Tel Aviv, Israel— March 26, 2019 – InspireMD, Inc. (NYSE American: NSPR, NSPR.WS, NSPR.WSB), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that its Board of Directors has approved a one-for-fifty reverse stock split of its common stock that is scheduled to become effective after trading closes on March 29, 2019. Beginning on April 1, 2019, the Company’s common stock will trade on the NYSE American on a split adjusted basis under a new CUSIP number 45779A 853. The Company’s common stock will continue to trade on the NYSE American under the symbol “NSPR.” As previously disclosed, at the InspireMD Annual Meeting of Stockholders held on March 21, 2019, the Company’s stockholders approved a proposal authorizing the Company’s Board of Directors to effect a reverse stock split at a ratio in the range of one-for-twenty-five and one-for-fifty in order to help regain compliance with the NYSE American’s minimum price requirements.

Upon effectiveness after market close on March 29, 2019, the reverse stock split will cause a reduction in the number of shares of common stock outstanding and issuable upon the conversion of the Company’s outstanding shares of preferred stock and the exercise of its outstanding stock options and warrants in proportion to the ratio of the reverse stock split and will cause a proportionate increase in the conversion and exercise prices of such preferred stock, stock options and warrants. The number of shares of common stock issuable upon exercise or vesting of outstanding stock options and warrants will be rounded up to the nearest whole share. Accordingly, upon effectiveness of the reverse stock split, each outstanding warrant currently trading on the NYSE American under the symbol “NSPR.WS” shall become a warrant to purchase 1/1,750 of one share of common stock at an exercise price of $8,750 per full share of common stock, and each outstanding warrant currently trading on the NYSE American under the symbol “NSPR.WSB” shall become a warrant to purchase 1/1,750 of one share of common stock at an exercise price of $3,500.00 per full share of common stock, pursuant to the terms of such warrants. Warrants may only be exercisable for a whole number of shares of common stock. Warrants exercised on or prior to March 29, 2019, will be on a pre-adjusted basis.

The number of authorized shares of the Company’s common stock will remain at 150,000,000, while the number of outstanding shares will be reduced from approximately 44 million to 0.9 million. No fractional shares will be issued following the reverse stock split.

Registered stockholders holding their shares of common stock in book-entry or through a bank, broker or other nominee form do not need to take any action in connection with the reverse stock split. For those stockholders holding physical stock certificates, the Company’s transfer agent, Action Stock Transfer Corp, will send instructions for exchanging those certificates for new certificates representing the post-split number of shares. Action Stock Transfer Corp can be reached at (801) 274-1088.

Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on February 19, 2019, a copy of which is also available at www.sec.gov or at www.inspiremd.com under the SEC Filings tab located on the Investors page.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for 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 symbol NSPR.WS.

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 — March 22, 2019 – 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 provided an amended disclosure to conform to the Company’s Form 10-K that was filed with the SEC on February 19, 2019.

As disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, which was filed on February 19, 2019 with the Securities and Exchange Commission, the audited financial statements contained a going concern qualification paragraph in the audit opinion from its independent registered public accounting firm.  See further discussion in Note 1 to the Company’s consolidated financial statements included in the Company’s Annual Report on Form 10-K. This announcement is made pursuant to NYSE American Company Guide Section 610(b), which requires public announcement of the receipt of an audit opinion containing a going concern paragraph.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for 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 symbol NSPR.WS.

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

2018 CGuard^TM EPS annual sales increased 55% compared to 2017

On-Track to Submit U.S. IDE in Mid-2019

Company to Host Investor Conference Call at 8:00am ET

Tel Aviv, Israel— February 19, 2019 – 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 results for the fourth quarter ending December 31, 2018.

