InspireMD Announces Independent Study Published in the Journal of Endovascular Therapy that Continues to Support the Clinical Benefit and Utility of the CGuard™ Embolic Prevention System

100% procedural success rate in a 30 patient study using the new CGuardTM Embolic Prevention System with no procedural related complications and zero strokes at 6-month follow up

Companion Editorial Highlights Need for More Effective Management of Carotid Artery Stenosis for Stroke Prevention

 

BOSTON, MAOctober 17, 2016InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced the online publication of positive clinical data in a new independent study performed by Prof. Christian Wissgott, M.D., entitled “Clinical Results and Mechanical Properties of the Carotid CGUARDTM Double-Layered Embolic Prevention Stent,” which evaluated the Company’s CGuard™ EPS in patients with symptomatic or high-grade  asymptomatic internal carotid artery (ICA) stenosis. The study, published in the Journal of Endovascular Therapy online-ahead-of-print, is available digitally on the journal’s OnlineFirst website section. The OnlineFirst section also includes an accompanying editorial written by Prof. Piotr Musialek, M.D., entitled “Carotid Artery Revascularization for Stroke Prevention: A New Era,” which underscores the use of CGuardTM EPS as a novel approach to potentially reducing the risk of stroke by avoiding the risks associated with conventional carotid stenting.

 

Prof. Christian Wissgott, M.D., Assistant Director at Westkustenklinikum, Heide, Germany, independently evaluated CGuard™ properties against other carotid stents and conducted a study in 30 consecutive patients with Internal Carotid Artery Stenosis (ICA) disease. The average stenosis of the treated arteries was 84% with a mean lesion length of 17 mm.  The majority of the patients (83%) had symptomatic disease. Patients were followed for six months post-procedure and were assessed using a number of variables, including stroke, change in modified Rankin Scale (mRS), CGuardTM EPS patency, and new ipsilateral lesions as measured by DW-MRI. Key findings from the six month study included:

  • 100% success in implanting the CGuardTM EPS;
  • No peri- or post-procedural complications;
  • No deaths, major adverse events, minor or major strokes, or new neurologic symptoms during the six months following the procedure;
  • Modified Rankin Scale improved for the symptomatic patients from 1.56 prior to the procedure to 0 afterwards;
  • All vessels treated with the CGuardTM system remained patent (open) at six months; and
  • DW-MRI performed in 19 of 30 patients found no new ipsilateral lesions after 30 days and after six months compared with the baseline DW-MRI studies.

Additionally, based on engineering evaluations, the study concluded that the CGuardTM EPS provides a high radial force and strong support in stenotic lesions, and its structure, in contrast to some other stents, adapted well to changes in vessel diameter and direction. The MicroNet™ mesh of the CGuardTM did not cause any changes to specific mechanical parameters of the underlying stent.

 

“The novel construction of the CGuardTM EPS prevented post-procedural embolic events in this series of patients undergoing routine carotid artery stenting,” said Prof. Wissgott. “The CGuardTM EPS is easy and safe to implant because it more readily adapts to the shape and diameter of the vessel wall versus other carotid artery stents. Importantly, none of the patients in this series experienced any complications or strokes as a result of the procedure or in the following six months. Consequently, I believe that the CGuardTM EPS is an important new treatment option for both symptomatic and asymptomatic carotid artery stenosis patients.”

 
Key points highlighted in the companion editorial from Piotr Musialek, M.D., DPhil, FESC, Prof. in the Jagiellonian University Department of Cardiac & Vascular Diseases include:

  • 85% of strokes occur without warning signs, raising questions about the validity of “watchful waiting” in patients with asymptomatic carotid artery stenosis;
  • Novel stent technology ensures viability of endovascular approaches to carotid revascularization in both primary and secondary stroke prevention;
  • Consistent clinical evidence is accumulating that demonstrates that mesh covered stents, with InspireMD’s CGuardTM EPS in particular, prevent post-procedural embolic events; and
  • Data in Wissgott et al is consistent with the positive outcomes reported in all other clinical trials of CGuard™.

“Given the risks associated with prior carotid stent options to date, many physicians prefer to treat their asymptomatic patients with medication-only rather than medication plus interventional plaque pacification,” said Prof. Musialek. He continued, “The growing body of data for the CGuardTM EPS demonstrates that this novel system may have a much lower risk of peri- or post-procedural complications and embolic events. Prof. Wissgott’s study and the results of the CARENET and PARADIGM 101 studies demonstrate that CGuardTM EPS may help to reduce the risk of stroke for asymptomatic patients and provide them with improved long-term cerebrovascular outcomes. There is little to no doubt today that a new carotid revascularization era has arrived.”

