InspireMD Announces Publication of an Independent Clinical Review Authored by Leading U.S. and European Physicians Supporting Safety Advantages of Mesh-Covered Carotid Stents

 Comprehensive Review of Clinical Trial Data Supports the Safety and Efficacy of Carotid Artery Stenting (CAS) Versus Carotid Endarterectomy (CEA)

 Mesh Covered Carotid Devices Transforming the CAS Field

 Highlights Key Advantages of CGuard™ EPS Versus Conventional Stents Including Better Patient Outcomes

Tel Aviv, Israel—August 9, 2017 – InspireMD, Inc. (NYSE MKT:NSPR) (NYSE MKT:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced the publication of the independent study entitled, “One swallow does not a summer make but many swallows do: accumulating clinical evidence for nearly-eliminated peri-procedural and 30-day complications with mesh-covered

stents, transforms the carotid revascularization field,” in the Advances in Interventional Cardiology Journal 2017. The paper illustrates that carotid artery stenting (CAS) has the potential to be an equally safe, but less invasive, alternative to the surgical carotid endarterectomy (CEA) procedure. A link to the full article is available on the InspireMD website

The paper was co-authored by Dr Piotr Musiałek, Department of Cardiac and Vascular Diseases, Jagiellonian University, School of Medicine, John Paul II Hospital, Krakow, Poland, Professor L. Nelson Hopkins and Professor Adnan H. Siddiqui, both of the Departments of Neurosurgery and Radiology, School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Jacobs Institute, Gates Vascular Institute Kaleida Health, Buffalo, New York, USA.

The review finds that data from more than 550 patients in mesh-covered and dual layered carotid device clinical studies show an overall 30-day complication rate of ~1% with near-elimination of post-procedural events. This data, combined with other historical data on patients with symptomatic and asymptomatic carotid stenosis confirming no difference between CAS and CEA long term stroke risk, serve to illustrate the potential transformation of the carotid revascularization field.

Additional highlights from the paper include:

  • CGuard™ EPS’ open cell stent design together with SmartFit technology provides superior conformability compared to other next generation carotid devices, even in torturous lesions;
  • MicroNet™ covering has a very small pore size, thus provides maximum protection from protruding plaque;
  • CGuard™ EPS has a better radial force than current alternatives, and this, together with the open stent design, allows it to conform effectively to the vessel wall;
  • Current alternatives have no known tapered version of their stent, so unlike CGuardTM EPS, the operator needs to make measurements and calculations to ensure proper coverage of the lesion as there is considerable foreshortening.

Dr Jim Barry, CEO of InspireMD, commented, “This review paper, yet again, continues to underline the mounting evidence for treating carotid artery disease with the next generation carotid devices, both safely and less invasively, thereby reducing the need for surgery.  We are especially pleased that the review highlights CGuardTM EPS’ clinical data, compared to its competitors, making it the clearly preferred choice of the authors.”

About InspireMD, Inc.

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

InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

Forward-looking Statements

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

 

Investor Contacts:

InspireMD, Inc.

Craig Shore

Chief Financial Officer

Phone: 1-888-776-6804 FREE

Email: craigs@inspiremd.com  
 

Crescendo Communications, LLC

David Waldman

Phone: (212) 671-1021

Email: NSPR@crescendo-ir.com

 

 

 

 

 

InspireMD’s CGuard™ Carotid Embolic Prevention System Featured at the SOLACI CACI Congress of Cardiology 2017 in Buenos Aires

CGuardTM EPS procedure recorded and broadcast to the entire congress

Tel Aviv, Israel – August 3, 2017 – InspireMD, Inc. (NYSE MKT:NSPR) (NYSE MKT:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that an endovascular interventional procedure featuring the CGuard™ EPS performed by the team of Dr. Anibal Damonte, Interventional Cardiologist, Director of Interventional Cardiology at the Cardiovascular Institute of Rosario, and Vice President of the Argentine College of Interventional Cardiology, as well as Dr. Maximiliano Rossi, Interventional Cardiologist at the Cardiovascular Institute of Rosario was recorded and broadcast at the SOLACI CACI Congress of Cardiology 2017 (SOLACI CACI ’17) in Buenos Aires.  The case, entitled “Self Expanding Stent to Avoid Distal Embolization: Carotid InspireMD Stent Case presentation,” was displayed to the entire congress.

