InspireMD Announces MGuard™ Prime Approval in Brazil

BOSTON, MAApril 27, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), today announced it received approval to commercialize MGuard™ Prime™ with MicroNet™ technology in Brazil. The approval was granted by the Agência Nacional de Vigilância Sanitária (ANVISA). The BRICCS (Brazil, Russia, India, China, South Africa and South Korea) coronary stents sector is estimated to reach $1 billion by 2016, growing at an average compound annual rate of 9.6% in 2012 to 2018, according to Research and Markets.

Alan Milinazzo, CEO of InspireMD, commented, “Brazil is the largest Latin American coronary stent market with a rapidly aging population, growing economy, and improving healthcare system, fueling coronary stenting procedure volumes.” Mr. Milinazzo also added, “approval of MGuard Prime™ is significant as we look to return to revenue growth as Brazil has traditionally been a very strong market for us with support from a number of leading interventional cardiologists around the country.”

Dr. Alex Abizaid, Chief of Coronary Interventions at Institute Dante Pazzanese de Cardiologia in São Paulo, Brazil, commented, “I am gratified that MGuard Prime™ is now approved and available to treat STEMI patients in Brazil. Clinical trials and registry studies have provided a substantial body of evidence supporting the use of MGuard™ in primary PCI with the objective of improving patient outcomes. With MGuard Prime™, the treatment of acute MI has reached a new level involving a simple device that can be used in daily practice in the cardiac cath laboratory.”

About InspireMD, Inc.

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

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

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: 1-212-554-5482

InspireMD Announces Completion of Sales Restructuring Program

BOSTON, MAApril 15, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced the completion of its sales restructuring program which began on January 4, 2015. The restructuring was implemented to conserve capital and to align the organization to a new commercial strategy built on third party distribution partners. Reflecting some impact from the transition, as well as the trend towards drug eluting stent use in STEMI patients discussed during our fourth quarter 2014 earnings call last month, total revenues for the first quarter 2015 were approximately $500,000, down sequentially from $850,000 in the fourth quarter 2014.

Alan Milinazzo, CEO of InspireMD, commented, “2015 is a transition year for us, as we pivot our strategy to exploit the immediate carotid and emerging neurovascular opportunities while being more selective with our sales resource allocation and shift to a distributor based commercial model.”

Mr. Milinazzo, concluded, “With our sales restructuring program now behind us, our cash projections remain on track and we look forward to improving our sales performance, mindful of less linear growth in the coming quarters, as we intend to lead our commercial efforts with our carotid platform. We began shipping our new CGuard™ RX product during the quarter and while quantities were limited due to short term supply constraints, we expect improvements beginning in the second quarter.”

InspireMD will report full first quarter 2015 results and host its investor earnings conference call on May 11, 2015.

About InspireMD, Inc.

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

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

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 Plan of Compliance Accepted by NYSE MKT

BOSTON, MAMarch 16, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), announced today that the New York Stock Exchange has accepted InspireMD’s plan to regain compliance with the NYSE MKT’s market capitalization continued listing standards. As previously disclosed, the NYSE notified the Company on January 20, 2015 that it had fallen below the NYSE’s continued listing standards.

Based upon a review of the compliance plan and information submitted by the Company, the Exchange determined that the Company made a reasonable demonstration of its ability to make substantial progress toward regaining compliance with Sections 1003(a)(i), 1003(a)(ii) and 1003(a)(iii) of the Company Guide by July 20, 2016. The Exchange also determined that the Company has resolved the continued listing deficiency with respect to Section 1003(a)(iv) of the Company Guide.

The Company will be subject to periodic review by the exchange staff during the period covered by the plan. Failure to make progress consistent with the plan or to regain compliance with the continued listing standards by the end of the plan period could result in the Company’s shares being delisted from the Exchange.

Alan Milinazzo, CEO of InspireMD stated, “The management team and the Board of Directors are pleased our compliance plan has been accepted by the Exchange. We will strategically move forward with the business initiatives discussed on our earnings call.”