 

About CGuard™ EPS

The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels.

MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate (PET).

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

Carotid stenosis is a narrowing of the carotid arteries, the major arteries that supply blood and oxygen to the brain. This narrowing results from a buildup of plaque inside the blood vessel and reduces blood flow to the brain. The presence of plaque in the blood vessel can also cause the development of blood clots, which may also reduce blood flow to the brain. In some cases, plaque may rupture or dislodge from the vessel wall and block smaller downstream arteries. Patients with carotid stenosis have an increased risk of stroke as a result of cerebral embolism and decreased blood flow to the brain.

Patients with symptomatic carotid stenosis are typically treated by placement of a stent inside the blood vessel in order to re-open the carotid artery and improve blood flow to the brain. InspireMD’s CGuardTM EPS uses the company’s patented MicroNet™ technology to provide the revascularization benefits of a stent with a mesh “safety net” that secures the plaque against the blood vessel’s arterial wall and thereby prevents plaque and other debris from flowing through the stent’s scaffold.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

Forward-looking Statements

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

 

Investor Contacts:

InspireMD, Inc.

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

 

Lazar Partners
David Carey
Investor Relations
(212) 867-1768
Email: dcarey@lazarpartners.com

 

InspireMD to Present at the Dawson James Securities 2nd Annual Growth Stock Conference on October 20

BOSTON, Mass. – October 13, 2016 – InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced that President and Chief Executive Officer James Barry, PhD will present at the Dawson James Securities 2nd Annual Growth Stock Conference on Thursday, October 20, 2016 at 12:15 p.m. ET in Jupiter, Florida. Dr. Barry will provide a corporate overview and discuss the Company’s proprietary MicroNet™ technology developed to overcome key issues found with current steting options.

A live webcast of the presentation will be available in the investor section of the Company’s website or by clicking here. A replay will be available on the Company’s website or by clicking here following the presentation.

 

About InspireMD, Inc.

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

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

 

Forward-looking Statements

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

 

Investor Contacts:

InspireMD, Inc.

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

 

Lazar Partners
David Carey
Investor Relations
(212) 867-1768
Email: dcarey@lazarpartners.com

InspireMD Announces Adjustments to Shares Receivable Upon Warrant Exercise and Exercise Price Per Share

BOSTON, MA – October 6, 2016 – InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced that in conjunction with the 1-for-25 reverse stock split announced last week following the Company’s special meeting of stockholders, the number of shares of common stock of InspireMD receivable upon exercise of one warrant currently trading on the NYSE MKT and the exercise price will adjust from 1 share at the exercise price of $0.20 per share of common stock to 1/25 of one share at the exercise price of $0.20 per 1/25 of one share of common stock, effective at 5:00 p.m. ET on October 7, 2016. Warrants may only be exercisable for a whole number of shares of common stock. Warrants exercised on or prior to October 7 will be on a pre-adjusted basis.

InspireMD’s warrants will continue to trade on the NYSE MKT under the symbol “NSPR.WS.” The CUSIP number for the Company’s warrants will remain 45779A 119.

Additional information regarding these warrant adjustments can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on August 18, 2016, a copy of which is also available at www.sec.gov or at www.inspiremd.com under the SEC Filings tab located on the Investors page.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

Forward-looking Statements

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

 

Investor Contacts:

InspireMD, Inc.

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

 

Lazar Partners

David Carey
Investor Relations
(212) 867-1768
Email: dcarey@lazarpartners.com

InspireMD Announces 1-for-25 Reverse Stock Split

BOSTON, MA – September 28, 2016 – InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced a 1-for-25 reverse split of its common stock, effective as of October 7, 2016.  Beginning on October 10, 2016, the Company’s common stock will trade on the NYSE MKT on a split adjusted basis.

At InspireMD’s special meeting of stockholders on September 28, 2016, the Company’s stockholders authorized the Board of Directors to amend the Amended and Restated Certificate of Incorporation of the Company to effect a reverse stock split at a ratio in the range of 1-for-10 to 1-for-25.

