InspireMD Announces Notification of NYSE MKT Listing Deficiency

BOSTON, MAJanuary 21, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced the receipt of a notice indicating that InspireMD does not meet certain of the NYSE MKT LLC’s (the “NYSE MKT”) continued listing standards as set forth in Part 10 of the NYSE MKT Company Guide (“Company Guide”). The Exchange’s notice has no immediate effect on the listing of the Company’s common stock on the Exchange. The Company’s management is reviewing its options to address the deficiency and expects to submit a compliance plan on or before the deadline set by the Exchange.

On January 20, 2015, InspireMD received a letter from the NYSE MKT notifying InspireMD that it is not in compliance with Section 1003(a)(i), Section 1003(a)(ii) and Section 1003(a)(iii) of the Company Guide because it reported stockholders’ equity of less than $2 million, $4 million, and $6 million respectively, as of September 30, 2014 and had net losses in its five most recent fiscal years ended June 30, 2013. In addition, the NYSE MKT indicated that InspireMD is not in compliance with Section 1003(a)(iv) of the Company Guide because it has sustained losses that are substantial in relation to its overall operations or its existing financial resources, or its financial condition has become impaired such that it appears questionable, in the opinion of the NYSE MKT, as to whether InspireMD will be able to continue operations and/or meet its obligations as they mature. As a result, InspireMD has become subject to the procedures and requirements of Section 1009 of the Company Guide.

In order to maintain its listing on the Exchange, InspireMD must submit a plan of compliance to the NYSE MKT by February 19, 2015 addressing how it intends to regain compliance with Sections 1003(a)(i), 1003(a)(ii) and 1003(a)(iii) of the Company Guide by July 20, 2016 and Section 1003(a)(iv) of the Company Guide by June 1, 2015.

InspireMD’s management believes that the recent shift in the strategic focus of the Company outlined in November 2014, as well as subsequent reductions in spending on headcount and clinical programs has improved the Company’s near term financial outlook. Targeting both CGuard™ in the carotid market and favorable bare metal stent (BMS) markets by geography, in combination with streamlined development and pre-clinical drug eluting stent (DES) spending, has had an immediate positive financial impact to the Company. Additionally, the full board of directors has converted 2015 cash compensation to equity- based compensation. The net financial impact of improving revenues and recent organizational and spending reductions is anticipated to reduce the cash consumption rate of the company by 50% during 2015.

The Company is pursuing a number of financing transactions to address the Company’s financial requirements. Such financing activities may include equity financings, asset sales, strategic partnerships, or other arrangements, in order to execute its operating plans. The Company intends to submit a Plan in the prescribed form to the Exchange prior to the due date that management anticipates will address the concerns of the Exchange and regain compliance with the Exchange’s continued listing standards.

If InspireMD does not submit a plan or if the plan is not accepted, delisting proceedings will commence. Furthermore, if the plan is accepted but InspireMD is not in compliance with the continued listing standards by June 1, 2015 for Section 1003(a)(iv) of the Company Guide and July 20, 2016 for Sections 1003(a)(i), 1003(a)(ii) and 1003(a)(iii) of the Company Guide, or if InspireMD does not make progress consistent with the plan during the applicable plan period, the NYSE MKT will initiate delisting proceedings.

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 (CGuard™) 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: craigs@inspiremd.com / Email: grussell@kcsa.com

Media Contact
Samantha Wolf
KCSA Strategic Communications
Phone: 212-896-1220
Email: swolf@kcsa.com

InspireMD to Announce Positive Six Month Results from the CGuardTM CARENET Trial at LINC 2015

CGuardTM All Comer Data Continues to Show Excellent Clinical Benefits of the MicroNet™TM Covered Technology

Six-Month Ultrasound Analysis is Indicative of Patent Carotid Arteries Without Restenosis Concern When Compared to Conventional Carotid Stents
 

BOSTON, MAJanuary 13, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced that six month follow-up data from its CGuardTM CARENET (CARotid Embolic protection Study using MicroNet™) trial continued to show promising clinical benefits, including exceptional safety and efficacy, and most importantly resolution of ischemic lesions and a reduced incidence of restenosis.

More detailed data will be presented at the upcoming LINC (Leipzig InterveNtional Course) meeting in Leipzig, Germany on Tuesday, January 27 at 10:58am.

The reduction in both the incidence and volume of new ischemic lesions, as well as this six-month data showing minimal restenosis concern, indicates that the therapeutic benefits of the CGuardTM MicroNet™TM technology may extend well beyond the acute procedural period. The CARENET trial recruited a total of 30 patients and showed very promising safety and efficacy with 0% MACCE (meaning no death, stroke or myocardial infarction) at 30 days, substantially lower than in other non-mesh covered carotid stenting trials. Additionally, the incidence of new ischemic ipsilateral lesions as assessed by Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) after carotid artery stenting (CAS) was reduced by almost 50% when compared to published historical control groups of non-mesh covered carotid stents. All but one of the new ischemic lesions at 48 hour follow up were completely resolved at 30 days. The CARENET trial also reported an average lesion volume per patient that was 10 times smaller than historical control groups. The ultrasound analysis performed at six months has shown healthy healing of the carotid artery without restenosis concern when compared to other CAS.

