at 30 days post-procedure.

“COVID-19 placed significant pressure on the operations of healthcare facilities worldwide, resulting in interruptions in elective procedure volumes, including critical carotid artery treatments.  However, we are encouraged by the gradual resumption of these crucial procedures in a growing number of our key markets in Europe and other territories, and we look forward to this expansion taking hold in South America as well. We are also buoyed by the scientific validation we continue to receive in both peer-reviewed publications and opportunities to present at medical conferences where our CGuard MicroNet™ technology is being recognized as a valued advancement in the carotid stent category,” said Marvin Slosman, InspireMD’s Chief Executive Officer. “Our expansion strategy continues to progress, with our recent Brazilian approval for CGuard™ MicroNet™^â introducing us to the largest market for medical devices in Latin America and one of the top overall global markets for carotid artery disease. We believe this approval will set the stage for continued expansion into other countries in South America.

“We are in the process of addressing the agencies remaining requests, specifically related to the stent-embolic protection device (EPD) compatibility performance testing to gain full FDA approval of our Investigational Device Exemption (IDE) application to initiate a pivotal study of CGuard™ EPS. We have already completed the testing of additional stents according to the FDA’s specifications, and have employed alternative visualization modalities that, we believe, will ultimately allow us to gain full approval. Having an approved IDE is an extremely significant step towards enabling us to initiate a pivotal trial in the United States, clearly one of the world’s most important markets for carotid artery disease and other vascular treatments. We previously indicated that the FDA has concurred with our clinical study design and data requirements to support the market approval of the device. Accordingly, we believe that we are well positioned from a regulatory perspective in terms of our ability to initiate a trial.

“In addition, we believe the completion of our $11.5M financing will help ensure we are capable of advancing our commercial expansion and research and development activities as a pillar of our growth objectives. Although the pandemic has put a spotlight on the supply chain infrastructure challenges many in our field are facing, we stand at the ready to fulfill the needs of physicians and their patients for these serious and lifesaving procedures,” Mr. Slosman concluded.

Financial Results for the Second Quarter and Six Months ended June 30, 2020

For the three months ended June 30, 2020, revenue decreased by $1,041,000, or 76.9%, to $313,000, from $1,354,000 during the three months ended June 30, 2019. This decrease was predominantly driven by a 75.7% decrease in sales volume of CGuard EPS from $1,116,000 during the three months ended June 30, 2019, to $271,000 during the three months ended June 30, 2020. This decrease was mainly due to the fact that procedures with CGuard EPS, which are generally scheduled or non-emergency procedures, were mostly postponed as hospitals shifted resources to patients affected by COVID-19. The decrease was also due to the large shipments of CGuard EPS that we made during the three months ended June 30, 2019 of backlog that accumulated in the three months ended March 31, 2019 that we were unable to ship previously due to our former third-party sterilizer equipment failures. Those large shipments did not recur during the three months ended June 30, 2020. In addition, there was an 82.4% decrease in sales volume of MGuard Prime EPS, from $238,000 during the three months ended June 30, 2019, to $42,000 during the three months ended June 30, 2020, mainly due to similar reasons as mentioned above.

The company recorded a gross loss for the quarter ended June 30, 2020 of $120,000, compared to a gross profit of $442,000 for the same period in 2019. This decrease in gross profit resulted primarily from a $448,000 decrease in revenues (as described above), less the related material and labor costs, and a decrease following a receipt of $135,000 compensation received in the quarter ended June 30, 2019 from our former third-party sterilizer for the delays related to the product sterilization interruption during the three months ended March 31, 2019, which did not reoccur in the three months ended June 30, 2020, offset by a $21,000 decrease in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) decreased to (38.3)% during the three months ended June 30, 2020 from 32.6% during the three months ended June 30, 2019, driven by the reasons mentioned above.

Total operating expenses for the quarter ended June 30, 2020 were $2,326,000, a decrease of 11.4% compared to $2,625,000 for the same period in 2019. This decrease was primarily due to a reduction of $382,000 in clinical expenses associated with CGuard EPS, mainly related to the IDE approval process, $235,000 in compensation related to temporary salary reductions due to the immediate impact of COVID-19 on cash flow, and $82,000 of miscellaneous expense reductions offset by  an increase of $400,000 due to a settlement agreement with the underwriter of our prior offerings.

Financial expenses for the quarter ended June 30, 2020 were $34,000 compared to $23,000 for the same period in 2019. Net loss for the second quarter of 2020 totaled $2,480,000, or $0.20 per basic and diluted share, compared to a net loss of $2,206,000, or $1.59 per basic and diluted share, for the same period in 2019.