Fourth Quarter 2018 and recent highlights:

• CGuard™ EPS featured in the transmission of two successful live cases at Leipzig Interventional Course (LINC) 2019
• Also, at LINC 2019, interim data from the first 50 patients in the investigator-initiated SIBERIA trial were presented. Patients treated with CGuard™ EPS had a significantly lower incidence of multiple lesions in the brain (16% vs 44%), large cerebral lesions (24% vs 40%) and major adverse clinical events after 30 days (0% vs 12%) as compared to patients treated with a conventional open-cell carotid stent
• Also, at LINC 2019, Prof. Christian Wissgott presented his findings using CGuard™ EPS with SmartFit™ technology to treat a range of carotid artery diameters with a single diameter size device. SmartFit™ readily adapts to different artery diameters even over a range of diameters in the same patients with a single diameter sized device
• Announced the publication of a meta-analysis involving dual layered and mesh-covered carotid devices in JACC: Cardiovascular Interventions concluding that carotid artery disease (CAD) patients treated with mesh-covered devices experienced a lower 30-day minor stroke rate than rates reported in other widely cited studies, such as CREST and ACT 1, for patients treated with both carotid endarterectomy (CEA) and those treated with conventional carotid stents
• During the 45th Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons Symposium (VEITHsymposium), updated positive efficacy and safety data from the ongoing PARADIGM-Extend and IRONGUARD 2 studies were presented
• Received regulatory and reimbursement approval of CGuard™ EPS in Australia and Mexico and regulatory approval in South Africa.
• Recently opened the third “Center of Excellence” for vascular surgeons in Rome Italy with Prof. Speziale that included participation by key physicians from Italy, Poland and Slovenia.
• Pre-clinical testing remains on track for U.S. IDE submission mid 2019
• Year-to-date CGuard™ EPS revenue through December 31 was $3.0 million compared to $1.9 million for the comparable period in 2017, an increase of 55%
• $9.4 million of cash as of December 31, 2018

“During the fourth quarter and subsequent period, we continued to build upon the mounting evidence demonstrating the numerous clinical advantages of CGuard™ EPS versus conventional carotid stents, with numerous presentations prominently featuring CGuard at two international vascular medicine conferences,” commented James Barry, PhD, Chief Executive Officer of InspireMD. “These presentations complement our internal sales efforts and help drive awareness among cardiologists and vascular surgeons as to the use of  CGuard as a safer treatment of carotid artery disease. Receiving regulatory approval in South Africa came as a direct result of treating physicians learning of CGuard at a medical conference and working proactively with local regulators and distributors to get access to the product for use in their own practices. We are gratified by this ‘pull-through’ demand that we are seeing and believe it speaks to physicians’ desire to offer safer, more durable and less-invasive treatment alternatives to their patients.  We are awaiting reimbursement approval in South Africa, which we expect to receive shortly, and look forward to receiving such approval.”

Financial Results

Overall revenue for the fourth quarter ended December 31, 2018 was $822,000 compared to $833,000 during the same period in 2017. CGuard EPS sales increased by 16% or $95,000 compared to the sales made in the fourth quarter ended December 31, 2017, primarily due to our continued focus on expanding in existing markets such as Russia and Germany, expanding into new geographies such as India and our transition from our prior exclusive distribution partner for most of Europe to local distributors.  Total sales for the fourth quarter ended December 31, 2018 compared to the fourth quarter ended December 31, 2017 declined due to a decrease in MGuard Prime™ EPS sales, driven largely by doctors predominantly using drug-eluting coronary stents rather than bare metal stents such as MGuard Prime EPS in patients with coronary artery disease. The Company’s gross profit for the quarter ended December 31, 2018 was $227,000 compared to $210,000 for the same period in 2017. Gross margin increased to 27.6% in the three months ended December 31, 2018 from 25.2% in the same period in 2017.

Total operating expenses for the quarter ended December 31, 2018 were $2,433,000, an increase of 46.6%, compared to $1,660,000 for the same period in 2017. This increase was primarily due to an increase in salary expenses, primarily due to a salary related accrual adjustment which reduced our salary expenses in 2017, and an increase in clinical expenses associated with CGuard™ EPS, mainly related to IDE efforts in 2018. Financial expenses for the quarter ended December 31, 2018 were $7,000 compared to $24,000 for the same period in 2017. Net loss for the quarter ended December 31, 2018 totaled $2,213,000, or $0.05 per basic and diluted share, compared to a net loss of $1,500,000, or $7.38 per basic and diluted share, for the same period in 2017.