Alan Milinazzo, CEO of InspireMD, commented, “We continue to be impressed with the clinical data from our CGuardTM CARENET study. After we first presented our 30-day follow-up data at TCT 2014 in September of last year, we gained additional market feedback through a limited market release of the technology. Now, the six-month follow-up data, to be presented at LINC in a few weeks, will show that the CGuardTM has minimal restenosis concern when compared to other carotid stents. In addition, Mr. Milinazzo added, “this data, combined with the earlier DW-MRI data showing a vast reduction in the incidence, and volume, of new ipsilateral lesions continues to validate the short and long term benefits of this MicroNet™TM covered technology when treating patients with carotid artery disease.”

The CGuardTM CARENET data will be presented during the main carotid session at LINC titled, “Deep Dive Session: Carotid Revascularization” chaired by Dr. Frank Veith and Dr. William Gray on Tuesday, January 27 from 9:00am – 12:30pm. Prof Piotr Musiałek, Co- Principal Investigator for the CARENET study, from Jagiellonian University Medical College at John Paul II Hospital, in Krakow, Poland will present this CARENET late breaking clinical data in his talk titled, “The CARENET All-Comer Trial Using the CGuardTM MicroNet™TM Covered Embolic Prevention Stent.” In addition to presenting all-comer data from the CARENET trial he will also present the 6 month follow up data from the study that was originally presented at TCT 2014.

The Leipzig Interventional Course (LINC) is one of the world’s fastest growing courses committed to advancing the scientific and clinical evaluation and treatment of patients with complex vascular disease through the interdisciplinary discussion of novel endovascular techniques and systemic scientific evaluation. More than 4,000 participants from over 70 countries are expected to attend with a faculty of over 200 leading physicians and interventionalists from around the world.

 
About CGuardTM EPS

The proprietary CGuardTM EPS uses the same MicroNet™TM technology featured on the MGuardTM and MGuard PrimeTM coronary embolic protection systems. The MicroNet™TM 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™TM ‘pore’ is only 150-180 microns in order to maximize protection against the potentially dangerous plaque and thrombus within the carotid artery.
CGuardTM EPS is CE Mark approved. CGuardTM 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 MGuardTM 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™TM 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:
Craig Shore
Chief Financial Officer
InspireMD, Inc.
Phone: 1-888-776-6804
Email: craigs@inspiremd.com

InspireMD Pre-Announces a Fourth Quarter 2014 Revenue Increase of 200% Over the Third Quarter of 2014 and Provides Update on Corporate and Commercial Strategies

Near-term Focus On Carotid and DES Products, Streamlined Operations
 
BOSTON, MAJanuary 5, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced its revenue and cash position for the 2014 fourth quarter, ended December 31. Total revenues were approximately $900,000, which represented a greater than 200% sequential increase over the reported revenue for the third quarter of 2014. InspireMD is also reporting cash and cash equivalents of approximately $6.3 million, as compared to approximately $5 million reported for the 2014 third quarter, reflecting net proceeds of $7.4 million from the Company’s registered direct offering in November 2014.

Alan Milinazzo, CEO of InspireMD, commented: “The robust fourth quarter sequential revenue growth reflects further traction in our coronary market re-entry with the MGuard PrimeTM EPS. Our selling efforts were bolstered by MASTER II 30 day data, which were consistent with the positive mortality data trend we have seen in previous MGuardTM studies. Further, the Limited Market Release (LMR) of our CGuardTM complemented our selling efforts and we expect significant revenue contributions throughout 2015 after we launch our RX CGuardTM platform in the latter half of the first quarter of 2015.”

The recent shift in the strategic focus of the Company outlined in November, as well as subsequent reductions in spending on headcount and clinical programs has improved the Company’s near term financial outlook. Targeting both CGuardTM and favorable bare metal stent (BMS) markets by geography, in combination with streamlined development and pre-clinical drug eluting stent (DES) spending, has had an immediate positive financial impact to the Company. Additionally, the full board of directors has converted 2015 cash compensation to equity based compensation. The net financial impact of improving revenues and recent organizational and spending reductions is anticipated to reduce the cash consumption rate of the company by 50% during 2015.

Mr. Milinazzo added: “With revenues ramping and spending reduced, we believe the Company can do two key things: focus on the foundation work required to make an impact with CGuardTM in the carotid market, as well as finalize our strategic partners for the DES program. We are confident that the success of our pre-clinical work should position the company to submit a DES MicroNet™ platform for CE Registration no later than the second half of 2015.”

InspireMD initiated limited market release of CGuardTM for carotid stenting in October 2014, and plans to launch a full market commercial program in the first quarter of 2015 after the RX CGuardTM system receives CE approval. In September, at the TCT Conference, InspireMD reported positive results from the CARENET clinical trial. The trial achieved its primary endpoint with 0% MACE, which is defined as no death, stroke or myocardial infarction at 30 days. The incidence of new ischemic lesions as assessed by Diffusion Weighted Magnetic Resonance Imaging after carotid artery stenting was also reduced by almost 50%, in comparison to published historical control groups of non-mesh covered carotid stents. Furthermore, the CARENET trial also reported an average lesion volume per patient that was 10 times smaller than the historical control groups. The Company expects to receive a CE mark for the Carotid RX system as well as report six-month CARENET data early in the first quarter of 2015.
 

