InspireMD’s CGuard™ Embolic Prevention System to be Prominently Featured in Two Live Case Transmissions at LINC 2018

Tel Aviv, Israel— January 26, 2018 – InspireMD, Inc.  (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that its CGuard™ Embolic Prevention System (EPS) will be featured in two separate live case transmissions at the Leipzig Interventional Course (LINC) 2018 to be held from January 30th to February 2nd at the Trade Fair Leipzig, Hall 2 in Leipzig, Germany.  CGuard™ EPS will also be featured in two scientific sessions and a poster presentation at the conference.

On January 30, from 11:50 AM – 12:16 PM Central European Time, Dr. Antonio Micari and Dr. Fausto Castriota, interventional cardiologists with Maria Cecilia Hospital, Cotignola, Italy, will perform a live endovascular procedure entitled, “Symptomatic left internal carotid disease in a 79-year old woman,” featuring  CGuard™ EPS  that will be transmitted real time to the congress.

On January 30, from 4:30 – 6:00 PM Central European Time, Dr. Andrej Schmidt and Dr. Matthias Ulrich from the Department of Angiology, University Hospital Leipzig, Division of Interventional Angiology, Leipzig, Germany, will perform a live endovascular procedure entitled, “Restenosis after TEA left internal carotid artery,” featuring  CGuard™ EPS  that will be transmitted real time to the congress.

The CGuard™ Carotid Embolic Prevention System will also be featured at the Company’s booth (18c2).

Additional presentations featuring CGuard™ EPS will include:

What:               Comparative analysis of new mesh-covered stent designs using MRI parameters (Maria Antonella Ruffino, MD, EBIR; Italy)
When:              January 30, 10:05 – 10:12 AM Central European Time
Where:            Room 3 – Technical Forum

 

What:               Transcervical carotid stenting (TECAR) with flow reversal vs. CEA in highly symptomatic patients (Professor Ralf R. Kolvenbach MD, PhD, FEBVS; Germany)
When:              January 30, 10:26 – 10:33 AM Central European Time
Where:            Room 3 – Technical Forum

 

CGuard™ EPS will also be featured in a poster presentation, entitled, “Single-center experience with MicroNet™ covered embolic prevention stent in a treatment of vulnerable carotid plaque: short and mid-term results” (Valdimir Gavrilovic, MD; Italy) on January 31, from 3:00 – 3:05 PM Central European Time in front of the Main Arena 1.

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

“It is a true honor to have CGuard™ EPS, once again, chosen by these leading physcians  to be prominently featured in two live case transmissions at LINC 2018, in addition to the two podium presentations and and a poster presentation,” said James Barry, PhD, Chief Executive Officer of InspireMD.  “This continues to support the progress we have made in demonstrating the truly meaningful safety benefits of CGuardTM EPS and this can be seen in the support we are receiving from key opinion leaders in Europe and around the world.”

About InspireMD, Inc.

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

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

Investor Contacts:

 

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

 

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

 

InspireMD Announces Publication of an Independent Imaging Study Highlighting the Advantages of CGuard™ EPS Compared to Another Next Generation Carotid Stent

Tel Aviv, Israel— January 19, 2018 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced the publication of an independent observational study conducted by Tomoyuki Umemoto, MD and colleagues in the December 2017 issue of the journal EuroIntervention demonstrating the advantage of CGuard™ EPS in reducing stent plaque prolapse (vascular tissue or thrombus protruding through the stent and into the carotid artery following stenting that is vulnerable to embolizing into the brain) in carotid artery stenting patients.
The aim of this study was to compare plaque prolapse after carotid artery stenting (CAS) with CGuard™ versus a competing device as assessed by optical coherence tomography (OCT), a technique that performs high definition images inside of the artery. A series of sixteen consecutive patients undergoing CAS were enrolled in the study. A total of 248 cross-sectional OCT images (166 images for CGuardTM and 82 for the competing device) were analyzed to assess the incidence of plaque prolapse.
As introduction to this OCT study, an editorial appeared in the same EuroIntervention issue, authored by Professor Piotr Musialek, Jagiellonian University Department of Cardiac & Vascular Diseases, John Paul II Hospital, Krakow, Poland, and Prof Eugenio Stabile, Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples “Federico II”, Naples, Italy. The editorial authors state: “With conventional carotid stenting, plaque prolapse occurs via the ‘cheese-grater’ effect.” They go on to highlight the permanent protective role of CGuard™ EPS, the unique MicroNet™ covered carotid stent, which already demonstrated neuro-protection in the CARENET Study. The editorial authors noted that the competing device had a two-fold greater risk of plaque prolapse compared with CGuard™ in the OCT frames analysis.
James Barry, PhD, Chief Executive Officer of InspireMD, commented, “We are pleased to see another study conducted on CGuard™ EPS that was again, focused on proving out the mechanism of the protective properties of MicroNet™ in the treatment of carotid artery disease. While this observational study was conducted on a limited number of patients, it was encouraging to see that CGuard™ EPS continues to perform as advertised in the clinical setting. Moreover, the fact that yet another independent clinical investigation was conducted and the investigators saw it fit to once again publish further validates the interest in CGuard™ EPS and the future the device holds for potentially preventing catastrophic events that can occur with conventional carotid artery stents.”
EuroIntervention is a monthly peer-reviewed journal of interventional cardiovascular medicine that has become one of the benchmarks in its field. EuroIntervention is the official journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI). The Journal is endorsed by the European Society of Cardiology (ESC) and has a distinguished European and International editorial board led by Prof Patrick W. Serruys from the Erasmus MC, Rotterdam.
The Company also announced that it has received notice from the NYSE American LLC (the “NYSE American”) pursuant to Section 1003(f)(v) of the NYSE American’s Company Guide that, due to the Company’s current low selling share price, the Company’s continued listing on the NYSE American is contingent upon the Company effecting a share consolidation or otherwise demonstrating a sustained improvement in its share price within the next six months but not longer than July 16, 2018 (or such longer period as may be agreed to by the NYSE American).

