InspireMD Announces the Issuance of Two United States Patents

Continued Focus on Intellectual Property Results in Continued Portfolio Expansion

BOSTON, MA – September 17, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”) a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, announced today that the United States Patent & Trademark Office has issued two new patents to the Company on September 15th, U.S. Patent No. 9,132,261 entitled “In Vivo Filter Assembly” and U.S. Patent No. 9,132,003 entitled “Optimized Drug Eluting Stent Assembly.”

The In Vivo Filter Assembly patent covers an assembly for filtering debris flow in a blood vessel.
The Optimized Drug Stent Assembly patent covers a stent assembly with the Company’s proprietary MicroNet™TM technology that elutes a drug.

InspireMD continues to maintain a focus on its intellectual property portfolio, expanding coverage for its proprietary MicroNet™TM technology, CGuardTM Embolic Prevention System for the treatment of carotid artery disease, and MGuardTM for coronary applications, in addition to several pending applications directed to its neurovascular and peripheral vascular platforms. The issuance of these two patents provides further support for these pending therapies and applications. To-date, the Company’s patent rights in the United States include 4 issued patents and 10 pending applications.  Foreign patent rights include 13 issued patents focused in Israel, Canada, and China, and 16 pending patent applications.


About InspireMD, Inc.

InspireMD (www.inspiremd.com) 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.


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.


About MGuard Prime EPS

MGuard Prime EPS, integrated with MicroNet™, is designed to trap and seal thrombus and ruptured plaque, preventing distal embolization. While offering superior performance relative to standard stents in STEMI patients, MGuard Prime™ requires no change in current physician practice – an important factor in time-critical settings.
MGuard Prime™ is a Cobalt Chromium stent wrapped in MicroNet™.
MGuard EPS and CGuard EPS are CE Marked and are not approved for sale in the U.S. by the U.S. Food and Drug Administration at this time.


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
Email: craigs@inspiremd.com

 

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

 

InspireMD Announces Allowance of US Patent Claims

Continues to Strengthen and Broaden Intellectual Property Portfolio

 

BOSTON, MA – September 9, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”) a leader in embolic prevention systems (EPS), neurovascular devices and thrombus management technologies, announced today that the United States Patent & Trademark Office has allowed claims for its United States Patent Application, published as US2014/0309725 and entitled “Optimized Drug Eluting Stent Assembly.” This patent covers any stent assembly with the Company’s proprietary MicroNet™TM technology that employs the use of a drug.

InspireMD continues to expand its intellectual property portfolio, including claims that cover its proprietary MicroNet™TM technology, CGuardTM Embolic Prevention System for the treatment of carotid artery disease, and MGuardTM for coronary applications, in addition to several pending applications directed to its neurovascular and peripheral vascular platforms. To-date, the Company’s patent rights in the United States include 2 issued patents and 12 pending applications. Foreign patent rights include 13 issued patents focused in Israel, Canada, and China, and 16 pending patent applications.

Jim Barry, Ph.D., the COO of InspireMD, commented, “We are pleased to see continued improvements in our patent portfolio. These allowed claims in the United States have applications across our commercial and pipeline products. As previously noted, we continue to execute on our new “neck-up” strategy with CGuard™ and our neurovascular flow diverter, in addition to enabling new solutions in peripheral embolic protection. These claims will not only support product development with our current portfolio, but will also support opportunities we are exploring with our coronary platform.”

 

About InspireMD, Inc.

InspireMD (www.inspiremd.com) 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.

 

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.

 

About MGuard Prime EPS

MGuard Prime EPS, integrated with MicroNet™, is designed to trap and seal thrombus and ruptured plaque, preventing distal embolization. While offering superior performance relative to standard stents in STEMI patients, MGuard Prime™ requires no change in current physician practice – an important factor in time-critical settings.

MGuard Prime™ is a Cobalt Chromium stent wrapped in MicroNet™.

