InspireMD’s CGuardTM Highlighted at the Late-Breaking Clinical Trial Session at the EuroPCR 2016 Conference

BOSTON, MA – May 17, 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 that CGuardTM EPS reported positive results in PARADIGM-101, an investigator led clinical evaluation of the system for routine use in 101 consecutive, increased risk patients undergoing carotid artery stenting.  Principle investigator Prof. Piotr Musialek presented the results of the study at the EuroPCR 2016 Late-Breaking Clinical Trial Session in Paris, France.

PARADIGM-101 is Prof. Musialek’s clinical evaluation of the safety and periprocedural and 30 day clinical efficacy of routine use of the CGuardTM system in unselected carotid stenosis patients, building upon the earlier PARADIGM study.  The trial also assessed the CGuardTM system’s ability to minimize vessel narrowing after carotid stenting.

In the presentation, Prospective evaluation of all-comer percutaneous carotid revascularisation In symptomatic and increased-risk asymptomatic carotid artery stenosis using the MicroNet™-covered embolic prevention stent system in 101 consecutive patients: PARADIGM-101, Prof. Musialek’s key findings included:

  • CGuardTM delivery success was 99.1%. The clinical evaluation also found no device foreshortening or elongation;
  • Angiographic diameter stenosis or vessel narrowing was reduced from 83±9% to only 6.7±5% (p<0.001);
  • Periprocedural complications were 0%;
  • One event was adjudicated by the Clinical Events Committee as a minor stroke (0.9%), with no change in NIH Stroke Scale or modified Ranking scale;
  • At 30 days, no new events (0%) were noted by independent neurologist evaluation.

 

Prof. Musialek commented, “PARADIGM-101 supports the use of CGuardTM in a high risk, all comer population of patients with carotid artery stenosis, building upon the safety of the MicroNet™TM covered CGuardTM as a novel, therapeutic stent platform.  This latest data indicates that routine use of CGuardTM may prevent cerebral events – such as strokes – by holding plaque against the vessel wall, preventing emboli from being released into the blood stream.”  Prof. Musialek concluded, “On the basis of PARADIGM findings, CGuard may open a safe door for endovascular management to more than 90% of all-comer patients with carotid stenosis who require interventional treatment.”

EuroPCR is a leading course in interventional cardiovascular medicine, with over 12,000 attendees.

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

 
About PARADIGM

PARADIGM is an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard™ Mesh-covered embolic prevention stent system.  At EuroPCR 2015, Dr. Musialek summarized the results of his PARADIGM evaluation of 71 CGuardTM procedures in unselected all-comer patients:  1) stent system success and procedure success rate of 100%; 2) periprocedural complications of 0%, and remained at 0% at 30 days; and 3) no MACNE occurred periprocedurally or at 30 days, by operator-independent neurologist and non-invasive cardiologist evaluation.


About CGuard™ EPS

The proprietary CGuard™ Embolic Prevention System (EPS) uses the same MicroNet™ technology featured on the MGuard™ and MGuard Prime™ coronary Embolic Protection Systems.  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 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), 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

InspireMD Reports Financial Results for the First Quarter Ended March 31, 2016

BOSTON, MA – May 10, 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 its financial and operating results for the first quarter ended March 31, 2016.

During the first quarter, InspireMD announced initiatives to support ongoing commercial operations and development programs.  Key activities include announced:

  • Completed private placement and public offering;
  • Strengthened Board of Directors with appointment of Isaac Blech as Vice Chairman; and
  • Continued operational and financial alignment, with ongoing implementation of a comprehensive cash management program.

 

Sol Barer, Chairman of the Board of InspireMD, commented, “In line with our focused execution of our strategy, a key priority is our ongoing management transition plan with attention on our European commercial and development activities.  These efforts were aided by our recent capital raise and addition to the board.  We look for timely and continuous updates as we execute on our plans.”

Dr. Barer continued, “We remain pleased with consistent, positive feedback with our CGuardTM commercial activities, noting progress with our early efforts to drive market traction.  We look forward to continued clinical presentations of CGuardTM patient evaluations at relevant medical industry conferences, including the investigator-led PARADIGM-101 at the Late-Breaking Clinical Trial session at EuroPCR on May 17th.”