About InspireMD, Inc.

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

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

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 Reports Financial Results for the Fourth Quarter and Year Ended December 31, 2014

BOSTON, MA – March 12, 2015 – InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in stent embolic protection systems (“EPS”), today announced its financial and operating results for the fourth quarter and year ended December 31, 2014.

Alan Milinazzo, CEO of InspireMD, commented, “The fourth quarter was a commercial turning point for the Company. With highly positive CARENET data in hand, we began our initial CGuard™ selling activities in a limited market release. Early results are very promising as we ramp our launch activities for CGuard RX which recently received CE approval. Further, we restarted selling MGuard™ Prime into most markets, which enables a return to revenue growth for 2015.”

Mr. Milinazzo concluded, “This week, we completed a difficult but necessary capital raise for $13.7 million in gross proceeds. This cash infusion is expected to be sufficient to support key milestones, including the launch of CGuard RX, and critical pipeline development in our neurovascular and peripheral MicroNet™ programs.” “We believe we have put the challenges of 2014 behind us and have the strategic plan, the sense of urgency, and the resources to deliver a strong 2015.” 

Recent Operating Highlights:

Commercial

  • Initiated a Limited Market Release (LMR) of CGuard.
  • Resumed shipping of MGuard Prime into hospital accounts. Certain distribution partners also resumed MGuard Prime restocking with hospital customers following European approval of the manufacturing process changes.

REGULATORY / CLINICAL / PRODUCT DEVELOPMENT

  • Announced CE Mark approval for CGuard RX rapid exchange delivery system, a MicroNet™TM covered carotid stent technology.
  • Reported Six-Month Ultrasound Analysis from the CARENET study, which confirmed widely patent internal and external carotid arteries.
  • Successfully completed pre-clinical PK study with initial DES candidate with promising results.
  • Reported positive trends in mortality in the 30 day results on the 310 patients enrolled in MASTER II, as well as pooled data from MASTER II, and the 433 patient MASTER I trial completed and published in 2012.

FINANCIAL

  • Strengthened cash position with the completion of financing on November 7th, 2014, with gross proceeds of $8.1 million and March 9th, 2015 with gross proceeds of $13.7 million.
  • Implemented cost containment activities, including measures to significantly reduce the burn rate throughout 2015.

Quarter Ended December 31, 2014 Financial Results

Revenue for the quarter ended December 31, 2014 decreased $0.7 million to $0.9 million compared to $1.6 million during the same period in 2013. The 2014 period included an expected decline in sales volume associated with the limited resumption of sales activity following the temporary stoppage of sales activities for the MGuard Prime EPS following our voluntary field action (VFA).

The Company’s gross profit for the quarter ended December 31, 2014 was $0.4 million, a decrease of 54.2% compared to a gross profit of $0.9 million for the same period in 2013. The decrease was largely attributable to the impact of the VFA on product revenues.

Total operating expenses for the quarter ended December 31, 2014 were $4.8 million, a decrease of 16.6% compared to $5.8 million for the same period in 2013. This decrease was primarily due to a reduction of clinical and development expenses related to our bare metal stent product, a reduction in sales and marketing expenses related to fewer trade shows and a decrease in general and administrative expenses primarily due to the fact that bonuses in the quarter ended December 31, 2014 were lower than the same period in 2013.

The loss from operations for the quarter ended December 31, 2014 was $4.4 million, a decrease of 10.0% compared to a loss of $4.9 million for the same period in 2013.

Financial expenses for the quarter ended December 31, 2014 decreased 24.4% to $0.3 million from $0.4 million during the same period in 2013. This decrease was primarily due to a non-cash expense of $0.1 million associated with certain anti-dilution rights that we incurred in the three months ended December 31, 2013. No such expense was incurred during the same period in 2014.

The net loss for the quarter ended December 31, 2014 totaled $4.8 million, or $0.12 per basic and diluted share, compared to a net loss of $5.4 million, or $0.16 per basic and diluted share, in the same period in 2013.