Revenue for the twelve months ended December 31, 2018 was $3,601,000 compared to $2,761,000 for the same period in 2017. The increase was primarily due to an increase in sales of CGuard™ EPS as a result of our transition from our prior exclusive distribution partner for most of Europe to local distributors, continued focus on expanding existing markets such as Germany, Russia, Spain and Italy, and expansion into new geographies such as India.  The Company’s gross profit for the twelve months ended December 31, 2018 was $995,000 compared to $585,000 for the same period in 2017. Gross margin increased to 27.6% in the twelve months ended December 31, 2018 from 21.2% in the same period in 2017, driven mainly by higher volume of sales and more efficient utilization of fixed manufacturing resources.

Total operating expenses for the twelve months ended December 31, 2018 were $8,606,000, a decrease of 2.4% compared to $8,817,000 for the same period in 2017. This decrease was primarily due to a decrease in share-based compensation expenses and a decrease in salary expenses, primarily due to a salary related accrual in 2017. These decreases were partially offset by an increase in in quality assurance and regulatory expenses related to annual audit activities which included validation reviews required every two years and an increase in clinical expenses associated with CGuard™ EPS that we cited earlier. Financial income for the twelve months ended December 31, 2018 was $371,000 compared to $179,000 of financial expenses for the same period in 2017, largely due to non-cash income associated with preferred stock. Net loss for the twelve months ended December 31, 2018 totaled $7,240,000, or $0.33 per basic and diluted share, compared to a net loss of $8,438,000, or $34.98 per basic and diluted share, for the same period in 2017.

As of December 31, 2018, cash and cash equivalents were $9,384,000, compared to $3,710,000 as of December 31, 2017.

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 13683949. To access the webcast, please go to the following link: http://public.viavid.com/index.php?id=133118

A webcast will also be archived on the Company’s website and a telephone replay of the call will be available approximately one hour following the call for approximately two weeks, and can be accessed by dialing 844-512-2921 for U.S. callers or +1 412-317-6671 for international callers and entering conference ID: 13687159.

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

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

jeremy@lifesciadvisors.com

Conference Call Scheduled for 8am Eastern Time

Tel Aviv, Israel— February 7, 2019 – 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, announced today that it will host a conference call and webcast on Tuesday, February 19, 2019, to discuss financial results for the three and twelve months ended December 31, 2018, and provide a corporate update.

Conference Call & Webcast:

Tuesday, February 19 @ 8:00am Eastern Time

Within the US:                                   877-451-6152

Outside the US:                                 201-389-0879

Israel:                                                    1 809 406 247

Conference ID:                                  13687159

Webcast:                                             http://public.viavid.com/index.php?id=133118

Replays, Available through March 5^th:                    

Domestic:                                            844-512-2921

International:                                    412-317-6671

Replay PIN:                                         13687159

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for 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 symbol NSPR.WS.

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

CGuard™ EPS shows encouraging interim results verses a conventional carotid stent in absence of any adverse clinical events in the CGuard™ arm

 Data presented at the LINC 2019 Congress in Leipzig, Germany

Tel Aviv, Israel — January 24, 2019 – 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 the presentation of positive interim results from an investigator-initiated study of CGuard™ EPS. The presentation, entitled, “The SIBERIA Trial – CGuard™ MicroNet™® Covered Stent vs. AcculInk™: Basal, 30d DW-MRI and 1y Clinical Evaluation in 100 RandomIzed pAtients,” is occurring at the Leipzig Interventional Course (LINC), which is being held January 22-25, 2019 in Leipzig Germany.

Dr. A. Karpenko and Dr. P. Ignatenko from the Siberian Federal Biomedical Research Center, Russia, presented interim data from their first 50 patients in an independent, randomized clinical trial designed to ultimately include 100 consecutive patients with symptomatic and asymptomatic carotid artery disease. The patients are randomly assigned (1:1) into two treatment groups: 50 patients will receive the CGuard™ EPS MicroNet™® mesh covered stent and 50 patients will receive a conventional carotid stent. The primary endpoints are the incidence and volume of new lesions within the brain after carotid stenting using diffusion weighted magnetic resonance imaging (DW-MRI) peri-procedurally and at 30 days.