 

Recent Operating Highlights:

Commercial

  • Continued focus on expanding European commercial activities in new geographies.
  • Successful CGuardTM commercial efforts across distributor network, particularly in select European regions, such as Italy.
     

Regulatory / Clinical / Product Development

CGuardTM evaluation on 101 consecutive all comer patients in PARADIGM-101 or PARADIGM-EXTEND study selected for Late-Breaking Clinical Trial presentation at EuroPCR conference from May 17-20, 2016 in Paris, France.

 

Financial

  • Comprehensive and active cash management program, including a March 16th, 2016 pricing of an underwritten public offering of 1,900,000 shares of its common stock and warrants to purchase up to 950,000 shares of common stock and a concurrent private placement of 1,033,051shares of its common stock and warrants to purchase up to 516,526 shares of common stock to certain of the Company’s directors.
  • Continued implementation of cost containment activities while supporting key development programs.
     

Quarter Ended March 31, 2016 Financial Results

Revenue for the first quarter ended March 31, 2016 increased $0.1 million to $0.6 million compared to $0.5 million during the same period in 2015. The increase was predominantly driven by sales of $0.3 million of CGuard™ EPS, our carotid product. This increase, however, was partially offset 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.

The Company’s gross profit for the quarter ended March 31, 2016 was $66,000 compared to a gross loss of $37,000 for the same period in 2015. This increase in gross profit was largely attributable to the increase in product revenues and 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 quarter ended March 31, 2016 were $2.5 million, a decrease of 49.5% compared to $4.9 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 quarter ended March 31, 2016 was $2.4 million, a decrease of 51.2% compared to a loss of $4.9 million for the same period in 2015.

Financial expenses for the quarter ended March 31, 2016 were $0.2 million, a decrease of 27.8% 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 March 31, 2016 totaled $2.6 million, or $0.32 per basic and diluted share, compared to a net loss of $5.2 million, or $1.04 per basic and diluted share, in the same period in 2015.

Non-GAAP net loss for the quarter ended March 31, 2016 was $1.9 million, or $0.23 per basic and diluted share, a decrease of 51.6% compared to a non-GAAP net loss of $3.8 million, or $0.77 per basic and diluted share, for the same period in 2015.  The non-GAAP net loss for the quarter ended March 31, 2016 primarily excludes $0.7 million of share-based compensation. The non-GAAP net loss for the quarter ended March 31, 2015 primarily excludes $1.0 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 March 31, 2016, cash and cash equivalents were $2.0 million, compared to $3.3 million as of December 31, 2015.

 

 No Conference Call Scheduled

The Company is not hosting a conference call to discuss first quarter March 31, 2016 results.  Additional updates will be provided as they become available.

 

About PARADIGM

PARADIGM is an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard™ Mesh-covered embolic prevention stent system.  At EuroPCR 2015, Dr. Musialek summarized the results of his PARADIGM evaluation of 71 CGuardTM procedures in unselected all-comer patients:  1) stent system success and procedure success rate of 100%; 2) periprocedural complications of 0%, and remained at 0% at 30 days; and 3) no MACNE occurred periprocedurally or at 30 days, by operator-independent neurologist and non-invasive cardiologist evaluation.

 

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), 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

 

 

 

 

 

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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 March 31, 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 Announces Late-Breaking Trial Presentation on CGuardTM Embolic Prevention System at EuroPCR 2016 Conference

BOSTON, MA – May 5, 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 that CGuardTM EPS will be featured at the Late-Breaking Trial presentation at the upcoming EuroPCR conference from May 17-20, 2016 in Paris, France.

A leading course in interventional cardiovascular medicine, EuroPCR hosts over 120 companies from the industry, including device and equipment manufacturers. The event allows attendees to discover new products and R&D projects, as well as interact with practitioners and industry partners to drive continued development and innovation in the interventional cardiovascular field.

