-Earnings Conference Call to be held Tuesday, May 10, 2022, at 8:30 a.m. ET-

Tel Aviv, Israel— April 28, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today it will report first quarter 2022 financial results on Tuesday,
May 10, 2022, before the market opens. 

Management will host a conference call and webcast with the investment community at
8:30 am (ET) that same day to review financial results and provide an update on corporate developments. 

The webcast should be accessed 15 minutes prior to the conference call start time. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company’s website.

About InspireMD, Inc.

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

Forward-looking Statements

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

Investor Contacts:

Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
craigs@inspiremd.com

Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
investor-relations@inspiremd.com

Tuesday, March 22^nd @ 2 p.m. ET

Tel Aviv, Israel— March 16, 2022 – InspireMD, Inc. (Nasdaq: NSPR), a global developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today that it will host a Key Opinion Leader (KOL) webinar on its CGuard Stent Platform and it’s MicroNet™ portfolio on Tuesday, March 22, 2022 at 2 p.m. Eastern Time.

The webinar will feature presentations from KOL’s Chris Metzger, MD, PhD, from Ballad Health, Adnan Siddiqui, MD, PhD, FACS, FAHA, FAANS, from State University of New York at Buffalo’s Jacobs School of Medicine and Biomedical Sciences, and Sean Lyden, MD, from Cleveland Clinic, who will discuss the current unmet medical need in the carotid/neurovascular market, and how InspireMD’s products have the potential to offer a differentiated solution.

The InspireMD management team will provide a brief corporate overview and plans to utilize their proprietary MicroNet™ technology to make CGuard EPS and additional pipeline products the industry standard for sustained embolic protection, neurovascular protection, and stroke prevention.

A live question and answer session will follow.  To register for the webinar, please click here.

Chris Metzger, MD, is Ballad Health’s System Chair of Clinical Research. The role of System Chair of Clinical Research is to oversee the advancement of clinical research activities within Ballad Health hospitals and clinics, including clinical trials. Dr. Metzger is a practicing interventional cardiologist who serves as director of Holston Valley Medical Center’s diagnostic catheterization and interventional labs. He has helped Holston Valley earn national and international acclaim in cardiology, and his work has led to significant growth in cardiac clinical trials and research.

Under Dr. Metzger’s leadership, the cardiology program at Holston Valley has performed as the No. 1 or No. 2 enroller in the United States and globally in at least 29 top research trials, including being the current leading enroller in four major trials. Advancements made through this work not only improved cardiac care for patients nationwide but have also given local patients first access to leading-edge treatments and therapies. He has also forged a strong professional relationship with Harvard Medical School. Seven times, he has hosted endovascular fellows to train at Holston Valley before completing their education.

Sean Lyden, MD is the Chairman of the Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute. 

Dr. Lyden earned his medical degree from the University of Cincinnati College of Medicine following an undergraduate degree from the University of Notre Dame. He served a residency in general surgery at the University of Tennessee Health Sciences Center in Memphis where he was inducted into the Alpha Omega Alpha Medical Honor Society. His training included a year long trauma research.  He subsequently served a fellowship in vascular surgery at the University of Rochester-Strong Memorial Hospital, Rochester, NY.

Dr. Lyden performs more than 200 procedures each year. His specialty interests include failed endovascular aneurysm repair, drug coated balloon use in arterial disease, popliteal artery entrapment syndrome. Currently, he is involved in clinical trials studying various topics including thoracic and abdominal stent grafting; lower extremity interventional therapies with drug coated balloons, drug-eluting stents and percutaneous femoral popliteal bypass; carotid stenting; and deep venous thrombosis treatments.

He serves on the editorial boards of Endovascular Today and Annals of Vascular Surgery and serves as reviewer for several journals, including the Journal of Vascular Surgery, Annals of Vascular Surgery and the Journal of the American College of Surgeons. He has authored and co-authored more than 85 articles in leading publications, including the Journal of Vascular Surgery, New England Journal of Medicine and Circulation. He also has also authored chapters in several vascular textbooks.

Adnan H. Siddiqui, MD, PhD, FACS, FAHA, FAANS, is Professor and Vice Chairman in the Department of Neurosurgery (UBNS) at the State University of New York at Buffalo’s Jacobs School of Medicine and Biomedical Sciences.  He joined UBNS in December 2006. Dr. Siddiqui completed fellowship training in Interventional Neuroradiology, Cerebrovascular Surgery and Neurocritical Care from Thomas Jefferson University in Philadelphia. He completed his Neurosurgical residency at Upstate Medical University and received his PhD in Neuroscience from the University of Rochester and medical degree from Aga Khan University in Pakistan. He is a Fellow of the American Association of Neurological Surgeons, American College of Surgeons and American Heart Association. He is profoundly indebted to his mentors Nick Hopkins, Robert Rosenwasser, Charles Hodge and Shirley Joseph in shaping his career as a dual-trained cerebrovascular surgeon, clinician scientist and entrepreneur.