At the protocol-mandated interim analysis, after recruiting the first 50 patients in the study, the results at one month show that, despite having patients with higher risk factors in the CGuard™ group compared to the conventional carotid stent arm, the CGuard™-treated patients had a significantly lower incidence of multiple lesions in the brain (16% vs 44%), and a lower incidence of large cerebral lesions (24% vs 40%). Finally, major adverse clinical events after 30 days occurred in the conventional carotid stent arm but not in the CGuard™ EPS-treated patients (12% vs 0%).   

Dr. Karpenko commented, “We are excited that despite the higher-risk patient profile in the CGuard™ group, the interim results show a significant reduction of cerebral embolization while patient outcomes suggest a clinically-relevant benefit of the CGuard™ EPS. This mandated interim analysis gives us confidence to continue enrolling patients in this trial and extending the data-set in this potentially important advancement in the stroke prevention field.”

About LINC

LINC is a leading global forum for new methods in the field of vascular medicine. LINC brings together medical professionals from different specialties around the world who perform endovascular interventions.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for 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 symbol NSPR.WS.

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

Cases demonstrate ease-of-use of CGuard™ EPS in two challenging clinical situations physicians face when treating carotid artery disease

Tel Aviv, Israel — January 23, 2019 – 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 two successful live cases featuring CGuard™ EPS were presented at LINC 2019, which is being held January 21 – 23 in Leipzig, Germany.
“The live demonstrations of CGuard™ EPS at this year’s LINC conference, a major international interventional conference covering the latest innovations in vascular medicine, allowed attending physicians to see first-hand the simplicity of the CGuard EPS procedure as conducted by world renowned interventional cardiologists and angiologists,” said Dr. James Barry, President and Chief Executive Officer of InspireMD. “It is immensely gratifying to once again have CGuard™ EPS chosen by these leading interventionalists to be prominently featured in two live case transmissions today at LINC 2019.”
Live case #1: Patient with Symptomatic Left Carotid Artery Disease and Concomitant Coronary Artery Disease
The first live case was conducted by Dr. Antonio Micari and Dr. Fausto Castriota, interventional cardiologists at Humanitas Gavazzeni Hospital, Bergamo, Italy. The patient had stable angina over the prior twelve months, with one hospital admission for one transient ischemic attack (TIA) approximately one month ago. The risk factors included hypertension, hypercholesterolemia and critical left interior carotid artery (LICA) stenosis with evidence of soft plaque. The procedure was successfully performed with the 8mm x 40mm CGuard™ EPS, lasted approximately 20 minutes and had an excellent angiographic result.
Following the procedure, Drs. Micari and Castriota commented, “This patient presented with multiple co-morbidities, including a history of transient ischemic attacks, and a large amount of soft plaque that significantly increases the chance of embolization associated with conventional carotid stents. There were no adverse events during the procedure. At this early stage, it appears that CGuard™ EPS offers superior patient protection where conventional carotid stents may not.”
Live case #2: Restenosis of the Left Common Carotid Artery after TEA
The second live case was conducted by Drs. Andre Schmidt and Matthias Ullrich of Universitaetsklinikum of Leipzig, in Leipzig, Germany. The patient was symptomatic with a high grade stenosis of the right common carotid artery, likely caused by post radiation and open surgery due to a parotid tumor, and had dizziness. The risk factors included hypertension, hyperlipidemia and the patient is a former smoker. The patient received a 8mm x 40mm CGuard™ EPS and the case also lasted approximately 20 minutes with an excellent angiographic result.
Following the procedure, Drs. Schmidt and Ullrich commented, “We were very happy with the performance of the CGuard in today’s challenging case that is not seen in everyday practice. It continues to reinforce our positive impressions of this innovative product and we look forward to continuing to implement it in our practice.”

About LINC
LINC is a leading global forum for new methods in the field of vascular medicine. LINC brings together medical professionals from different specialties around the world who perform endovascular interventions.

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for 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 symbol NSPR.WS.