For the six months ended June 30, 2020, revenue decreased by $422,000, or 23.9%, to $1,347,000, from $1,769,000 during the six months ended June 30, 2019. This decrease was predominantly driven by a 16.8% decrease in sales volume of CGuard EPS from $1,492,000 during the six months ended June 30, 2019, to $1,242,000 during the six months ended June 30, 2020, mainly due to the postponement of procedures with CGuard EPS, which are generally scheduled or non-emergency procedures, as hospitals shifted resources to patients affected by COVID-19. In addition, there was a 62.1% decrease in sales volume of MGuard Prime EPS from $277,000 during the six months ended June 30, 2019, to $105,000 during the six months ended June 30, 2020, mainly due to the impact of COVID-19, as mentioned above.

For the six months ended June 30, 2020, gross profit decreased by $194,000, or 52.6%, to $175,000 from $369,000 for the same period in 2019. This decrease in gross profit resulted primarily from a $225,000 decrease in revenues (as mentioned above), less the related material and labor costs and a $61,000 increase in write-offs driven by a non-recurring component supply issue. This decrease was partially offset by a decrease of $69,000 of expenses related to upgrades made to our production facilities during the six months ended June 30, 2019, which did not reoccur during the six months ended in June 30, 2020 and a decrease of $23,000 in miscellaneous expenses during the six months ended June 30, 2020.  Gross margin (gross profits as a percentage of revenue) decreased to 13.0% during the six months ended June 30, 2020 from 20.9% during the six months ended June 30, 2019, driven by the reasons mentioned above. 

Total operating expenses for the six months ended June 30, 2020 were $4,642,000, a decrease of 18.3% compared to $5,682,000 for the same period in 2019. This decrease was primarily due to a reduction of $710,000 in clinical expenses associated with CGuard EPS, mainly related to the IDE approval process, $354,000 due to settlement expenses that were paid to a former service provider pursuant to a settlement agreement during the six months ended June 30, 2019, $235,000 in compensation expenses, primarily related to temporary salary reductions due to the immediate impact of COVID-19 on cash flow, and $141,000 of miscellaneous expense reductions offset by an increase of $400,000 due to a settlement agreement with the underwriter of our prior offerings.

Financial income for the six months ended June 30, 2020 was $9,000 compared to $100,000 of financial expenses for the same period in 2019. Net loss for the six months ended June 30, 2020 totaled $4,458,000, or $0.52 per basic and diluted share, compared to a net loss of $5,413,000, or $4.86 per basic and diluted share, for the same period in 2019.

As of June 30, 2020, cash and cash equivalents were $13,861,000 compared to $5,514,000 as of December 31, 2019.

Conference Call and Webcast Details

 Management will host a conference call at 8:30AM 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. Participants are asked to pre-register for the call through the following link: http://dpregister.com/10146840. Please note that registered participants will receive their dial in number upon registration and will dial directly into the call without delay. Those without internet access or unable to pre-register may dial in by calling: 1-866-777-2509 (domestic) or 1-412-317-5413 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask for the InspireMD call. The conference call will also be available through a live webcast, which can be accessed through the following link: https://services.choruscall.com/links/nspr200805.html .

The link is also available through the company’s website at https://www.inspiremd.com/en/investors/investor-relations/.

A webcast replay of the call will be available approximately one hour after the end of the call through November 4, 2020 at the above links. A telephonic replay of the call will be available through August 19, 2020 and may be accessed by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 10146840.

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 NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB.

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” 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) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy; (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) 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 (xiv) 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 

CORE IR
investor-relations@inspiremd.com

(1) All 2020 financial information is derived from the Company’s 2020 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2019 financial information is derived from the Company’s 2019 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

(2) All June 30, 2020 financial information is derived from the Company’s 2020 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, 2019 financial information is derived from the Company’s 2019 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2019 filed with the Securities and Exchange Commission.

Conference Call to be held Wednesday, August 5, 2020 at 8:30am ET

Tel Aviv, Israel — July 28, 2020 – InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announces it will report fiscal second quarter 2020 financial results on Wednesday, August 5, 2020 at 8:00 AM ET.  Management will host a conference call at 8:30AM 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.

Participants are asked to pre-register for the call through the following link: http://dpregister.com/10146840. Please note that registered participants will receive their dial in number upon registration and will dial directly into the call without delay. Those without internet access or unable to pre-register may dial in by calling: 1-866-777-2509 (domestic) or 1-412-317-5413 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the InspireMD call. The conference call will also be available through a live webcast, which can be accessed through the following link: https://services.choruscall.com/links/nspr200805.html, which is also available through the company’s website at https://www.inspiremd.com/en/investors/investor-relations/.

