New Chinese Distributor Will Also Invest in At-The-Market Private Placement

Tel Aviv, Israel – February 3, 2021 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of the stroke caused by carotid artery disease, today announced a transaction intended to achieve distribution of CGuard EPS in mainland China. 

InspireMD’s agreement with three China-based investment partners, including Shanghai Micro Medical (SMM) and QIDI Asia Medical, stipulates that the Chinese partners will be responsible for conducting all necessary registration trials for commercial approval, followed by an eight-year exclusive distribution right in China.  In addition, QIDI has agreed to make a $900,000 investment in InspireMD’s common stock at the closing price on the day immediately prior to entering into the transaction in a private placement.  The transactions are expected to close this month.  Following announcement of the transaction the Chinese partners plan to initiate the process of securing registration with Chinese regulatory authorities to establish distribution. 

“One of our pillars of growth is global expansion of CGuard EPS into significant markets of opportunity and this step in China establishes a foundation for our overall Asia plan.  China, believed to be the second fastest growing market for peripheral stent procedures[1], establishes a foundation for Asia and builds on our goal to establish market leadership throughout the world. This step, combined with our efforts to achieve commercial registration in the United States, positions us to expand into the two largest markets outside of those currently served with true global presence for our vascular portfolio.  We are pleased to have formed a partnership with an established leader in the medical device field in this important market,” said Marvin Slosman, CEO of InspireMD. 

Stroke is the leading cause of death in China[2].  In contrast with the United States and most European countries, the Asia-Pacific region performs more stenting procedures as a proportion of overall carotid artery revascularizations than any region in the world.[3]

“The opportunity to distribute InspireMD’s CGuard EPS stent platform represents a significant opportunity to provide leading technology to the Chinese market.  We believe the superior clinical results and growing and consistent body of evidence from CGuard will provide a foundation for success and an optimal solution for our portfolio to address this significant and ever-growing medical need,” said Tony Liu, Chairman of Shanghai Micro Medical, one of the investment partners.

The offer and sale of the foregoing securities are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or applicable state securities laws.  Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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

About the CGuard® EPS

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

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes.  For more information, visit www.inspiremd.com. InspireMD routinely posts information that may be important to investors in the Investors section of its website.

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

[1] https://www.prnewswire.com/news-releases/peripheral-stent-implants-market-to-close-in-on-us-6-bn-by-2030-driven-by-increasing-peripheral-artery-disease-patient-pool-worldwide—persistence-market-research-301206261.html

[2] Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in China: huge burden, significant workload, and a national priority. Stroke. 2011; 42:3651–3654.

[3] 2017 Health Research International Market Report

Tel Aviv, Israel – January 26, 2021 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of the stroke caused by carotid artery disease, announced today multiple presentations regarding CGuard EPS, including a live demonstration, during the Leipzig Interventional Congress being held virtually from January 25-29, 2021.

Highlights include:

Wednesday, January 27, 2021, “Innovative Concepts in Carotid Revascularization”

• “12-month results from a prospective real world multicenter clinical practice of CAD using the CGuard Embolic Prevention system: the IRONGUARD 2” Author: Pasqualino Sirignano, M.D., Vascular and Endovascular Surgery Division, Department of Surgery “Paride Stefanini,” Policlinico Umberto I “Sapienza,” University of Rome.  
• “Carotid artery revascularization: a systematic review and meta-analysis comparing clinical outcomes of second vs. first generation stents and CEA.” Author: Dr. Adam Mazurek, Department of Cardiac & Vascular Diseases, John Paul II Hospital, Jagiellonian University, Medical College, Krakow, Poland; on behalf of CARMEN Collaborators (CArotid Revascularization systematic review and MEta-aNalysis). 

Friday, January 29, 2021, “Innovative Concepts in Peripheral Interventions”

• “CGuard EPS Live Case Transmission from Leipzig,” a live demonstration of CGuard implantation”
• “Combining TCAR reversed flow with mesh covered carotid stents: can the outcome be as good as open surgery?” Author: Prof. Ralf Kolvenbach, Head of the Cardiovascular Diseases Department, and Medical Director of the Catholic Hospitals, Düsseldorf, Germany
• “CGuard MicroNet™ covered stent: clinical evidence.” Author: Prof. Piotr Musiałek – Department of Cardiac and Vascular Diseases, Jagiellonian University, John Paul II Hospital, Krakow, Poland.