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.
InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS.

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 Projects 211% Increase in CGuard™ EPS Sales for the Fourth Quarter of 2017

Conference call to be held at 10AM Eastern today to discuss recent developments, preliminary sales results and proposals for upcoming shareholder meeting

 

Tel Aviv, Israel— January 10, 2018 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced preliminary unaudited sales results for the fourth quarter of 2017.  The Company anticipates sales of approximately $833,000 for the fourth quarter of 2017, compared to $322,000 for the same period last year.  This represents an approximately 159% increase, which is primarily due to increased sales of CGuard™EPS.  The Company anticipates a 211% increase in sales of CGuard™ EPS to approximately $606,000, compared to $195,000 for the same period last year.

 

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “CGuard™ EPS is not only gaining acceptance among key opinion leaders (KOLs) that treat carotid artery disease, but these physicians are now asking us, unsolicited, to be more involved with our program.  We believe this growing interest, combined with our specialized distribution network, positions us for even stronger sales growth as these KOLs support our expansion into the mainstream group of users that include vascular surgeons, interventional cardiologists, interventional radiologists and interventional neuroradiologists. In addition to Europe, we are now establishing a foothold in Asia, evidenced by recent distribution agreements in India, Hong Kong, Taiwan, Australia, New Zealand and Vietnam. For these and other reasons, we are extremely encouraged heading into 2018.”

 

Conference Call

The Company plans to host a conference call today, Wednesday, January 10th, at 10:00 a.m. Eastern Time to discuss recent developments, preliminary unaudited fourth quarter 2017 sales results, and proposals under consideration for the upcoming shareholder meeting. A link to the Company’s definitive proxy statement is available at: https://www.sec.gov/Archives/edgar/data/1433607/000149315217015034/def14a.htm.

 

The conference call will be available via telephone by dialing toll free 877-407-0782 for U.S. callers or +1 201-689-8567 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 January 24, 2018, 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: 23561.

 

About InspireMD, Inc.

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

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

 

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 Conference Call to Discuss Recent Developments, Preliminary Sales Results and Proposals for Upcoming Shareholder Meeting

Tel Aviv—January 3, 2018 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that it will host a conference call on Wednesday, January 10th at 10:00 a.m. Eastern Time to discuss recent developments, preliminary unaudited fourth quarter 2017 sales results, and proposals under consideration for the upcoming shareholder meeting. A link to the Company’s definitive proxy statement is available at: https://www.sec.gov/Archives/edgar/data/1433607/000149315217015034/def14a.htm.

The conference call will be available via telephone by dialing toll free 877-407-0782 for U.S. callers or +1 201-689-8567 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 January 24, 2018, 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: 23561.

About InspireMD, Inc.

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

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

 

Investor Contacts:

 

InspireMD, Inc.