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

 

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
Email: craigs@inspiremd.com

 

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

InspireMD to Present at the Rodman & Renshaw 17th Annual Global Investment Conference

BOSTON, MA – September 1, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) a leader in stent embolic prevention systems (“EPS”) and thrombus management technologies, today announced that its Chief Executive Officer, Alan Milinazzo, will present at the Rodman & Renshaw 17th Annual Global Conference on Thursday, September 10, 2015 at 10:25 a.m. ET. The conference will be held in New York, NY.

A live webcast will be available for those participants who are unable to attend, which can be found at: http://wsw.com/webcast/rrshq25/nspr. The webcast will be available for 180 days following the presentation.

 

About InspireMD, Inc.

InspireMD (www.inspiremd.com) 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.

 

 Investor Contacts:

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

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

InspireMD Reports Financial Results for the Second Quarter Ended June 30, 2015

BOSTON, MA – August 5, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in stent embolic prevention systems (“EPS”), today announced its financial and operating results for the second quarter ended June 30, 2015.

The Company is in the second full quarter of a strategic transition into penetrating the carotid and neuro intervention markets utilizing its proprietary MicroNet™TM technology. MicroNet™ technology has the potential to improve the clinical outcomes for patients who are at risk of embolization during Carotid Artery Stenting (CAS), a highly attractive $500 million dollar global market segment within the interventional medical device industry. Early clinical results of the CGuardTM Embolic Prevention System have been highly positive in the CARENET and PARADIGM data sets.

Alan Milinazzo, CEO of InspireMD, commented, “As previously stated, 2015 is a transition year for InspireMD, as we continue to execute on our strategic plan with a sense of urgency and the resources to deliver on key milestones.  We remain on course to drive increased market adoption of our carotid platform and look forward to a full European market launch with our new strategic distribution partner, Penumbra Inc.  We also advanced our development program for our neurovascular platform and we look forward to broader collaboration discussions, including those facilitated by our Penumbra partnership.”


Recent Operating Highlights:

 

COMMERCIAL

  • Secured a CGuard strategic distribution agreement with Penumbra Inc., a market leader in the interventional neuroradiology and peripheral vascular markets.
  • Reported sequential revenue increases of 182% for carotid and 24% for coronary product sales in the quarter.
  • On track for full Penumbra commercial launch of CGuard in Q4 of 2015.

 

REGULATORY / CLINICAL / PRODUCT DEVELOPMENT

  • Reported positive results from the investigator led PARADIGM trial in an all comers patient population.
  • Advanced our next generation neurovascular flow diverter program for a 2016 CE Mark submission.
  • Received CE approval for MGuard Prime in Brazil.
  • Awarded 2015 Frost and Sullivan European Innovation Award for Product Development.
  • Received an OEM (Original Equipment Manufacturer) partnership proposal to develop a next generation coronary DES (Drug Eluting Stent) platform with MicroNet™ technology.

 

FINANCIAL

  • Comprehensive cash management, with steady, measured declines in monthly cash use.
  • Continued implementation of cost containment activities while supporting key development programs.

 

Quarter Ended June 30, 2015 Financial Results

Revenue for the second quarter ended June 30, 2015 increased $0.5 million to $0.7 million compared to $0.2 million during the same period in 2014. The 2015 period included an increase in sales of MGuard™ Prime EPS, our coronary product, due to the suspension of sales that occurred in the three months ended June 30, 2014 due to our voluntary field corrective action (“VFA”) which began on April 30, 2014, as well as sales of our new product CGuard™ EPS, our carotid product, which was launched in October 2014.

The Company’s gross loss for the quarter ended June 30, 2015 was $0.2 million compared to a gross loss of $0.4 million for the same period in 2014. The improvement of 45.8% was largely attributable to the increase in product revenues and no costs associated with our VFA, which occurred during the three months ended June 30, 2014. This improvement was partially offset by 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.

Total operating expenses for the quarter ended June 30, 2015 were $3.4 million, a decrease of 50.9% compared to $6.8 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 plans.