About Stenting and MGuard PrimeTM EPS

Standard stents were not engineered for heart attack patients. They were designed for treating stable angina patients whose occlusion is different from that of an occlusion in a heart attack patient. In acute heart attack patients, the plaque or thrombus is unstable and often breaks up as the stent is implanted causing downstream blockages (some of which can be fatal) in a significant portion of heart attack patients.

The MGuard PrimeTM EPS is integrated with a precisely engineered micro net mesh that is designed to prevent the unstable arterial plaque and thrombus (clots) that caused the heart attack blockage from breaking off. While offering superior performance relative to standard stents in STEMI patients with regard to mortality based on our MASTER I and MASTER II data, the MGuard PrimeTM EPS requires no change in current physician practice – an important factor in promoting acceptance and general use in time-critical emergency settings.
 

About CGuardTM EPS

The proprietary CGuardTM EPS uses the same MicroNet™TM technology featured on the MGuardTM and MGuard PrimeTM coronary embolic protection systems. The MicroNet™TM 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™TM ‘pore’ is only 150-180 microns in order to maximize protection against the potentially dangerous plaque and thrombus within the carotid artery.

MGuardTM EPS and CGuardTM EPS are CE Mark approved. MGuardTM EPS and CGuardTM EPS, however, are 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 MGuardTM 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™TM 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:

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

 

InspireMD Announces Important Clinical Data from MASTER and CARENET Trials

MASTER I and MASTER II Pooled Data Show Statistically Significant Mortality Benefit

 CARENET 30 Day DW-MRI Data Demonstrates Significant Reduction in New Ischemic Ipsilateral Lesions

BOSTON, MADecember 15, 2014InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced results from two important clinical trials. 30 day results from the MASTER II trial which enrolled 310 of a planned 1114 patients was presented at a major cardiology congress in Israel earlier today. The trial was suspended in October 2014 as a result of a corporate shift in strategy to a next generation MGuard drug eluting stent (DES) platform. The Company also announced ipsilateral DW-MRI results from the CARENET Trial for the CGuard system which successfully completed enrollment in July.

MASTER II was a global clinical trial conducted under a U.S. Food and Drug Agency (FDA) Investigational Device Exemption (IDE) and was intended for U.S. registration of the MGuard Prime coronary EPS for use in patients presenting with STEMI (ST-segment Elevated Myocardial Infarction). The MASTER II trial was designed to show superiority of ST segment resolution 60-90 minutes post procedure as well non-inferiority in all-cause death or recurrent target vessel myocardial infarction. While the trial was halted well short of the planned enrollment, the Company elected to unblind the data and present the results on behalf of the study investigators.

Today at the International Conference for Innovations in Cardiovascular Systems meeting in Tel Aviv Israel, Dr. Gregg Stone, Professor of Medicine at Columbia University and principal investigator of the trial, presented 30 day results on the 310 patients enrolled in MASTER II as well as pooled data from MASTER II and the 433 patient MASTER I trial completed and published in 2012.  While in MASTER I, the primary endpoint of superiority in ST-segment resolution was achieved (57.8% vs. 44.7%, p=0.008), MASTER II did not show a difference in ST-segment resolution between MGuard  and control stents (FDA-approved bare metal or drug eluting stents) 56.9% vs. 59.3% (p=0.68). Pooled data between MASTER I and MASTER II for ST resolution continued to favor MGuard 57.5% vs. 50.7% for control (p=0.07).

Impressively, 30 day mortality results for the MGuard in the MASTER II trial remained low (0.6% vs. 1.9%, p=0.62), consistent with all previous MGuard trials and registries and overall MACE (Major Adverse Cardiac Events) was favorable for MGuard (2.6% vs. 4.5% p=0.36). Pooled mortality data for MASTER I and II showed a statistically significant reduction in mortality with MGuard (0.3% vs. 1.9%, p=0.04). Infarct size, another important indicator of mortality, showed a positive trend for MGuard in MASTER II (mean 22.60% vs. 27.48%, p=0.16), as well as in the pooled analysis (mean 18.80% vs. 22.24%, p=0.26).

“The data from MASTER II supports further clinical evaluation of the MGuard Prime EPS,” stated Dr. Stone. “While the number of patients enrolled in MASTER II were not powered for any endpoints, it was encouraging to see the significant difference in mortality with the pooled data, with other indicators of improved reperfusion success with the MGuard technology.  We look forward to the development of a DES version of MGuard in the near future to continue a pivotal clinical evaluation of the MicroNet™ embolic protection system.”

