InspireMD Announces Initial Commercial Sales of the CGuard™ EPS

BOSTON, MA – October 1, 2014 – InspireMD, Inc. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in embolic protection systems (EPS), today announced that it has recorded the first commercial sales of the CGuard™ carotid EPS. The Company accelerated the limited market release (LMR) of the CGuard based on strong interest created by the recent positive data reported in the CARENET clinical trial.

“We are excited to begin the commercial phase of our carotid business strategy and have had strong interest in the CGuard since our CARENET data was presented at the TCT conference on September 16th. The initial commercial phase of our launch will be through our direct sales team in Europe and will focus on high volume, key opinion leaders in the carotid space. Our plan is to generate usage and a broader awareness of the CGuard in key European markets throughout the next two quarters and then convert to a full market release (FMR) in Q2 of 2015.” stated Alan Milinazzo, CEO of InspireMD.

InspireMD initiated limited commercial sales of the CGuard EPS through its direct sales organization in select European countries following the announcement of positive results from the CARENET (CARotid Embolic protection study using microNET) Trial. CARENET was a multi-specialty trial that assessed the peri-procedural safety and efficacy of CGuard systems in the treatment of carotid lesions. The CARENET trial recruited 30 patients and achieved its primary endpoint with 0 percent MACE (meaning no death, stroke or myocardial infarction) at 30 days. Additionally, as compared to published historical control groups of non-mesh covered carotid stents, the incidence of new ischemic lesions as assessed by Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) after carotid artery stenting was reduced by almost 50 percent. The CARENET trial also reported an average lesion volume per patient that was 10 times smaller than these historical control groups. The reduction in both the number of new ischemic lesions and the volume of those lesions indicates therapeutic benefits of the MicroNet™ technology in this patient cohort after 30 days, as compared to the historical control groups.

The proprietary CGuard EPS uses the same MicroNet™ technology featured on the MGuard™ and MGuard Prime™ coronary embolic protection systems. The MicroNet™ technology is a single fiber knitted mesh wrapped on an open cell stent platform designed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods. This technology seeks to protect patients from plaque debris and blood clots breaking off which can lead to life threatening strokes. The size, or aperture, of the MicroNet™ ‘pore’ is only 150-180 microns in order to maximize protection against the potentially dangerous plaque and thrombus within the carotid artery.

InspireMD held an informative conference call discussion that focused on the clinical benefits that the MicroNet™ covered CGuard carotid EPS may offer patients undergoing carotid artery stenting compared to existing treatments on the market. A digital replay of the event is available until October 24, 2014 on the Investor Relations section of the Company’s website athttp://www.inspiremd.com/site_en/for-investors/.

CGuard EPS is CE Mark approved. CGuard EPS is not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.

For more information about InspireMD and its offerings, visit www.inspiremd.com.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM) and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

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 Transition Report on Form 10-KT 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:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contact:

Samantha Wolf

KCSA Strategic Communications

212-896-1220

swolf@kcsa.com

InspireMD to Host Conference Call and Webinar and to Discuss Recently Released Results of CGuard™ CARENET Trial on September 24th

CARENET Trial data presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference, September 16, 2014,showed 0% MACE at 30 Days

 

BOSTON, MASeptember 18, 2014InspireMD, Inc.(NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), will host a live webinar and Q&A to discuss the positive results of its recent CARENET (CARotid Embolic protection study using microNET) Trial for its CGuardTM Embolic Protection System (EPS) which were announced at the Transcatheter Cardiovascular Therapeutics (TCT) conference, in Washington, D.C. on Tuesday September 16, 2014. The live webinar and Q&A will take place on Wednesday, September 24 at 8:30 AM ET.

 

Josh Jennings, MD, Senior Research Analyst at Cowen & Company, will moderate a panel discussion featuring one of the Principal Investigators (PIs) of the CARENET trial, Professor Piotr Musialek, from Jagiellonian University Medical College at John Paul II Hospital, in Krakow, Poland. The discussion will be followed by a question and answer session.

 

The webinar will be available on the Investor Relations section of the Company’s website at http://www.inspiremd.com/site_en/for-investors/ . To participate by telephone, participants should call (877) 407-0789 (United States) or (201) 689-8562 (International) and request the InspireMD call. A digital replay of the webinar will be available for 30 days after the event.

 

The discussion will focus on the clinical benefits that the MicroNet™TM covered CGuardmay offer patients undergoing carotid artery stenting compared to existing treatments on the market.

 

Findings from The CARENET trial, which recruited a total of 30 patients, include:

  • Achieving its primary endpoint with 0% MACE (meaning no death, stroke or myocardial infarction) at 30 days.
  • The incidence of new ischemic lesions as assessed by Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) after carotid artery stenting was reduced by almost 50%, compared to published historical control groups of non-mesh covered carotid stents
  • The CARENET trial also reported an average lesion volume per patient that was 10 times smaller than these historical control groups.
  • The reduction in both the number of new ischemic lesions and the volume of those lesions indicates therapeutic benefits of the MicroNet™ technology in this patient cohort.