“Our body of evidence that demonstrates the advantages of CGuard over first-generation stents continues to grow through presentations such as the ones being offered at this very prestigious conference,” said Marvin Slosman, InspireMD’s President and CEO.  “We continue to collaborate with the many practitioners who are excited about CGuard for their patients and to widen the awareness of the product throughout the world in order to optimize CAD treatment.”

About the CGuard® EPS

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

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes.  For more information, visit www.inspiremd.com. InspireMD routinely posts information that may be important to investors in the Investors section of its website.

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

Third quarter 2020 revenue returns to pre-COVID-19 levels

Management to host investor conference call today, November 9, 2020 at 8:30 a.m. ET

Tel Aviv, Israel— November 9, 2020 – InspireMD, Inc. (NYSE American: NSPR)(“Inspire” or the “Company”), 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 third quarter ended September 30, 2020.

Third Quarter 2020 and recent highlights:

• The U.S. Food and Drug Administration (FDA) granted InspireMD approval of its Investigational Device Exemption (IDE) application to initiate a pivotal study of CGuard™ EPS. The company has begun to plan its pivotal study and has retained Dr. Christine Brennan, recognized expert in carotid artery disease, as a consultant during the planning process.

• InspireMD added Dr. Gary Roubin to its Board of Directors. One of the most recognized interventional cardiologists in the world, Dr. Roubin’s pioneering work in carotid stenting and embolic protection devices brings knowledge and experience that will be invaluable.  During his tenure as Chief of Interventional Cardiology at The University of Alabama at Birmingham and later as Department Chairman and Chief of Service of the Lenox Hill Hospital Cardiac and Vascular program in New York, he helped bring both programs to international standing in peripheral, neurovascular, and cardiac interventions.  Roubin’s vast clinical experience has enabled him to recognize and advance technical innovations that improve patient outcomes.  He played a pivotal role in the success of Mednova Inc., which was acquired by Abbott Vascular, resulting in the introduction and marketing in the U.S. of the top selling carotid embolic protection system (NAV6) and stent system (XACT). 

• The Company appointed Andrea Tommasoli as senior vice president of global sales and marketing. Andrea’s leadership of our global sales and marketing effort is an investment in our customer and commercial focus and provides the essential leadership needed to elevate our growth and acceleration to standard of care with CGuard EPS.  Andrea’s experience in leading commercial teams, in particular, indirect channel partners, globally adds immediate value to our geographic expansion and higher performance in served markets.

• InspireMD appointed Patrick Jamnik as vice president of business development and strategic initiatives. Patrick will oversee the Company’s business development activities and play a key role in advancing our short and long-term strategic goals. 

Marvin Slosman, InspireMD’s Chief Executive Officer commented, “Our third quarter financial results return us to our pre-COVID revenue levels, and while we remain cautiously optimistic about the fourth quarter, new restrictions instituted to combat the spread of COVID-19 may provide additional uncertainly in our markets.  Nevertheless, our strategic pathway to growth for CGuard EPS is robust, rooted in broadening market share in endovascular carotid artery stent procedures in our served markets, while encouraging practitioners to make the shift from carotid endarterectomy to carotid stenting and launching our products in new countries.  We view carotid artery disease as the next significant vascular condition to shift toward an endovascular standard of care, much the same way cerebral aneurysms, coronary artery disease, thoracic/abdominal aortic aneurysms, and peripheral artery disease already have.  Therefore, making the case for the value of expanded application of carotid stenting to the vascular surgeon and INR (interventional neuroradiology) communities remains a top priority.

“Another of our key goals is the initiation of our pivotal study in the United States, and we are buoyed by the addition of Dr. Gary Roubin to our Board of Directors and Dr. Christine Brennan as a strategic advisor, both of whom will be instrumental in the development and implementation of the trial.  While it is important to continue to grow revenues in the markets we currently serve, we believe our investments in the world’s largest markets, including the United States, China and Japan, will pave a pathway to global adoption of CGuard EPS.