Non-GAAP net loss for the quarter ended December 31, 2014 was $3.8 million, or $0.09 per basic and diluted share, a decrease of 17.3% compared to a non-GAAP net loss of $4.5 million, or $0.13 per basic and diluted share, for the same period in 2013. The non-GAAP net loss for the quarter ended December 31, 2014 primarily excludes $1.0 million of share-based compensation. The non-GAAP net loss for the quarter ended December 31, 2013 primarily excludes $0.7 million in share-based compensation expenses and $0.1 million in non-cash financial expenses.

Twelve Months Ended December 31, 2014 Financial Results

Revenue for the twelve months ended December 31, 2014 decreased $3.3 million to $2.8 million compared to $6.1 million during the same period in 2013. The 2014 period included a decline in sales volume associated with the temporary stoppage of sales activities for the MGuard Prime EPS following our VFA.

Gross profit for the twelve months ended December 31, 2014 totaled $0.8 million, a decrease of 75.3%, compared to $3.2 million for the same period in 2013. This decrease in gross profit was attributable to the impact of the VFA, which included a decrease in revenues as well as $0.4 million in expenses related to the modification of the MGuard Prime EPS.

Total operating expenses for the twelve months ended December 31, 2014 were $24.5 million, an increase of 26.0%, compared to $19.4 million for the same period in 2013. This increase was primarily due to higher research and development expenses attributable to the MASTER II trial, clinical trial and development expenses associated with our CGuard EPS product and expenditures in sales and marketing, as the Company increased its sales efforts in key European markets.

The loss from operations for the twelve months ended December 31, 2014 was $23.7 million, an increase of 45.8%, compared to a loss of $16.3 million for the same period in 2013.

Financial expenses for the twelve months ended December 31, 2014 decreased 89.3% to $1.4 million from $13.0 million during the same period in 2013. The decrease in financial expenses resulted primarily from $9.9 million of non-cash effects in the twelve months ended December 31, 2013 related to the conversion and repayment of our convertible debentures in April 2013, as well as $1.7 million of non-cash expenses associated with the issuance of certain shares of common stock without consideration in satisfaction of anti-dilution rights during this period. No such expense occurred during the twelve months ended December 31, 2014.

The net loss for the twelve months ended December 31, 2014 totaled $25.1 million, or $0.71 per basic and diluted share, compared to a net loss of $29.2 million, or $0.86 per basic and diluted share, in the same period in 2013.

Non-GAAP net loss for the twelve months ended December 31, 2014 was $20.9 million, or $0.59 per basic and diluted share, an increase of 63.3% compared to a non-GAAP net loss of $12.8 million, or $0.38 per basic and diluted share, for the same period in 2013. The non-GAAP net loss for the twelve months ended December 31, 2014 primarily excludes $4.1 million of share-based compensation. The non-GAAP net loss for the twelve months ended December 31, 2013 primarily excludes $12.4 million in non-cash financial expenses and $4.0 million in share-based compensation expenses.

Cash and Cash Equivalents

As of December 31, 2014, cash and cash equivalents were $6.3 million, compared to $17.5 million as of December 31, 2013.

Subsequent to the quarter’s close, the Company successfully completed a gross $13.7 million financing.  The Company believes its cash resources should be sufficient to support key milestones, including the launch of CGuard, progress on strategic partnership discussions, pipeline development in neurovascular and peripheral, and clinical work on an IDE submission for CGuard.

Forward-looking Statements

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

 

CONSOLIDATED STATEMENTS OF OPERATIONS (1)
(U.S. dollars in thousands, except per share data)
Twelve months ended
Three months ended  
December 31,   December 31,
2014 2013   2014   2013
Revenues $870 $1,553 $2,818 $6,119
Cost of revenues 476 692 2,034 2,948
Gross Profit (Loss) 394 861 784 3,171
Operating Expenses:
Research and development 1,259 1,771 8,744 5,269
Selling and marketing 1,583 1,817 6,613 4,655
General and administrative 1,999 2,215 9,125 9,500
Total operating expenses 4,841 5,803 24,482 19,424
Loss from operations (4,447) (4,942) (23,698) (16,253)
Financial expenses 334 442 1,385 12,946
Loss before tax expenses (4,781) (5,384) (25,083) (29,199)
Tax expenses (Income) 9 7 12 (31)
Net Loss $(4,790) $(5,391) $(25,095) $(29,168)
Net loss per share – basic and diluted $(0.12) $(0.16) $(0.71) $(0.86)
Weighted average number of shares of common stock used in computing net loss per share – basic and diluted 40,152,953 33,968,030 35,393,644 33,983,346