 

                        The proprietary CGuard EPS uses the same MicroNet™ technology featured on the MGuard™ and MGuard Prime™ coronary embolic protection systems. The MicroNet™ technology is a single fiber knitted mesh wrapped on an open cell stent platform designed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods. This technology seeks to protect patients from plaque debris and blood clots breaking off and which can lead to life threatening strokes. The size, or aperture, of the MicroNet™ ‘pore’ is only 150-180 microns in order to maximize protection against the potentially dangerous plaque and thrombus within the carotid artery.

 

CGuard EPS is CE Mark approved. CGuard EPS, however, is not approved for sales in the U.S. by the U.S. Food and Drug Administration at this time.

 

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM) and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

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 Transition Report on Form 10-KT 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:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contact:

Samantha Wolf

Phone: KCSA Strategic Communications

Email: 212-896-1220

swolf@kcsa.com

InspireMD Announces Positive Results from CGuard™ CARENET Trial with 0% MACE reported at 30 Days

Achieved Primary 30 Day Endpoint

 

Patients in CARENET Trial had significantly lower incidence of new ischemic lesions    compared to historical control groups of non-mesh covered carotid stents

 

BOSTON, MASeptember 16, 2014InspireMD, Inc.(NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced positive results from the CARENET (CARotid Embolic protection study using microNET) Trial for its CGuardTM EPS. This trial demonstrates that the MicroNet™TM covered CGuardmay offer important clinical benefits for patients undergoing carotid artery stenting (CAS).

 

CARENET was a multi-specialty trial that assessed the peri-procedural safety and efficacy of CGuard systems in the treatment of carotid lesions. The CARENET trial recruited a total of 30 patients and achieved its primary endpoint with 0% MACE (meaning no death, stroke or myocardial infarction) at 30 days. Additionally, compared to published historical control groups of non-mesh covered carotid stents, the incidence of new ischemic lesions as assessed by Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) after carotid artery stenting was reduced by almost 50%. The CARENET trial also reported an average lesion volume per patient that was 10 times smaller than these historical control groups. The reduction in both the number of new ischemic lesions and the volume of those lesions indicates therapeutic benefits of the MicroNet™ technology in this patient cohort.

 

“The very positive data from the CARENET trial indicates that the CGuard EPS, with InspireMD’s proprietary MicroNet™ technology, may provide patients an improved treatment for carotid artery disease,” stated Alan Milinazzo, President and Chief Executive Officer of InspireMD. “Given the positive results from the trial, we plan to immediately initiate a limited market release of the CGuard in Europe through our direct sales organization in anticipation of a full market release in early 2015.”

 

“This CARENET study shows that the CGuard reduces the incidence, as well as the total volume of ischemic lesions,” stated Professor Joachim Schofer, MD, a Principal Investigator for the CARENET study, from the Hamburg University Cardiovascular Center, in Hamburg, Germany. “The results from this study seem to confirm that the small pore size of the MicroNet™ technology allows excellent blood flow while trapping potentially harmful plaque debris and thrombus. The DW-MRI follow up data confirmed that the MicroNet™ covered CGuard offers unique benefits for patients undergoing a CAS procedure.”

 

 

Professor Piotr Musialek, Co- Principal Investigator for the CARENET study, from Jagiellonian University Medical College at John Paul II Hospital, in Krakow, Poland, commented, “My experience using the CGuard device has been extremely positive. The CARENET study involved an all-comer spectrum of patients and lesion types, making it truly reflective of the CAS population we treat today. While compatible with all types of embolic protection devices, the CGuard may provide an increase in the safety of carotid artery stenting irrespective of the type of protection used due to the ability of the MicroNet™ to prevent plaque protrusion and late embolization. I have seen the benefit of this device past 30-days, when the carotid stent can safely heal, in absence of any plaque protrusion through the stent struts. The 50 percent decrease in the incidence of new ischemic lesions as compared to traditional carotid non-mesh covered stents was impressive. I look forward to the continued use of the CGuard in my daily practice.”

 

TCT Innovation Session on Late Breaking Early Human Clinical Studies

Comprehensive results from the CARENET trial are being presented by Professor Joachim Schofer, MD, from the Hamburg University Cardiovascular Center, at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington, D.C. today, September 16, 2014. The detailed findings are being presented at 4:01 p.m. ET at the TCT 2014 Innovation Session: Late Breaking Early Human Clinical Studies under the title “Evaluation of a PET Mesh Covered Stent in Patients with Carotid Artery Disease: Results of the First in Man CARENET Trial.”

 

To view the CARENET trial results presentation please visit InspireMD’s website at www.inspiremd.com

 

About CGuard EPS

The proprietary CGuard EPS uses the same MicroNet™ technology featured on the MGuard™ and MGuard Prime™ coronary embolic protection systems. The MicroNet™ technology is a single fiber knitted mesh wrapped on an open cell stent platform designed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods. This technology seeks to protect patients from plaque debris and blood clots breaking off and which can lead to life threatening strokes. The size, or aperture, of the MicroNet™ ‘pore’ is only 150-180 microns in order to maximize protection against the potentially dangerous plaque and thrombus within the carotid artery.