“Finally, to meet the needs of each physician specialty, our strategy includes developing a new advanced tool set of adjunctive delivery system options including periprocedural embolic protection, specifically targeted for the vascular surgical community, all intended to drive adoption of CGuard EPS.  These advances represent additional significant revenue pathways for InspireMD, and we are excited to broaden our portfolio and build on our growth and market adoption,” concluded Mr. Slosman.

Financial Results for the Third Quarter and Nine Months ended September 30, 2020

For the three months ended September 30, 2020, revenue increased by $41,000, or 4.4%, to $980,000, from $939,000 during the three months ended September 30, 2019.  This increase was predominantly driven by a 69.0% increase in sales volume of MGuard EPS from $87,000 during the three months ended September 30, 2019, to $147,000 during the three months ended September 30, 2020.  This increase was mainly due to the timing of shipments to one of the distributors for a tender recently won.  This increase was offset, in part, by a 2.2% decrease in sales volume of CGuard Prime EPS from $852,000 during the three months ended September 30, 2019, to $833,000 during the three months ended September 30, 2020, largely driven by procedures with CGuard EPS, which are generally scheduled or non-emergency procedures, only beginning to return to normal levels towards the end of the quarter as hospitals began to re-shift resources to non-COVID-19 patients.

For the three months ended September 30, 2020, gross profit increased by 132.8%, or $170,000, to $298,000, from $128,000 during the three months ended September 30, 2019.  This increase in gross profit resulted from a $94,000 increase in revenues (as described above), less the related material and labor costs, a $56,000 decrease in write-offs, which were driven by a component supply issue during the three months ended September 30, 2019 and which did not reoccur during the three months ended September 30, 2020, and a decrease of $20,000 in miscellaneous expenses during the three months ended September 30, 2020.  Gross margin increased to 30.4% during the three months ended September 30, 2020 from 13.6% during the three months ended September 30, 2019, driven by the factors mentioned above.

Total operating expenses for the quarter ended September 30, 2020 were $2,493,000, an increase of 17.3% compared to $2,125,000 for the same period in 2019.  This increase was primarily due to increases of $127,000 in compensation expenses, $116,000 in development expenses associated with CGuard EPS, mainly related to the new advanced delivery system, $92,000 of Directors’ and Officers’ Liability Insurance expense due to recent economic changes in the insurance industry, $71,000 in regulatory expenses associated with compliance to new European Union standards, $60,000 mainly due to the timing of our annual shareholders meeting, and $79,000 of miscellaneous expense. These increases were partially offset by a decrease in travel expenses of $177,000 in light of restrictions imposed by governments worldwide in order to mitigate the spread of COVID-19.

For the three months ended September 30, 2020, financial expenses decreased by 47.9%, or $35,000, to $38,000, from $73,000 during the three months ended September 30, 2019.  The decrease in financial expenses primarily resulted from changes in exchange rates.  

Net loss for the third quarter of 2020 totaled $2,233,000, or $0.06 per basic and diluted share, compared to a net loss of $2,070,000, or $1.26 per basic and diluted share, for the same period in 2019.

For the nine months ended September 30, 2020, revenue decreased by $381,000, or 14.1%, to $2,327,000, from $2,708,000 during the nine months ended September 30, 2019.  This decrease was predominantly driven by a 11.5% decrease in sales volume of CGuard EPS from $2,344,000 during the nine months ended September 30, 2019, to $2,075,000 during the nine months ended September 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 30.8% decrease in sales volume of MGuard Prime EPS from $364,000 during the nine months ended September 30, 2019, to $252,000 during the nine months ended September 30, 2020, mainly due to the impact of COVID-19, as mentioned above.

For the nine months ended September 30, 2020, gross profit decreased by 4.8%, or $24,000, to $473,000, compared to a $497,000 for the same period in 2019.  This decrease in gross profit resulted from a $119,000 decrease in revenues (as mentioned above), less the related material and labor costs.  This decrease was partially offset by a decrease of $69,000 in expenses related to upgrades made to our production facilities during the nine months ended September 30, 2019 that did not reoccur during the nine months ended September 30, 2020 and a decrease of $26,000 in miscellaneous expenses during the nine months ended September 30, 2020.  Gross margin increased to 20.3% during the nine months ended September 30, 2020 from 18.4% during the nine months ended September 30, 2019, driven by the factors mentioned above.