 

RECONCILIATION OF NON-GAAP NET LOSS (2)        
(U.S. dollars in thousands, except per share data)
Twelve months ended
Three months ended  
December 31,   December 31,
2014 2013   2014   2013
GAAP Net Loss $(4,790) $(5,391) $(25,095) $(29,168)
Non-GAAP Adjustments:
Non-cash financial expenses (income)(3) 123 (47) 12,355
Share-based compensation expenses 987 698 4,138 3,957
Royalties buyout expenses and amortization 40 21 100 53
Total Non-GAAP Adjustments 1,027 842 4,191 16,365
Non-GAAP Net Loss $(3,763) $(4,549) $(20,904) $(12,803)
Non-GAAP net loss per share – basic and diluted $(0.09) $(0.13) $(0.59) $(0.38)
Weighted average number of shares of common stock used in computing net loss per share – basic and diluted 40,152,953 33,968,030 35,393,644 33,983,346
 

 

CONSOLIDATED BALANCE SHEETS (4)
(U.S. dollars in thousands)
ASSETS December 31, December 31,
2014 2013
Current Assets:
Cash and cash equivalents $6,300 $17,535
Restricted cash 93
Accounts receivable:
Trade 635 1,855
Other 359 387
Prepaid expenses 150 141
Inventory 1,924 1,593
Total current assets 9,368 21,604
Non-current assets:
Property, plant and equipment, net 622 652
Deferred issuance costs 153 310
Funds in respect of employee rights upon retirement 498 434
Long term prepaid expenses 66 114
Royalties buyout 752 852
Total non-current assets 1,469 1,710
Total assets $11,459 $23,966

 

LIABILITIES AND EQUITY (CAPITAL DEFICIENCY) December 31, December 31,
2014 2013
Current liabilities:
Accounts payable and accruals:
Trade $909 $1,623
Other 3,576 3,141
Advanced payment from customers 179 179
Current maturity of loan 3,809 1,181
Total current liabilities 8,473 6,124
Long-term liabilities:
Liability for employees rights upon retirement 687 610
Long term loan 5,086 8,593
Total long-term liabilities 5,773 9,203
Total liabilities 14,246 15,327
Equity:
Common stock, par value $0.0001 per share; 125,000,000 shares authorized; 41,368,889 and 33,983,346 shares issued and outstanding at December 31, 2014 and December 31, 2013, respectively 4 3
Additional paid-in capital 104,620 90,952
Accumulated deficit (107,411) (82,316)
Total equity (capital deficiency) (2,787) 8,639
Total liabilities and equity (less capital deficiency) $11,459 $23,966
(1) 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, filed with the Securities and Exchange Commission. All financial information for the three months ended December 31, 2014 as well as all 2013 financial information is derived from the Company’s unaudited, internal financial statement.
(2) Our non-GAAP net loss is presented as management uses this supplemental non-GAAP financial measure to evaluate performance period over period, analyze the underlying trends in our business, and establish operational goals and forecasts that are used in allocating resources. We believe by presenting this additional measurement, we are providing investors with greater transparency to the information used by our management for our financial and operational decision-making, as well as allowing investors to see our results “through the eyes” of management. We further believe that providing this information assists our investors in understanding our operating performance and the methodology used by management to evaluate and measure such performance.
(3) Non-cash financial expenses (income) are items related to the induced conversion of the convertible loan, the amortization of the discount on the convertible loan and its related issuance costs, the issuance of shares as a result of the anti-dilution rights of our March 2011 investors and the revaluation of warrants.
(4) All December 31, 2014 financial information is derived from the Company’s 2014 audited financial statements and all December 31, 2013 financial information is derived from the Company’s 2013 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 Closing of Public Offering for Approximately $13.7 Million