 InspireMD’s CGuardTM system will be featured in a session comprising selected EuroPCR 2016 Late-Breaking Trial submissions with emphasis on pioneering studies that are changing clinical practice:

 

Tuesday, May 17th

12:26 – 12:34, Room Maillot

Renal Denervation, Carotid Stenting

Prospective evaluation of all-comer percutaneous carotid revascularisation In symptomatic and increased-risk asymptomatic carotid artery stenosis using the MicroNet™-covered embolic prevention stent system in 101 consecutive patients: PARADIGM-101, Piotr Musialek, Poland

PARADIGM-101 or PARADIGM-EXTEND is Dr. Musialek’s clinical evaluation of CGuardTM procedures in 101 consecutive all-comer patients, building upon the earlier PARADIGM study.
For more information about InspireMD and its offerings, visit  www.inspiremd.com

 

About PARADIGM

PARADIGM is an investigator-initiated Prospective evaluation of All-comer peRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis, using CGuard™ Mesh-covered embolic prevention stent system.  At EuroPCR 2015, Dr. Musialek summarized the results of his PARADIGM evaluation of 71 CGuardTM procedures in unselected all-comer patients:  1) stent system success and procedure success rate of 100%; 2) periprocedural complications of 0%, and remained at 0% at 30 days; and 3) no MACNE occurred periprocedurally or at 30 days, by operator-independent neurologist and non-invasive cardiologist evaluation.

 

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), 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

InspireMD Receives Audit Opinion with Going Concern Explanation

BOSTON, MA – March 31, 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 that as previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2015, which was filed on March 28, 2016 with the Securities and Exchange Commission, the audited financial statements contained a going concern qualification paragraph in the audit opinion from its independent registered public accounting firm. See further discussion in Note 1 to the Company’s consolidated financial statements included in the Company’s Annual Report on Form 10-K.

This announcement is made pursuant to NYSE MKT Company Guide Section 610(b), which requires public announcement of the receipt of an audit opinion containing a going concern paragraph. This announcement does not represent any change or amendment to the Company’s consolidated financial statements or to its Annual Report on Form 10-K for the year ended December 31, 2015.

 
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), 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

 

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(1) All financial information for the twelve months ended December 31, 2015 is derived from the Company’s 2015 audited financial statements and all financial information for the twelve months ended December 31, 2014 is derived from the Company’s 2014 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.  All financial information for the three months ended December 31, 2015 and 2014 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 income relates to the issuance of shares as a result of the anti-dilution rights of our March 2011 investors.

(4) All December 31, 2015 financial information is derived from the Company’s 2015 audited financial statements and all December 31, 2014 financial information is derived from the Company’s 2014 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 Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2015

BOSTON, MA – March 28, 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 its financial and operating results for the fourth quarter and year ended December 31, 2015.

In 2015, InspireMD advanced its strategic transition into the carotid and neuro interventional markets utilizing its proprietary MicroNet™TM technology.  Key activities include announced:

  • Consistent, positive clinical results, with therapeutic benefits sustained at 12 months from the CGuardTM CARENET trial, as well as the ongoing investigator-led PARADIGM study;
  • Expanded regulatory footprint, with CGuardTM approvals in Argentina and Columbia;
  • Strategic distribution agreement with global interventional therapies company Penumbra, Inc., a market leader in the interventional neuroradiology and peripheral vascular markets;
  • Initiated European commercial market launch activities of CGuardTM with Penumbra Inc;
  • Strengthened intellectual property coverage; and
  • Operational and financial realignment, with ongoing implementation of a comprehensive cash management program.

 

Sol Barer, Chairman of the Board of InspireMD, commented, “We close 2015 with continued focus and sense of urgency to execute on our strategic plan.  While a challenging year, we note progress made.  We look forward to completing additional initiatives that position us for sustainable growth, including our ongoing management transition plan with attention on our European commercial and development activities, which were aided by our recent capital raise.  Gross proceeds from the March 16th, 2016 private placement and public offering were approximately $1.7 million.”

Dr. Barer continued, “We are also pleased with consistent, positive feedback from the CGuardTM launch and are encouraged by its early market traction.  In addition, our development efforts in the high value neurovascular field are progressing through positive development milestones..  We look forward to providing timely and continuous updates as we execute on our plans.”


Recent Operating Highlights:

COMMERCIAL

  • Initial European commercial launch of CGuardTM by Penumbra.
  • Continued focus on expanding European commercial activities in new geographies.
     