CARENET data was also presented today at the ICI in Tel Aviv by Prof. Piotr Musiałek, Co-Principal Investigator for the CARENET study, from Jagiellonian University Medical College at John Paul II Hospital, in Krakow, Poland. He reported new positive clinical data from the CGuardTM CARENET (CARotid Embolic protection study using microNET) Trial. The CARENET trial recruited a total of 30 patients and showed exceptional safety and efficacy with 0% MACCE (meaning no death, stroke or myocardial infarction) at 30 days, substantially lower than in other carotid stenting trials. Additionally, the incidence of new ischemic ipsilateral lesions as assessed by Diffusion Weighted Magnetic Resonance Imaging (DW-MRI) after carotid artery stenting was 37.0%, a reduction of approximately 50% when 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 historical control groups. The reduction in both the incidence and volume of new ischemic lesions indicates therapeutic benefits of the MicroNet™ technology and that the benefits of using this device may extend beyond the acute procedural period.

Alan Milinazzo, CEO of InspireMD commented, “We are very encouraged to see the trend in mortality improvement with MGuard in MASTER II and very excited to show a statistically significant benefit in mortality when our two MASTER randomized trials are pooled together.  These data further support our strategy in partnering with a drug eluting stent manufacturer to re-enter the clinic to conduct a pivotal trial that will not only enroll more quickly but may ultimately show the definitive benefit of the MicroNet™ embolic protection in patients presenting with STEMI.” Milinazzo added, “Our CGuard product continues to excite physicians during our limited market release (LMR) and today’s positive CARENET data should generate even more interest in using this breakthrough technology.”

 

About Stenting and MGuard™ Prime EPS

Standard stents were not engineered for heart attack patients. They were designed for treating stable angina patients whose occlusion is different from that of an occlusion in a heart attack patient.

In acute heart attack patients, the plaque or thrombus is unstable and often breaks up as the stent is implanted causing downstream blockages (some of which can be fatal) in a significant portion of heart attack patients.

The MGuard Prime EPS is integrated with a precisely engineered micro net mesh that is designed to prevent the unstable arterial plaque and thrombus (clots) that caused the heart attack blockage from breaking off.

While offering superior performance relative to standard stents in STEMI patients with regard to mortality based on our MASTER I and MASTER II data, the MGuard Prime EPS requires no change in current physician practice – an important factor in promoting acceptance and general use in time-critical emergency settings.

 

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.

MGuard EPS and CGuard EPS are CE Mark approved. MGuard EPS and CGuard EPS, however, are 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 Reports Financial Results for the Third Quarter ended September 30, 2014

Master II 30 day data to be presented December 15th at the ICI Meeting 2014, Tel-Aviv

 Announced first pre-clinical implant with partner DES platform

BOSTON, MA – November 12, 2014 – InspireMD, Inc.(NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in stent embolic protection systems (“EPS”), today announced its financial and operating results for the third quarter, ended September 30, 2014.

 

Alan Milinazzo, CEO of InspireMD, commented, “The third quarter was a commercial turning point for the company. With the European regulatory approvals in hand we have put the Voluntary Field Action (VFA) behind us and started shipping MGuard Prime back into multiple key international markets. Further, the strong CARENET data reported in September provides an excellent platform for our initial CGuard selling activities.”

 

Mr. Milinazzo concluded, “Subsequent to the end of the third quarter, we successfully completed a capital raise for $8.1 million in gross proceeds. This cash infusion is expected to be sufficient to support key commercial milestones, including advancing development of the Company’s proprietary DES platform. Our progress in this critical development program is highlighted today with our announcement of the first pre-clinical product implants being successfully completed.”

 

Recent Operating Highlights:

 

Commercial

  •  Began shipping MGuard Prime product back into hospital accounts; distributor partners began restocking MGuard Prime product with hospital customers post European approval of the manufacturing process changes.

 

  • During the final days of the third quarter and following the quarter’s close, sales of InspireMD’s  MGuard Prime EPS resumed in direct markets. Third quarter total revenues increased 41% over the second quarter. 
  • Initiated a Limited Market Release (LMR) of CGuard, and first sales announced October 1st.
    • Full Market Release (FMR) anticipated in late Q1 2015

 

REGULATORY / CLINICAL / PRODUCT DEVELOPMENT

 

  • Received FDA approval for Investigational Device Exemption (IDE) amendment for manufacturing process changes to the MGuard Prime EPS. While MGuard Prime EPS is not approved for sale in the U.S., this approval is an important validation of the process changes and is expected to support sales activities in international markets.
  • Reported positive CARENET first-in-man 30 day results at TCT
    • Results demonstrated 0% MACE at 30 days and a significant improvement in reducing new ischemic lesions as measured by diffusion weighted magnetic resonance imaging (DW-MRI), as compared to historical controls.
  •  Commenced animal studies with initial DES strategic partner in the fourth quarter of 2014
    • Successful pre-clinical results would lead to submission for CE registration of a DES MicroNet™ platform in the second half of 2015
  •  30 day Master II trial data of 310 patients to be presented on December 15th at the Innovations in Cardiovascular Interventions (ICI) Meeting 2014

 

FINANCIAL

  •  Strengthened cash position with completion of financing with gross proceeds of $8.1 million
  • Initiated cost containment efforts, including discontinuation of Master II trial enrollment
    • Strategy intended to direct more resources to the DES program and commercial activities for the MGuard Prime and CGuard.
  • Obtained shelf-life extension from two years to three years, which positively impacts inventory management and working capital outlook

 

Quarter Ended September 30, 2014 Financial Results

Revenue for the quarter ended September 30, 2014 decreased $1.3 million to $0.3 million compared to $1.6 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 voluntary field action.