Total operating expenses for the nine months ended September 30, 2020 were $7,135,000, a decrease of 8.6% compared to $7,807,000 for the same period in 2019.  This decrease was primarily due to a decrease of $708,000 in clinical expenses associated with CGuard EPS, mainly related to the IDE approval process, for which an approval from the FDA was received on September 8, 2020, $354,000 due to settlement expenses that were paid to a former service provider pursuant to a settlement agreement during the nine months ended September 30, 2019, $316,000 in travel expenses in light of restrictions imposed by governments worldwide in order to mitigate the spread of COVID-19, $150,000 in quality assurance and regulatory expenses related to the development of various projects and $91,000 in promotional expenses, primarily related to having already built our social media infrastructure in 2019.  These decreases were partially offset by an increase in expenses of $400,000 due to the settlement agreement with the underwriter of our prior offerings paid during the nine months ended September 30, 2020, $280,000 in development expenses related to CGuard EPS new advanced delivery system, $130,000 in regulatory expenses required for new regulatory standards set by the European Union, and $115,000 in our Directors’ and Officers’ Liability Insurance expenses, partially due to recent changes in the insurance industry, and $22,000 of miscellaneous expenses.

Financial expenses for the nine months ended September 30, 2020 was $29,000 compared to $173,000 for the same period in 2019.  The decrease in financial expenses primarily resulted from changes in exchange rates.  

Net loss for the nine months ended September 30, 2020 totaled $6,691,000, or $0.38 per basic and diluted share, compared to a net loss of $7,483,000, or $5.79 per basic and diluted share, for the same period in 2019.

As of September 30, 2020, cash and cash equivalents were $10,882,000 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 today, November 9, 2020, 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: https://dpregister.com/sreg/10149730/dc9d128e76.

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 found here: https://services.choruscall.com/links/nspr201109.html

Additionally, it will be broadcast live through the Company’s website via the following link: 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 February 9, 2021 at the above links.  A telephonic replay of the call will be available through November 23, 2020 and may be accessed by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 10149730.

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 September 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.

Tel Aviv, Israel – November 3, 2020 – InspireMD, Inc. (NYSE American: NSPR) (“Company”), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announces the appointment of Andrea Tommasoli as senior vice president of global sales and marketing.

Mr. Tommasoli has more than 20 years of experience in commercializing innovative medical technology solutions that improve and advance standards of care.  He has served in commercial leadership positions at Integra Life Sciences and St. Jude Medical-Abbott.  Most recently in his role as senior director of indirect markets at Integra, he led the commercial expansion and integration of Codman’s acquired portfolio in all OUS. indirect countries.  He received his B.A. in nuclear engineering from Bologna University, Italy and his M.B.A. from HEC Paris, France.

“Andrea’s commercial leadership fills the important role of overseeing the entirety of our sales and marketing efforts throughout our served markets and provides the essential leadership needed to elevate our overall Go To Market strategy,” commented Marvin Slosman, CEO of InspireMD.  “Andrea’s experience in building commercial teams comprised of direct and indirect channels across international markets brings a unique and valuable capability to our business along with a pedigree of senior leadership capabilities, important to our growth.”

“InspireMD’s CGuard EPS and MicroNet™ technology represent an innovative platform that provides practitioners with clinically meaningful results, which should advance across the globe as the new standard of care in carotid artery disease management and stroke prevention.  I’m looking forward to joining the InspireMD organization at a pivotal time, where our results can be fully realized in next levels of value creation and growth,” added Mr. Tommasoli.

InspireMD also announces that the Company has granted Andrea Tommasoli, 271,534 shares of restricted stock and options to purchase 90,511 shares of the Company’s common stock as inducement awards outside the Company’s 2013 Long-Term Incentive Plan.  The grant was approved by the Compensation Committee and was made as an inducement material to the employee entering into employment.  The grant was made in reliance on the employment inducement exception to shareholder approval provided under the NYSE American Company Guide, Section 711(a), which requires public announcement of inducement awards.