REGULATORY / CLINICAL / PRODUCT DEVELOPMENT

  • Announced positive 12 month follow up data from its CGuardTM CARENET (CARotid Embolic protection Study using microNET) trial which demonstrated zero strokes or stroke-related deaths at 12 months.
  • Received a DEKRA medical device certification for the manufacture and commercialization of its CGuardTM delivery catheter. The certification also allows the Company to add-on facilities for additional manufacturing work flow.
  • Advanced next generation neurovascular flow diverter program with positive pre-clinical data results.
  • Received regulatory approvals to commercialize CGuardTM in Colombia and Argentina.

 

 FINANCIAL

  • Comprehensive and active cash management program, including a March 16th, 2016 pricing of an underwritten public offering of 1,900,000 shares of its common stock and warrants to purchase up to 950,000 shares of common stock and a concurrent private placement of 1,033,051shares of its common stock and warrants to purchase up to 516,526 shares of common stock to certain of the Company’s directors.
  • Announced one-for-ten reverse stock split effective October 1st, 2015.
  • Continued implementation of cost containment activities while supporting key development programs. 

     

Quarter Ended December 31, 2015 Financial Results

 Revenue for the fourth quarter ended December 31, 2015 decreased $0.4 million to $0.5 million compared to $0.9 million during the same period in 2014. The 2015 period included 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 offset by sales of our new product CGuard™ EPS, which was partially launched in October 2014.

The Company’s gross loss for the quarter ended December 31, 2015 was $0.1 million compared to a gross profit of $0.4 million for the same period in 2014. The decrease of 134.5% was largely attributable to the decrease in product revenues and an increase of write-offs and other related adjustments of MGuard™ Prime EPS inventory due to the trend of increased usage of drug eluting stents rather than bare metal stents in STEMI patients., however, were partially offset by a decrease in labor and material costs attributable to lower revenues.

Total operating expenses for the quarter ended December 31, 2015 were $2.5 million, a decrease of 48.9% compared to $4.8 million for the same period in 2014. This decrease was primarily due to a reduction of expenses related to MGuard™ Prime EPS’s MASTER II trial, which was suspended in October 2014, a decrease in compensation related expenses and other savings associated with our cost reduction plan.

The loss from operations for the quarter ended December 31, 2015 was $2.6 million, a decrease of 41.3% compared to a loss of $4.4 million for the same period in 2014.

Financial expenses for the quarter ended December 31, 2015 was $0.2 million, a decrease of 28.1% compared to the same period in 2014. This decrease was primarily due to a decrease in interest expenses due to the reduction in principal of our outstanding indebtedness.

The net loss for the quarter ended December 31, 2015 totaled $2.9 million, or $0.37 per basic and diluted share, compared to a net loss of $4.8 million, or $1.19 per basic and diluted share, in the same period in 2014.

Non-GAAP net loss for the quarter ended December 31, 2015 was $2.3 million, or $0.31 per basic and diluted share, a decrease of 37.9% compared to a non-GAAP net loss of $3.8 million, or $0.94 per basic and diluted share, for the same period in 2014.  The non-GAAP net loss for the quarter ended Dec 31, 2015 primarily excludes $0.5 million of share-based compensation. The non-GAAP net loss for the quarter ended December 31, 2014 primarily excludes $1.0 million of share-based compensation.
 

Twelve Months Ended December 31, 2015 Financial Results

 Revenue for the twelve months ended December 31, 2015 decreased $0.5 million to $2.3 million compared to $2.8 million during the same period in 2014. The 2015 period included 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 offset by sales of our new product CGuard™ EPS, which was partially launched in October 2014.

The Company’s gross loss for the twelve months ended December 31, 2015 was $0.3 million, a decrease of 137.8% compared to a gross profit of $0.8 million for the same period in 2014. The decrease was largely attributable to the decrease in product revenues, an increase in labor and material costs attributable to higher costs for CGuard™ EPS, an increase of write-offs and other related adjustments of MGuard™ Prime EPS inventory due to the trend of increased usage of drug eluting stents rather than bare metal stents in STEMI patients. and longer shelf life requirements.