 

CGuard EPS is CE Mark approved. CGuard EPS, however, is not approved for sales in the U.S. by the U.S. Food and Drug Administration at this time.

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM) and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

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 Transition Report on Form 10-KT 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:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contact:

Samantha Wolf

Phone: KCSA Strategic Communications

Email: 212-896-1220

swolf@kcsa.com

InspireMD to Present at the Aegis Healthcare and Technology Conference

BOSTON, MASeptember 03, 2014InspireMD, Inc.(NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced that its Chief Financial Officer, Craig Shore, will be presenting at the Aegis Healthcare and Technology Conference at the Encore at Wynn Las Vegas. The Company will present on Friday, September 12, 2014 at 8:30 a.m. PT.

 

A live webcast will be available for those participants who are unable to attend, which can be found on the Investors section of the Company’s website at www.inspiremd.com/site_en/for-investors/.The webcast will be available for 90 days following the presentation.

 

For more information and to register, please visit the conference website: http://www.bit.ly/AegisConference.

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM) and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

Investor Contacts:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contact:

Samantha Wolf

KCSA Strategic Communications

212-896-1220

swolf@kcsa.com

InspireMD to Announce Results of CGuard™ CARENET Trial at the TCT Innovation Session on Late Breaking Early Human Clinical Studies

Results will be announced on Tuesday, September 16in Washington, D.C.


BOSTON, MA
August 11, 2014InspireMD, Inc.(NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced that Professor Joachim Schofer, MD, at the Hamburg University Cardiovascular Center, will present the results of the CARENET (CARotid Embolic protection using microNET) trial at the Transcatheter Cardiovascular Therapeutics (TCT) conference, in Washington, D.C. on Tuesday September 16, 2014.

 

The detailed findings from the CARENET trial, which completed enrollment last month, will be presented at the TCT 2014 Innovation Session: Late Breaking Early Human Clinical Studies at 4:20 pm ET under the title “Evaluation of a PET Mesh Covered Stent in Patients with Carotid Artery Disease: Results of the First in Man CARENET Trial.”

 

CARENET is a multi-specialty trial – including Interventional Cardiologists, Interventional Radiologists and Vascular Surgeons – assessing the peri-procedural safety and efficacy of CGuard systems in the treatment of carotid lesions. The trial evaluates data from traditional assessments carried out post-procedure and at 30 days to include MACE (death, stroke, myocardial infarction), and ipsilateral stroke (31 days to one year). In addition, DW-MRI (Diffusion Weighted Magnetic Resonance Imaging) will be evaluated pre- and post-procedure and at 30 days, as well as ultrasound examination at 30 days and one year on every patient.

 

“The Innovation Session with late breaking trials updates at TCT showcases cutting-edge clinical studies from around the world,” said Alan Milinazzo, CEO of InspireMD. “We are proud that the CARENET trial has been included in this exclusive session at TCT alongside other exciting new technologies. We look forward to sharing the results from the trial with medical professionals and those at the forefront of advances in interventional cardiovascular medicine globally.”

 

The proprietary CGuard carotid embolic protection system uses the same MicroNet™ technology featured on the MGuard™ and MGuard Prime™ coronary embolic protection systems. The MicroNet™ technology is a single fiber knitted mesh wrapped on an open cell stent platform designed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods. This technology seeks to protect patients from plaque debris and blood clots breaking off and which can lead to life threatening strokes. The size, or aperture, of the MicroNet™ ‘pore’ is only 150-180 microns in order to maximize protection against the potentially dangerous plaque and thrombus within the carotid artery.

 

 

About TCT

 

Transcatheter Cardiovascular Therapeutics (TCT) is the world’s largest educational meeting specializing in interventional cardiovascular medicine. For over 25 years, TCT has been the center of cutting-edge educational content. TCT showcases the latest advances in current therapies and clinical research.

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM) and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

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 Transition Report on Form 10-KT 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:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contact:

Samantha Wolf

KCSA Strategic Communications

212-896-1220

swolf@kcsa.com

 

 

 

InspireMD Reports Financial Results for the Second Quarter Ended June 30, 2014

BOSTON, MA – July 23, 2014 – InspireMD, Inc.(NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced its financial and operating results for the second quarter, which ended June 30, 2014.