The option award has an exercise price of $0.35 per share, the closing price of the Company’s common stock on the grant date of November 2, 2020 and has a ten-year term.  Both the option and restricted stock awards will vest in three equal installments on the first, second, and third anniversaries of the date of grant, provided Mr. Tommasoli remains employed by the Company through the applicable vesting dates.  These inducement awards also provide for accelerated vesting in connection with a change in control of the Company or certain involuntary terminations of Mr. Tommasoli’s employment. 

About The CGuard® EPS

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

About InspireMD, Inc.

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

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

Earnings conference call to be held Monday, November 9, 2020 at 8:30 a.m. ET

Tel Aviv, Israel — November 2, 2020 – InspireMD, Inc. (NYSE American: NSPR) (“InspireMD” or the “Company”), 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 third quarter 2020 financial results on Monday, November 9, 2020 before the market opens. 

Management will host a conference call on Monday, November 9, at 8:30 a.m. 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: https://dpregister.com/sreg/10149730/dc9d128e76.

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 found here: https://services.choruscall.com/links/nspr201109.html

Additionally, it will be broadcast live through the Company’s website via the following link: 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 February 9, 2020 at the above links.  A telephonic replay of the call will be available through November 23, 2020 and may be accessed by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 10149730.

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 — October 13, 2020 – InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announced the addition of Gary Roubin, M.D., Ph.D., to InspireMD’s Board of Directors.

Dr. Gary Roubin is an internationally renowned interventional cardiologist recognized for his pioneering work in carotid stenting and embolic and protection devices.  He is also acknowledged for the development of coronary stenting and the first FDA-approved coronary stent.

“The CGuard EPS carotid stent with the unique MicroNet™ platform has demonstrated a true clinical advantage in served markets around the world. This carotid stent represents a major advancement in Carotid Artery Stenting (CAS). Multiple clinical studies outside the U.S. and extensive clinical practice experience have demonstrated superior outcomes compared to currently available technology.  I’m honored to join InspireMD’s Board of Directors, as the Company now has the opportunity to expand globally.  I look forward to contributing to the next chapter at InspireMD and working closely with management and the Board to bring this remarkable technology to the U.S. market” said Dr. Roubin. 

During his tenure as Chief of Interventional Cardiology at The University of Alabama at Birmingham and later as Department Chairman and Chief of Service of the Lenox Hill Hospital Cardiac and Vascular program in New York, he helped bring both programs to international standing in peripheral, neurovascular, and cardiac interventions.  Dr. Roubin’s vast clinical experience has enabled him to recognize technical innovations that improve patient outcomes.  He has been central to the success of several biotech startup businesses and is the named inventor on 10 issued U.S. and EU patents and 41 additional patent applications worldwide.

Dr. Roubin played a pivotal role in the success of Mednova Inc., which was acquired by Abbott Vascular, resulting in the introduction and marketing in the U.S. of the top selling carotid embolic protection system (NAV6) and stent system (XACT).  From 2002-2003, he served as Chief Medical Officer of the Medicines Company during the successful release of its Angiomax product.  Most recently, he cofounded Essential Medical Inc., which has had success in bringing a large bore vascular closure device to world markets and was recently acquired by Teleflex Inc.

Dr. Roubin attended medical school at the University of Queensland where he completed his degree in 1975.  After completing his cardiology training, he enrolled as a Ph.D. candidate at Sydney University and was awarded this degree in 1983. He then joined Andreas Gruentzig at Emory University to continue his post-doctoral research.  In October of 1987, he developed and placed the world’s first balloon expandable coronary stent.  In 1989, he moved to the University of Alabama at Birmingham, where he was Professor of Medicine and Radiology and Director of the Cardiac Catheterization Laboratories and Interventional Cardiology Section at the University of Alabama Hospital.  Dr. Roubin has co-authored more than 280 papers and 225 abstracts in peer reviewed journals.  He has also edited three textbooks on interventional cardiovascular medicine, coronary, and carotid artery stenting and contributed to 20 textbooks on interventional cardiology and vascular medicine.  His book “The First Balloon Expandable Coronary Stent: An Expedition that Changed Cardiovascular Medicine” was published in 2015.  He lectures extensively in the United States and abroad and has received numerous national and international awards for his notable contributions to cardiac and vascular care.  Dr. Roubin has been on record for the last decade advocating the use of optimally designed “fine mesh” stents to further reduce the risk of embolic complications from CAS.