 

The Company reported a gross loss for the quarter ended September 30, 2014 of $0.1 million, a decrease of 109.5% compared to a gross profit of $0.8 million for the same period in 2013. The loss was largely attributable to the impact of the VFA on product revenues.

 

Total operating expenses for the quarter ended September 30, 2014 were $6.4 million, an increase of 36.7% compared to $4.7 million for the same period in 2013. This increase was primarily due to higher research and development expenses attributable to expenditures in sales and marketing, as the Company increased its sales efforts in key European countries and clinical trial and development expenses associated with our CGuardTM EPS product.

 

The loss from operations for the quarter ended September 30, 2014 was $6.5 million, an increase of 66.8% compared to a loss of $3.9 million for the same period in 2013.

 

Financial expenses for the quarter ended September 30, 2014 increased 449.1% to $0.3 million from $0.1 million during the same period in 2013. The increase in financial expenses resulted primarily from an increase in amortization and interest expenses relating to our loan.

 

The net loss for the quarter ended September 30, 2014 totaled $6.8 million, or $0.20 per basic and diluted share, compared to a net loss of $4.0million, or $0.12 per basic and diluted share, in the same period in 2013.

 

Non-GAAP net loss for the quarter ended September 30, 2014 was $5.7 million, or $0.16 per basic and diluted share, an increase of 89.7% compared to a non-GAAP net loss of $3.0 million, or $0.09 per basic and diluted share, for the same period in 2013. The non-GAAP net loss for the quarter ended September 30, 2014 primarily excludes $1.1 million of share-based compensation. The non-GAAP net loss for quarter ended September 30, 2013 primarily excludes $0.9 million in share-based compensation expenses and $0.1 million in non-cash financial expenses.

 

Nine Months Ended September 30, 2014 Financial Results

 

Revenue for the nine months ended September 30, 2014 decreased $2.6 million to $1.9 million compared to $4.6 million during the same period in 2013. The 2014 period included a decline in sales volume associated with the temporary stoppage of sales activities for the MGuard™ Prime EPS following our VFA.

 

Gross profit for the nine months ended September 30, 2014 totaled $0.4 million, a decrease of 83.1%, compared to $2.3 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 nine months ended September 30, 2014 were $19.6 million, an increase of 44.2%, compared to $13.6 million for the same period in 2013. This increase was primarily due to higher research and development expenses attributable to the MASTER II trial,clinical trial and development expenses associated with our CGuardTM EPS product and expenditures in sales and marketing, as the Company increased its sales efforts in key European countries.

 

The loss from operations for the nine months ended September 30, 2014 was $19.3 million, an increase of 70.2%, compared to a loss of $11.3 million for the same period in 2013.

 

Financial expenses for the nine months ended September 30, 2014 decreased 91.6% to $1.1 million from $12.5 million during the same period in 2013. The decrease in financial expenses resulted primarily from $9.9 million of non-cash effects in the nine months ended September 30, 2013 related to the conversion and repayment of our convertible debentures in April 2013, as well as $1.5 million of non-cash associated with the issuance of certain shares of common stock without consideration in satisfaction of anti-dilution rights during this period. No such expense occurred during the nine months ended September 30, 2014 2014.

 

The net loss for the nine months ended September 30, 2014 totaled $20.3 million, or $0.59 per basic and diluted share, compared to a net loss of $23.8million, or $0.86 per basic and diluted share, in the same period in 2013.

 

Non-GAAP net loss for the nine months ended September 30, 2014 was $17.1 million, or $0.50 per basic and diluted share, an increase of 107.7% compared to a non-GAAP net loss of $8.3 million, or $0.30, for the same period in 2013. The non-GAAP net loss for the nine months ended September 30, 2014 primarily excludes $3.2 million of share-based compensation. The non-GAAP net loss for the nine months ended September 30, 2013 primarily excludes $12.2 million in non-cash financial expenses and $3.3 million in share-based compensation expenses.

 

Cash and Cash Equivalents

 

As of September 30, 2014, cash and cash equivalents were $5.0 million, compared to $17.5 million as of December 31, 2013.

 

The Company reported that subsequent to the quarter’s close, it successfully completed a gross $8.1 million financing. InspireMD said it believes that these enhanced cash resources should be sufficient to achieve key commercial milestones, including advancing development of the Company’s proprietary DES platform as well as sales ramps of its two commercial products, MGuard™ and CGuard™ EPS.

 

Investor Conference Call

 

The Company will host a conference call at 4:30 p.m. ET on Wednesday, November 12th 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: 13595115. 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 November 26, 2014. To access the replay, dial (877) 870-5176 (United States) or (858) 384-5517 (International) and enter code: 13595115.

 

 

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.

 

None of InspireMD’s products are approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.