Dr. Siddiqui has over 500 peer reviewed publications, more than 50 chapters, almost 70,000 citations and an H index of 72. He is particularly proud of representing Buffalo and the U.S. at most major cerebrovascular conferences around the world with over 200 international presentations to date. He has designed, conducted and lead multiple major national and international clinical trials and currently serves as National and International Principal Investigator (PI) for multiple major funded multi-site trials. These efforts have significantly contributed to the success of the department, which was ranked 7th in academic impact in North America by the Journal of Neurosurgery.

He serves as Chief Executive and Chief Medical Officer for the Jacobs Institute, a medical innovation center focused on accelerating device development in vascular medicine based in Buffalo, NY.

He leads the Canon Stroke & Vascular Research Center (CSVRC) at University at Buffalo. In addition, he serves as the Director of the Neurosurgical Stroke Service at the Gates Vascular Institute in Buffalo, one of the busiest Comprehensive Stroke Services in New York State and the United States.

Dr. Siddiqui has continuously served on multiple scientific and educational committees of American Association of Neurological Surgeons (AANS), Congress of Neurological Surgeons (CNS) and Society of NeuroInterventional Surgery (SNIS). He is the Chairman of the Joint Section of Cerebrovascular Surgery of the AANS and CNS and Secretary for the SNIS. It has been a major focus for him to achieve consensus between the various organizations involved in fellowship training and credentialing for Neuroendovascular Surgery.

He serves as a Neurosurgeon Director on the Executive Committee of the SNIS Patient Safety Organization which runs the NVQI-QOD Quality Outcomes Registry.

About InspireMD, Inc.

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

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

Forward-looking Statements

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

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com

– CGuard™ Revenue Generated 87.5% growth over Q4’20 and 55.9% Year-over-Year –-

– Published CGuard Clinical trial results in Journals of the American College of Cardiology –

– Established Reimbursement Approval for CGuard from the French National Authority –

– CGuard Included as Carotid Stent Treatment Option in National Institute of Neurological Disorders and Stroke (NINDS) Sponsored CREST-2 Trial Following
FDA Approval of IDE Supplement Application –

—

Management to Host Investor Conference Call Today, March 8, at 8:30am ET
—

Tel Aviv, Israel— March 8, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of Carotid Artery Disease, today announced financial and operating results for the fourth quarter and year ended
December 31, 2021.

Fourth Quarter 2021 and Recent Highlights:

• CGuard revenues for the fourth quarter 2021 were $1,291,000 an 87.5% increase over the same period in 2020 and for the 12-month period ended December 31, 2021, CGuard revenues totaled $4,309,000 representing a year over year increase of 55.9%. 
• Appointed Katherine Arnold, to the Board of Directors and Dr. Adnan Siddiqui to the Scientific Advisory Board; each provide leadership and guidance to their respective boards with vast industry specific experience in the medical device market.
• Accelerated enrollment in the C-Guardian Investigational Device Exemption (IDE) Clinical Trial despite surging Omicron infection rates, staffing limitations and resource constraints at hospitals and healthcare systems across the United States. Under the leadership of Chris Metzger, M.D., system chair of clinical research at Ballad Health System in Eastern Tennessee the trial has 12 sites actively enrolling or recruiting patients.
• Gained approval and reimbursement coverage for CGuard EPS in France from the French National Authority for Health (HAS) and instituted a direct sales structure for commercial expansion, building on European market growth.
• Published a randomized study (SIBERIA) in Journals of the American College of Cardiology (JACC), comparing InspireMD CGuard EPS to the Abbott Acculink™, demonstrating CGuards’s 4.5-fold superiority in clinical outcomes versus this first-generation open cell Abbott stent.

Marvin Slosman, CEO of InspireMD, commented: “InspireMD continues its quest to change the standard of care for the prevention of stroke caused by carotid artery disease, through measurable progress advancing our goals of execution and growth. 2021 CGuard EPS revenue results reflected a significant rebound to the prior year with a 55.9% increase year over year, reflecting our sustained focus on commercial growth in our current 40 served markets along with continued work towards gaining approvals in both China and the United States. We advanced our pipeline of innovation with two new stent delivery accessories planned in 2022, to facilitate greater utilization of CGuard EPS as a first line stent solution for carotid artery disease management. 