SOLACI CACI ’17 is the official annual meeting of the Latin American Society of Interventional Cardiology and the Argentinian School of Interventional Cardiologists, and is the largest meeting of cardiologists and interventional cardiologists in Latin America. SOLACI CACI ’17 is taking place from August 2-4, 2017.

Dr. Anibal Damonte, commented, “The CGuardTM EPS performed exceedingly well in a challenging case. The MicroNet™TM technology enables us to treat carotid artery disease safely in cases that would not have been possible with conventional carotid stents.”

“We are proud to have been selected to have our CGuard™ EPS featured in an endovascular interventional procedure to the entire congress at SOLACI CACI ’17,” said James Barry, PhD, Chief Executive Officer of InspireMD.  “We are truly honored and grateful to have Dr. Damonte and Dr. Rossi, two of the top key opinion leaders in Latin America perform this procedure.  We believe the selection of a clinical case conducted with CGuardTM by the Congress organizers further illustrates the growing interest and support for our technology.”

Additionally, InspireMD, is hosting an event to provide local distributor training, in addition to its booth on the general floor of SOLACI CACI ’17 featuring the Company’s MicroNet™ technology including CGuard™ Embolic Prevention System and MGuard Prime™.

About InspireMD, Inc.

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

InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

Forward-looking Statements

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

 

Investor Contacts:

 

InspireMD, Inc.

Craig Shore

Chief Financial Officer

Phone: 1-888-776-6804 FREE

Email: craigs@inspiremd.com   

 

Crescendo Communications, LLC

David Waldman

Phone: (212) 671-1021

Email: NSPR@crescendo-ir.com

InspireMD Schedules Second Quarter 2017 Earnings Conference Call

Tel Aviv—August 2, 2017 – InspireMD, Inc. (NYSE MKT:NSPR) (NYSE MKT:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that it will host a conference call on Wednesday, August 9th at 8:00 a.m. Eastern Time to discuss the company’s financial results for the second quarter ended June 30, 2017, as well as the Company’s corporate progress and other meaningful developments.The conference call will be available via telephone by dialing toll free 866-682-6100 for U.S. callers or +1 862-255-5401 for international callers, or on the Company’s Investor Relations section of the website: https://www.inspiremd.com/en/investors/investor-relations/.A webcast will also be archived on the Company’s website and a telephone replay of the call will be available approximately one hour following the call, through midnight August 23, 2017, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 15963.

About InspireMD, Inc.

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

InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

Forward-looking Statements

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

Investor Contacts:

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

Crescendo Communications, LLC
David Waldman
Phone: (212) 671-1021
Email: NSPR@crescendo-ir.com

InspireMD Announces Completion of Transition from Exclusive European Distributor to InspireMD Managed Local Distribution Network

Agreements Completed with Leading Distributors in Austria and Belgium

Tel Aviv, Israel—June 13, 2017 – InspireMD, Inc. (NYSE MKT:NSPR) (NYSE MKT:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced it has signed distribution agreements for CGuard™ EPS with Comesa GmbH, as well as “be medical,” who are among the leading medical distributors in Austria and Belgium, respectively. Consequently, all territories previously covered by Penumbra, InspireMD’s former European distributor, have now been transferred to local distributors.

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “We are pleased to announce these latest distributor agreements with leading medical device distributors in Austria and Belgium. In just a few months we have completed our transition from a single distributor to a comprehensive network of regional distributors with deeper penetration in their respective markets and in each of the relevant clinical specialties. Furthermore, we have been able to launch CGuard™ in markets that were part of the previous exclusive distribution agreement, but were not commercially active. As a result, we now have a comprehensive European sales and distribution network.  We appreciate the support of our former distributor in ensuring a smooth transition.”

 

About InspireMD, Inc.