The loss from operations for the quarter ended June 30, 2015 was $3.6 million, a decrease of 50.6% compared to a loss of $7.2 million for the same period in 2014.

Financial expenses for the quarter ended June 30, 2015 remained flat at $0.3 million compared to the same period in 2014.

The net loss for the quarter ended June 30, 2015 totaled $3.9 million, or $0.05 per basic and diluted share, compared to a net loss of $7.6 million, or $0.22 per basic and diluted share, in the same period in 2014.

Non-GAAP net loss for the quarter ended June 30, 2015 was $2.9 million, or $0.04 per basic and diluted share, a decrease of 55.6% compared to a non-GAAP net loss of $6.5 million, or $0.19 per basic and diluted share, for the same period in 2014.  The non-GAAP net loss for the quarter ended June 30, 2015 primarily excludes $1.0 million of share-based compensation. The non-GAAP net loss for the quarter ended June 30, 2014 primarily excludes $1.1 million of share-based compensation.

 

Six Months Ended June 30, 2015 Financial Results
Revenue for the six months ended June 30, 2015 decreased $0.5 million to $1.2 million compared to $1.7 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 patients and the impact of the transition to a new commercial strategy built on using third party distributors for our products offset by sales of our new product CGuard™ EPS, which was launched on a limited basis in October 2014.

The Company’s gross loss for the six months ended June 30, 2015 was $0.2 million, a decrease of 153.4% compared to a gross profit of $0.5 million for the same period in 2014. The decrease was largely attributable to the decrease in product revenues and write-offs of inventory due to the trend of increased usage of DES stents in STEMI patients, longer shelf life requirements and the transition to the rapid exchange delivery system for CGuard from the over the wire platform.

Total operating expenses for the six months ended June 30, 2015 were $8.2 million, a decrease of 37.9% compared to $13.2 million for the same period in 2014. This decrease was primarily due to a reduction of expenses related to MGuard’s MASTER II trial, a decrease in compensation related expenses and other savings associated with our cost reduction plans.
The loss from operations for the six months ended June 30, 2015 was $8.5 million, a decrease of 33.7% compared to a loss of $12.8 million for the same period in 2014.

Financial expenses for the six months ended June 30, 2015 decreased 14.9% to $0.6 million from $0.7 million during the same period in 2014. This decrease was primarily due to a decrease in interest expenses.

The net loss for the six months ended June 30, 2015 totaled $9.1 million, or $0.14 per basic and diluted share, compared to a net loss of $13.5 million, or $0.40 per basic and diluted share, in the same period in 2014.

Non-GAAP net loss for the six months ended June 30, 2015 was $6.7 million, or $0.11 per basic and diluted share, a decrease of 41.3% compared to a non-GAAP net loss of $11.4 million, or $0.34 per basic and diluted share, for the same period in 2014.  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. The non-GAAP net loss for the six months ended June 30, 2014 primarily excludes $2.1 million of share-based compensation.

 

Cash and Cash Equivalents
As of June 30, 2015, cash and cash equivalents were $9.8 million, compared to $6.3 million as of December 31, 2014.

 

Quarterly Conference Call Details
The Company has scheduled a conference call to discuss the second quarter 2015 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 of the call will also be available on the Investor Relations section of the Company’s website at www.inspire-md.com/site_en/for-investors.
Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

An archive of the webcast will be available approximately two hours after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.inspire-md.com/site_en/for-investors for a limited time.  A dial-in replay of the call will also be available to those interested until August 19, 2015.  To access the replay, dial (877) 344-7529 (United States) or (412) 317-0088 (International)
and enter code: 10068462.