“In 2021, we initiated and accelerated enrollment in our ongoing C-Guardians IDE pivotal study of CGuard™ EPS (C-Guardian) in the United States, with the leadership and advisory support of renowned interventional cardiologist Gary Roubin, M.D., Ph.D., who serves on our Board of Directors, Dr. Chris Metzger, principal investigator, and lead enroller to date as well as Christina Brennan, M.D., supporting trial execution.  We secured 12 of the leading interventional sites in the United States to contribute to expanding enrollment. The results to date, along with enthusiasm and feedback of the interventional community to participate and gain experience with CGuard, are an important step in maintaining our post approval commercial momentum,” Marvin Slosman added. 

“In terms of our global strategy, in 2021 we continued to expand our market presence, obtaining registration and reimbursement in France along with the establishment of a direct sales presence to serve this key European market.  We are currently applying for and exploring regulatory and reimbursement approvals in important new markets such as Japan and Taiwan to bolster our global footprint and advance our strategic plan for Asia.

“Our cash position remains sound, having raised an aggregate of approximately $51 million in 2020 and 2021, providing sufficient capital to continue our growth initiatives and business development plans.  Our company focus and foundation is built on the superiority of our CGuard stent system, through the unique MicroNet™ mesh platform, providing sustained cerebral protection. InspireMD is committed to become an industry leader by addressing the broadest physician base of vascular specialist. We believe that expanding our leadership in transfemoral delivery of CGuard into our rapid advancing trans carotid artery revascularization (TCAR) accessory device platform will enable broader adoption of trans carotid procedural preference, thus enabling greater conversion of surgeries to stenting,” added Mr. Slosman.

“We enter 2022 with tremendous momentum, anticipating growth of CGuard, continuing pipeline development and advancing the growing body of evidence demonstrating CGuards’s superiority in clinical performance amongst all other stent options and surgery,” said Marvin Slosman, CEO of InspireMD.
 

Financial Results for the Fourth Quarter ended December 31, 2021

For the fourth quarter of 2021, revenue increased by $1,222,000, or 773.8%, to $1,380,000, from $158,000 during the fourth quarter of 2020.  Excluding the $580,000 negative impact on revenue from our settlement of litigation with a former distributor from 2014 in the fourth quarter of 2020, total revenue increased by $642,000, or 87.0%, to $1,380,000, from $738,000 during the fourth quarter of 2020. This increase was predominately driven by an increase in revenue of CGuard EPS by $603,000, or 87.5%, to $1,291,000 for the fourth quarter of 2021, from $689,000 during the fourth quarter of 2020. This increase is mainly due to growth in market share in major markets, expansion into new markets and due to the fact that in the fourth quarter of 2021, procedures with CGuard EPS, which are generally scheduled for non-emergency procedures began to return to normal levels as compared to the fourth quarter of 2020, when procedures with CGuard EPS were postponed as hospitals shifted resources to patients affected by COVID-19 beginning in February 2020.

For the fourth quarter of 2021, gross profit increased $684,000, to $294,000, compared to a gross loss of $390,000 for the fourth quarter of 2020. This increase in gross profit resulted from the impact of the $580,000 settlement with our former distributor in 2014 which was recorded in the three months ended December 31, 2020 (as mentioned above), as well as $207,000 increase in revenues less the related material and labor costs. Gross margin increased to 21.3% during the fourth quarter of 2021 from a negative 246.8% during the fourth quarter of 2020, driven by the reasons mentioned above.

For the fourth quarter of 2021, total operating expenses were $4,225,000, an increase of $897,000, or 27.0% compared to $3,328,000 for the fourth quarter of 2020.  This increase was primarily due to increases in expenses related to the commencement of the C-Guardians U.S. Food and Drug Administration (FDA) study, share-based compensation-related expenses due to the recognition of grants made since August 31, 2020 and sales and marketing expenses associated with expansion of existing and new markets.

For the fourth quarter of 2021, financial expenses decreased by 7.6%, or $10,000, to $121,000, from $131,000 during the fourth quarter of 2020. Net loss for the fourth quarter of 2021 totaled $4,097,000, or $0.53 per basic and diluted share, compared to a net loss of $3,853,000, or $1.52 per basic and diluted share, for the same period in 2020. The average amount of shares outstanding used for the earnings per share calculation were 7,796,027 in the fourth quarter of 2021 and 2,533,936 in the fourth quarter of 2020, both adjusted to reflect the 1:15 reverse split effected by us on April 26, 2021.

Financial Results for the full year ended December 31, 2021

Total revenue for the year ended December 31, 2021 were $4,495,000, an increase of 80.9% compared to $2,485,000 for the year ended 2020.

Gross profit for the year ended December 31, 2021 was $754,000, or 16.8 % of revenue, as compared to $83,000, or 3.3 % of revenue for the year ended 2020.

Total operating expenses for the year ended December 31, 2021 were $15,470,000, an increase of 47.9%, compared to $10,463,000 for the year ended 2020. 