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

“Initial Clinical Study of the New CGuard™ EPS MicroNet™® Covered Carotid Stent: ‘One Size Fits All’” presented at the LINC 2019 Congress

Tel Aviv, Israel— January 22, 2019 – 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 details of a new investigator-initiated trial entitled, “Initial Clinical Study of the New CGuard™ EPS MicroNet™® Covered Carotid Stent: ‘One Size Fits All,’” at the Leipzig Interventional Course (LINC), which is being held January 22-25, 2019 in Leipzig Germany.

Prof. Christian Wissgott, from the Institute for Diagnostic and Interventional Radiology/Neuroradiology, Westkuestenklinikum Heide – Academic Teaching Hospital of the Universities of Kiel, Luebeck and Hamburg, presented his findings using a 10mm diameter CGuard™ EPS with SmartFit™ technology across a broad range of carotid artery diameters, under a differentiated concept of “One Size Fits All.”

“One of the keys to successfully treating patients with carotid artery disease is to employ a device that is optimally sized,” commented Prof. Wissgott. “With variations of diameters between the common carotid artery (CCA) and the internal carotid artery (ICA), as well as x-ray images giving significant diameter errors due to projection angles, the correct size choice of a carotid stent is frequently challenging. I believe CGuard™ EPS with SmartFit™ technology overcomes this significant challenge.”

Prof. Wissgott concluded through in-vitro bench testing that the “One Size Fits All” CGuard™ EPS with SmartFit™ technology demonstrated a near flat chronic outward radial force in the range of 5.5 to 9.0mm diameters, meaning the force against a vessel wall in a 5.5mm vessel and that in a 9.0mm vessel are similar.  In the subsequent initial clinical study of 30 consecutive routine patients with a range of carotid artery diameters from 9.0 mm in the CCA to 5.2 mm in the ICA and diameter changes between the CCA and ICA of 2.6mm, Prof. Wissgott demonstrated that, by using a 10mm diameter CGuard™ EPS in all cases, the “One Size Fits All” SmartFit™ technology readily adapts to a range of carotid artery diameter changes and offers additional protection against embolic events that can lead to stroke.

The CGuard™ EPS with SmartFit™ was implanted with 100% technical success with no peri-procedural complications and no major or minor strokes at the six-month follow up.  Duplex ultrasound, which measures flow through the carotid artery, confirmed that all ECA (external carotid arteries) were fully patent in all cases. In addition, a subgroup of 10 patients underwent DW-MRI follow-up at 30 days and at six months with no new ipsilateral lesions observed.

Dr. James Barry, President and CEO of InspireMD, Inc., commented, “Prof. Wissgott’s in vitro and initial clinical evaluations show the potential of the CGuard™ EPS with SmartFit™ technology to simplify treating patients with carotid artery disease by using a “One Size Fits All” concept for a majority of carotid artery diameters within patients, and between patients, with excellent clinical results. Additionally, the CGuard™ EPS with SmartFit™ does not forshorten when implanted as do many conventional closed-cell stents and next generation double-layer stents. This allows us to offer what we believe is the easiest-to-use carotid device and procedure available on the market today, while most importantly continuing to provide maximum protection against stroke.”

About LINC

LINC is a leading global forum for new methods in the field of vascular medicine. LINC brings together medical professionals from different specialties around the world who perform endovascular interventions.

 About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for 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 symbol NSPR.WS.

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

Several Clinical Presentations, Updates, and Panel Discussions on CGuard EPS to also be presented 

Tel Aviv, Israel— January 18, 2019 – InspireMD, Inc.  (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that its CGuard™ Carotid Embolic Prevention System (EPS) will be featured in two live case transmissions at the Leipzig Interventional Course (LINC) 2019 to be held from January 22nd to the 25th at the Trade Fair Leipzig, Hall 2 in Leipzig, Germany.  CGuard™ EPS will also be featured in two panel discussions at the conference.

