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

Tel Aviv, Israel— June 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, announced today the closing, on June 5, 2020, of its $11.5 million follow-on underwritten public offering, which included $1.5 million from the exercise, in full, by the underwriter of its over-allotment option for the offering. Pursuant to the offering, InspireMD issued 25,555,500 shares of common stock or common stock equivalents, along with an equivalent number of Series F warrants to purchase common stock, in units, at a price to the public of $0.45 per unit. Each Series F warrant is exercisable for one share of common stock at an exercise price of $0.495 per share. The common stock (or common stock equivalents) and the accompanying Series F warrants included in the units were issued separately to investors at the closing.

A.G.P. / Alliance Global Partners served as the sole book-running manager for the offering.

InspireMD intends to use the net proceeds of this offering—estimated at $10.7 million— for research and development, sales and marketing, working capital and other general corporate purposes.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

A registration statement on Form S-1 (File No. 333-238247) relating to the public offering of the securities described above was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on June 2, 2020. The offering was carried out only by means of a prospectus forming part of the effective registration statement. The final prospectus relating to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, by calling (212) 624-2060 or emailing investmentbanking@allianceg.com, or at the SEC’s website at http://www.sec.gov.

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 traded 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 includes statements related to the offering of InspireMD’s units, including as to the use of net proceeds from that offering. These statements and other statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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, potential risks and uncertainties associated with (i) the uses of the proceeds from the underwritten public offering and the adequacy of those proceeds, (ii) market acceptance of the Company’s existing and new products, (iii) negative clinical trial results or lengthy product delays in key markets, (iv) the inability to secure regulatory approvals for the sale of the Company’s products, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) the Company’s limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third-party payers for the Company’s products, (x) the Company’s efforts to successfully obtain and maintain intellectual property protection covering its products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) the Company’s reliance on single suppliers for certain product components, (xiii) the fact that the Company will need to raise additional capital to meet its 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 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 website 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, unless required by law.

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

Tel Aviv, Israel— June 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, today announced the pricing of an underwritten public offering of 22,222,200 units at a price to the public of $0.45 per unit. InspireMD expects to receive aggregate gross proceeds of approximately $10.0 million from the offering, assuming no exercise of the underwriter’s option to purchase additional securities. Each unit contains one share of common stock (or common stock equivalent) and one Series F warrant to purchase one share of common stock at an exercise price of $0.495 per share. The common stock (or common stock equivalents) and the accompanying Series F warrants included in the units can only be purchased together in this offering, but will be issued separately and will be immediately separable upon issuance.

In connection with the offering, InspireMD has granted the underwriter a 45-day option to purchase up to an additional 3,333,333 units, consisting of shares of common stock and/or Series F warrants, for additional gross proceeds of up to $1.5 million. The offering is expected to close on or about June 5, 2020, subject to customary closing conditions.

A.G.P. / Alliance Global Partners is acting as the sole book-running manager for the offering.

InspireMD intends to use the net proceeds of this offering for research and development, sales and marketing, working capital and other general corporate purposes.

A registration statement on Form S-1 (File No. 333-238247) relating to the public offering of the securities described above was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on June 2, 2020. The offering is being made only by means of a prospectus forming part of the effective registration statement. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus and, when available, electronic copies of the final prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, by calling (212) 624-2060 or emailing investmentbanking@allianceg.com, or at the SEC’s website at http://www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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 traded 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 includes statements related to the offering of InspireMD’s units, including as to the closing of the offering and the use of net proceeds therefrom. These statements and other statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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) the underwritten public  offering, including the potential non-completion of the offering, the actual proceeds therefrom and the uses thereof, (ii) market acceptance of the Company’s existing and new products, (iii) negative clinical trial results or lengthy product delays in key markets, (iv) an inability to secure regulatory approvals for the sale of the Company’s products, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) the Company’s limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third-party payers for the Company’s products, (x) the Company’s efforts to successfully obtain and maintain intellectual property protection covering its products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) the Company’s reliance on single suppliers for certain product components, (xiii) the fact that the Company will need to raise additional capital to meet its 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 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 website 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, unless required by law.

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

First quarter revenue growth driven by continued strong uptake of the CGuard™ Embolic Prevention System (EPS) in the company’s major markets

Management to host investor conference call today, May 12, at 8:30am ET

Tel Aviv, Israel— May 12, 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 first quarter ended March 31, 2020.