Recent Operating Highlights

 

  • Received European approval to resume manufacturing and distribution of MGuard™ Prime EPS

           o    Manufacturing and sales were temporarily suspended due to Voluntary Field Action (VFA) implemented on April 30, 2014

           o    Modified manufacturing process now in place to enhance system performance

  • Completed the expansion of its international sales organization and is positioned to ramp up MGuard Prime EPS sales and limited market release (LMR) launch of CGuard in the second half of 2014
  • Completed CARENET (CARotid Embolic protection study using MicroNet™) trial for the CGuardTM EPS

             o    100% procedural success rate

             o    Results expected to be announced in mid September 2014 at the TCT Conference

  • Appointed Dr. James Barry as Chief Operating Officer

             o    More than 18 years’ experience in senior roles at Boston Scientific

             o    Extensive background in developing drug eluting stents

“The financial performance for the quarter is within our expectations, as sales activities for the MGuard Prime EPS were temporarily halted following our voluntary field action (VFA). We successfully managed the VFA regulatory process in Europe and have now shifted our focus to ramping our commercial activities,” said Alan Milinazzo, CEO of InspireMD. “This quarter also marked the successful completion of enrollment in the CARENET trial, which we view as a significant milestone in our plans to develop the CGuard EPS for patients with carotid artery disease. Enrollment had a 100% procedural success rate and we are looking forward to sharing the results of the trial at the TCT conference in September.”

“Additionally, we are pleased to welcome Dr. Jim Barry as our new Chief Operating Officer. We are now entering a critical phase in the development of our DES strategies and Jim’s expertise will be invaluable to us,” Concluded Milinazzo.

Operational Overview

European regulatory approval for a new manufacturing process improving stent retention and performance in the MGuard Prime EPS was granted following the Company’s VFA that was implemented on April 30, 2014. The Company is in the process of modifying and redeploying all the MGuard Prime EPS stents that were returned by clinical and commercial sites. The Company expects sales of the MGuard Prime EPS to ramp over the next several months. Due to the VFA, the Company did not fill any new customer sales orders during the past two months. The MGuard Prime EPS is currently InspireMD’s primary commercial product and, as a result, the Company recorded sales of $0.2 million for the second quarter ended June 30, 2014.

The planned expansion of the Company’s international sales organization has been completed with the additional hiring of several direct salespeople in Tier 1 countries in Europe and Latin America. The team currently includes 20 people positioned to advance sales of the Company’s coronary and carotid devices.

The Company successfully completed enrollment in the CARENET (CARotid Embolic protection using MicroNet™)study. CARENET is a multi-specialty trial to evaluate the safety and efficacy of the CGuard EPS for use in carotid artery disease. The acute procedural performance of the CGuard device was 100% successful for all of the 30 patients enrolled in the trial. Follow up will be done using traditional assessments post procedure and at 30 days to include MACE (death, stroke, MI) and ipsilateral stroke. The Company is in the process of evaluating the results and anticipates sharing these data in September at the upcoming TCT Conference in Washington DC.

The Company continues to conduct studies to ascertain the safety and efficacy of combining its proprietary MicroNet™ technology with existing drug eluting stent technologies. Pre-clinical tests are being done with several already CE Marked or FDA approved drug eluting coronary stents and the Company continues to negotiate with manufacturers and evaluate opportunities in this space. InspireMD remains committed to this phase of the development of the next generation embolic protection system.

Enrollment in the MASTER II trial remains temporarily suspended, pending review by the FDA of the manufacturing improvements to the MGuard Prime EPS. However, the Company continues to move forward with site activation and audit activities so that the Company will be able to accelerate enrollment once the study is resumed, which is expected to be in the third or fourth quarter of 2014. The MASTER II trial will evaluate the safety and effectiveness of the MGuard™ Prime EPS in patients suffering from ST Elevation Myocardial Infarction (STEMI).The results are also intended to support the Company’s Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA) to market the MGuard™ Prime MicroNet™ covered coronary stent system in the U.S.

Quarter Ended June 30, 2014 Financial Results

On April 30, 2014 sales were temporarily suspended due to the VFA. As such, revenue for the quarter ended June 30, 2014 was $0.2 million compared to $1.5 million during the same period in 2013.

Gross profit (loss) for the quarter ended June 30, 2014 totaled $(0.4) million, a decrease of 158.5% compared to $0.7 million for the same period in 2013. This decrease in gross profit was attributable to the impact of the VFA which included a decrease in revenues as well as $0.4 million in expenses related to the modification of the MGuard Prime EPS.

Total operating expenses for the quarter ended June 30, 2014 were $6.8 million, an increase of 40.2% compared to $4.9 million for the same period in 2013. This increase was primarily due to higher research and development expenses attributable to the MASTER II trial, the CARENET trial, efforts to improve stent retention and expenditures in sales and marketing as the Company increased its efforts to support the new sales strategies in key European and Latin American countries.

The loss from operations for the quarter ended June 30, 2014 was $7.2 million, an increase of 71.6% compared to a loss of $4.2 million for the same period in 2013.

Financial expenses for the quarter ended June 30, 2014 decreased 97.0% to $0.3 million from $10.8 million during the same period in 2013. The decrease in financial expenses resulted primarily from $9.9 million of non-cash effects in the quarter ended June 30, 2013 related to the adjustment of the conversion ratio of our convertible debentures prior to their retirement in April 2013. No such expense occurred during the same period in 2014.