A webcast replay of the call will be available approximately one hour after the end of the call through November 4, 2020 at the above links. A telephonic replay of the call will be available through August 19, 2020 and may be accessed by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 10146840.

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 NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB.

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” 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 

CORE IR
investor-relations@inspiremd.com

Tel Aviv, Israel — July 23, 2020 – InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announced it has obtained registration from the Brazilian registration authority, Agéncia Nacional de Vigiláncia Sanitária (ANVISA), for its CGuard™ MicroNet™®- covered stent, clearing it for sale and distribution in Brazil. 

“As the largest market for medical devices in Latin America and one of the top overall global markets for carotid artery disease, the Brazilian registration clearance for CGuard™ is an important accomplishment for our company and represents a significant opportunity to serve an emerging healthcare system. The global carotid artery disease market is expected to reach up to $11.6 billion by 2023, and with an expected 12% CAGR in the overall stent market in Brazil, it is a pillar of our 2020 and 2021 growth strategy,” said Marvin Slosman, InspireMD’s CEO. “We look forward to working with our Brazilian partner, SUPRI Artigos Médicos Hospitalares Ltda, to reach and serve this crucial market with our advanced technology.”

Regulatory approval of CGuard™ EPS in Brazil reflects not only the ANVISA’S recognition of CGuard’s differentiating features versus conventional carotid stents, but also the need for safer treatments for carotid artery disease. Brazil ranks as the sixth largest populated country in world and the largest healthcare market in Latin America. With a population over 213 million, Brazil represents an important step toward expanding commercial availability of InspireMD products into new territories.

“The Brazilian clearance further supports our goals of broader expansion into South America, particularly into adjacent markets such as Argentina, Mexico and Columbia, and as part of our global expansion strategy, capitalizing on the potential of CGuard™ EPS – and its novel MicroNet™® technology –  to fundamentally disrupt the current standard of care in carotid artery disease. While the COVID-19 related interruptions have had an impact on elective surgeries worldwide, we expect a resumption in elective procedures as the healthcare system gains a foothold in returning to more normalized operations, as is occurring in our key markets in Europe and other parts of the world. The Brazilian clearance for our CGuard™ EPS represents a milestone in our broader strategy to continue growing our market share in existing markets while expanding in growth markets such as South America, Asia/Pacific, and the U.S. We are also continuing our concerted focus on numerous opportunities for growing our pipeline, leveraging new indications for use of CGuard™ and MicroNet™® along with our research into a peri procedural protection device technology as we seek to build upon our strong growth performance in the first quarter of 2020,” Mr. Slosman concluded.

Marcos Ramin of SUPRI Artigos Médicos Hospitalares Ltda, added, “At SUPRI, we strive to bring the latest technologies to health care professionals across Brazil, and we are pleased to add CGuard™️ EPS to our portfolio, the most innovative and effective carotid stent available today to prevent embolic stroke of Brazilians.”

The CGuard® Embolic Protection System is an advanced platform solution designed to deliver the flexibility of the traditional open cell stent with an advanced protection from peri procedural and post procedural embolic events caused by plaque prolapse through the stent strut that can lead to stroke. CGuard’s unique MicroNet™® technology mitigates the prolapse and associated embolization and has shown superior clinical outcomes for patients against alternative carotid stent types, conventional or next generation double layer stents, as well as invasive procedures such as endarterectomy, a major surgical procedure. InspireMD’s CGuard™ has created a new dimension in protected treatment of carotid artery disease with the potential to truly establish a new standard of care for management of carotid artery disease and stroke prevention.

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 NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB.

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” 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 

In a head-to-head evaluation, significantly fewer silent brain infarcts were associated with CGuard™ EPS versus Acculink™ at 30 days post-procedure

Tel Aviv, Israel — June 25, 2020 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease treatment, announced today that early results from the investigator-initiated SIBERIA randomized clinical trial of CGuard™ EPS are being featured as a late-breaking presentation in an EuroPCR e-Course, which is being held June 25-27, 2020. The study evaluated 30-day silent brain infarcts associated with the use of the Acculink™ conventional open-cell nitinol stent vs the CGuard™ MicroNet™-covered stent.