BOSTON, MAMarch 9, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced the closing of its offering of approximately 34.4 million shares of common stock and warrants to purchase approximately 34.4 million shares of common stock. The common stock was sold at a negotiated purchase price of $0.40 per share, and each purchaser received a warrant to purchase one share of common stock for each share of common stock that it purchased in the offering. The warrants are exercisable immediately and have a term of exercise of five years from the date of issuance and an exercise price of $0.55 per share. The Company received gross proceeds from the offering of approximately $13.7 million, before deducting placement agents’ fees and estimated offering expenses.

H.C. Wainwright & Co., LLC served as the sole bookrunner for this offering. Dawson James Securities, Inc. served as co-manager.

The Company intends to use the net proceeds from this offering to commercially launch CGuard™ EPS, conduct sales activities related to MGuard Prime™ EPS, advance the development of its pipeline, and for general corporate purposes.

The securities described above were offered pursuant to a shelf registration statement on Form S-3 which was filed with the Securities and Exchange Commission (“SEC”) and was declared effective on November 27, 2013. A prospectus supplement relating to the offering was filed with the SEC on March 9, 2015. Copies of the prospectus supplement and accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC by e-mailing placements@hcwco.com or by calling 212-356-0530.

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

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

InspireMD to Report Financial Results for the Fourth Quarter and Year Ended December 31, 2014 on Thursday, March 12th

BOSTON, MAMarch 6, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), announced today that it will release its full financial results for the fourth quarter and year end December 31, 2014 on Thursday, March 12th after market close, followed by a conference call at 4:30 p.m. ET to review its financial results and business outlook.

Participants should call (888) 243-4451 (United States) or (412) 542-4135 (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.inspiremd.com/en/investors/investor-relations/. Please allow 10 minutes prior to the call to visit this site to download and install any necessary audio software.

An archive of the webcast will be available approximately two hours after completion of the live event and will be accessible on the Investor Relations section of the Company’s website at www.inspiremd.com/en/investors/investor-relations/. for a limited time. A dial-in replay of the call will also be available to those interested until March 27, 2015. To access the replay, dial (877) 344-7529 (United States) or (412) 317-0088 (International) and enter code: 10062039.

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.

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, MAMarch 4, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), 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. H.C. Wainwright & Co., LLC, is serving as the sole bookrunner for this offering. Dawson James Securities, Inc. is serving as co-manager.

The Company intends to use the net proceeds from this offering to commercially launch CGuard™ EPS, conduct sales activities related to MGuard Prime™ EPS, advance the development of its pipeline, 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 3, 2015 and a final prospectus supplement relating to the offering will be filed with the SEC by March 5, 2015. Copies of the prospectus supplement and accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC by e-mailing placements@hcwco.com or by calling 212-356-0530.

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

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

InspireMD Announces Public Offering for Approximately $13.5 Million

BOSTON, MAMarch 3, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced that it has entered into a definitive agreement to sell up to approximately 34 million shares of common stock and warrants to purchase up to approximately 34 million shares of common stock in a public offering. The common stock will be sold at a negotiated purchase price of $0.40 per share, and each purchaser will receive a warrant to purchase one share of common stock for each share of common stock that it purchases in the offering. 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 $0.55. The Company expects to receive gross proceeds from the offering of approximately $13.5 million, before deducting placement agents’ fees and estimated offering expenses.

The offering is expected to close on or about March 9, 2015, subject to customary closing conditions.

H.C. Wainwright & Co., LLC, is serving as the sole bookrunner for this offering. Dawson James Securities, Inc. is serving as co-manager.

