UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

_________________

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

_________________

Date of Report (Date of earliest event reported): September 9, 2015

InspireMD, Inc.


(Exact name of registrant as specified in its charter)

Delaware

 

001-35731

 

26-2123838

(State or other jurisdiction
of incorporation) 		  (Commission File Number)   (IRS Employer
Identification No.)
     

 

321 Columbus Avenue

Boston, Massachusetts

 

02116

(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (857) 453-6553

 

 

(Former name or former address, if changed since last report)

 

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4 (c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 

 

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan

 

On September 9, 2015, InspireMD, Inc. (the “Company”) held its 2015 annual meeting of stockholders (the “Annual Meeting”). At the Annual Meeting, the stockholders approved an amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (the “Plan”) to increase the number of shares of common stock available for issuance pursuant to awards under the Plan by 4,700,000 shares of common stock, to a total of 9,700,000 shares of common stock (the “Plan Amendment”). The board of directors of the Company (the “Board”) previously approved the Plan Amendment, subject to stockholder approval of the Plan Amendment at the Annual Meeting.

 

Election of Class 1 Directors

 

As previously reported in the Company’s definitive proxy statement dated July 29, 2015 (the “2015 Proxy”), the term of the Company’s Class 1 directors, Alan Milinazzo, Sol J. Barer, Ph.D. and Paul Stuka, was scheduled to expire at the Annual Meeting, and the Board nominated each of Mr. Milinazzo, Dr. Barer and Mr. Stuka for reelection at the Annual Meeting as Class 1 directors.

 

At the Annual Meeting, Mr. Milinazzo, Dr. Barer and Mr. Stuka were each elected as a Class 1 member of the Board to serve for a term expiring at the Company’s 2018 annual meeting of stockholders.

 

For more information about the matters above, see the Company’s 2015 Proxy, the relevant portions of which are incorporated herein by reference. The description of the Plan above and such portions of the 2015 Proxy are qualified in their entirety by reference to the full text of the First Amendment to the Plan, filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

Item 5.07 Submission of Matters to a Vote of Security Holders.

 

At the Annual Meeting, the following five proposals were submitted to the Company’s stockholders:

 

(1) Election of three Class 1 directors to serve on the Board for a term of three years or until their successors are elected and qualified, for which the following were nominees: Alan Milinazzo, Sol J. Barer, Ph.D. and Paul Stuka.

 

(2) The Plan Amendment.

 

(3) Authorization of the Board to amend the Amended and Restated Certificate of Incorporation of the Company to (i) effect a reverse stock split of the Company’s common stock at a ratio of one-for-ten and (ii) reduce the number of authorized shares of the Company’s common stock from 125,000,000 to 50,000,000.

 

(4) An advisory vote on executive compensation as disclosed in the 2015 Proxy.

 

(5) Ratification of the appointment of Kesselman & Kesselman, Certified Public

 

 

  

Accountants, as our independent registered public accounting firm for the year ending December 31, 2015.

 

For more information about the foregoing proposals, see the Company’s 2015 Proxy. Holders of the Company’s common stock were entitled to one vote per share. The number of votes cast for and against and the number of abstentions and broker non-votes with respect to each matter voted upon are set forth below:

 

(1) Election of three Class 1 directors to serve on the Board for a term of three years or until their successors are elected and qualified:

 

Director   For   Withheld   Broker Non-Votes
Alan Milinazzo 16,960,265 435,935   37,443,315
Sol J. Barer, Ph.D.   16,251,338   1,144,862   37,443,315
Paul Stuka   16,770,689   625,511   37,443,315

 

(2) The Plan Amendment:

 

For   Against   Abstain   Broker Non-Votes
13,629,752   3,552,189   214,259   37,443,315

 

(3) Authorization of the Board to amend the Amended and Restated Certificate of Incorporation of the Company to (i) effect a reverse stock split of the Company’s common stock at a ratio of one-for-ten and (ii) reduce the number of authorized shares of the Company’s common stock from 125,000,000 to 50,000,000:

 

For   Against   Abstain   Broker Non-Votes
48,036,337   6,797,405   5,773   0

 

(4) An advisory vote on executive compensation as disclosed in the 2015 Proxy:

 

For   Against   Abstain   Broker Non-Votes
14,060,905   2,661,035   674,260   37,443,315

 

(5) Ratification of the appointment of Kesselman & Kesselman, Certified Public Accountants, as our independent registered public accounting firm for the year ending December 31, 2015:

 

For   Against   Abstain   Broker Non-Votes
53,399,382   1,360,829   79,304   0

 

The results reported above are final voting results. No other matters were considered or voted upon at the meeting.