Craig Shore

Chief Financial Officer

Phone: 1-888-776-6804 FREE

Email: craigs@inspiremd.com   

 

Crescendo Communications, LLC

David Waldman

Phone: (212) 671-1021

Email: NSPR@crescendo-ir.com

 

InspireMD Announces Regulatory Approval of CGuard™ EPS in India; Signs Agreement with Leading Indian Medical Device Distributor

Tel Aviv, Israel— January 3, 2018 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that it has received regulatory approval for the CGuard™ Embolic Prevention System (EPS) in India. The approval was granted by India’s Central Drugs Standard Control Organisation within the Ministry of Health & Family Welfare. The Company also announced it signed Hester Diagnostics Pvt. Ltd. as its exclusive distributor in India. This partnership follows similar distribution agreements across Asia, including Hong Kong, Taiwan, Australia, New Zealand and Vietnam

 

Hester Diagnostics brings over 25 years of distribution and marketing experience in India, including medical devices, diagnostic kits and a wide range of additional products for the healthcare industry. Hester works with many of the leading medical device companies in the United States, Europe and Japan covering clinical specialties that include interventional cardiology, interventional neuroradiology, and interventional radiology.

 

Sanjiv Gandhi, Managing Director of Hester Diagnostics, commented, “We are excited to partner with InspireMD, given the extensive clinical data illustrating the safety advantages of CGuard™ EPS. We are now gearing up and look forward to commencing the formal commercial launch of the product.” 

 

“The approval of CGuard™ EPS in India marks another commercial milestone as we continue to expand our global footprint,” said Agustin Gago, EVP and Chief Commercial Officer of InspireMD.  “We are excited to partner with Hester Diagnostics, which brings an impressive track record launching medical devices in India and to the key clinical specialties that treat carotid artery disease.”

 

About InspireMD, Inc.

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

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

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™ Embolic Prevention System Once Again Featured in a Successful Live Clinical Case at Leading Industry Conference

Professor Pierfrancesco Veroux treated a patient
with carotid artery disease using CGuard™ EPS

Tel Aviv, Israel— December 18, 2017 – InspireMD, Inc.  (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that CGuardTM EPS was once again prominently featured in a live clinical case at an industry conference. Professor Pierfrancesco Veroux, Head of Vascular Surgery and Transplant Center, Policlinico Vittorio Emanuele di Catania, performed the live procedure featuring the CGuard™ EPS at ENDOGRAFT. ENDOGRAFT is the Endovascular Global Roman Arterial Featured Therapies conference, which was held from December 14th-16th, 2017 in Rome. The case was transmitted real time to the entire congress on December 15, 2017. Professor Veroux is also a President of the conference.
The ENDOGRAFT conference is an international and multidisciplinary conference dedicated to the treatment of complex vascular diseases. The conference brings together endovascular specialists including vascular surgeons, interventional cardiologists, radiologists and neurologists from around the world.
Professor Veroux commented, “The CGuard™ EPS performed extremely well during the live procedure, and I believe this technology should become standard-of-care given the strong supporting clinical data which demonstrates the MicroNet™ technology’s ability to reduce the risk of post-procedural embolism and stroke.”
“We were honored to have Professor Veroux feature CGuard™ and the MicroNet™ technology in a live case transmission at the ENDOGRAFT conference,” said James Barry, PhD, Chief Executive Officer of InspireMD. “We continue to see that key opinion leaders across all clinical specialties not only want to use CGuard™ EPS to treat their patients suffering from carotid artery disease, but are also demonstrating its benefits to other physicians. We are especially gratified to have our technology featured so prominently at this leading industry conference by a surgeon of Professor Veroux’s caliber and reputation. While most of these conferences have a limited amount of live transmissions, CGuard™ is being chosen by these thought leaders once again.”

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.
InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS.

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™ EPS Demonstrates Improved Outcomes over Carotid Endarterectomy in 50 Patient Comparative Study; Preliminary Results Featured at the 7th Munich Vascular Conference 2017

Tel Aviv, Israel— December 7, 2017 – InspireMD, Inc.  (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that Professor Ralf Kolvenbach, head of the Vascular Surgery and Endovascular Therapy Department, and Medical Director of the Catholic Hospital, Düsseldorf, Germany, presented the preliminary results of a 50 patient study at the 7th Munich Vascular Conference, which demonstrated improved outcomes using CGuard™ EPS versus carotid endarterectomy (CEA).
Key highlights of this preliminary study include:
⦁ The gold standard more invasive CEA surgical procedure did not show show any clinical benefit versus CGuard™ EPS
⦁ Cranial nerve injury was significantly lower in patients with CGuard™ EPS versus patients undergoing CEA
⦁ Hospital discharge was faster in the CGuard™ EPS group compared to CEA