The Company intends to use the net proceeds from this offering to commercially launch CGuard™ EPS, conduct sales activities related to MGuard Prime™ EPS, advance the development of its pipeline, 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 3, 2015 and a final prospectus supplement relating to the offering will be filed with the SEC by March 5, 2015. Copies of the prospectus supplement and accompanying prospectus relating to the offering may be obtained from H.C. Wainwright & Co., LLC by e-mailing placements@hcwco.com or by calling 212-356-0530.

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

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

InspireMD to Present at the Cowen and Company 35th Annual Healthcare Conference

Presentation to be Webcast on March 3, 2015 at 10:40 a.m. ET

BOSTON, MAFebruary 26, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced that its Chief Executive Officer, Alan Milinazzo, will present at the Cowen and Company 35th Annual Healthcare Conference on Tuesday, March 3, 2015 at 10:40 a.m. ET. The conference will be held in Boston, MA.

A live webcast will be available for those participants who are unable to attend, which can be found at: http://wsw.com/webcast/cowen22/nspr. The webcast will be available for 90 days following the presentation.

About InspireMD, Inc.

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

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

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

InspireMD Receives CE Mark Approval for Its New CGuard RX and Announces Positive Six Month Follow-Up CARENET Trial Data at LINC 2015

The New CGuardTM RX Rapid Exchange System Receives CE Mark Approval

Six-Month Ultrasound Analysis Confirms Widely Patent Internal and External Carotid Arteries When Compared to Conventional Carotid Stents
 

BOSTON, MAJanuary 27, 2015InspireMD, Inc. (NYSE MKT: NSPR) (“InspireMD” or the “Company”), a leader in embolic protection systems (“EPS”), today announced that it received CE mark approval for its new CGuard RX rapid exchange system for its MicroNet™TM covered carotid stent technology. Concurrently, the Company announced positive 6 month follow up data from its CGuardTM CARENET (CARotid Embolic protection Study using microNET) trial at the LINC (Leipzig InterveNtional Course) meeting in Leipzig, Germany.

The Company announced today that it received CE mark approval for its new CGuardTM RX rapid exchange delivery system for its MicroNet™TM covered embolic prevention system. The new state- of- the- art RX delivery system will enable clinicians to place the CGuard technology using an easy-to-use, and familiar, delivery system. The CGuard MicroNet™ mesh covered carotid stent remains unchanged.

Also today, Prof. Piotr Musiałek, Co- Principal Investigator for the CARENET study, from Jagiellonian University Medical College at John Paul II Hospital, Krakow, Poland, presented the CARENET 6 month data at a late breaking trial session at the LINC Meeting. There was one MACCE (major adverse cardiac and cerebrovascular) event reported at 6 months which was not device related. This 6 month MACCE rate is substantially lower than MACCE rates reported in other conventional carotid stenting trials. The duplex ultrasound analysis performed at 6 months confirmed widely patent carotid arteries, which were stented with the CGuard as determined by flow measurements indicating no sign of vessel narrowing, consistent with historical data of conventional carotid artery stenting. Importantly, the external carotid artery showed unimpeded flow in 100% of cases demonstrating that the MicroNet™ allows excellent blood flow into bifurcated arteries. The reduction in both the incidence and the volume of new ischemic lesions, as well as this 6 month data showing minimal restenosis concern, and 100% patent internal and external carotid arteries, indicates that the therapeutic benefits of the CGuardTM MicroNet™ technology may extend well beyond the acute procedural period.

Alan Milinazzo, CEO of InspireMD, commented, “We are very pleased to have received the CE mark approval for our CGuard RX rapid exchange system. This is an important milestone for the Company as it creates significant near term commercial opportunities for us.” He stated, “Physicians continue to be impressed with the superior clinical data and our 6 month results further validate that CGuard with MicroNet™ may represent a superior next generation of stenting technology. We plan to use the new clinical data and the RX approval to expand our commercial launch activities starting immediately.”
About CGuardTM EPS

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

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

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

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

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Transition Report on Form 10-KT and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Investor Contacts:
Craig Shore
Chief Financial Officer
InspireMD, Inc.
Phone: 1-888-776-6804
Email: craigs@inspiremd.com