 

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

 

 

CONSOLIDATED STATEMENTS OF OPERATIONS (1)
(U.S. dollars in thousands, except per share data)
Three months ended
June 30,
       
   Six months ended
June 30,
2015 2014   2015   2014
Revenues $685 $193 $1,162 $1,675
Cost of revenues 897 584 1,411 1,209
Gross Profit (Loss) (212) (391) (249) 466
Operating Expenses:
Research and development 747 2,448 2,099 5,025
Selling and marketing 995 1,948 2,012 3,224
General and administrative 1,587 2,448 3,557 4,987
Restructuring and impairment expenses 32 546
Total operating expenses 3,361 6,844 8,214 13,236

Loss from operations

(3,573) (7,235) (8,463) (12,770)

Financial expenses

322 325 628 738
Loss before tax expenses (3,895) (7,560) (9,091) (13,508)
Tax expenses (Income) (17) 2 (1) 22
Net Loss $(3,878) $(7,562) $(9,090) $(13,530)
Net loss per share – basic and diluted $(0.05) $(0.22) $(0.14) $(0.40)
Weighted average number of shares of common stock used in computing net loss per share – basic and diluted 76,035,721 34,115,814 63,067,454 34,083,936

 

 

 

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

 

 Three months ended
June 30,
  
Six months ended
June 30,
 
     
2015 2014   2015   2014
GAAP Net Loss $(3,878) $(7,562) $(9,090) $(13,530)
 
Non-GAAP Adjustments:
Share-based compensation expenses 970 1,080 1,999 2,099
Impairment of royalties buyout 316
Royalties buyout expenses and amortization 22 25 58 40
Non-cash financial expenses (income)(3) (41) (47)
Total Non-GAAP Adjustments 992 1,064 2,373 2,092

Non-GAAP Net Loss
$(2,886) $(6,498) $(6,717) $(11,438)
 
Non-GAAP net loss per share – basic and diluted $(0.04) $(0.19) $(0.11) $(0.34)
Weighted average number of shares of common stock used in computing net loss per share – basic and diluted 76,035,721 34,115,814 63,067,454 34,083,936

 

 

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

 

ASSETS June 30, December 31,
2015 2014
Current Assets:
Cash and cash equivalents $9,768 $6,300
Accounts receivable:
Trade 728 635
Other 193 359
Prepaid expenses 76 150
Inventory 1,229 1,924
Total current assets 11,994 9,368
 

 

Non-current assets:
Property, plant and equipment, net 546 622
Deferred issuance costs 119 153
Funds in respect of employee rights upon retirement 495 498
Long term prepaid expenses 30 66
Royalties buyout 378 752
Total non-current assets 1,568 2,091
 
Total assets $13,562 $11,459

 

 

 

LIABILITIES AND EQUITY (CAPITAL DEFICIENCY) June 30, December 31,
2015 2014
Current liabilities:
Accounts payable and accruals:
Trade $491 $909
Other 2,654 3,576
Advanced payment from customers 169 179
Current maturity of loan 4,015 3,809
 

 

Total current liabilities 7,329 8,473
Long-term liabilities:
Liability for employees rights upon retirement 698 687
Long term loan 3,159 5,086
Total long-term liabilities 3,857 5,773
 

 

Total liabilities 11,186 14,246
Equity:
Common stock, par value $0.0001 per share; 125,000,000 shares authorized; 76,048,385 and 41,368,889 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively 7 4
Additional paid-in capital 118,870 104,620
Accumulated deficit (116,501) (107,411)
Total equity (capital deficiency) 2,376 (2,787)
Total liabilities and equity (less capital deficiency) $13,562 $11,459

(1) 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, all 2014 financial information is derived from the Company’s 2014 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

(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 June 30, 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. 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, 2014 filed with the Securities and Exchange Commission.

 

InspireMD Announces Distribution Partnership of its CGuardTM Embolic Prevention System with Penumbra, Inc.

Accelerates InspireMD’s Access into Key Geographic & Specialty Markets
Enables CGuardTM to be Commercialized as Part of a Total Systems Solution

BOSTON, MA – August 5, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) a leader in stent embolic prevention systems (“EPS”) and thrombus management technologies, today announced that it has entered into a partnership with Penumbra, Inc. to distribute its carotid CGuardTM EPS through their direct commercialization team. Penumbra is a leading interventional technology company that develops and markets innovative medical devices to the neurovascular and peripheral vascular communities around the world.