Title: The SIBERIA trial for carotid artery stenosis: A randomized controlled trial of conventional versus MicroNet™-covered stent use in percutaneous neuroprotected carotid artery revascularization: Peri-procedural and 30-day diffusion-weighted magnetic resonance imaging and clinical outcomes

Presenter: Pavel Ignatenko, MD, E.N. Meshalkin Siberian Federal Biomedical Research Center, Ministry for Public Health of the Russian Federation, Novosibirsk, Russia

Date: June 25, 2020

Time: 4:00pm CEST (10:00am EDT)

The SIBERIA trial evaluated one hundred patients who qualified for carotid revascularization with high risk for surgery and were randomized 1:1 to either CGuard or Acculink™. Primary endpoints were incidence and volume of new cerebral embolic post-procedural lesions (24-48 hours) as determined by diffusion weighted magnetic resonance imaging (DW-MRI). Principal secondary endpoints included incidence of periprocedural or postprocedural stroke, myocardial infarction and death at 30 days.

• Post Procedure (24-48 hours), the CGuard™ arm was observed to have a 78% reduction in the average volume of new cerebral lesions (157 mm³ 700 mm³), a statistically significant improvement (p=0.007)
• At 30 days, DW-MRI showed zero new cerebral lessons in the CGuard™ arm versus six in the Acculink™ arm (p=0.03)
• At 30 days, there were zero strokes, myocardia infarctions or deaths in the CGuard arm and three events the Acculink™ arm (two strokes and one myocardial infarction)

Dr. Ignatenko stated, “CGuard™ MicroNet™-covered stent use in consecutive unselected patients subjected to neuroprotected carotid artery stenting was associated with a greater than three-fold reduction in the procedure-generated mean cerebral lesion volume, and with zero post-procedural cerebral embolisms observed.”

“The SIBERIA trial is the first randomized, controlled clinical trial to directly compare CGuard™ EPS head-to-head against a widely used conventional stent, and needless to say, we are very pleased with the results,” said Marvin Slosman, Chief Executive Officer of InspireMD. “The data from this important study provide critical validation and adds to the growing body of evidence as we work to make CGuard™ EPS the standard of care not only in carotid stenting, but also as a safe and less-invasive alternative to carotid endarectomy, which accounts for more than 75% of carotid artery revascularization procedures. We are grateful to Prof. Karpenko, Dr. Ignatenko, their colleagues and the patients who made this trial possible.”

About EuroPCR

EuroPCR is the official annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the world-leading course in interventional cardiovascular medicine.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for the treatment of carotid artery disease by providing outstanding acute results and durable stroke-free long-term outcomes.

InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbols NSPR.WS and NSPR.WSB.

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” 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 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

Results indicate that 12 months after carotid intervention the CGuard EPS MicroNet™-covered stent delivers sustained protection against postprocedural neurologic events

Tel Aviv, Israel — June 10, 2020 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease treatment, announced today that 12-month PARADIGM trial results have been published in the EuroIntervention journal. The paper, entitled, “Routine MicroNet™ covered embolic prevention stent system use for consecutive symptomatic and increased stroke-risk asymptomatic carotid stenosis revascularization: Twelve-month outcomes from the PARADIGM study,” details the results of 101 unselected consecutive real-life patients treated with the CGuard™ MicroNet™ covered stent for carotid stenosis and the 12-month prevention of postprocedural neurologic events.

101 unselected consecutive patients for carotid revascularization were enrolled in the PARADIGM trial. At 30 days, only one adverse event occurred (a minor transient stroke with no other strokes, myocardial infarctions, or deaths. Furthermore, these study results show that no strokes occurred between 30 days and twelve months.

“PARADIGM evaluates CGuard™ in unselected consecutive patients for carotid revascularization, with higher clinical standards, and constitutes a reference for future carotid stenting studies,” said Marvin Slosman, Chief Executive Officer of InspireMD. “This is substantiated by a new paper in EuroIntervention, a prestigious medical journal covering the latest advancements in vascular intervention. The risk of peri-procedural or post-procedural stroke in the treatment of carotid stenotic lesions has long been a significant obstacle to more widespread adoption of less invasive stenting as an alternative to surgery for carotid revascularization. We believe these new data demonstrate the sustained safety of our unique CGuard™ EPS system incorporating proprietary MicroNet™ technology. Data such as these are integral to our ongoing efforts to make CGuard™ the eventual standard of care because of the many clinical benefits of CGuard™.

“Our present work indicates that an effective MicroNet™-covered stent protection against post-procedural neurologic events extends at least mid-term in the absence of any procedure- or device-related issues,” stated Dr. Piotr Musialek, co-author of the paper and lead investigator of the PARADIGM study.

EuroIntervention is an international peer-reviewed journal whose aim is to create a community of high-quality research and education in the field of percutaneous cardiovascular interventions. EuroIntervention is the official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for the treatment of carotid artery disease by providing outstanding acute results and durable stroke-free long-term outcomes.

InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbols NSPR.WS and NSPR.WSB.

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” 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 

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com