Upon effectiveness, the reverse stock split will cause a reduction in the number of shares of common stock outstanding and issuable upon the conversion of the Company’s outstanding shares of preferred stock and the exercise of its outstanding stock options and warrants in proportion to the ratio of the reverse stock split and will cause a proportionate increase in the conversion and exercise prices of such preferred stock, stock options and warrants. The number of shares of common stock issuable upon exercise or vesting of outstanding stock options and warrants will be rounded up to the nearest whole share.

The Company’s common stock will continue to trade on the NYSE MKT under the symbol “NSPR.” The new CUSIP number for the common stock following the reverse stock split is 45779A 804.

The number of authorized shares of the Company’s common stock will remain at 150,000,000, while the number of outstanding shares will be reduced from approximately 36 million to 1.4 million. No fractional shares will be issued following the reverse stock split.

Registered stockholders holding their shares of common stock in book-entry or through a bank, broker or other nominee form do not need to take any action in connection with the reverse stock split. For those stockholders holding physical stock certificates, the Company’s transfer agent, Action Stock Transfer Corp, will send instructions for exchanging those certificates for new certificates representing the post-split number of shares. Action Stock Transfer Corp can be reached at (801) 274-1088.

Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on August 18, 2016, a copy of which is also available at www.sec.gov or at www.inspiremd.com under the SEC Filings tab located on the Investors page.


About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.


Forward-looking Statements

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

 

Investor Contacts:

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

 

Lazar Partners
David Carey
Investor Relations
(212) 867-1768
Email: dcarey@lazarpartners.com

 

InspireMD Appoints Thomas Kester to Board of Directors

BOSTON, MA – September 7, 2016 – InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced the appointment of Thomas Kester to the Company’s Board of Directors and Chairman of the Company’s Audit Committee. Mr. Kester brings over 40 years of public accounting experience as well as Board member experience with publicly traded companies.

“Tom has extensive audit and Director experience and we are pleased to welcome him to the InspireMD Board,” said James Barry, PhD, Chief Executive Officer of InspireMD. “His expertise and insight will be assets for our company as we expand our commercial opportunities for CGuard™ EPS and MGuard Prime™ EPS and advance additional development programs that have the potential to transform the treatment and outcomes for patients with neurovascular and cardiovascular diseases.”

Mr. Kester’s experience includes 28 years at KPMG LLP, a leading global accounting firm, including 18 years as an audit partner. In this capacity a few of his major clients included BMW Manufacturing Corp, Fuji Photo Film, Kemet Electronics, Cryovac, a division of Sealed Air Corp and Bowater, Inc. He also has more than a decade of Board experience with several public and not-for-profit organizations, including over six years with Orthofix International, a global medical device company, where he was Chairman of the Compensation Committee and a member of the Audit Committee. He is currently the Chief Financial Officer of Kester Search Group, Inc, a private executive search firm specializing in sales force placement for medical, dental and diagnostic device companies.  He holds a BS in Mechanical Engineering from Cornell University and an MBA from Harvard University.

“InspireMD has a truly innovative technology that has broad potential to improve human health and patient outcomes, and I am excited for the opportunity to join the Company’s Board of Directors,” said Mr. Kester. “I believe that InspireMD is positioned for growth and I look forward to working with the management team and the other Board members to realize the potential of the Company’s products, pipeline, and technology.”

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS

 

Forward-looking Statements

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

 

Investor Contacts:

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

 

Lazar Partners
David Carey
Investor Relations
(212) 867-1768
dcarey@lazarpartners.com

InspireMD Reports Financial Results for the Second Quarter Ended June 30, 2016

 Company to Host Conference Call Today at 4:30pm ET

BOSTON, MA – August 9, 2016 – InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced financial and operating results for the second quarter ended June 30, 2016, and provided a business update.

“We continue to see steady traction in sales of our CGUARD™ Embolic Prevention System, and are encouraged by the solid growth in second quarter sales for this product versus the same quarter last year. Notably, sales in Italy, one of the first countries in which we launched CGuard, grew more than 190% this quarter compared to the same quarter last year, and 20% compared to the first quarter of 2016,” said James Barry, PhD, Chief Executive Officer of InspireMD. “In addition, our MicroNet™ technology continues to gain recognition among industry experts, as evidenced by the selection of the investigator-initiated PARADIGM study for presentation in the late-breaking clinical trial session at the EuroPCR 2016 Conference, highlighting the clinical efficacy of routine use of the CGuard™ system, including use in high risk patients.”