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

InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

Forward-looking Statements

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

Investor Contacts:

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

 

Crescendo Communications, LLC
David Waldman
Phone: (212) 671-1021
Email: NSPR@crescendo-ir.com

InspireMD Announces Distribution Agreement for CGuard™ EPS in Taiwan

Tel Aviv, Israel—June 8, 2017 – InspireMD, Inc. (NYSE MKT:NSPR) (NYSE MKT:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced it has signed an agreement with LORION Enterprises Inc., a leading medical distributor in Taiwan, to distribute CGuard™ EPS (Embolic Prevention System).

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “In line with our strategy to expand our global footprint, we are now pleased to announce our partnership with LORION Enterprises, a leading medical device distributor in Taiwan. The agreement includes minimum required purchases and, in addition to Hong Kong, represents another important step in our expansion strategy in the Asia Pacific region. The Asia Pacific region is an important component of our growth strategy due to the prevalence of carotid stenting as a preferred alternative to vascular surgery. LORION Enterprises brings extensive relationships with the top key opinion leaders in Taiwan, as well as physicians across all the relevant clinical specialties. We are planning to announce further partnerships in the coming months” 

Mr. Chin Ching Yu, General Manager of LORION Enterprises Inc. noted, “We look forward to launching CGuard™ EPS and believe we can rapidly capture a significant share of the Taiwanese market, which has a population of more than 20 million people.  Given the safety advantages of CGuard™, supported by positive clinical data demonstrating its ability to significantly reduce the risk of embolism and stroke, we believe CGuard™ will rapidly become standard of care.”

About InspireMD, Inc.

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

InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

Forward-looking Statements

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

Investor Contacts:

 

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

 

Crescendo Communications, LLC
David Waldman
Phone: (212) 671-1021
Email: NSPR@crescendo-ir.com

InspireMD Announces the Publication of an Investigator Initiated Clinical Registry Reaffirming MGuardTM Prime as a Highly Effective Tool to Prevent Heart Damage in Coronary Artery Blockages with High Thrombotic Content

Study Entitled “Long term Outcomes of MGuard™ Stent Deployment in Saphenous Vein Grafts and Native Coronary Arteries: A Single Center Experience”

 Tel Aviv, Israel—June 7, 2017 – InspireMD, Inc. (NYSE MKT:NSPR) (NYSE MKT:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced the publication of an independent clinical study entitled, “Long term Outcomes of MGuard™ Stent Deployment in Saphenous Vein Grafts and Native Coronary Arteries: A Single Center Experience,” in the Israel Medical Association Journal.

The study was published by the Department of Cardiology, Rabin Medical Center, affiliated with the Sacker Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. The study followed 163 consecutive patients who underwent MGuard™ stent deployment during the period 2009 to 2014. The MGuard™ stent was used in 67% of patients who underwent Saphenous Vein Grafts (SVG) procedure while 33% were treated for native coronary artery disease, the majority during ST-Elevation Myocardial Infarction (STEMI) in the latter group.

One of the lead authors, Dr. Ran Kornowski, commented: “Our study is one of the largest and longest running analysis of MGuard™ charting the outcomes of these patients for up to one year. We have found MGuard™ to be a highly effective solution to prevent no-reflow syndrome. No-reflow syndrome manifests itself by the absence of blood flow in the capillary system after a blocked coronary artery has been opened and is related to heart damage that may increase post-interventional mortality rates. Revascularization rates in the study were 7% in the native vessel group and 15% in the SVG group. In the native vessel group, this rate is satisfactory where the presence of thrombus and possible no-reflow syndrome is a major concern. In the SVG group, revascularization levels were comparable to drug eluting stents (DES) stents. We have thus concluded that the MGuardTM Prime stent remains a very effective treatment option in patients with Saphenous Vein Grafts and in STEMI patients with vessels with high thrombotic content.”

James Barry, PhD, Chief Executive Officer of InspireMD, commented: “This study clearly shows that MGuard™ remains an important, potentially live saving tool in the treatment paradigm of STEMI with highly thrombotic lesions and Saphenous Vein Grafts, and is consistent with previous clinical trial results using MGuardTM Prime. This is an important message on the benefits of MGuard™ in treating complex coronary artery disease and we intend to continue to re-enforce this clinical data within the clinical community in the coming months.”