The net loss for the quarter ended June 30, 2014 totaled $7.6 million, or $0.22 per basic and diluted share, compared to a net loss of $14.9 million, or $0.48 per basic and diluted share, in the same period in 2013.

Non-GAAP net loss for the quarter ended June 30, 2014 was $6.5 million, or $0.19 per basic and diluted share, an increase of 107.8%, compared to a non-GAAP net loss of $3.1 million, or $0.10 per basic and diluted share, for the same period in 2013. The non-GAAP net loss for the quarter ended June 30, 2014 primarily excludes $1.1 million of share-based compensation. The non-GAAP net loss for quarter ended June 30, 2013 primarily excludes $10.7 million in non-cash financial expenses and $1.1 million in share-based compensation expenses.

Six Months Ended June 30, 2014 Financial Results

Revenue for the six months ended June 30, 2014 decreased $1.3 million to $1.7 million compared to $3.0 million during the same period in 2013. The 2014 period included an expected decline in sales volume associated with the temporary stoppage of sales activities for the MGuard™ Prime EPS following our VFA.

Gross profit for the six months ended June 30, 2014 totaled $0.5 million, a decrease of 69.1% compared to $1.5 million for the same period in 2013. This decrease in gross profit was attributable to a decrease in revenues as well as the impact of expenses related to the VFA.

Total operating expenses for the six months ended June 30, 2014 were $13.2 million, an increase of 48.2% compared to $8.9 million for the same period in 2013. This was primarily due to increased research and development expenses attributable to the MASTER II trial, the CARENET trial, efforts to improve stent retention and expenditures in sales and marketing as the Company increased its efforts to support the new sales strategies in key European and Latin American countries.

The loss from operations for the six months ended June 30, 2014 was $12.8 million, an increase of 72.0% compared to a loss of $7.4 million for the same period in 2013.

Financial expenses for the six months ended June 30, 2014, decreased 94.1% to $0.7 million from $12.4 million during the same period in 2013. The decrease in financial expenses resulted primarily from $9.9 million of non-cash effects in the six months ended June 30, 2013 related to the adjustment of the conversion ratio of our convertible debentures prior to their retirement in April 2013, as well as $1.5 million of non-cash expense in the six months ended June 30, 2013 related to our issuance of common stock without new consideration to certain investors resulting from anti-dilution rights. No such expense occurred during the six months ended June 30, 2014.

The net loss for the six months ended June 30, 2014 totaled $13.5 million, or $0.40 per basic and diluted share, compared to a net loss of $19.8million, or $0.80 per basic and diluted share, in the same period in 2013.

Non-GAAP net loss for the six months ended June 30, 2014 was $11.4 million, or $0.34 per basic and diluted share, an increase of 118.0% compared to a non-GAAP net loss of $5.2 million, or $0.21 per basic and diluted share, for the same period in 2013. The non-GAAP net loss for the six months ended June 30, 2014 primarily excludes $2.1 million of share-based compensation. The non-GAAP net loss for the six months ended June 30, 2013 primarily excludes $12.2 million in non-cash financial expenses and $2.4 million in share-based compensation expenses.

Cash and Cash Equivalents

As of June 30, 2014, cash and cash equivalents were $9.0 million, compared to $17.5 million as of December 31, 2013.

Investor Conference Call

 

The Company will host a conference call at 4:30 p.m. ET on Wednesday, July 23rd to review its financial results and business outlook. Participants should call (877) 407-0784 (United States) or (201) 689-8560 (International) and request the InspireMD call or provide confirmation code: 13586684. A live webcast of the call will also be available on the Investor Relations section of the Company’s website at www.inspiremd.com/site_en/for-investors.   Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

An archive of the webcast will be available approximately one hour after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.inspiremd.com/site_en/for-investors for a limited time. A dial-in replay of the call will also be available to those interested until August 6th. To access the replay, dial (877) 870-5176 (United States) or (858) 384-5517 (International) and enter code: 13586684.

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MGuard™ with 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™) and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

Use of Non-GAAP Financial Measures

 

To supplement the Company’s consolidated financial statements presented on a GAAP basis, the Company discloses a non-GAAP measure as non-GAAP net loss because management uses this supplemental non-GAAP financial measure to evaluate performance period over period, to analyze the underlying trends in its business, and to establish operational goals and forecasts that are used in allocating resources. In addition, the Company believes many investors use this non-GAAP measure to monitor the Company’s performance. This non-GAAP measure should not be considered as an alternative to GAAP measures as an indicator of the Company’s operating performance.

Non-GAAP net loss is defined by the Company as net loss excluding non-cash financial expenses, share-based compensation expenses and royalties buyout amortization. Non-cash financial expenses are items that are related to the amortization of discount on convertible debt and related issuance costs, the revaluation of warrants and expenses related to the anti-dilution rights of our March 2011 investors.

Generally, a non-GAAP financial measure is a numerical measure of a company’s performance, financial position or cash flow that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The non-GAAP measures discussed above, however, should be considered in addition to, and not as a substitute for or superior to operating loss, cash flows, or other measures of financial performance prepared in accordance with GAAP. A reconciliation of non-GAAP to GAAP financial measure is set forth in the table below.