First Quarter 2020 and recent highlights:

• Generated CGuard™ EPS revenue of $971,000, an increase of 158.2% compared to $376,000 in the first quarter of 2019, when the company’s previous third-party sterilizer equipment failures caused a significant interruption in sterilized product supply for the majority of the first quarter.
• For the third consecutive year, company was chosen to demonstrate a successful live clinical case transmission featuring CGuard™ EPS at the Leipzig Interventional Course (LINC) 2020 that showcased CGuard’s ease-of-use and exceptional patient safety features
• Completed all additional bench testing requested by FDA in support of the company’s pending IDE application, which the company expects to re-file in May 2020
• Continued to advance plans to broaden the company’s product portfolio with procedural protection devices based on its reverse flow technology as well as develop new indications for the CGuard EPS with MicroNet™.

“The ongoing COVID-19 pandemic has placed unprecedented pressure on healthcare systems around the world, and we are seeing this impact on elective procedure volumes, including carotid artery disease treatments,” stated Marvin Slosman, Chief Executive Officer of InspireMD. “However, these procedures must ultimately occur to save lives, and we stand ready with our support and supply infrastructure to quickly fulfill the needs of physicians and their patients as a more normalized healthcare environment reemerges.”

“I am more enthusiastic than ever about the potential of CGuard EPS – and its novel MicroNet™® technology – to fundamentally disrupt the current standard of care in carotid stenosis. During the quarter, we continued to see consistent growth across all our current markets while we simultaneously worked to open new opportunities in Brazil, France, the Asia/Pacific region and, of course, the United States. Longer-term, I believe we can establish another pillar of growth by further exploiting our reverse flow technology in a procedural protection device and to expand our product pipeline with CGuard with MicroNet™ into new high-value indications.

“During these highly challenging and uncertain times, I am buoyed by our team’s ability to maintain these essential growth drivers in light of the changes we have made in order to operate safely and effectively. This is a reflection of our team’s ongoing quest for high achievement, high accountability and laser focus,” concluded Mr. Slosman.

Financial Results

For the three months ended March 31, 2020, revenue increased by $619,000, or 149.2%, to $1,034,000, from $415,000 during the three months ended March 31, 2019. This increase was predominantly driven by a 158.2% increase in sales volume of CGuard EPS from $376,000 during the three months ended March 31, 2019, to $971,000 during the three months ended March 31, 2020, mainly due to the company’s previous third-party sterilizer equipment failures which caused a significant interruption in sterilized product supply for the majority of the first quarter 2019 as well as the company’s continued focus in expanding revenue base in the company’s major markets. In addition, MGuard Prime EPS sales increased from $39,000 during the three months ended March 31, 2019, to $63,000 during the three months ended March 31, 2020, due to the delayed shipments of sterilized products during the three months ended March 31, 2019, as mentioned above. The company’s gross profit for the quarter ended March 31, 2020 was $295,000, compared to a gross loss of $73,000 for the same period in 2019. This increase in gross profit was primarily driven by a higher volume of sales of CGuard EPS less the related material and labor costs and a decrease in write-offs of inventory during the three months ended March 31, 2020 due to the same sterilization issue mentioned above. Gross margin increased to 28.5% in the first quarter of 2020 from (17.6%) for the same period in 2019.

Total operating expenses for the quarter ended March 31, 2020 were $2,316,000, a decrease of 24.2% compared to $3,057,000 for the same period in 2019. This decrease was primarily due to a reduction of $328,000 in clinical expenses associated with CGuard EPS, mainly related to the IDE approval process, a decrease of $354,000 due to settlement expenses made to a former service provider pursuant to a settlement agreement during the three months ended March 31, 2019, which did not occur during the three months ended on March 31, 2020 as well as $59,000 of miscellaneous expense reductions.

Financial income for the quarter ended March 31, 2020 was $43,000 compared to financial expenses of $77,000 for the same period in 2019. This increase in income of $120,000 was predominately due to changes in exchange rates.  Net loss for the fourth quarter of 2020 totaled $1,978,000, or $0.43 per basic and diluted share, compared to a net loss of $3,207,000, or $3.82 per basic and diluted share, for the same period in 2019.

As of March 31, 2020, cash and cash equivalents were $3,141,000, compared to $5,514,000 at December 31, 2019.

Conference Call and Webcast Details

The conference call will be available via telephone by dialing toll free 877-451-6152 for U.S. callers, or +1 201-389-0879 for international callers, and referencing conference ID 13703268. To access the webcast, please go to the following link: http://public.viavid.com/index.php?id=139696. The webcast will be archived 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.

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, including the transition to the new European Medical Devices Regulation, (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 and public health crisis 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

CONSOLIDATED STATEMENTS OF OPERATIONS⁽¹⁾

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

(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 March 31, 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.