In contrast to conventional stents, CGuard™ EPS has been designed to deliver post-procedural long term protection for treatment of carotid lesions. The transcervical carotid stenting (T-CAR ) method was used in the CGuard™ EPS group, and is a less invasive method than CEA. TCAR is a method used by many vascular surgeons to facilitate direct stent implanation into the carotid artery.
Professor Kolvenbach commented, “I am very pleased with the preliminary results in this study. Our goal is to demonstrate with long term data that the CGuard™ EPS when implanted with the TCAR method will continue to perform as it did in this preliminary cohort of patients and ultimately show better results to CEA.”
50 consecutive symptomatic patients were evaluated. In one study group, 31 patients were treated with CGuard™ EPS using the TCAR method, and in the other group 19 patients were treated with CEA. The study did not find advantages for CEA in clinical endpoints or in DW-MRI postprocedural images, while cranial nerve injury was significantly more frequent in the CEA group compared to the CGuard™ EPS group. Hospital discharge in the CGuard™ EPS group was an average of 1.5 days earlier compared to CEA.
James Barry, PhD, Chief Executive Officer of InspireMD, commented, “The results of this trial further demonstrate the effectiveness of our technology. These results continue to support the protective role of CGuard™ EPS in the treatment of carotid artery disease.”
The 7th Munich Vascular Conference (MAC), held on December 7-9, 2017, is a platform for mutual exchange between vascular clinicians from all vascular medical specialties and colleagues from translational and basic research. The 7th MAC addresses aortic, carotid, venous and peripheral arterial diseases, featuring the latest advances in clinical and translational vascular research, including the newest open and endovascular technologies, biological mechanisms of atherosclerosis and the latest imaging modalities.

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.
InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS.

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 Preliminary 2 Year Follow-up Results from the PARADIGM Clinical Study Using CGuard™ EPS

No procedure or device related adverse events at 24 months

Results presented at the 2017 VEITHsymposium in New York
and ICI Meeting 2017 in Tel Aviv

Tel Aviv, Israel— December 5, 2017 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced the preliminary 24 month follow-up results in the PARADIGM 101 Clinical Study utilizing CGuard™ EPS. Dr. Piotr Musiałek, Department of Cardiac and Vascular Diseases, John Paul II Hospital, Kraków, Poland, presented the long-term follow-up at the 2017 VEITH Symposium in New York on November 16th, 2017 and the ICI Meeting 2017 in Tel Aviv on December 4, 2017.

PARADIGM-101 is an investigator-led clinical study evaluating the use of CGuard™ EPS in 101 consecutive all-comer patients with symptomatic or high-risk asymptomatic carotid artery stenosis. The data presented illustrate that no periprocedural or postprocedural intervention related death, major stroke, or myocardial infarction had occurred in the study patients at 24-month follow-up.

These excellent results in PARADIGM-101 are consistent with the other CGuard™ EPS Trials, including CARENET, IRON-GUARD, WISSGOTT Study and CASANA Study. The PARADIGM study long-term preliminary results further confirm the sustained benefits of CGuard™ out to two years and make it a potential permanent therapeutic protection option for all-comer patients with carotid artery disease.

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “We are excited to see Prof. Musialek’s report out on the long-term follow-up data from the PARADIGM study, which represents the longest known clinical follow-up with any such carotid devices to date. This is just antoher piece of data that continues to reinforce the potential benefits of CGuard EPS. The 24 month follow-up data from this trial simply confirms the sustained long term benefit CGuard could provide to pateints with carotid artery disease.”
The VEITHsymposium provides vascular surgeons, interventional radiologists, interventional cardiologists and other vascular specialists with a unique and exciting format to learn the most current information about what is new and important in the treatment of vascular disease. The 5-day event features rapid-fire presentations from world renowned vascular specialists with emphasis on the latest advances, changing concepts in diagnosis and management, pressing controversies and new techniques.
The ICI Meeting 2017 is the premier international conference for innovations in cardiovascular systems (heart, brain and peripheral vessels) and high-tech life science companies.

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™ technology to make its products the industry standard for embolic protection and to provide a superior solution to the key clinical issues of current stenting in patients with a high risk of distal embolization, no reflow and major adverse cardiac events.
InspireMD intends to pursue applications of this MicroNet™ technology in coronary, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS.

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 Expansion of its Distribution Network for CGuard™ EPS in Australia, New Zealand and Vietnam

Tel Aviv, Israel— December 4, 2017 – InspireMD, Inc. (NYSE AMER:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced it has signed Diverse Devices Pty Ltd as its exclusive distributor for Australia and New Zealand, and has signed Do Gia Production and Trading JSC as its exclusive distributor in Vietnam.