The Company believes that presenting a non-GAAP net loss, in addition to the corresponding GAAP financial measures, provides investors greater transparency to the information used by management for financial and operational decision-making and allows investors to see the Company’s results “through the eyes” of management. The Company further believes that providing this information assists investors in understanding the Company’s operating performance and the methodology used by management to evaluate and measure such performance.

 

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 Transition Report on Form 10-KT 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:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

Media Contacts:

Lewis Goldberg / Samantha Wolf

KCSA Strategic Communications

Phone: 212-896-1216 / 212-896-1220

Email: lgoldberg@kcsa.com / swolf@kcsa.com

######

CONSOLIDATED STATEMENTS OF OPERATIONS (1)
(U.S. dollars in thousands, except per share data)
Six months ended
Three months ended  
June 30,   June 30,
2014 2013   2014   2013
Revenues $193 $1,500 $1,675 $3,014
Cost of revenues 584 832 1,209 1,506
Gross Profit (Loss) (391) 668 466 1,508
Operating Expenses:
Research and development 2,448 1,047 5,025 1,954
Selling and marketing 1,948 1,204 3,224 2,008
General and administrative 2,448 2,632 4,987 4,972
Total operating expenses 6,844 4,883 13,236 8,934
Loss from operations (7,235) (4,215) (12,770) (7,426)
Financial expenses 325 10,755 738 12,447
Loss before tax expenses (7,560) (14,970) (13,508) (19,873)
Tax expenses (Income) 2 (23) 22 (41)
Net Loss $(7,562) $(14,947) $(13,530) $(19,832)
Net loss per share – basic and diluted $(0.22) $(0.48) $(0.40) $(0.80)
Weighted average number of shares of common stock used in computing net loss per share – basic and diluted 34,115,814 31,033,657 34,083,936 24,650,333
RECONCILIATION OF NON-GAAP NET LOSS (2)
(U.S. dollars in thousands, except per share data)
Six months ended
Three months ended  
June 30,   June 30,
2014 2013   2014   2013
GAAP Net Loss $(7,562) $(14,947) $(13,530) $(19,832)
Non-GAAP Adjustments:
Non-cash financial expenses (income)(3) (41) 10,698 (47) 12,156
Share-based compensation expenses 1,080 1,109 2,099 2,408
Royalties buyout expenses and amortization 25 13 40 21
Total Non-GAAP Adjustments 1,064 11,820 2,092 14,585
Non-GAAP Net Loss $(6,498) $(3,127) $(11,438) $(5,247)
Non-GAAP net loss per share – basic and diluted $(0.19) $(0.10) $(0.34) $(0.21)
Weighted average number of shares of common stock used in computing net loss per share – basic and diluted 34,115,814 31,033,657 34,083,936 24,650,333

 

CONSOLIDATED BALANCE SHEETS (4)
(U.S. dollars in thousands)
ASSETS June 30, December 31,
2014 2013
Current Assets:
Cash and cash equivalents $8,988 $17,535
Restricted cash 93
Accounts receivable:
Trade 493 1,855
Other 420 387
Prepaid expenses 215 141
Inventory 1,514 1,593
Total current assets 11,630 21,604
Property, plant and equipment, net 663 652
Non-current assets:
Deferred issuance costs 276 310
Funds in respect of employee rights upon retirement 493 434
Long term prepaid expenses 84 114
Royalties buyout 812 852
Total non-current assets 1,665 1,710
Total assets $13,958 $23,966
LIABILITIES AND EQUITY (CAPITAL DEFICIENCY) June 30, December 31,
2014 2013
Current liabilities:
Accounts payable and accruals:
Trade $1,529 $1,623
Other 4,344 3,141
Advanced payment from customers 214 179
Current maturity of loan 3,037 1,181
Total current liabilities 9,124 6,124
Long-term liabilities:
Liability for employees rights upon retirement 745 610
Long term loan 6,886 8,593
Total long-term liabilities 7,631 9,203
Total liabilities 16,755 15,327
Equity:
Common stock, par value $0.0001 per share; 125,000,000 shares authorized; 34,159,043 and 33,983,346 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively 3 3
Additional paid-in capital 93,046 90,952
Accumulated deficit (95,846) (82,316)
Total equity (capital deficiency) (2,797) 8,639
Total liabilities and equity (less capital deficiency) $13,958 $23,966
(1) All 2014 financial information is derived from the Company’s 2014 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission, and all 2013 financial information is derived from the Company’s unaudited internal financial statements.
(2) Our non-GAAP net loss is presented as management uses this supplemental non-GAAP financial measure to evaluate performance period over period, analyze the underlying trends in our business, and establish operational goals and forecasts that are used in allocating resources. We believe by presenting this additional measurement, we are providing investors with greater transparency to the information used by our management for our financial and operational decision-making, as well as allowing investors to see our results “through the eyes” of management. We further believe that providing this information assists our investors in understanding our operating performance and the methodology used by management to evaluate and measure such performance.
(3) Non-cash financial expenses (income) are items related to the induced conversion of the convertible loan, the amortization of the discount on the convertible loan and its related issuance costs, the issuance of shares as a result of the anti-dilution rights of our March 2011 investors and the revaluation of warrants.
(4) All June 30, 2014 financial information is derived from the Company’s 2014 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission and all December 31, 2013 financial information is derived from the Company’s 2013 audited financial statements, as disclosed in the Company’s Transition Report on Form 10-KT, filed with the Securities and Exchange Commission.