Total operating expenses for the twelve months ended December 31, 2015 were $14.2 million, a decrease of 42.0% compared to $24.5 million for the same period in 2014. This decrease was primarily due to a reduction of expenses related to the suspension of the MGuard MASTER II trial, a decrease in compensation related expenses and other savings associated with our cost reduction plan offset by restructuring and impairment expenses.

The loss from operations for the twelve months ended December 31, 2015 was $14.5 million, a decrease of 38.9% compared to a loss of $23.7 million for the same period in 2014.

Financial expenses for the twelve months ended December 31, 2015 decreased 20.9% to $1.1 million from $1.4 million during the same period in 2014. This decrease was primarily due to a decrease in interest expenses due to the reduction in principal of our outstanding indebtedness.

The net loss for the twelve months ended December 31, 2015 totaled $15.6 million, or $2.23 per basic and diluted share, compared to a net loss of $25.1 million, or $7.09 per basic and diluted share, in the same period in 2014.

Non-GAAP net loss for the twelve months ended December 31, 2015 was $11.8 million, or $1.69 per basic and diluted share, a decrease of 43.5% compared to a non-GAAP net loss of $20.9 million, or $5.91 per basic and diluted share, for the same period in 2014.  The non-GAAP net loss for the twelve months ended December 31, 2015 primarily excludes $3.1 million of share-based compensation and $0.6 million of expense related to an impairment of a royalties buyout asset. The non-GAAP net loss for the twelve months ended December 31, 2014 primarily excludes $4.1 million of share-based compensation.


Cash and Cash Equivalents

As of December 31, 2015, cash and cash equivalents were $3.3 million, compared to $6.5 million as of September 30, 2015 and $6.3 million as of December 31, 2014.


No Conference Call Scheduled

The Company is not hosting a conference call to discuss fourth quarter and year end December 31, 2015 results.  Additional updates will be provided as they become available.


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), 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

 

 

 

Table 1

 

 

 

Table 2

Table 3

table 4

(1) All financial information for the twelve months ended December 31, 2015 is derived from the Company’s 2015 audited financial statements and all financial information for the twelve months ended December 31, 2014 is derived from the Company’s 2014 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.  All financial information for the three months ended December 31, 2015 and 2014 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 income relates to the issuance of shares as a result of the anti-dilution rights of our March 2011 investors.

(4) All December 31, 2015 financial information is derived from the Company’s 2015 audited financial statements and all December 31, 2014 financial information is derived from the Company’s 2014 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 Announces Closing of Public Offering

BOSTON, MA – March 21, 2016 – InspireMD, Inc. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in embolic protection systems (“EPS”), today announced the closing of an underwritten public offering of 1,900,000 shares of its common stock and warrants to purchase up to 950,000 shares of common stock (the “Public Offering”).  The common stock was sold at a price of $0.59 per share, and each purchaser received a warrant to purchase one half of one share of common stock for each share of common stock that it purchased. The warrants are exercisable immediately and have a term of exercise of five years from the date of issuance and an exercise price of $0.59 per full share of common stock. Dawson James Securities, Inc. served as the sole bookrunner for the Public Offering.

The Company received gross proceeds from the Public Offering of approximately $1.12 million, before deducting the applicable underwriting discount and estimated offering expenses payable by the Company.

The Company intends to use the net proceeds from the Public Offering to conduct sales activities related to CGuard™ EPS™, and MGuard Prime™ EPS, and for general corporate purposes.

The securities sold in the Public Offering 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 Public Offering was filed with the SEC on March 16, 2016. Copies of the prospectus supplement and accompanying prospectus relating to the Public 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 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), 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:

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

 

PCG Advisory
Vivian Cervantes
Phone:  1-212-554-5482

InspireMD Announces Closing of Private Placement to Certain Officers and Directors

BOSTON, MA – March 21, 2016 – InspireMD, Inc. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in embolic protection systems (“EPS”), today announced the closing of its private placement of 1,033,051 shares of its common stock and warrants to purchase up to 516,526 shares of common stock to certain of the Company’s officers and directors (the “Private Placement”).  The common stock was sold at a price of $0.59 per share, and each purchaser received a warrant to purchase one half of one share of common stock for each share of common stock that it purchased. The warrants are exercisable immediately and have a term of exercise of five years from the date of issuance and an exercise price of $0.59 per full share of common stock.