Net loss for the year ended December 31, 2021, was $14,918,000, or $2.03 per basic and diluted share, as compared to a net loss of $10,544,000, or $6.97 per basic and diluted share, for the year ended 2020.  The average amount of shares outstanding used for the earnings per share calculation were 7,346,022 for the full year 2021, and 1,512,439 for the same period in 2020, both adjusted to reflect the 1:15 reverse split effected by us on April 26, 2021.

As of December 30, 2021, cash, cash equivalents and short-term bank deposits were $34.0 million compared to $12.6 million as of December 31, 2020.

Conference Call and Webcast Details

Management will host a conference call at 8:30AM ET today, March 8, 2022, to review financial results and provide an update on corporate developments.  Following management’s formal remarks, there will be a question-and-answer session.  

Tuesday, March 8, 2022 at 8:30 a.m. ET

Domestic:                              877-407-4018

International:                       201-689-8471

Conference ID:                    13727214

Webcast:                               Webcast Link

About InspireMD, Inc.

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

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

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. For example, the company is using forward looking statements when it discusses its plans to apply for regulatory and reimbursement approvals in new jurisdictions, its belief that it has sufficient capital to continue its growth initiatives and business development plans and that it anticipates momentum in 2022, the belief that expanding its leadership in transfemoral delivery of CGuard into its rapid advancing TCAR accessory device platform, will enable  broader adoption of trans carotid procedural preference, thus enabling greater conversion of surgeries to stenting and its anticipation for continuing pipeline development and advancing the growing body of evidence demonstrating CGuards’s superiority in clinical performance amongst all other stent options and surgery.  Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com

(1) All financial information for the twelve months ended December 31, 2021 is derived from the Company’s 2021 audited financial statements and all financial information for the twelve months ended December 31, 2020 is derived from the Company’s 2020 audited financial statements, included in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2021 filed with the Securities and Exchange Commission.  All financial information for the three months ended December 31, 2021 and 2020 is derived from the Company’s unaudited, financial statements.

(2) All December 31, 2021 financial information is derived from the Company’s 2021 audited financial statements and all December 31, 2020 financial information is derived from the Company’s 2020 audited financial statements, as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2021 filed with the Securities and Exchange Commission.

– CGuard™ Carotid Stent will now be a treatment option in the stenting plus medical therapy arm of the trial for patients –

– CREST-2 Trial is sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) and actively engaged at more than 140 study locations –

 
Tel Aviv, Israel— February 28, 2022 – InspireMD, Inc. (Nasdaq: NSPR), a global developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, today announced its CGuard Carotid Stent, utilizing its proprietary MicroNet™ mesh, will be included as a device option for stenting in the CREST-2 Trial. Following the approval of the Carotid Revascularization Endarterectomy or Stenting Trial (CREST-2) Investigational Device Exemption (IDE) supplement application from the U.S. Food and Drug Administration (FDA) last week, InspireMD will be evaluating strategic sites to enable expediated access.

Marvin Slosman, Chief Executive Officer of InspireMD commented, “This approval for use of CGuard EPS in a trial as significant as CREST-2 is proxy to the validation of our technology platform, contributing to this important work. The CREST-2 Trial is widely acknowledged as the most significant ongoing trial to scientifically investigate the optimal course of treatment to prevent stokes for asymptomatic patients with significant carotid disease. The opportunity to be a part of CREST-2 is a tremendous milestone for our company, and we look forward to CGuard playing an important role in the stenting results,” Mr. Slosman added.

The study first enrolled patients in 2014, as two parallel multi-center randomized, observer-blinded endpoint clinical trials with the purpose of being to determine the best way to prevent strokes in patients with high grade carotid stenosis but no stroke symptoms related to that blockage. The trial will enroll an estimated 2,480 participants which will remain in the study for 4 years following the start of intervention.

“The CREST-2 Executive Committee is keenly focused on positioning the results of the trial to be relevant, actionable, and informative to contemporary practices,” said Dr. Thomas Brott, Principal Investigator of the NINDS sponsored trial. “Over the course of the trial we have continually introduced state of the art medical, pharmacological therapies to reduce the risk of stroke in our randomized patient population. It is critical of any long-term study to remain aligned with evolving technology and relevant devices. After examining the extensive clinical experience with the CGuard stent and the large body of evidence to its effectiveness, the study executive committee felt it appropriate to include this stent as a treatment option. Patients that agree to participate in the CREST-2 Trial, depending on accessibility and operator training and discretion, will now have access to this state of the art, carotid stent device.”

About Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)

CREST-2 is two independent, parallel, multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial randomizes patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another randomizes patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management is uniform for all randomized treatment groups and is centrally directed.  The purpose of this trial is to determine the best way to prevent strokes in people who have a high amount of blockage of their carotid artery, but no stroke symptoms related to that blockage.