InspireMD to Report Financial Results for the Second Quarter Ended June 30, 2014 on Wednesday, July 23rd

BOSTON, MA – July 17, 2014 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems, announced today that it will release its financial results for the second quarter ended June 30, 2014 on Wednesday, July 23rd.

The Company will host a conference call at 4:30 p.m. ET on Wednesday, July23rd to review its financial results and business outlook. Participants should call (877) 407-0784 (United States) or (201) 689-8560(International) and request the InspireMD call or provide confirmation code: 13586684. A live webcast of the call will also be available on the Investor Relations section of the Company’s website at www.inspiremd.com/site_en/for-investors.  Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

 

An archive of the webcast will be available approximately two hours after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.inspiremd.com/site_en/for-investors for a limited time. A dial-in replay of the call will also be available to those interested until August 6, 2014. To access the replay, dial (877) 870-5176(United States) or (858) 384-5517(International) and enter code: 13586684.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MGuard™ with 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™) and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

Investor Contacts:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contacts:

Samantha Wolf

KCSA Strategic Communications

Phone: 212-896-1220

Email: swolf@kcsa.com

InspireMD Appoints Dr. James Barry as Chief Operating Officer

Strengthens Leadership Team with Addition of Experienced Medical Device Executive

 

BOSTON, MA – July 15, 2014 – InspireMD, Inc.(NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems, today announced the appointment of James Barry, Ph.D. as Chief Operating Officer. Barry, who has more than two decades of experience in the medical device industry, will be based in the Company’s Boston headquarters.

 

Dr. Barry will focus on three critical performance areas: advancing the product pipeline including finalizing the drug eluting stent MGuard platform; managing all global clinical trial activities and driving the operational activities to systematically enhance quality and reduce product costs, including finalizing the outsourcing of the manufacturing activities of the Company.

 

“Jim’s deep experience in developing next generation medical devices is particularly relevant at this phase of our growth,” commented Alan Milinazzo, CEO of InspireMD. “We are delighted to have Jim join us and we expect to immediately benefit from his leadership in several critical areas of the business. Leading organizations through research and development, clinical trial activities and the production of novel medical devices is what Jim does best. In particular, during his tenure at Boston Scientific Jim was central to the success achieved in identifying and developing next generation drug eluting stents.”

For more than 18 years, Dr. Barry held senior roles at Boston Scientific Corporation. Barry initiated and oversaw the development of Boston Scientific’s Taxus™ stent which quickly became the number one selling drug eluting stent worldwide. He also oversaw the development of the technology that is employed in the next generation Synergy™ Everolimus-Eluting Stent System, which received CE Mark in November 2012.

 

Dr. Barry currently serves on a number of advisory boards including the College of Biomedical Engineering at Yale University, the College of Sciences at University of Massachusetts-Lowell, and the Massachusetts Life Science Center.

 

Dr. Barry holds a Bachelor’s Degree in Chemistry from St. Anselm College and a PhD in Biochemistry from the University of Massachusetts.

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM) and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

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 Transition Report on Form 10-KT 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:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contact:

Samantha Wolf

KCSA Strategic Communications

212-896-1220

swolf@kcsa.com

# # #

InspireMD Announces Successful Completion of CGuard™ CARENET (CARotid Embolic protection study using MicroNet™) Trial

100% procedural success rate achieved in first multi-specialty clinical experience


BOSTON, MA
– July 8, 2014 — InspireMD, Inc.(NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced that it has concluded enrollment in its CARENET clinical trial. The multi-specialty (Interventional Cardiologists, Interventional Radiologists and Vascular Surgeons) trial is assessing the peri-procedural safety and efficacy of CGuard systems in the treatment of carotid lesions. The acute procedural performance of the CGuard device was 100% successful for all of the 30 patients enrolled in the trial.

 

Thirty patients were enrolled at four sites across Europe and will be followed up using traditional assessments post-procedure and at 30 days to include MACE (death, stroke, MI), and ipsilateral stroke (31 days to 1 year). In addition, DW-MRI (Diffusion Weighted Magnetic Resonance Imaging) is being done pre and post procedure and at 30 days, as well as ultrasound examination at 30 days and 1 year on every patient.