 InspireMD has aggressively been pursuing a strategy in treating carotid artery disease and other neurovascular applications for its proprietary MicroNet™TM technology.  Clinical trials of the CGuardTM system, including the recent CARENET and PARADIGM studies, have continued to support the benefits of the MicroNet™TM enhanced CGuardTM system resulting in increased commercial adoption throughout the European market.

 Penumbra has a direct and distributor sales organization in all markets where the CGuardTM system is commercially available. Penumbra’s neurovascular product portfolio includes medical devices for ischemic stroke and brain aneurysms, as well as peripheral vascular products that include products for embolization and thrombectomy.  Penumbra has approximately 1,000 global employees with direct sales operations in North America, Europe, and Australia.  Penumbra sells through distributors in Asia and select other international markets.

 Alan Milinazzo, CEO of InspireMD, commented, “We are excited to partner with a leading global organization such as Penumbra.  The Penumbra commercial organization is a well-respected, strong and growing team of experienced professionals that will help communicate the benefits of our proprietary CGuardTM EPS to all specialists that manage carotid artery disease.”  Milinazzo continued, “We are confident that the Penumbra team will successfully commercialize CGuardTM over the next several months.  Penumbra’s customers have already started placing the CGuardTM device and are anxious to discuss additional possible uses of the MicroNet™TM technology in the neurovascular space.”

 In addition, Jim Pray, President, International of Penumbra, stated, “The Penumbra team is looking forward to offering the CGuardTM to our customers. The CGuardTM carotid system from InspireMD is unique and addresses many limitations of existing carotid stents. The CGuardTM offers an unmatched ability to protect against plaque protrusion and prevent embolic events. The InspireMD team has done a remarkable job getting this breakthrough technology to market and our customers are looking forward to incorporating it into their practices. We are fortunate to be able to partner with InspireMD.”

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

 

About Penumbra, Inc.
Penumbra, Inc. (www.penumbrainc.com) is a global interventional therapies company that designs, develops, manufactures and markets innovative medical devices. The company has a broad portfolio of products that address challenging medical conditions and significant clinical need across two major markets, neuro and peripheral vascular. Penumbra has approximately 1,000 employees and sells its products to hospitals primarily through its direct sales organization in the U.S., most of Europe, Canada and Australia, and through distributors in select international markets.

 

About InspireMD, Inc.
InspireMD (www.inspiremd.com) 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
Email: craigs@inspiremd.com 

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

Penumbra, Inc
Penumbra Media Relations:
Merryman Communications
Betsy Merryman
310-560-8176
betsy@merrymancommunications.com

InspireMD to Report Financial Results for the Second Quarter Ended June 30, 2015 on Wednesday, August 5th

BOSTON, MA – July 14, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems, announced today that it will release its full financial results for the second quarter ended June 30, 2015 on Wednesday, August 5th after the market close, followed by a conference call at 4:30 p.m. ET to review its financial results and update key strategic partnership programs.

Participants should call (866) 652-5200 (United States) or (412) 317-6060 (International) and request the InspireMD call. A live webcast of the call will also be available on the Investor Relations section of the Company’s website at www.inspire-md.com/site_en/for-investors.   Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

An archive of the webcast will be available approximately two hours after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.inspire-md.com/site_en/for-investors for a limited time.  A dial-in replay of the call will also be available to those interested until August 19, 2015.  To access the replay, dial (877) 344-7529 (United States) or (412) 317-0088 (International) and enter code: 10068462.

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 Frost & Sullivan 2015 European Coronary Stent New Product Innovation Award

Recognized for Successful Introduction of New and Innovative Products, with Emphasis on Quality and Customer Value

BOSTON, MAJuly 7, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), a leader in embolic protection systems (“EPS”), today announced that its MGuard Prime Embolic Protection System integrated with MicroNet™ has received the Frost & Sullivan 2015 European Coronary Stent New Product Innovation Award.  Through active market research efforts, Frost & Sullivan’s global team of analysts and consultants recognize the successful introduction of new and innovative products, with emphasis on quality and customer value.