The trial is being conducted in the United States, Canada, Spain, Israel, and Australia by physicians carefully selected on their ability to perform revascularization at low risk. Another key component of the trial is that important stroke risk factors, including hypertension, diabetes, high cholesterol, cigarette smoking, physical activity, and diet are managed intensively. The trial will enroll an estimated 2,480 participants who will remain in the study for 4 years following the start of intervention/treatment. Clinical Trial Identifier: NCT02089217

For additional information please visit www.ClinicalTrials.gov

About InspireMD, Inc.

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

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

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. For example, the company is using forward looking statements when it discusses the belief that the approval for use of CGuard EPS in the CREST-2 trial is proxy to the validation of its technology platform and the expected enrollment of patients in the trial.  Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com

-Earnings Conference Call to be held Tuesday, March 8, 2022, at 8:30 a.m. ET-

Tel Aviv, Israel— February 22, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease (CAD) and stroke prevention, today announces it will report fourth quarter and full year 2021 financial results on Tuesday, March 8, 2022, before the market opens. 

Management will host a conference call and webcast with the investment community at
8:30 am (ET) that same day to review financial results and provide an update on corporate developments. 

The webcast should be accessed 15 minutes prior to the conference call start time. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company’s website.

About InspireMD, Inc.

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

Forward-looking Statements

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

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com

Dr. Siddiqui is recognized for his extensive experience in Microsurgical, Radiosurgical and Endovascular Techniques for the Comprehensive Management of Vascular Disease

Tel Aviv, Israel— February 15, 2022 – InspireMD, Inc. (Nasdaq: NSPR), a global developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease (CAD) and stroke prevention, today announced the appointment of Adnan Siddiqui, MD, PhD, FAANS, FACS, FAHA to the Company’s Scientific Advisory Board. Dr. Siddiqui brings extensive knowledge and expertise to InspireMD as a neurovascular surgeon and clinical scientist focused on and dedicated to the comprehensive management of ischemic stroke and vascular diseases involving the brain and spinal cord. 

“We are delighted to welcome Dr. Siddiqui as a member of our Scientific Advisory Board and as a strategic consultant to the Company,” said Marvin Slosman, Chief Executive Officer of InspireMD. “His significant expertise and insight in treating acute stroke and other cerebrovascular conditions, will provide valuable support and guidance in advancing our CGuard stent platform and MicroNet™ mesh as we expand our portfolio and consider additional indications. CGuard continues to deliver superior patient outcomes and stroke prevention when compared to conventional stents and endarterectomy surgery in patients with life-threatening carotid artery disease. We look forward to Dr. Siddiqui’s contributions to the success and direction of the Company.”

“The potential advancement of the CGuard Carotid stent using its proprietary MicroNet™ mesh for sustained embolic protection without excessive increase in metal surface area, provides a foundational advantage for improved patient outcomes and prevention of stroke. It is my pleasure to be affiliated with the InspireMD team to collaborate and advance new and innovative solutions for this growing market focus and improved patient care,” said Dr. Adnan Siddiqui.  

Dr. Adnan Siddiqui is Vice-Chairman and Professor of Neurosurgery at the State University of New York at Buffalo (UB). He serves as Director of Neuroendovascular Research, Fellowship, and the Canon Stroke and Vascular Research Center at UB. He also serves as Director of Neurosurgical Stroke Service at Kaleida Health, and is the Chief Executive and Chief Medical Officer for the Jacobs Institute, a medical innovation center focused on accelerating device development in vascular medicine based in Buffalo, NY. Dr. Siddiqui recently served as Chair (2020-2021) of the Joint Section of Cerebrovascular Surgery of the American Association of Neurological Surgery (AANS) and Congress of Neurological Surgeons (CNS). He has also served as the Secretary for the Society of NeuroInterventional Surgery (SNIS) (2020-2021). He has served on the Endovascular Task Force of AANS, and been on multiple scientific and educational committees of the AANS, CNS, SNIS, American Board of Neurological Surgery and the Society Neurological Surgeons.

Dr. Siddiqui is a reviewer for Stroke, Neurosurgery, Journal of Neurosurgery and Journal of NeuroInterventional Surgery as well as for numerous other medical journals, and he has over 500 peer reviewed publications.

Dr. Siddiqui completed fellowship training in Interventional Neuroradiology, Cerebrovascular Surgery and Neurocritical Care at Thomas Jefferson University in Philadelphia. He completed his Neurosurgical residency at Upstate Medical University. He received his PhD in Neuroscience from the University of Rochester and his medical degree from Aga Khan University, Pakistan.

About InspireMD, Inc.