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “We are pleased to announce these two additional distributors in the Asia Pacific Rim, which represents the continuation of our planned expansion into the Asian market and further expand our global distribution footprint. Our partners have strong physician networks across all the relevant clinical specialties that treat carotid artery disease in their respective regions. These agreements follow similar announcements in Hong Kong and Taiwan. The Asia-Pacific region represents a sizable and important market given the prevalence of carotid stenting as a preferred alternative to vascular surgery. We look forward to announcing additional partnerships for the region 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, carotid (CGuard™), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS.

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 Planned Recapitalization

Tel Aviv, Israel— November 29, 2017 – InspireMD, Inc. (NYSE MKT:NSPR), a leader in embolic prevention systems (EPS) / thrombus management technologies and neurovascular devices, today announced that it entered into a securities purchase agreement with an institutional investor for the issuance and sale of 750 shares of InspireMD’s Series D Preferred Stock for aggregate gross proceeds of $750,000 as part of a planned recapitalization of the Company.

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “At the time of our last capital raise, we were in the early stages of a turnaround, which limited our funding options and resulted in a complicated capital structure.  We have since executed against our operational plan as illustrated by the strong sequential and year-over-year growth in sales of CGuard™ EPS.  Despite this growth, our current capital structure has proven an impediment to driving shareholder value.  As such, we decided to undertake a proposed recapitalization.  We believe these steps were necessary and will ultimately prove beneficial for shareholders given the operational success we are now experiencing.”

The Series D Preferred are convertible into shares of common stock at the lesser of $0.50 or 60% of the closing bid price immediately prior to the closing date under the securities purchase agreement, which shall be the earlier of December 11, 2017, and the date immediately following the date that the closing bid price of the common stock is $0.33 per share or less, subject to a $0.20 floor (“Series D Conversion Price”).  To the extent that the Series D Conversion Price is greater than $0.33, it will be reset to $0.20 per share if the price of the common stock is less than $0.33 per share at any time subsequent to the closing date. The Series D preferred stock does not contain any substantive features that differ materially from the Company’s common stock other than a mechanism that would prevent a holder of such preferred stock from converting the preferred stock into common stock or voting such preferred stock to the extent it would cause such holder to beneficially own more than 19.99% of the Company’s common stock until shareholder approval of the conversion of the Series D Preferred into in excess of 19.99% of our outstanding common stock.  The closing is subject to the satisfaction of customary closing conditions. 

As a result of the issuance and sale of the Series D Preferred Stock, the conversion price of the outstanding shares of Series B Stock will be reduced to the Series D Conversion Price pursuant to the anti-dilution adjustment provisions of the Series B Preferred Stock.  There will, however, be no change to the conversion price of the outstanding Series C Preferred Stock as a result of holders of a majority of the outstanding Series C Preferred Stock consenting to an amendment to the terms of the Series C Preferred exempting the issuance of the Series D Preferred from the anti-dilution adjustment provisions of the Series C Preferred Stock.

Among other things, in connection with the securities purchase agreement, the Company has agreed (1) to refrain from issuing shares of common stock until 90 days after the closing date of the securities purchase agreement, except that the Company may commence an offering of its common stock or common stock equivalents for gross proceeds of at least $8 million (a “Qualified Offering”) at any time after February 26, 2018, and make certain other exempt issuances, (2) to use 12.5% of the proceeds from any subsequent offering of the Company’s securities to redeem the outstanding shares of Series B Preferred Stock owned by the purchasers executing the securities purchase until the Company has redeemed an aggregate of up to $1.5 million of stated value of Series B Preferred Stock, and (3) to refrain from entering into certain variable rate transactions until the date that is six months after the closing date.

In addition, upon the consummation of a Qualified Offering, the purchaers have agreed to exchange shares of Series B Preferred Stock and Series C Preferred Stock owned by them into the securities sold by the Company in the Qualified Offering upon the terms set forth in the securities purchase agreement.  The purchasers shall also have the option to exchange their Series D Preferred Stock into the seucrities issued in a Qualfied Offering. 

Additional details of the transaction will be available in the Company’s Form 8-K filed with the Securities & Exchange Commission on or prior to November 29, 2017, and is available at www.sec.gov.  

The Company also announced that on November 22, 2017 it recevieved an additional letter from the New York Stock Exchange that it is not in compliance with Section 1003(a)(ii) of the Company Guide relating to the stockholders’ equity and net income continued listing standards.  This follows the Company’s announcement on October 24, 2017 that the New York Stock Exchange has accepted the Company’s plan to regain compliance with the NYSE American’s stockholder’s equity continued listing standard (Part 10, Section 1003(a)(iii)). The Company has until February 17, 2019 to regain compliance with the continued listing requirements and believes that the proposed recapitalization will help further address the requirements of the New York Stock Exchange.

 

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