“The closing of our $14.6 million financing and recent debt restructuring provide us with the financial flexibility to advance the commercialization of CGuard™ EPS and MGuard Prime™ EPS in key markets,” Dr. Barry continued. “We also continue to advance our robust product pipeline with the goal of utilizing our proprietary MicroNet™ technology for other indications, including the development of our NGuard™ Flow Diverter for an anticipated 2017 CE Mark submission.”

 

Recent Highlights:

 

COMMERCIAL

  • Sales growth of CGuardTM increased by 112% in the second quarter of 2016 versus same quarter last year.
  • Continued strong sales growth of CGuardTM in Italy, which grew 194% compared to the second quarter of 2015, and 20% compared to the first quarter of 2016.

     

REGULATORY / CLINICAL / PRODUCT DEVELOPMENT

  • CGuardTM’s evaluation in the investigator-initiated PARADIGM-101 highlighted in the late-breaking clinical trial session at EuroPCR 2016 in Paris, France. This study found that CGuard may be a safe and effective treatment option for endovascular management in more than 90% of all-comer patients with carotid artery stenosis who require treatment.
     

 FINANCIAL

  • Closing of a $14.6 million public offering of approximately 442,424 shares of Series B Convertible preferred stock and warrants to purchase up to 44,242,400 shares of common stock.
  • Restructuring of an outstanding loan with Hercules Capital, including four principal payment deferrals which began May 1st, 2016.

 

EXECUTIVE APPOINTMENT

  • In June, James Barry, Ph.D. was appointed President and CEO of InspireMD. Prior to this appointment, Dr. Barry served as InspireMD’s Chief Operating Officer for two years. For more than 18 years, Dr. Barry held senior roles at Boston Scientific Corporation, which included overseeing the development of Boston Scientific’s Taxus™ stent which became the number one selling drug eluting stent worldwide.

 

Second Quarter 2016 Financial Results

Revenue for the second quarter ended June 30, 2016 was $0.5 million compared to $0.7 million during the same period in 2015. The decrease was primarily the result of an expected decline in sales of MGuard™ Prime EPS associated with the trend of doctors increasingly using drug eluting stents rather than bare metal stents in STEMI patients. This decrease was partially offset by an increase in sales of $0.2 million of CGuard™ EPS, the Company’s carotid product.

The Company’s gross profit for the quarter ended June 30, 2016 was $62,000 compared to a gross loss of $0.2 million for the same period in 2015. The increase in gross profit was largely attributable to a decrease of write-offs of MGuard™ Prime EPS inventory and a decrease in labor and material costs attributable to lower revenues, offset by a decrease in product revenues.

Total operating expenses for the quarter ended June 30, 2016 were $1.9 million, a decrease of 44.6% compared to $3.4 million for the same period in 2015. This decrease was primarily due to a reduction of compensation related expenses and other savings associated with our ongoing cost reduction plan.

The loss from operations for the quarter ended June 30, 2016 was $1.8 million, a decrease of 49.6% compared to a loss of $3.6 million for the same period in 2015.

 Financial expenses for the quarter ended June 30, 2016 were $0.2 million, a decrease of 44.1% compared to the same period in 2015. This decrease was primarily due to a reduction in interest expense of our outstanding loan.

The net loss for the quarter ended June 30, 2016 totaled $2.0 million, or $0.19 per basic and diluted share, compared to a net loss of $3.9 million, or $0.51 per basic and diluted share, in the same period in 2015.

Non-GAAP net loss for the quarter ended June 30, 2016 was $1.7 million, or $0.16 per basic and diluted share, a decrease of 41.6% compared to a non-GAAP net loss of $2.9 million, or $0.38 per basic and diluted share, for the same period in 2015.  The non-GAAP net loss for the quarter ended June 30, 2016 primarily excludes $0.3 million of share-based compensation. The non-GAAP net loss for the quarter ended June 30, 2015 primarily excludes $1.0 million of share-based compensation.

 

Six Months Ended June 30, 2016 Financial Results

Revenue for the six months ended June 30, 2016 was $1.1 million compared to $1.2 million during the same period in 2015. The decrease was predominantly driven by an expected decline in sales of MGuard™ Prime EPS associated with the trend of doctors increasingly using drug eluting stents rather than bare metal stents in STEMI patients.

The Company’s gross profit for the six months ended June 30, 2016 was $0.1 million compared to a gross loss of $0.3 million for the same period in 2015. This increase in gross profit was largely attributable to a decrease of write-offs of MGuard™ Prime EPS inventory, offset by expenses related to the underutilization of our manufacturing resources.