Frost & Sullivan Senior Research Analyst Parthasarathy Raghava stated, “While significant improvements in clinical outcomes of percutaneous coronary interventions have been achieved with the use of coronary stents, distal embolization remains a major complication, resulting in poorer functional recovery and adverse outcomes.  However, our market research activities noted that InspireMD’s MGuard Primewith MicroNet™ addresses this challenge with its innovative design to trap and seal thrombus and plaque against the vessel wall, helping prevent distal embolization, while optimizing flow and ensuring excellent deliverability.  We are pleased to confer this Innovation Award on InspireMD.”

MGuard Prime™ is a Cobalt Chromium stent wrapped in MicroNet™. MicroNet™ is a bio-stable mesh  woven from a single strand of 20 micrometers Polyethylene Terephthalate.

Alan Milinazzo, CEO of InspireMD commented, “We are honored to receive the Frost & Sullivan 2015 European Coronary Stent New Product Innovation Award, supporting our efforts to develop and commercialize embolic protection stent systems that improve patient outcomes by leveraging our proprietary MicroNet™ technology.

“We look forward to further enhancements to our coronary platform, including strategic partnerships in the development of a drug eluting stent system.”  Mr. Milinazzo continued, “We are also in active development of new applications for our MicroNet™ technology, in addition to MGuardand our carotid system, CGuard, bringing innovation to treatment programs in the neurovascular and peripheral markets.”

For more information about InspireMD and the Frost & Sullivan New Product Innovation Award, or The Coronary Stent Industry Research Report, visit www.inspiremd.com/en/investors/investor-relations/.

 

About Frost & Sullivan

Frost & Sullivan, founded in 1961, has more than 40 global offices with more than 1,800 industry consultants, market research analysts, technology analysts and economists. It is a growth partnership company focused on helping clients achieve transformational growth as they work through an economic environment dominated by accelerating change, increasing risk and the powerful disruptive impact of the conversion of new business models, disruptive technologies and Mega Trends on their industry.

Frost & Sullivan is a world leader in growth consulting and the integrated areas of technology research, market research, Mega Trends, economic research, best practices, training, customer research, competitive intelligence, and corporate strategy. For more information, visit www.frost.com.

 

About MGuard Prime EPS

MGuard Prime EPS, integrated with MicroNet™, is designed to trap and seal thrombus and ruptured plaque, preventing distal embolization. While offering superior performance relative to standard stents in STEMI patients with regard to ST segment resolution, MGuard Prime™ requires no change in current physician practice – an important factor in time-critical settings.

 

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.

MGuard EPS and CGuard EPS are CE Marked and are 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™ 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:
InspireMD, Inc.
Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804
Email: craigs@inspiremd.com

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

InspireMD’s CGuard™ Highlighted at Clinical Presentation at EuroPCR 2015 Conference

PARADIGM Evaluation Reports CGuard™ Favorable Outcomes in All-Comer Carotid Disease Population

BOSTON, MAMay 12, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced that its CGuard™ Embolic Prevention System reported positive results in PARADIGM, lead by principle investigator Prof. Piotr Musialek, at the EuroPCR conference on May 22, 2015 in Paris, France.

PARADIGM, 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, indicated that the CGuard™ system is appropriate for use in an all-comer carotid revascularization population and is associated with an extremely favorable angiographic and clinical outcome.

Dr. Musialek, commented, “Our experience with CGuard™ continues to be very positive. Evidence shows the device’s applicability for use in an all-comer population with no major adverse cardiac or neurological events (MACNE) during the procedure and at 30 days. We were also pleased with CGuard™’s anti-embolic performance as well as its flexibility. Impressively, we had a procedure success rate of 100%.”