 

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, (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 and (xiv) the escalation of hostilities in Israel, which could impair our ability to manufacture our products. 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:

Samantha Wolf

KCSA Strategic Communications

Phone: 212-896-1220

Email: swolf@kcsa.com

 

######

 

CONSOLIDATED STATEMENTS OF OPERATIONS (1)
(U.S. dollars in thousands, except per share data)

 

Nine months ended
Three months ended  
September 30,   September 30,
2014 2013   2014   2013
Revenues $273 $1,552 $1,948 $4,566
Cost of revenues 349 750 1,558 2,256
Gross Profit (Loss) (76) 802 390 2,310
Operating Expenses:
Research and development 2,460 1,544 7,485 3,498
Selling and marketing 1,806 830 5,030 2,838
General and administrative 2,139 2,313 7,126 7,285
Total operating expenses 6,405 4,687 19,641 13,621
Loss from operations (6,481) (3,885) (19,251) (11,311)
Financial expenses 313 57 1,051 12,504
Loss before tax expenses (6,794) (3,942) (20,302) (23,815)
Tax expenses (Income) (19) 3 3 (38)
Net Loss $(6,775) $(3,945) $(20,305) $(23,777)
Net loss per share – basic and diluted $(0.20) $(0.12) $(0.59) $(0.86)
Weighted average number of shares of common stock used in computing net loss per share – basic and diluted 34,581,521 33,959,773 34,251,620 27,787,580

 

 

 

 

RECONCILIATION OF NON-GAAP NET LOSS (2)        
(U.S. dollars in thousands, except per share data)

 

Nine months ended
Three months ended  
September 30,   September 30,
2014 2013   2014   2013
GAAP Net Loss $(6,775) $(3,945) $(20,305) $(23,777)
Non-GAAP Adjustments:
Non-cash financial expenses (income)(3) 77 (47) 12,232
Share-based compensation expenses 1,052 851 3,151 3,259
Royalties buyout expenses and amortization 20 11 60 32
Total Non-GAAP Adjustments 1,072 939 3,164 15,523
Non-GAAP Net Loss $(5,703) $(3,006) $(17,141) $(8,254)
Non-GAAP net loss per share – basic and diluted $(0.16) $(0.09) $(0.50) $(0.30)
Weighted average number of shares of common stock used in computing net loss per share – basic and diluted 34,581,521 33,959,773 34,251,620 27,787,580
 

 

 

CONSOLIDATED BALANCE SHEETS (4)
(U.S. dollars in thousands)

 

ASSETS September 30, December 31,
2014 2013
Current Assets:
Cash and cash equivalents $4,978 $17,535
Restricted cash 93
Accounts receivable:
Trade 397 1,855
Other 544 387
Prepaid expenses 138 141
Inventory 1,682 1,593
Total current assets 7,739 21,604
Property, plant and equipment, net 636 652
Non-current assets:
Deferred issuance costs 170 310
Funds in respect of employee rights upon retirement 474 434
Long term prepaid expenses 80 114
Royalties buyout 792 852
Total non-current assets 1,516 1,710
Total assets $9,891 $23,966

 

 

LIABILITIES AND EQUITY (CAPITAL DEFICIENCY) September 30, December 31,
2014 2013
Current liabilities:
Accounts payable and accruals:
Trade $1,548 $1,623
Other 4,113 3,141
Advanced payment from customers 180 179
Current maturity of loan 3,710 1,181
Total current liabilities 9,551 6,124
Long-term liabilities:
Liability for employees rights upon retirement 719 610
Long term loan 6,002 8,593
Total long-term liabilities 6,721 9,203
Total liabilities 16,272 15,327
Equity:
Common stock, par value $0.0001 per share; 125,000,000 shares authorized; 35,107,046 and 33,983,346 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively 4 3
Additional paid-in capital 96,236 90,952
Accumulated deficit (102,621) (82,316)
Total equity (capital deficiency) (6,381) 8,639
Total liabilities and equity (less capital deficiency) $9,891 $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, all 2013 financial information pertaining to the three months ended September 30, 2013 is derived from the Company’s 2013 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 pertaining to the nine months ended September 30, 2013 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 September 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, as amended by Amendment No. 1 filed with the Securities and Exchange Commission.

InspireMD Completes $8.1 Million Registered Direct Offering

BOSTON, MA – November 7, 2014 – InspireMD, Inc. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in stent Embolic Protection Systems (EPS), today announced the closing of its registered direct offering of approximately 6.2 million shares of common stock and warrants to purchase up to approximately 3.1 million shares of common stock at a price of $1.30 per share. Each purchaser received a warrant to purchase 0.5 of a share of common stock for each share of common stock that it purchased in the offering. The warrants are non-exercisable for six months and have a term of exercise of 42 months from the date of issuance and an exercise price of $1.75.

The Company received gross proceeds of $8.1 million, before deducting placement agents’ fees and estimated offering expenses. The Company intends to use the net proceeds from this offering to advance the development of its MGuard™ drug-eluting stent platform and develop the CGuard™ rapid exchange platform, commercially launch CGuard EPS, and for general corporate purposes.

H.C. Wainwright & Co., LLC, served as the exclusive placement agent for this offering.