Total operating expenses for the six months ended June 30, 2016 were $4.3 million, a decrease of 47.5% compared to $8.2 million for the same period in 2015. This decrease was primarily due to a reduction of compensation related expenses, restructuring and impairment costs and other savings associated with our ongoing cost reduction plan.

The loss from operations for the six months ended June 30, 2016 was $4.2 million, a decrease of 50.5% compared to a loss of $8.5 million for the same period in 2015.

Financial expenses for the six months ended June 30, 2016 were $0.4 million, a decrease of 36.1% compared to the same period in 2015. This decrease was primarily due to a reduction in interest expense of our outstanding loan.

The net loss for the six months ended June 30, 2016 totaled $4.6 million, or $0.49 per basic and diluted share, compared to a net loss of $9.1 million, or $1.44 per basic and diluted share, in the same period in 2015.

Non-GAAP net loss for the six months ended June 30, 2016 was $3.5 million, or $0.38 per basic and diluted share, a decrease of 47.3% compared to a non-GAAP net loss of $6.7 million, or $1.07 per basic and diluted share, for the same period in 2015.  The non-GAAP net loss for the six months ended June 30, 2016 primarily excludes $1.0 million of share-based compensation. The non-GAAP net loss for the six months ended June 30, 2015 primarily excludes $2.0 million of share-based compensation and $0.3 million of expense related to an impairment of a royalties buyout asset.

 

Cash and Cash Equivalents

As of June 30, 2016, cash and cash equivalents were $0.9 million, compared to $3.3 million as of December 31, 2015. This amount does not include the net proceeds from the Company’s public offering which closed on July 7, 2016. The aggregate net proceeds to InspireMD from the financing were $13.0 million.

 

Conference Call

The company has scheduled a conference call to discuss second quarter 2016 financial results for today at 4:30 PM Eastern.  To participate in the conference call, please dial 866-652-5200 (United States) or 412-317-6060 (International) and request the InspireMD call. A live webcast will be available in the Investor Relations section of the Company’s website or by clicking here.  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 following the call and will be accessible in the Investor Relations section of the Company’s website or by clicking here.  A dial-in replay of the call will also be available to those interested until August 23, 2016.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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), neurovascular, and peripheral artery procedures.  InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR and certain warrants are quoted on the NYSE MKT under the ticker symbol NSPR.WS.

 

Forward-looking Statements

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

 

Investor Contacts:

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

 

Lazar Partners
David Carey
Investor Relations
(212) 867-1768
dcarey@lazarpartners.com

 

 

 

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(1) All 2016 financial information is derived from the Company’s 2016 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission, all 2015 financial information is derived from the Company’s 2015 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.
(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) All June 30, 2016 financial information is derived from the Company’s 2016 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2015 financial information is derived from the Company’s 2015 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2015 filed with the Securities and Exchange Commission.

InspireMD to Report Second Quarter Financial Results on Tuesday, August 9, 2016

BOSTON, MA – August 2, 2016 – InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS), a leader in embolic protection systems, announced today that it will release its financial results for the second quarter ended June 30, 2016 on Tuesday, August 9 after the market close, followed by a conference call at 4:30 p.m. ET to review results and provide a company update.

Participants should call (866) 652-5200 (United States) or (412) 317-6060 (International) and request the InspireMD call. A live webcast will be available in the Investor Relations section of the Company’s website or by clicking here.

An archive of the webcast will be available approximately two hours following the call and will be accessible in the Investor Relations section of the Company’s website or by clicking here.  A dial-in replay of the call will also be available to those interested until August 23, 2016.

 

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™TM technology in coronary, carotid (CGuardTM), neurovascular, and peripheral artery procedures. InspireMD’s common stock is quoted on the NYSE MKT under the ticker symbol NSPR.

 

Investor Contacts:

InspireMD, Inc.

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

 

Lazar Partners

David Carey
Investor Relations
(212) 867-1768
dcarey@lazarpartners.com

InspireMD Announces Listing of Warrants on the NYSE MKT

BOSTON, MAAugust 1, 2016InspireMD, Inc. (NYSE MKT: NSPR, NSPR.WS) (“InspireMD” or the “Company”), a leader in embolic protection systems (EPS), neurovascular devices and thrombus management technologies, today announced the listing of the Company’s 44,242,424 previously issued warrants on the NYSE MKT (the “Exchange”).  Beginning at the market open on August 1, 2016, the warrants will commence trading under the ticker symbol “NSPR.WS.”