About InspireMD, Inc.

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

InspireMD intends to pursue applications of this MicroNet™ technology in coronary (MGuard™ Prime), carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

Forward-looking Statements

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

 

Investor Contacts:

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

Crescendo Communications, LLC
David Waldman
Phone: (212) 671-1021
Email: NSPR@crescendo-ir.com

 

InspireMD Announces Distribution Agreement for CGuardTM EPS in Poland

Tel Aviv, Israel—June 5, 2017 – InspireMD, Inc. (NYSE MKT:NSPR) (NYSE MKT:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced it has signed an agreement with Arteriae Sp. z o.o. sp.k, a leading medical distributor in Poland, to distribute CGuard™ EPS (Embolic Prevention System).

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “We are delighted to partner with Arteriae, a leading device distributor in Poland. The agreement includes minimum required purchases, reinforcing Arteriae’s confidence in our device. Arteriae brings strong relationships with the top key opinion leaders and physicians across all relevant clinical specialites and plans to expand its sales force to focus on CGuardTM EPS.  Importantly, this agreement further illustrates our success in expanding our direct distribution model in markets previously covered by our former distributor.”

Mrs. Joanna Niedzielska, CEO of Arteriae, noted, “We look forward to aggressively launching CGuard™ in Poland.  Given the important safety advantages of CGuard™ that have been demonstrated to date, our near-term goal is to capture a signicant share of the Polish market and we believe this device will soon become standard of care.”

About InspireMD, Inc.

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

InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

Forward-looking Statements

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

 

Investor Contacts:

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

Crescendo Communications, LLC
David Waldman
Phone: (212) 671-1021
Email: NSPR@crescendo-ir.com

InspireMD Announces Appointment of Paul Stuka as Chairman of the Board

Tel Aviv, Israel—June 2, 2017 – InspireMD, Inc. (NYSE MKT:NSPR) (NYSE MKT:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that Paul Stuka, who has served on the Company’s Board of Directors since 2011, has been appointed Chairman of the Board, replacing Sol Barer, Ph.D., who is stepping down from the Board due to conflicting professional commitments, but will serve as a special advisor to the Board.

Mr. Stuka currently serves as the managing member of Osiris Partners, LLC, an investment fund, since 2000. Prior to forming Osiris Partners, LLC, Mr. Stuka was a managing director of Longwood Partners, managing small cap institutional accounts. In 1995, Mr. Stuka joined State Street Research and Management as manager of its Market Neutral and Mid Cap Growth Funds. From 1986 to 1994, Mr. Stuka served as the general partner of Stuka Associates, where he managed a U.S. based investment partnership. Mr. Stuka began his career in 1980 as an analyst at Fidelity Management and Research. As an analyst, Mr. Stuka followed a wide array of industries including healthcare, energy, transportation, and lodging and gaming. Early in his career he became the assistant portfolio manager for three Fidelity Funds, including the Select Healthcare Fund which was recognized as the top performing fund in the United States for the five-year period ending December 31, 1985.

James Barry, Ph.D., Chief Executive Officer of InspireMD, commented, “Both the management team and the Board are excited with the appointment of Paul as our new Chairman of the Board.  Paul not only brings over 35 years of capital markets experience, which will be extremely valuable as we enter the next phase of our growth, but he also knows our company well given his role as a Director since 2011.  He has an impressive track record helping micro- and small-cap companies navigate the capital markets and maximize shareholder value.”

Mr. Stuka commented, “I am honored to become Chairman of InspireMD.  Recent responses to our technology from key opinions leaders has been overwhelmingly positive and we look forward to capitalizing on this excitement as we rapidly grow our distribution network throughout the world.  First and foremost, we are committed to maximizing value for shareholders by continued revenue growth, careful management of our expenses, and an eye on potential partnerships across our technology platform. I would also like the thank Sol Barer for his tremendous contributions as Chairman of the Board.  His guidance and support over the years has been invaluable and we are grateful for his willingness to serve as a special advisor to the Board.”