During his clinical presentation from the 71 CGuard™ procedures in unselected all-comer patients in the PARADIGM evaluation, Prof. Musialek summarized:

•Stent system success and procedure success rate were 100%.
•Periprocedural complications were 0%, and remained at 0% at 30 days.
•No MACNE occurred periprocedurally or at 30 days, by operator-independent neurologist and non-invasive cardiologist evaluation.

Prof. Musialek stated, “The system is unique in that it combines the most closed of the closed cell designs with the most open of the open cell designs,” and concludes, “Our experience indicates routine use of CGuard™, which we believe presents a significant technological and clinical advancement, may form a new paradigm in carotid revascularization.”

Alan Milinazzo, CEO of InspireMD, commented, “We are pleased to see the very positive results from PARADIGM. Together with the other independent clinical studies presented at EuroPCR, it has confirmed confidence in our CGuard™ Embolic Prevention system.” “The customer response to the CGuard™ has been extremely positive during the conference and today’s positive data will further support our expanding commercial activities.”

Each year, more than 120 companies from the cardiovascular industry, including device and equipment manufacturers, attend EuroPCR, the leading cardiovascular event in Europe. This 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 cardiovascular field.

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

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

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

InspireMD Announces Clinical Presentations on CGuard™ and MGuard™ Systems with MicroNet™ Technology at EuroPCR 2015 Conference

Clinical Presentations Highlight Carotid and Coronary Applications of InspireMD’s Proprietary MicroNet™ Technology

BOSTON, MAMay 12, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced that there will be multiple clinical presentations across a broad range of indications for MicroNet™ Technology at the upcoming EuroPCR conference from May 19-22, 2015 in Paris, France.

Each year, more than 120 companies from the cardiovascular industry, including device and equipment manufacturers, attend EuroPCR, the leading cardiovascular event in Europe. This 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 cardiovascular field.

Alan Milinazzo, CEO of InspireMD, commented, “EuroPCR is a major annual meeting for InspireMD and we have a very busy schedule of meetings with customers, distributors and potential future partners ahead. We look forward to productive sessions and making progress on our many initiatives.”

Milinazzo continued, “Feedback on our CGuard™ Embolic Prevention system has been positive, with solid physician interest and the device steadily gaining market traction. We look forward to the clinical presentations at EuroPCR 2015 from a range of physicians, including Dr. Piotr Musialek of Poland and Dr. Joachim Schofer of Germany.”
At EuroPCR 2015, there will be 7 clinical presentations featuring InspireMD’s MicroNet™ Technology, with applications in the carotid, coronary arteries, and saphenous vein grafts. The sessions include:

Wednesday, May 20th
09:20 – 10:20, Room 243
Carotid and Supra-Aortic Disease Management
Mesh-covered stent in routine endovascular management of thrombus containing/subtotal lesions: a new paradigm in carotid revascularization? Piotr Musialek, Poland

15:45 – 16:45, Room Ternes 2
Interactive Case Corner: Challenging Peripheral Vascular Interventions
Mesh-covered stent in endovascular management of highly calcific lesions: a new paradigm in carotid revascularization? Adam Mazurek, Poland

Thursday, May 21st
08:15 – 09:15, Room 241
Primary PCI: Technical and Strategic Challenges
In-hospital and long-term outcomes of mesh-covered MGuard stent implantation for treatment of STEMI with high thrombus burden despite manual aspiration. Enrico Cerrato, Italy

12:30 – 13:30, Room 343
Solutions to Treat Degenerative Saphenous Vein Grafts
When a mesh-covered stent saves the day. Alexander Goldberg, Israel

Friday, May 22nd
10:40 – 11:40, Room 353
Coronary Aneurysms after PCI
STEMI patient and stent fracture treated with covered stent. David Baghdasaryan, Armenia

11:45 – 11:52, Room 242A
Evolutions in Carotid Angioplasty
Prospective, multicentre study on the safety and efficacy of a novel mesh-covered carotid stent in patients with symptomatic and asymptomatic carotid artery stenosis: the CGuard CARotid Embolic protection using MicroNet™ trial (CARENET). Joachim Schofer, Germany

12:09 – 12:16, Room 242A
Evolutions in Carotid Angioplasty
Novel PARADIGM in carotid revascularization: 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. Piotr Musialek, Poland

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

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:
InspireMD, Inc.
Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804
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, 2015

BOSTON, MAMay 11, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced its financial and operating results for the first quarter ended March 31, 2015.

