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

InspireMD’s CGuard™ Carotid Embolic Prevention System Featured in Live Case Transmission at EuroPCR 2017

Prof. Alberto Cremonesi’s team performed successful case  
treating a patient with carotid artery disease with CGuard™ EPS

 

Tel Aviv, Israel – May 18, 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 the team of Prof. Alberto Cremonesi, Chief of the Cardiovascular Department and Director of the Interventional Cardiovascular Unit of Maria Cecilia Hospital – GVM Care & Research, Cotignola (Italy), performed a live stent endovascular interventional procedure featuring the CGuard™ EPS Carotid Stent at EuroPCR 2017.  The case was transmitted real time to the entire congress. Dr. Cremonesi is one of the Course Directors of EuroPCR.

Professor Cremonesi commented, “The CGuard™ EPS Carotid Stent performance was excellent and lived up to our expectations. It will be an important tool in the treatment paradigm for carotid artery disease as the carotid artery stenting procedure becomes an increasingly viable alternative to carotid artery endarterectomy/surgery in Europe.”

EuroPCR is the official annual meeting of the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the world-leading course in interventional cardiovascular medicine.  Bringing together over 12,000 clinicians and industry executives each year, EuroPCR is the global forum for sharing within and between all interventional communities. EuroPCR 2017 is taking place from 16-19 May 2017.

“As one of the leading interventional cardiologists in Europe, we are truly honored and grateful to have Dr. Cremonesi and his team perform a live broadcast case treating a patient with carotid artery disease using CGuardTM at EuroPCR,” said James Barry, PhD, Chief Executive Officer of InspireMD.”

Additionally, a CGuard E-poster by Prof. Piotr Musialek, MD, DPhil, FESC, from the Jagiellonian University Department of Cardiac & Vascular Diseases was accepted and exhibited at EuroPCR 2017.

The poster is entitled “Durability of stroke prevention using routinely the CGuard™ MicroNet™ covered embolic prevention stent system to perform carotid revascularization in symptomatic and increased-stroke-risk asymptomatic patients: 12-month prospective evidence from PARADIGM study.” It is on show May 16 – May 19, 2017 at EuroPCR 2017.

 

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 Publication of the IRON-GUARD Registry in EuroIntervention

Zero incidence of major adverse cardiovascular events
including no major strokes

 

BOSTON, MA—May 17, 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 Investigator Initiated IRON-GUARD Italian clinical registry in the peer reviewed journal EuroIntervention, which appeared in the May 9th issue.  IRON-GUARD was an independent, multicentre, multi-disciplinary clinical study treating patients with carotid artery disease using the CGuardTM EPS (embolic prevention system) in 12 Italian centers.

The IRON-GUARD registry enrolled 200 patients, and showed results of 100% technical success placing the device, and zero incidence of major adverse cardiovascular events (MACE), comprised of death, major stroke or myocardial infarction, in all patients at 30 days. Five (2.5%) minor strokes  and two transient ischemic attacks (1%) were observed, which were resolved by  30 days.

Study authors included Professor Carlo Setacci, MD, Francesco Spezialie, MD; Laura Capoccia, MD; Pasqualino Sirignano, MD; Wassim Mansour, MD: Chiara Pranteda, MD; and Renato Casana, MD.

Dr. Francesco Spezialie, stated, “In our multi-center, multi-specialty experience, use of the CGuard EPS in routine clinical practice was associated with no major peri-procedural neurologic complications and a total elimination of post-procedural neurologic complications after 30 days. The CGuard EPS has shown itself to be a promising treatment for carotid lesions.”

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “We were pleased to see the results of the IRON-GUARD registry accepted and published in EuroIntervention.  These results further validate the positive clinical outcomes of other trials and registries utilizing CGuardTM EPS and the data is quite consistent with those other clinical trials.  To our knowledge, this now appears to be the largest registry utilizing CGuard. Following on from the very successful Paradigm 101 study, IRON-GUARD is a further high quality independent registry which continues to give us confidence in CGuard becoming the standard-of-care for treatment of carotid artery disease due to the significant safety advantages of our device.”