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

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

Forward-looking Statements

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

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com

Tel Aviv, Israel— January 27, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for prevention of stroke caused by Carotid Artery Disease (CAD), today announced that Marvin Slosman, Chief Executive Officer, is scheduled to present at the IAGS’ Biennial Scientific Meeting being held from January 31 – February 3, 2022 in Punta Cana, Dominican Republic. The 16^th Biennial Scientific Meeting of the IAGS will present multiple scientific sessions to address current challenges in the treatment of cardiovascular disease and to clarify and define areas of focus for medical researchers, industry, and clinicians.

Presentation Details:

Date:               Tuesday, February 1, 2022

Time:               11:30 am EST / 12:30 pm AST

Location:        Punta Cana, Dominican Republic

Presenter:      Marvin Slosman, Chief Executive Officer of InspireMD

For more information about the 16^th Biennial Scientific Meeting, please refer to the
conference website link. 

About The International Andreas Gruentzig Society (IAGS)

The IAGS is an international educational society of physicians and scientists interested in the health sciences in the cardiovascular and related fields. Society members cooperate in the advancement of knowledge and education through research, publication, study and teaching in the fields of cardiovascular disease. In addition, the society: (a) fosters the continuing development of the specialties of health sciences in the cardiovascular and related fields as an art and science; (b) improves the methods of teaching cardiovascular therapeutic techniques; (c) stimulates interest in the study of diseases of the vessel wall and research in treating cardiovascular disease; (d) fosters communication and fellowships between top tier, international investigators, clinicians and Industry Researchers/Developers, in the specialties of interventional radiology, cardiology, surgery, regenerative medicine and neuroradiology, who work towards developing novel products and/or techniques for the treatment of cardiac, vascular and structural disease; (e) conducts a scientific meeting amongst the above mentioned specialties in order to provide a platform for presenting problems, offering solutions and debating innovations with the end goal of advancing products and/or techniques for treating cardiac, vascular and structural diseases.

About InspireMD, Inc.

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

Forward-looking Statements

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

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com

investor-relations@inspiremd.com

– Live Case will be Broadcasted Today at 11:00am ET –

 Tel Aviv, Israel— January 18, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for prevention of stroke caused by Carotid Artery Disease (CAD), today announced that a live case demonstration featuring CGuard™ EPS will be broadcasted at the International Symposium on Endovascular Therapy (ISET) 2022 Conference by Dr. Chris Metzger, Chair of Clinical Research at Ballad Health on Tuesday, January 18, 2022.  

“We are extremely grateful to have been selected and approved for a Live Case Presentation at this year’s ISET Conference demonstrating the advantages of CGuard,” said Marvin Slosman, Chief Executive Officer of InspireMD. “The global recognition of the CGuard stent system continues to demonstrate clinical evidence and data supporting CGuard’s safety and efficacy and we are pleased to have been selected for a live case as an advanced device for treatment of CAD at this important conference.”

“Our team at Ballad Health have completed 40 patient enrollments in the C-Guardians IDE trial.  We are pleased with our device performance experience thus far,” said Dr. Chris Metzger, trial Principal Investigator. “The opportunity to highlight the CGuard stent system in a live case at the ISET conference offers the interventional community the chance to observe the CGuard with its unique MicroNet™ mesh protection in an important clinical setting.”

About International Symposium on Endovascular Therapy (ISET)

For more than 30 years, ISET has served as the premier arena for pioneering and practical endovascular education. Alumni have gone on to transform the fields of interventional radiology, interventional cardiology, vascular surgery, and more. There simply is no comparison. ISET is where legends—current and future—come together to explore groundbreaking techniques, technologies, and procedures while exchanging discussion and debate that ultimately drive patient care forward.

About InspireMD, Inc.

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

Forward-looking Statements

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

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com

investor-relations@inspiremd.com

-CGuard™ sales generated 24% YoY revenue growth-

-CGuard™ EPS received a positive opinion from the French National Authority  for Health (HAS) regarding reimbursement in France-

-$37.1 million in cash, cash equivalents and short-term bank deposits as of September 30, 2021, provides runway into first half of 2023-

-Management to host Call & Webcast Today, November 9, 2021, at 8:30am ET-

Tel Aviv, Israel— November 9, 2021 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of Carotid Artery Disease (CAD), today announced financial and operating results as of and for the third quarter ended September 30, 2021.

“This quarter has been extremely productive, and I am pleased to report our progress as we build momentum into the end of the year. On the commercial front, the successful expansion of CGuard™ into France represents further progress of our reimbursement initiative as well as growing global demand from physicians for our product when treating CAD,” explained Marvin Slosman, CEO of InspireMD. “Our performance this quarter has been particularly gratifying, both year over year and sequentially, as we continue to deliver growth in the use of CGuard EPS to prevent strokes and manage CAD.”