Alan Milinazzo, CEO of InspireMD, commented, “The first quarter marked the beginning of our full shift in activities towards our new strategy. We began positive early commercialization of the CGuard™ Rapid Exchange system, while completing our salesforce reorganization to a distributor model. Importantly, we aligned the organization for capital efficiency, regained financial flexibility, made progress with our pipeline, and implemented a plan to regain NYSE MKT listing compliance.”

Mr. Milinazzo concluded, “2015 will be a transition year for InspireMD, but we believe that we have the strategic plan, the sense of urgency, and the resources to deliver on our stated operational and strategic objectives. We are encouraged by the early market reception for our carotid platform, as well as the progress we have made with our neurovascular pipeline development.”

Recent Operating Highlights:

COMMERCIAL

• Early commercial launch of CGuard™ Rapid Exchange.

• Completed salesforce reorganization from direct to distributor model.

REGULATORY / CLINICAL / PRODUCT DEVELOPMENT

• Announced regulatory approval to market MGuard Prime™ in Brazil.

• Received regulatory approval to commercialize MGuard Prime™ in Columbia.

FINANCIAL

• Strengthened cash position with the completion of financing on March 9th, 2015 with gross proceeds of $13.7 million.

• Continued implementation of cost containment activities, including measures to reduce the burn rate throughout 2015.

Quarter Ended March 31, 2015 Financial Results

Revenue for the quarter ended March 31, 2015 decreased $1.0 million to $0.5 million compared to $1.5 million during the same period in 2014. The 2015 period included an expected decline in sales volume associated with the trend of doctors increasingly using drug eluting stents rather than bare metal stents in STEMI patients and the impact of the transition to a new commercial strategy built on using third party distributors for our products.

The Company’s gross loss for the quarter ended March 31, 2015 was $37,000, a decrease of 104.3% compared to a gross profit of $0.9 million for the same period in 2014. The decrease was largely attributable to the decrease in product revenues and write-offs of inventory due to the trend of increased usage of DES stents in STEMI patients, longer shelf life requirements for third party distributors and the transition to the RX delivery system for CGuard™ from the over the wire platform.

Total operating expenses for the quarter ended March 31, 2015 were $4.9 million, a decrease of 24.1% compared to $6.4 million for the same period in 2014. This decrease was primarily due to a reduction of expenses related to MGuard™’s MASTER II trial, a decrease in compensation related expenses and other savings associated with our cost reduction plan offset by onetime restructuring and impairment expenses.

The loss from operations for the quarter ended March 31, 2015 was $4.9 million, a decrease of 11.7% compared to a loss of $5.5 million for the same period in 2014.

Financial expenses for the quarter ended March 31, 2015 decreased 25.9% to $0.3 million from $0.4 million during the same period in 2014. This decrease was primarily due to a decrease in interest expenses.

The net loss for the quarter ended March 31, 2015 totaled $5.2 million, or $0.10 per basic and diluted share, compared to a net loss of $6.0 million, or $0.18 per basic and diluted share, in the same period in 2014.

Non-GAAP net loss for the quarter ended March 31, 2015 was $3.8 million, or $0.08 per basic and diluted share, a decrease of 22.4% compared to a non-GAAP net loss of $4.9 million, or $0.15 per basic and diluted share, for the same period in 2014. 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 the impairment of the value of our royalties buyout option associated with MGuard. The non-GAAP net loss for the quarter ended March 31, 2014 primarily excludes $1.0 million of share-based compensation.

Cash and Cash Equivalents

As of March 31, 2015, cash and cash equivalents were $13.2 million, compared to $6.3 million as of December 31, 2014.

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