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.

 

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 Agreements for CGuard™ EPS and MGuard Prime™ EPS in Peru and Ecuador

BOSTON, MA—May 15, 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 and the MGuard Prime™ EPS with Dispositivos Medicos E.I.R.L., as well as Cardiobene S.A., among the leading medical distributors in Peru and Ecuador, respectively.

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “We are pleased to announce these latest agreements with leading medical device distributors in Peru and Ecuador. This is yet another step in our strategy to expand our global distribution footprint for our current and future products built around the MicroNet™ technology. Latin America is a key region in this plan and we look forward to announcing additional distributor agreements there during the course of the year.”

 

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 Provides Business Update for the First Quarter of 2017

New Commercial Roll-Out of CGuard™ EPS on Schedule

 84% Sequential Increase in Sales of CGuard™

 

Tel Aviv—May 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 provided a business update, including an update on its new commercialization strategy.  The Company also reported financial and operating results for the first quarter ended March 31, 2017.

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “Earlier this year, we announced our transition away from a single distributor covering 18 European countries to a direct distribution model.  In just a few short months, we have announced numerous distribution agreements covering markets across Europe, Asia and South America, fulfilling our commitment to relaunch both more broadly and more focused in Europe, as well as expanding our global footprint.  We are extremely encouraged by the favorable response from our new partners and potential near-term future partners around the world. Not only have these distribution agreements expanded our geographic coverage, but in markets previously served by our former European distributor we are gaining deeper access into all four key clinical specialties that implant carotid stents.”

“While it has been a short time since we began signing these new distributors, the feedback has been very encouraging.  Specifically, each of our new distributors is targeting the key opinion leaders (KOL) in its respective markets, and the response from many of these KOLs has been extremely positive.  In fact, many of these KOLs who have not had access to the device until now, have become strong advocates for the CGuardTM EPS device and have begun to present at leading industry conferences such as ICCA Stroke 2017 in Russia and the Leipzig Interventional Course (LINC) 2017 in Germany, where a live case procedure performed by a leading German KOL was transmitted.”

“Despite the transition from our former distributor in the back half of the first quarter, we still managed to achieve 12% growth in year-over year sales of CGuard™ versus the same period last year.  More importantly, we saw an 84% sequential increase in CGuardTM sales versus the fourth quarter of 2016, reflecting the beginning of our turnaround.  Heading into the second quarter and balance of the year, we expect to generate both sequential and year-over-year growth in CGuard™ as we continue adding key hospitals and KOLs to our customer base around the world. As the device is put into the hands of new KOLs, it should, over time, lead to broader market adoption.  As such, we expect more meaningful growth towards the end of this year and into 2018 as our primary customers shift from the small population of KOLs to the mainstream groups of vascular surgeons, interventional cardiologists, interventional radiologists and interventional neuroradiologists.”

“As these initiatives begin to take hold, we continue to maintain strict financial discipline and remain extremely confident in the outlook for the business.” 

 

Financial Results

Revenue for the first quarter ended March 31, 2017 was $569,000 compared to $563,000 during the same period in 2016. The increase was primarily due to an increase in sales of CGuard™ EPS as we entered new regional markets despite the negative impact of the transition from our prior exclusive distribution partner for most of Europe.  The transition to local distributors reflects an effort to broaden our sales efforts from only interventional neuroradiologists to include vascular surgeons, interventional cardiologists and interventional radiologists, as well. The increase in sales of CGuard™ EPS was partially offset by a decrease in MGuard™ Prime EPS associated with the trend of doctors increasingly using drug eluting stents (DES) rather than bare metal stents in STEMI patients. In the meantime, based on positive feedback from physicians, the Company is evaluating potential partners to combine MGuard™ Prime EPS with DES technology.  Total operating expenses for the quarter ended March 31, 2017 were $2,478,000, an increase of 18.2% compared to $2,096,000 for the same period in 2016. This increase was primarily due to an increase in sales and marketing expenses (primarily to support the commercialization of CGuard™ EPS), as well as an increase in corporate related expenses. Net loss for the quarter ended March 31, 2017 totaled $2,559,000, or $0.81 per basic and diluted share, compared to a net loss of $2,252,000, or $7.00 per basic and diluted share, in the same period in 2016.