The Company received gross proceeds from the Private Placement of approximately $600,000, before deducting placement agent fees and estimated offering expenses payable by the Company.

The Company intends to use the net proceeds from the Private Placement to conduct sales activities related to CGuard™ EPS™, and MGuard Prime™ EPS, and for general corporate purposes.

The securities offered in the Private Placement have not been, and will not be, registered under the Securities Act of 1933 and may not offered or sold in the United States absent registration under the Securities Act of 1933 or an applicable exemption from such registration requirements.

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

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

 

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

 
PCG Advisory
Vivian Cervantes
Phone:  1-212-554-5482

InspireMD Announces Pricing of Public Offering

BOSTON, MA – March 16, 2016 – InspireMD, Inc. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in embolic protection systems (“EPS”), today announced the pricing of an underwritten public offering of 1,900,000 shares of its common stock and warrants to purchase up to 950,000 shares of common stock (the “Public Offering”). The common stock will be sold at a price of $0.59 per share, and each purchaser will receive a warrant to purchase one half of one share of common stock for each share of common stock that it purchases. The warrants shall be exercisable immediately and have a term of exercise of five years from the date of issuance and an exercise price of $0.59 per full share of common stock. Dawson James Securities, Inc., is serving as the sole bookrunner for the Public Offering.

The Company expects to receive gross proceeds from the Public Offering of approximately $1.12 million, before deducting the applicable underwriting discount and estimated offering expenses payable by the Company.

The Public Offering is expected to close on or about March 21, 2016, subject to customary closing conditions.

The Company intends to use the net proceeds from the Public Offering to conduct sales activities related to CGuard™ EPS™, and MGuard Prime™ EPS, and for general corporate purposes.

The securities intended to be sold in the Public Offering 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 preliminary prospectus supplement relating to the offering was filed with the SEC on March 15, 2016 and a final prospectus supplement relating to the offering will be filed with the SEC by March 16, 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 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), 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:
Craig Shore
Chief Financial Officer
InspireMD, Inc.
Phone: 1-888-776-6804
Email: craigs@inspiremd.com

InspireMD Announces Private Placement to Certain Officers and Directors

BOSTON, MA – March 16, 2016 – InspireMD, Inc. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in embolic protection systems (“EPS”), today announced a private placement (the “Private Placement”) of up to 1,100,000 shares of its common stock and warrants to purchase up to 550,000 shares of common stock to certain of the Company’s officers and directors (the “Private Placement”). The common stock will be sold at a price of $0.59 per share, and each purchaser will receive a warrant to purchase one half of one share of common stock for each share of common stock that it purchases. The warrants shall be exercisable immediately and have a term of exercise of five years from the date of issuance and an exercise price of $0.59 per full share of common stock.

The Company expects to receive gross proceeds from the Private Placement of approximately $600,000, before deducting placement agent fees and estimated offering expenses payable by the Company. The Private
Placement is expected to close on or about March 21, 2016, subject to certain closing conditions.

The Company intends to use the net proceeds from the Private Placement to conduct sales activities related to CGuard™ EPS™, and MGuard Prime™ EPS, and for general corporate purposes.

The securities offered in the Private Placement have not been, and will not be, registered under the Securities Act of 1933 and may not offered or sold in the United States absent registration under the Securities Act of 1933 or an applicable exemption from such registration requirements.

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

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

InspireMD Announces Proposed Public Offering of Common Stock and Warrants

BOSTON, MA – March 15, 2016 – InspireMD, Inc. (“InspireMD” or the “Company”) (NYSE MKT: NSPR), a leader in embolic protection systems (“EPS”), today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock and warrants to purchase common stock. Dawson James Securities, Inc., is serving as the sole bookrunner for this offering.

The Company intends to use the net proceeds from this offering to conduct sales activities related to CGuard™ EPS™ and MGuard Prime™ 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 preliminary prospectus supplement relating to the offering was filed with the SEC on March 15, 2016. Copies of the preliminary 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 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), 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:
Craig Shore
Chief Financial Officer
InspireMD, Inc.
Phone: 1-888-776-6804
Email: craigs@inspiremd.com

 

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