Third Quarter 2021 and Recent Highlights

• Total CGuard EPS revenue for the third quarter of $1,031,000, an increase of 23.8% compared to the same period in 2020, showed growing procedural share and return to normalized procedure levels in most geographies as the COVID pandemic has waned. For the nine months ended September 30, 2021, CGuard revenue increased by 45.4% compared to the same period in 2020.
• In November 2021, the Company announced a publications’ acceptance in the Journals of the American College of Cardiology (JACC), Randomized Controlled Trial of Conventional Versus MicroNet™-Covered Stent in Carotid Artery Revascularization. This publication demonstrates the latest randomized trial of CGuard compared to first generation stents and supports the large and growing body of clinical and scientific evidence showing the superiority of the CGuard device in preventing brain embolization.
• In October 2021, the Company announced that its CGuard EPS stent system had received a positive opinion from the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDIMTS) of the French National Authority for Health (HAS) regarding reimbursement in France. The CGuard EPS was also added to the list of reimbursed medical products (LPPR) at the end of October 2021 and will now receive this preferred status. CGuard carotid stent, is commercially established in 33 markets to date, adding France to our growing global expansion. 
• In July 2021, InspireMD announced the first patients enrolled in its U.S. Registration
  C-Guardians IDE clinical trial at the Ballad Health Systems (Kingsport, TN) under the guidance of Principal Investigator Dr. Christopher Metzger.
  • To date enrollment continues to increase at all sites as familiarity of CGuard is employed across each hospital system. A total of 315 participants are expected in the Multicenter, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the CGuard Carotid Stent System
  • Currently 5 trial sites have been opened and are actively enrolling:

Avera Heart Hospital; Ballad CVA Heart Institute; Turkey Creek Medical Center; Ascension Seton of the Seton Heart Institute and Pinnacle Health Cardiovascular Institute

 “We are encouraged by our commercial momentum as measured by demand for CGuard EPS in our served markets, particularly in Europe. Our trial enrollment levels for the U.S. C-Guardians trial, which began this quarter, is on track and we expect the fourth quarter of 2021 to yield additional site approvals and patient enrollments. Furthermore, we are pleased by ongoing expansion discussions in Asia with partnership plans for Japan and Taiwan. We are building our organizational resources and talent to drive CGuard EPS to be the leading Carotid stent system in the market. Lastly, I want to reiterate that investment in our pipeline of innovative solutions continues as we advance toward regulatory approvals of two new delivery systems, capable of expanding CGuard’s market penetration and conversion of open surgery to endovascular procedures,” Mr. Slosman commented.

Financial Results for the Third Quarter ended September 30, 2021

 For the three months ended September 30, 2021, revenue increased by $91,000, or 9.3%, to $1,071,000, from $980,000 during the three months ended September 30, 2020.  This increase was predominantly driven by a 23.8% increase in sales volume of CGuard EPS from $833,000 during the three months ended September 30, 2020, to $1,031,000 during the three months ended September 30, 2021.  This sales increase was mainly due to the fact that in the three months ended September 30, 2021, procedures with CGuard EPS, which are generally scheduled for non-emergency cases, continued to return to normalized levels in additional territories as compared to the three months ended September 30, 2020, when procedures with CGuard EPS were still somewhat postponed as hospitals shifted resources to patients affected by COVID-19.  In addition, the sales increased due to sales related to stents used in our FDA clinical trial which occurred in the three months ended September 30, 2021, but not in the corresponding period in 2020.  The increase in sales of CGuard EPS was partially offset by a decrease of 72.8% in sales of MGuard Prime EPS from $147,000 during the three months ended September 30, 2020, to $40,000 during the three months ended September 30, 2021, driven by the predominant industry preferences favoring drug-eluting stents rather than bare metal stents such as MGuard Prime EPS in STEMI patients.     

For the three months ended September 30, 2021, gross profit (revenue less cost of revenues) decreased by $206,000, to $92,000, from $298,000 during the three months ended September 30, 2020. This decrease in gross profit resulted from a $136,000 increase in material and labor costs (mainly due to an increase in sales volume as well as a short-term increase in production cost per unit), an increase in write-offs of $66,000, due to components supply issues, a $57,000 increase in new employee training costs, and an increase of $38,000 in miscellaneous expenses during the three months ended September 30, 2021. This decrease was partially offset by a $91,000 increase in revenues mainly due to an increase in sales volume (as mentioned above). Gross margin (gross profits as a percentage of revenue) decreased to 8.6% during the three months ended September 30, 2021 from 30.4% during the three months ended September 30, 2020, driven by the reasons mentioned above.Total operating expenses for the quarter ended September 30, 2021 were $4,123,000, an increase of 65.4% compared to $2,493,000 for the same period in 2020.  This increase was primarily due to increases of $708,000 in expenses related to the commencement of the C-Guardians FDA study, $400,000 in salary expenses and related accrual expenses due to additional resources mainly in our product development and sales infrastructure, $151,000 in development expenses associated with CGuard EPS new delivery system and accessory solutions, $147,000  in share-based compensation-related expenses due to the recognition of grants made since August 31, 2020, $102,000 in sales and marketing expenses associated with expansion of existing and new markets, $81,000 of Directors’ and Officers’ Liability Insurance expense due to increased premiums caused by recent trends in the overall insurance industry and $41,000 of miscellaneous expense.