The two live cases:

Tuesday, 10:57 – 11:22 Live from Bergamo Technical Forum · Room 3

Case 21 – BG 02: male, 64 years (D-V)

Symptomatic left carotid artery disease in a patient with coronary artery disease

Operators: F. Castriota, A. Micari

Tuesday, 16:30 – 18:00 Live from Leipzig Technical Forum · Room 3

Case 27 – LEI 09: female, 56 years (L-K)

Restenosis of the left common carotid artery after TEA

Operators: A. Schmidt, S. Brהunlich

Additional presentations featuring CGuard™ EPS will include:

What:              Initial clinical study of the new CGuard™ MicroNet™® covered carotid-stent: One size fits all – experimental data and clinical results C. Wissgott, MD, Germany

When:              January 22, 10:27 – 10:33 AM Central European Time

Where:            Room 3 – Technical Forum

What:              PARADIGM-EXTEND prospective academic trial of CGuard™ MicroNet™® covered self-expandable stent system: Cumulative 3-year clinical and duplex ultrasound evidence for safety, efficacy and durability of stroke prevention Professor P. Musialek, Poland

When:              January 22, 15:05 – 15:10 PM Central European Time

Where:            Room 7 – Speaker’s Room

What:              Intermediate results of a prospective randomized study in carotid artery revascularisation: the Acculink™ stent vs. the mesh covered stent (CGuard™) P. Ignatenko, MD, Russia

When:              January 22, 15:15 – 15:20 PM Central European Time

Where:            Room 7 – Speaker’s Room

What:              Interim results from a prospective real-world multicentre clinical practice of CAS using the CGuard™ embolic prevention system: the IRONGUARD 2 study W. Mansour, MD, Italy

When:              January 22, 15:20 – 15:25 PM Central European Time

Where:            Room 7 – Speaker’s Room

What:              Comparative analysis of carotid artery stenting and carotid endarterectomy in clinical practice Professor Andrey Karpenko, Russia

When:              January 22, 15:30 – 15:35 PM Central European Time

Where:            Room 7 – Speaker’s Room

The CGuard™ Carotid Embolic Prevention System will also be featured at the Company’s booth (18c2). InspireMD will be represented by its management, sales and clinical staff and welcomes all enquiries from clinicians and other interested parties.

LINC is a leading global forum for new methods in the field of vascular medicine. LINC brings together medical professionals from different specialties around the world who perform endovascular interventions.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.

InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. 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.

Investor Contacts:

InspireMD, Inc.
Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804 FREE
Email: craigs@inspiremd.com  

Jeremy Feffer

LifeSci Advisors, LLC

212-915-2568

Email: jeremy@lifesciadvisors.com

Growing awareness of CGuard™ EPS among treating physicians, and resulting demand, were key factors driving entry into the South African market

Tel Aviv, Israel— January 14, 2019 – 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 its novel CGuard EPS will be distributed by its local distribution partner, Torque Medical of Roodepoort, Johannesburg. Commercial launch will commence immediately.

Craig Goodburn, Managing Member of Torque Medical, commented, “We are extremely pleased with the opportunity to offer CGuard EPS in the South African market. We were approached by some of our key customers in the Vascular Surgery, Interventional Neurology and Interventional Cardiology field who had learned about CGuard EPS through conferences and publications and wanted us to make it available in South Africa. We are delighted that we are now able to do so. We see CGuard EPS as a key tool for fighting stroke caused by carotid artery disease in our country.

James Barry, PhD, Chief Executive Officer of InspireMD, said, “As awareness of CGuard among vascular surgeons, interventional neurologists, and cardiologists continues to grow through real-world experience, word-of-mouth, conference presentations, and publications, we are seeing more and more ‘pull-through’ demand in which treating physicians initiate contact with local distributors to make CGuard available in their market, such as what occurred in South Africa. In our view, this is a very significant validation of our technology and a clear reflection of CGuard’s clinical advantages relative to both conventional carotid stents and carotid endarterectomy.”

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for 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 symbol NSPR.WS.

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— January 11, 2019 – 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 on January 7, 2019, the Company received a letter from NYSE American LLC (“NYSE American”) stating that it is not in compliance with the continued listing standards as set forth in Part 10, Section 1003(f)(v) of the NYSE American Company Guide (the “Company Guide”) due to the Company’s current low selling share price.

The Company’s continued listing on the NYSE American is contingent upon the Company effecting a share consolidation or otherwise demonstrating a sustained improvement in its share price within a reasonable period of time but no later than July 7, 2019.

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for 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 symbol NSPR.WS.

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