On July 7, 2016, InspireMD announced the closing of a public offering of approximately $14.6 million, which included the issuance of these 44,242,424 warrants.  Each warrant entitles the holder to purchase one common share of InspireMD at an exercise price of $0.20 until July 7, 2021.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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), neurovascular, 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 Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov .The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Investor Contacts:

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

 

Lazar Partners
David Carey
Investor Relations
(212) 867-1768
dcarey@lazarpartners.com

 

InspireMD Regains Compliance with NYSE MKT Listing Standards

BOSTON, MAJuly 21, 2016InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (EPS), neurovascular devices and thrombus management technologies, today announced that the NYSE MKT (the “Exchange”) has notified the Company that it has regained compliance with the NYSE MKT continued listing standards.

InspireMD received notice on January 20, 2015 that the Company was not in compliance with Section 1003(a)(i), Section 1003(a)(ii), Section 1003(a)(iii), and Section 1003(a)(iv) of the NYSE MKT Company Guide due to certain financial conditions. On March 21, 2015, the Company announced that, based on information provided, the Exchange had determined the Company had resolved the continued listing deficiency with respect to Section 1003(a)(iv). In a letter dated July 20, 2016, the NYSE MKT notified InspireMD that the Company has successfully regained full compliance with the NYSE MKT continued listing standards.

“We are pleased that we have regained compliance with the NYSE MKT’s continued listing standards, and have strengthened our capital structure,” said Jim Barry, President and Chief Executive Officer of InspireMD. “Our focus remains on continuing to create shareholder value through expansion of the market for CGuard™ in Europe and other key markets in the world and advancing additional innovative products based on our proprietary MicroNet™TM technology for the neurovascular and peripheral vascular markets.”

 

About CGuard™ EPS

The proprietary CGuard™ Embolic Prevention System (EPS) uses InspireMD’s patented MicroNet™ technology.  The CGuard™ EPS is designed to prevent peri-procedural and late embolization by trapping potential emboli against the arterial wall while maintaining excellent perfusion to the external carotid artery and branch vessels.

 MicroNet™ is a bio-stable mesh woven from a single strand of 20 micron Polyethylene Terephthalate (PET).

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

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary 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), neurovascular, 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 Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Investor Contacts:

InspireMD, Inc.

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

 

Lazar Partners
David Carey
Investor Relations
(212) 867-1768
dcarey@lazarpartners.com

 

 

 

InspireMD Announces Closing of Public Offering of Approximately $14.6 Million

BOSTON, MA – July 7, 2016 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, today announced the closing of a “best efforts” public offering of 442,424 shares of Series B Convertible Preferred Stock and accompanying warrants to purchase up to 44,242,400 shares of common stock. Each share of Series B Convertible Preferred Stock is convertible into 100 shares of common stock at a conversion price equal to $0.33 per share, and the holders of Series B Convertible Preferred Stock will be entitled to receive cumulative dividends at the rate per share of 15% per annum of the stated value for five years. The warrants shall be exercisable immediately and have a term of exercise of five years from the date of issuance and have an exercise price of $0.20 per share of common stock. The Series B Convertible Preferred Stock and accompanying warrants were sold at a price of $33.00 per share. The Company received gross proceeds of approximately $14.6 million from the offering, before deducting placement agent fees and estimated offering expenses payable by the Company.

The Company intends to use the net proceeds from the offering to conduct sales activities related to CGuard™ EPS™, MGuard Prime™ EPS and develop its pipeline of new products and for general corporate purposes.

Dawson James Securities, Inc. served as the sole placement agent.

The securities sold in the offering described above were offered pursuant to a registration statement on Form S-1 which was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on June 30, 2016. A final prospectus supplement relating to the offering was filed with the SEC on July 1, 2016. Copies of the prospectus supplement and accompanying prospectus relating to the offering may be obtained from Dawson James Securities, Inc., Attention: Prospectus Department, 1 North Federal Highway, 5th Floor, Boca Raton, FL 33432,  mmaclaren@dawsonjames.com  or toll free at 866.928.0928.

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 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), neurovascular, 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 Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Investor Contacts:

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

 

PCG Advisory
Vivian Cervantes
Investor Relations
Phone:  (212) 554-5482