The securities described above were offered pursuant to a shelf registration statement on Form S-3 which was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on November 27, 2013. A prospectus supplement relating to the offering was filed with the SEC on November 5, 2014. Copies of the prospectus supplement and accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC by e-mailing placements@hcwco.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

 

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, (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 and (xiv) the escalation of hostilities in Israel, which could impair our ability to manufacture our products. 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 Report Financial Results for the Third Quarter Ended September 30, 2014 on Wednesday, November 12th

BOSTON, MA – November 5, 2014 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in stent embolic protection systems, announced today that it will release its financial results for the third quarter ended September 30, 2014 on Wednesday, November 12th.

 

The Company will host a conference call at 4:30 p.m. ET on Wednesday, November 12th 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: 13595115. 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 November 26, 2014. To access the replay, dial (877) 870-5176(United States) or (858) 384-5517(International) and enter code: 13595115.

 

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 Announces Registered Direct Offering for Approximately $8 Million

BOSTON, MA – November 4, 2014 – InspireMD, Inc. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in stent Embolic Protection Systems (EPS), today announced that it has entered into a definitive agreement to sell approximately 6.2 million shares of common stock and warrants to purchase up to approximately 3.1 million shares of common stock in a registered direct offering. The common stock will be sold at a negotiated purchase price of $1.30 per share, and each purchaser will receive a warrant to purchase 0.5 of a share of common stock for each share of common stock that it purchases in the offering. The warrants shall be non-exercisable for six months and have a term of exercise of 42 months from the date of issuance and an exercise price of $1.75. The Company expects to receive gross proceeds from the offering of approximately $8.0 million, before deducting placement agents’ fees and estimated offering expenses.

The offering is expected to close on or about November 7, 2014, subject to customary closing conditions.

H.C. Wainwright & Co., LLC, served as the exclusive placement agent for this offering.

 

The Company intends to use the net proceeds from this offering to advance the development of its MGuard™ drug-eluting stent platform and develop the CGuard™ rapid exchange platform, commercially launch CGuard EPS, and for general corporate purposes.

 

The securities described above are being offered pursuant to a shelf registration statement on Form S-3 which was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on November 27, 2013. A prospectus supplement relating to the offering will be filed with the SEC by November 5, 2014. Copies of the prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from H.C. Wainwright & Co., LLC by e-mailing placements@hcwco.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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, (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 and (xiv) the escalation of hostilities in Israel, which could impair our ability to manufacture our products. 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 Investigational Device Exemption (IDE) Amendment Approved by the FDA

Validation of manufacturing process changes for the MGuard Prime EPS

BOSTON, MA – October 29, 2014 – InspireMD, Inc. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in Embolic Protection Systems (EPS), today announced that the FDA has approved the Company’s submitted IDE amendment for certain manufacturing process changes to the MGuard Prime EPS that were proposed in response to the Company’s April 30, 2014 Voluntary Field Action (VFA).  InspireMD said while patient enrollment in the US MASTER II trial has been discontinued, which was intended to support this IDE application, the FDA’s approval of the IDE amendment is an important endorsement of the process changes.

 

“The FDA approval of the amendment to our MASTER II IDE further validates the safety of our manufacturing process changes to our MGuard Prime EPS,” commented Alan Milinazzo, CEO of InspireMD. “Along with the European approvals of our process changes, the rigorous review of the FDA should provide an extra level of confidence to our physicians worldwide.”

 

The Company received European regulatory approval for these process changes in June, and now believes all returned MGuard Prime EPS inventory has been successfully modified and returned to direct hospital customers and the majority of their distributors. As such, the Company resumed full commercial activities in direct markets in Western Europe as of mid-October and expects direct and distributor based selling to ramp up throughout the fourth quarter of 2014.

 

As previously announced, in light of current market conditions moving toward drug eluting stent (DES) adoption and the delay in enrollment due to the FDA review process, the Company revised its MGuard strategy for the U.S. This included the decision not to resume enrollment in the MASTER II trial for the primary endpoints of ST segment resolution and death and target vessel re MI. This decision will allow the Company to direct more resources to the DES program and commercial activities for the MGuard and CGuard.

 

The Company successfully enrolled 310 patients in the MASTER II trial prior to suspending enrollment in April due to the product manufacturing process changes that were just approved by the FDA. The initial clinical analysis of these 310 patients at 30 day follow up showed encouraging clinical results in the MGuard group versus the control group. The Company will continue to follow these 310 MASTER II patients for one year from time of enrollment, and expects to report 30 day data at a major medical meeting in the first quarter of 2015.

 

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

 

About Stenting and MGuardTM Prime EPS

 

Standard stents were not engineered for heart attack patients. They were designed for treating stable angina patients whose occlusion is different from that of an occlusion in a heart attack patient.

In acute heart attack patients, the plaque or thrombus is unstable and often breaks up as the stent is implanted causing downstream blockages (some of which can be fatal) in a significant portion of heart attack patients.

The MGuard Prime EPS is integrated with a precisely engineered micro net mesh that is designed to prevent the unstable arterial plaque and thrombus (clots) that caused the heart attack blockage from breaking off.