For the three months ended September 30, 2021, financial expenses increased by 5.3%, or $2,000, to $40,000, from $38,000 during the three months ended September 30, 2020. Net loss for the third quarter of 2021 totaled $4,071,000, or $0.53 per basic and diluted share, compared to a net loss of $2,233,000, or $0.96 per basic and diluted share, for the same period in 2020. The average amount of shares outstanding used for the earnings per share calculation were 7,739,463 in the third quarter of 2021 and 2,325,619 in the third quarter of 2020, both adjusted to reflect the 1:15 reverse split effected by us on April 26, 2021.

As of September 30, 2021, cash, cash equivalents and short-term bank deposits were $37.1 million compared to $12.6 million as of December 31, 2020.

Conference Call and Webcast Details

Tuesday, November 9, 2021 at 8:30 a.m. ET

Domestic:                 877-407-4018

International:            201-689-8471

Conference ID:         13724012

Webcast:                  Webcast Link

About InspireMD, Inc.

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

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. For example, the company is using forward-looking statements when it discusses that its expansion of CGuard into France represents further progress of its reimbursement initiative as well as  growing global demand from physicians for its product when treating CAD, that the CGuard EPS will now receive this preferred status as a result of it being added to the list of reimbursed medical products (LPPR) at the end of October 2021, that its U.S. trial enrollment is on track, that it expects the fourth quarter of 2021 to yield additional site approvals and patient enrollments and that it continues to investment in its pipeline of innovative solutions continues as it advances toward regulatory approvals of two new delivery systems, capable of expanding CGuard’s market penetration and conversion of open surgery to endovascular procedures. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com

investor-relations@inspiremd.com

Tel Aviv, Israel— November 3, 2021 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of Carotid Artery Disease (CAD), today announced that results from the investigator-initiated SIBERIA randomized clinical trial of CGuard EPS, that evaluated the peri-procedural and 30-day silent brain infarcts associated with the use of its MicroNet™^TM covered stent (CGuard) versus a conventional “workhorse” open-cell Acculink™ nitinol stent were published this week. The principal investigator study was published in Journals of the American College of Cardiology (JACC) and is titled Randomized Controlled Trial of Conventional Versus MicroNet™-Covered Stent in Carotid Artery Revascularization. 

The main findings of the study included:

• CGuard MicroNet™-covered carotid stent, in relation to a first-generation stent:

• reduced 4.5-fold the magnitude of peri-procedural silent brain infarcts volume; and
• abolished post-procedural silent infarcts, that were on-going with the first-generation stent.

• This data constitute level 1 evidence in favor of a CGuard MicroNet™-covered stent in demonstrating reduction of cerebral infarcts in neuroprotective CAS versus Acculink.

This randomized control study evaluated 30-day silent brain infarcts associated with the use of the Acculink conventional open-cell nitinol stent vs the CGuard MicroNet™-covered stent. The MicroNet™-covered stent significantly reduced periprocedural cerebral embolism, showing an average of 57% reduction in lesion per patient (171 mm³ vs 73 mm³ (P = 0.017)) and a 4.5 fold reduction in total volume of periprocedural lesions (701 mm³ vs 157 mm³ (P = 0.007)) when compared to Acculink. Additionally, postprocedural (48 hours to 30 day) cerebral was abolished by the MicroNet™ covered stent, while it was ongoing with the conventional, first-generation carotid stent.

“We are very pleased with the results of the SIBERIA trial and the subsequent publication, as the first randomized, controlled clinical trial to directly compare CGuard EPS head-to-head against a widely used conventional stent,” said Marvin Slosman, Chief Executive Officer of InspireMD. “The study highlights our growing body of real-world clinical evidence as well as scientific evidence showing the superiority of the CGuard device in preventing brain embolization. This proprietary technology has the potential to change the standard of care and help physicians make better treatment decisions for the management of stroke and overall carotid artery disease. We are excited to further demonstrate the technology behind CGuard EPS with our C-Guardians registrational trial in the United States, for which we are currently enrolling patients.”

About InspireMD, Inc.

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

Forward-looking Statements

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

Investor Contacts:

Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
craigs@inspiremd.com

Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com

investor-relations@inspiremd.com