Dr. Barer concluded, “I remain confident in the outlook for the Company.  Although my current responsibilities preclude me from serving on the Board, I look forward to remaining an active advisor, supporter and major shareholder of the Company.”

 

About InspireMD, Inc.

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

InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

Forward-looking Statements

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

 

Investor Contacts:

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

Crescendo Communications, LLC
David Waldman
Phone: (212) 671-1021
Email: NSPR@crescendo-ir.com

InspireMD to Present at the 6th Annual SeeThruEquity Microcap Investor Conference

NEW YORK, NY / ACCESSWIRE / May 31, 2017 / InspireMD, Inc. (NYSE MKT:NSPR) (NYSE MKT:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, announced today that it will be presenting at the 6th Annual SeeThruEquity Microcap Investor Conference at 11:30 AM EDT on June 1, 2017 at Convene Grand Central located at 101 Park Ave in New York City.  James Barry, PhD, Chief Executive Officer of InspireMD will be presenting, as well as meeting with investors.

Each company will be provided with a 30-minute time slot to present to an audience of investors and industry professionals and company management will also be available for one-on-one meetings with institutional investors.

Conference registration: complimentary for qualified investors and equity research analysts.
In order to register as an attendee of the conference, please click HERE.

News Compliments of ACCESSWIRE.

About InspireMD, Inc.

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

InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

About SeeThruEquity

Since the company’s founding in 2011, SeeThruEquity (STE) has been committed to its core mission: providing impactful, high quality research on uncovered and undercovered microcap stocks and hosting investor conferences throughout the year. STE has been able to grow its research universe to over 190 names.

STE conferences are the ultimate event for publicly traded companies with less than $1 billion in market capitalization because it augments the conference experience with the firm’s research which is part of Wall Street consensus and available across industry leading platforms including Thomson First Call, FactSet, S&P CapitalIQ, Yahoo! Finance and Bloomberg to name a select few. STE has hosted over 23 investor conferences which have showcased over 400 companies, attracted over 5000 attendees and have included over 2000 1-on-1 meetings. For more information please visit www.seethruequity.com/conference/.

 

Investor Contacts:

InspireMD, Inc.
Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804 FREE

Email: craigs@inspiremd.com  

Crescendo Communications, LLC
David Waldman
Phone: (212) 671-1021
Email: NSPR@crescendo-ir.com

SOURCE: InspireMD

 

InspireMD Announces First Two Patients in Hong Kong Successfully Treated with CGuard™ EPS

Tel Aviv, Israel—May 30, 2017 – InspireMD, Inc. (NYSE MKT:NSPR) (NYSE MKT:NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced the first two patients in Hong Kong have been successfully treated with CGuard™ EPS. The two cases were conducted on patients with carotid artery stenosis at St. Teresa Hospital by Dr. PW Cheng and Dr. YW Chow, a leading neurointerventional radiologist and leading cardiologist, respectively.

These first cases in Hong Kong follow the previously announced distribution agreement for CGuard™ EPS with a distribution partner in Hong Kong that was announced two months ago. These are the first cases performed in the Asia Pacific region and represent a further milestone for InspireMD’s global expansion strategy.

Dr. PW Cheng and Dr. YW Chow commented, “These procedures went seamlessly and we are very pleased with the way CGuard performed. We are very excited to have access to this innovative technology as it provides vastly superior safety to carotid artery stenting (CAS) patients compared to conventional stents. We envision this procedure becoming the standard of care for carotid stenting procedures.”

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “We are pleased to report another milestone in the continued execution of our growth strategy in the Asia Pacific region.  Dr. Cheng and Dr. Chow are among the top physicians in Hong Kong in their respective fields, further illustrating our ability to attract the top key opinion leaders around the world.  We look forward to announcing further progress in the Asia Pacific region over the coming months.”

 

About InspireMD, Inc.

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

InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

Forward-looking Statements

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

 

Investor Contacts:

 

InspireMD, Inc.

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

 

Crescendo Communications, LLC
David Waldman
Phone: (212) 671-1021
Email: NSPR@crescendo-ir.com