While offering superior performance relative to standard stents in STEMI patients with regard to ST segment resolution, the MGuard Prime EPS requires no change in current physician practice – an important factor in promoting acceptance and general use in time-critical emergency settings.

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MGuardTM 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, (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 and (xiv) the escalation of hostilities in Israel, which could impair our ability to manufacture our products. 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 Resumes MGuard Prime Sales and Prioritizes DES and Carotid – New Product Programs

MGuard Prime commercial re-launch complete in direct markets

 

Drug Eluting Stent (DES) program advances in development with partners

MASTER II trial to suspend enrollment to support DES and Carotid Opportunities

Investor conference call this morning at 8:30 a.m. ET

 

BOSTON, MA – October 14, 2014 – InspireMD, Inc. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in stent Embolic Protection Systems (EPS), today provided commercial, development and clinical updates on the MGuard Prime coronary EPS product line andpositioned the Company to address more efficiently its emerging MGuard and CGuard commercial opportunities.

 

The Company indicated that it believes all MGuard Prime inventory has been successfully modified and that it is back to full commercial activities in direct markets in Western Europe as of October 10th. Further, all returned distributor inventory has been modified and the majority of its distributor partners have begun shipping product back into hospital accounts. The Company expects direct and distributor based selling to ramp up throughout the fourth quarter of 2014 and to be enhanced by the launch of the CGuard Carotid product.

 

Positive CGuard first in man (FIM) data was reported last month in the CARENET trial presented at the Transcatheter Therapeutics Meeting (TCT) in Washington DC. CGuard demonstrated 100% procedural success, 0% MACE at 30 days and a significant improvement in reducing new ischemic lesions as measured by diffusion weighted magnetic resonance imaging (dwMRI), as compared to historical controls.

 

The Company reported today that it has successfully entered the second phase of development work with the first Drug Eluting Stent (DES) candidate via strategic partnership. As previously communicated, the Company expects to bring two viable (CE approved) DES products into an animal testing phase (II) which, if successful, is expected to lead to submission for CE registration of a DES MicoNet platform in the second half of 2015. The initial technical feasibility testing phase (I) of DES candidates had a 100% success rate, enabling the program to progress on schedule with no additional work required prior to commencing the next phase of testing.

 

In light of current market conditions moving toward continued DES adoption and the delay in enrollment due to the FDA review process, the Company has decided to revise its MGuard strategy for the U.S. This includes the decision not to resume enrollment in the MASTER II trial for the primary endpoints of ST segment resolution and death and target vessel re MI. This decision will allow the Company to direct more resources to the DES program and commercial activities for the MGuard and CGuard. As a result of this change, MASTER II will no longer be an FDA registration trial.

The Company successfully enrolled 310 patients in MASTER II trial prior to suspending enrollment in April due to product manufacturing process changes. The initial clinical analysis of these 310 patients at 30 day follow up showed encouraging clinical results in the MGuard group vs the control group. The Company will continue to follow these 310 MASTER II patients for one year from time of enrollment, and expects to report 30 day data at a major medical meeting in the first quarter of 2015.

 

Alan Milinazzo, CEO of InspireMD, stated, “On the commercial front, we are now back to full activities in our direct markets outside the US, and we are seeing usage return to pre-Voluntary Field Action (VFA) levels within our existing direct customer base. We will begin shipping product to new customers in our direct markets during this current quarter. Our final post-VFA MGuard Prime commercial milestone will be to return to full commercial activities in all of our distributor markets, which represent the majority of our current customer base. The simultaneous re launch of MGuard Prime with our new CGuard commercial activities should provide our sales channel with positive momentum going into 2015.”

 

Milinazzo continued, “During the past month we have made significant progress on our DES development program. Most importantly, we are ready to begin animal testing of our first DES candidate via partnership and expect to have a DES platform for CE submission in the back half of 2015. Finally, our decision to suspend enrollment in MASTER II and evaluate our interim data will guide our evolving clinical strategy in order to insure that we maximize our clinical investments to help drive adoption of our MGuard and CGuard technology.”

Investor Conference Call

The Company will host a conference call at 8:30 a.m. ET on Tuesday, October 14th to review these updates on its MGuard Prime coronary EPS 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: 13593465. 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 October 21st. To access the replay, dial (877) 870-5176 (United States) or (858) 384-5517 (International) and enter code: 13593465.

 

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

 

About Stenting and MGuard™ Prime EPS

 

Standard stents were not engineered for heart attack patients. They were designed for treating stable angina patients whose occlusion is different from that of an occlusion in a heart attack patient.

In acute heart attack patients, the plaque or thrombus is unstable and often breaks up as the stent is implanted causing downstream blockages (some of which can be fatal) in a significant portion of heart attack patients.

The MGuard Prime EPS is integrated with a precisely engineered micro net mesh that is designed to prevent the unstable arterial plaque and thrombus (clots) that caused the heart attack blockage from breaking off.

While offering superior performance relative to standard stents in STEMI patients with regard to ST segment resolution, the MGuard Prime EPS requires no change in current physician practice – an important factor in promoting acceptance and general use in time-critical emergency settings.

 

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, (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 and (xiv) the escalation of hostilities in Israel, which could impair our ability to manufacture our products. 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