“Dr. Roubin’s peerless reputation as a clinical scientist, innovator, and interventional cardiologist brings with it an important validation of our MicroNet™ technology and the CGuard Stent System,” added InspireMD’s CEO Marvin Slosman.  “We believe his presence on our Board will also provide meaningful insight, thoughtful direction, and unmatched perspectives in our focus to change the way carotid artery disease is treated and strokes are prevented.  Dr. Roubin’s confidence in our differentiated CGuard EPS platform and our direction for the business is a tremendous vote of confidence for the Company’s potential and we are very fortunate to have him join as a director and investor in the Company.”   

“On behalf of the Board of Directors, we welcome Dr. Roubin and look forward to his active participation in our Company.  His tremendous, unmatched experience and understanding of our business and the markets we serve provide relevant and immediate value to our current and future plans,” commented InspireMD’s Chairman of the Board Paul Stuka.   

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

About InspireMD, Inc.

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

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

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiv) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

Tel Aviv, Israel – October 6, 2020 – InspireMD, Inc. (NYSE American: NSPR) (“Company”), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announced the appointment of Patrick Jamnik as vice president, business development and strategic initiatives.  In this newly created position, Mr. Jamnik will oversee the Company’s business development activities and play a key role in advancing its short and long-term strategic goals, with much of his focus being the U.S. market.

“At different times throughout my career, I have been fortunate to see the powerful impact created when pioneering technology encounters genuine unmet clinical needs.  CGuard™ EPS presents the opportunity to create such an impact on the advancement of carotid artery stenting,” said Mr. Jamnik.  “I am thrilled to be joining InspireMD at such an important and exciting time.”

Mr. Jamnik brings with him more than 15 years of global market development experience in broad-based roles with both large and emerging medical technology companies.  Prior to joining InspireMD, he served   in a commercial leadership role for Stryker Corp. Before that, he served as director of global marketing at Stanmore Implants Worldwide and played a central role in establishing its U.S. business, contributing to its eventual acquisition by Stryker.  Mr. Jamnik received both a BA and MBA from The University of Wisconsin-Madison. 

“We welcome Patrick to the executive leadership team and look forward to his leadership in advancing our growth through market and portfolio expansion along with strategic initiatives to build on the success of our CGuard EPS and MicroNet™ platform.  As we gain traction and leverage the superior clinical results of our stent platform, we will continue to develop new strategic pathways for growth,” said Marvin L. Slosman, chief executive officer of InspireMD. 

InspireMD also today announced that the Company has granted Patrick Jamnik, the Company’s new vice president of business development, 162,920 shares of restricted stock and options to purchase 54,307 shares of the Company’s common stock as inducement awards outside the Company’s 2013 Long-Term Incentive Plan. The grant was approved by the Compensation Committee and was made as an inducement material to the employee entering into employment. The grant was made in reliance on the employment inducement exception to shareholder approval provided under the NYSE American Company Guide, Section 711(a), which requires public announcement of inducement awards.

The option award has an exercise price of $0.34 per share, the closing price of the Company’s common stock on October 5, 2020, the grant date, and has a ten-year term. Both the option and restricted stock awards will vest in three equal installments on the first, second, and third anniversaries of the date of grant, provided Mr. Jamnik remains employed by the Company through the applicable vesting dates. These inducement awards also provide for accelerated vesting in connection with a change in control of the Company or certain involuntary terminations of Mr. Jamnik’s employment. 

About The CGuard® EPS

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

About InspireMD, Inc.

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

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

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

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

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

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

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

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

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

About The CGuard® EPS

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

About InspireMD, Inc.

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

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

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiv) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

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

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

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

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

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

About InspireMD, Inc.

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

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

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements.  Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy; (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiv) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction.  More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov.  The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

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

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

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

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

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

About the PARADIGM-EXTEND Study

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

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

About InspireMD, Inc.

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

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

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements.  Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy; (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiv) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction.  More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov.  The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com