 

The proprietary CGuard carotid embolic protection system uses the same MicroNet™ technology featured on the MGuard™ and MGuard Prime™ coronary embolic protection systems. The MicroNet™ technology is a single fiber knitted mesh wrapped on an open cell stent platform designed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods. This technology seeks to protect patients from plaque debris and blood clots breaking off and which can lead to life threatening strokes. The size, or aperture, of the MicroNet™ ‘pore’ is only 150-180 microns in order to maximize protection against the potentially dangerous plaque and thrombus within the carotid artery.

 

“I am excited that enrollment in the CGuard CARENET study has just been completed. I have treated many patients with carotid artery disease over the years and the unique CGuard embolic protection system with MicroNet™ has changed the way I think about treating these challenging patients,” stated Professor Joachim Schofer, MD, from the Hamburg University Cardiovascular Center, in Hamburg, Germany. “The experience that we have gained using the CGuard device has given us a sense of confidence in regards to new technology options when treating these patients. The small pore size of the MicroNet™ technology allows excellent blood flow while trapping potentially harmful plaque debris and thrombus. The CGuard technology provides an elegantly simple solution for embolic protection that has not been available in the past. I look forward to reviewing and analyzing all of the CARENET data over the next several weeks and sharing the results soon afterward.”

 

“The completion of the CGuard CARENET trial on schedule with 100% procedural success rate is an important milestone for InspireMD,” stated Alan Milinazzo, President and Chief Executive Officer of InspireMD, “Our investigators have done a wonderful job throughout this trial, and their feedback on the CGuard has been very positive and informative. The initial results support our belief that the MicroNet™ technology may deliver life-saving benefits to patients with carotid artery disease and revolutionize the way the carotid stenting procedures are performed. We are looking forward to analyzing the data from the CARENET trial and sharing the results in mid-September at the upcoming TCT conference.”

 

For more information about InspireMD and its offerings, visit www.inspiremd.com.

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM) and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

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 Transition Report on Form 10-KT 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:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contact:

Samantha Wolf

KCSA Strategic Communications

212-896-1220

swolf@kcsa.com

InspireMD Selected for Inclusion in the Russell Microcap Index

BOSTON, MA – July 1, 2014 — InspireMD Inc.(NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems, today announced that it has been selected to join the Russell MicrocapIndex, as of June 27, 2014.

Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. Russell determines membership for its equity indexes primarily by objective, market-capitalization rankings and style attributes.

 

“We hope that our presence in the Russell Microcap index will increase awareness of our company within the investor community,” said Alan Milinazzo, InspireMD CEO. “We intend to accomplish a number of important milestones over the coming months. These include ramping MGuard Prime selling activities, completing enrollment in our CGuard CARENET trial and finalizing our approval to restart MASTER II clinical activities. We welcome the increased investor attention at such an important and exciting time for the Company.”

 

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Russell calculates more than 700,000 benchmarks daily covering approximately 98 percent of the investable market globally, 80 countries and more than 10,000 securities. Approximately $5.2 trillion in assets are benchmarked to the Russell Indexes.

 

Annual reconstitution of Russell Indexes captures the 4,000 largest U.S. stocks as of the end of May, ranking them by total market capitalization to create the Russell 3000Ò Index and Russell Microcap Index. These investment tools originated from Russell’s multi-manager investment business in the early 1980s when the company saw the need for a more objective, market-driven set of benchmarks in order to evaluate outside investment managers.

 

Total returns data for the Russell Microcap and other Russell Indexes is available at http://www.russell.com/indexes/data/US_Equity/Russell_US_Index_returns.asp.

 

About Russell

 

Russell Investments (Russell) is a global asset manager and one of only a few firms that offers actively managed multi-asset portfolios and services that include advice, investments and implementation. Russell stands with institutional investors, financial advisors and individuals working with their advisors—using the firm’s core capabilities that extend across capital market insights, manager research, portfolio construction, portfolio implementation and indexes to help each achieve their desired investment outcomes.

 

Russell has more than $259 billion in assets under management (as of 3/31/2014) and works with over 2,500 institutional clients, independent distribution partners and individual investors globally. As a consultant to some of the largest pools of capital in the world, Russell has $2.4 trillion in assets under advisement (as of 6/30/2013). It has four decades of experience researching and selecting investment managers and meets annually with more than 2,200 managers around the world. Russell traded more than $1.6 trillion in 2013 through its implementation services business. Russell also calculates approximately 700,000 benchmarks daily covering 98% of the investable market globally, including more than 80 countries and more than 10,000 securities. Approximately $5.2 trillion in assets are benchmarked (as of 12/31/2013) to the Russell Indexes, which have provided investors with 30 years of smarter beta.

  

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MGuard™ with MicroNet™TM 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 (CGuardTM) and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

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 Transition Report on Form 10-KT 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:

Todd Fromer / Garth Russell

KCSA Strategic Communications

Phone: 212-896-1215 / 212-896-1250

Email: tfromer@kcsa.com / grussell@kcsa.com

 

Media Contact:

Samantha Wolf

KCSA Strategic Communications

212-896-1220

swolf@kcsa.com

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