As of March 31, 2017, cash and cash equivalents were $8,572,000, compared to $7,516,000 as of December 31, 2016.


Conference Call

The Company will host a conference call on Wednesday, May 10 at 8:00 a.m. Eastern Time. 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 May 24, 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: 10378.

 

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

 

 

May 2017 A

 

May 2017 B

 

May 2017 C(1) All 2017 financial information is derived from the Company’s 2017 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission, all 2016 financial information is derived from the Company’s 2016 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

(2) All March 31, 2017 financial information is derived from the Company’s 2017 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2016 financial information is derived from the Company’s 2016 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2016 filed with the Securities and Exchange Commission.

InspireMD Schedules First Quarter 2017 Earnings Conference Call

Tel Aviv—May X, 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, May 10 at 8:00 a.m. Eastern Time to discuss the company’s financial results for the first quarter ended March 31, 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 May 24, 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: 10378.

 

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 CGuardTM EPS in Germany

Tel Aviv—May 1, 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 ab medica Deutschland GmbH & Co. KG, (“ab medica GmbH”) a leading medical distributor in Germany, to distribute CGuard™ EPS (Embolic Prevention System).

James Barry, PhD, Chief Executive Officer of InspireMD, commented, “ab medica GmbH is probably the leading distributor in the peripheral and vascular medical devices sector in Germany and this agreement is consistent with our new strategy of utlizing a direct distribution model focusing on regional distributors that have access to all of the key clinical specialties. Germany is the largest CAS market in Europe and, given the strong growth we saw in 2016 in the markets where this model has been in place and managed by InspireMD, we are very optimistic about the market potential for our product in Germany.”

Dr Georg Landsberg, CEO & Founder of ab medica GmbH, stated, “We are excited to partner with InspireMD to distribute CGuard in Germany. We are committed to building on the work done by InspireMD’s prior distributor in Germany and adding at least 50 new hospitals to our client list and thus more than doubling CGuard’s market presence and market share over the next twelve months. Our ability to include as yet untapped markets such as the Vascular Surgery segment in our sales efforts, makes us confident that we can add a new dynamic to the markerting of CGuard, which we believe will rapidly become the standard of care through its potential safety benefits.

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, noted, “ab medica GmbH is an ideal partner as it has long standing relations with all the major Group Purchasing Organizations in Germany covering all the relevant clinical specialists that use carotid stents. ab medica also has established relationships with Germany’s top KOLs, including interventional neuroradiologists, vascular surgeons, interventional cardiologists and interventional radiologists.  ab medica will immediateliy assume all the existing accounts supported by our former distributor, with plans to at least double the number of centers utilizing our device in Germany over the next year.”


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 CGuardTM EPS in the Netherlands

Tel Aviv—April 6, 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 Angiocare B.V., a leading medical distributor in the Netherlands, to distribute CGuardTM EPS (Embolic Prevention System).

Agustin Gago, EVP and Chief Commercial Officer of InspireMD, commented, “Our new partner in the Netherlands marks another important step towards building a local distribution model for InspireMD’s CGuard EPS across Europe.”

Mr. John Visscher, CEO of Angiocare B.V., stated, “We are delighted to offer CGuard through our extensive physician network across the Netherlands.  We believe that CGuard will rapidly become the standard-of-care due to its potential safety advantages for patients with 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 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