 

Item 7.01 Regulation FD Disclosure.

 

The Company intends, from time to time, to present and/or distribute to the investment community and utilize at various industry and other conferences a slide presentation, which is attached hereto as Exhibit 99.1. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.

 

 

 

In accordance with General Instruction B.2 of Form 8-K, the information furnished pursuant to this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in such a filing.

 

Item 8.01 Other Events.

 

On September 9, 2015, the Company issued a press release announcing that the United States Patent & Trademark Office has allowed claims for the Company’s United States Patent Application, published as US2014/0309725 and entitled “Optimized Drug Eluting Stent Assembly.” A copy of the press release is attached hereto as Exhibit 99.2, and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d)         Exhibits

 

Exhibit Number   Description
10.1   First Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan
*99.1   Slide Presentation of InpsireMD, Inc. dated September 2015.
99.2   Press release dated September 9, 2015.

 

*This exhibit is furnished pursuant to Item 2.02 or Item 7.01, as applicable, and shall not be deemed to be “filed.”

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

  InspireMD, Inc.
   
   
Date: September 9, 2015 By:  /s/ Craig Shore
    Name: Craig Shore
    Title: Chief Financial Officer

 

 

 

 

 

 

 

 

Exhibit 10.1

 

FIRST AMENDMENT

TO THE

INSPIREMD, INC. 2013 LONG-TERM INCENTIVE PLAN

 

 

This FIRST AMENDMENT TO THE INSPIREMD, INC. 2013 LONG-TERM INCENTIVE PLAN (this “ Amendment ”), dated as of September 9, 2015, is made and entered into by InspireMD, Inc., a Delaware corporation (the “ Company ”). Terms used in this Amendment with initial capital letters that are not otherwise defined herein shall have the meanings ascribed to such terms in the InspireMD, Inc. 2013 Long-Term Incentive Plan (the “ Plan ”).

 

RECITALS

 

WHEREAS , Article 9 of the Plan provides that the Board of Directors of the Company (the “ Board ”) may amend the Plan at any time and from time to time; and

 

WHEREAS , the Board desires to amend the Plan to increase the number of shares of Common Stock that may be delivered pursuant to Awards under the Plan by an additional four million seven hundred thousand (4,700,000) shares, for an aggregate maximum total of nine million seven hundred thousand (9,700,000) shares available under the Plan.

 

NOW, THEREFORE , in accordance with Article 9 of the Plan, the Company hereby amends the Plan, effective as of the date hereof, as follows:

 

1.             Section 5.1 of the Plan is hereby amended by deleting said section in its entirety and substituting in lieu thereof the following new Section 5.1:

 

5.1             Number Available for Awards . Subject to adjustment as provided in Articles 11 and 12 , the maximum number of shares of Common Stock that may be delivered pursuant to Awards granted under the Plan is nine million seven hundred thousand (9,700,000) shares, of which one hundred percent (100%) may be delivered pursuant to Incentive Stock Options. Subject to adjustment pursuant to Articles 11 and 12 , the maximum number of shares of Common Stock with respect to which Stock Options or SARs may be granted to an Executive Officer during any calendar year is one million (1,000,000) shares of Common Stock. Shares to be issued may be made available from authorized but unissued Common Stock, Common Stock held by the Company in its treasury, or Common Stock purchased by the Company on the open market or otherwise. During the term of this Plan, the Company will at all times reserve and keep available the number of shares of Common Stock that shall be sufficient to satisfy the requirements of this Plan.

2.           Except as expressly amended by this Amendment, the Plan shall continue in full force and effect in accordance with the provisions thereof.

 

* * * * * * * *

 

[ Remainder of Page Intentionally Left Blank

Signature Page Follows .]

 

 

 

IN WITNESS WHEREOF , the Company has caused this Amendment to be duly executed as of the date first written above.

 

  INSPIREMD, INC.
   
   
  By:  /s/ Craig Shore
  Name: Craig Shore
  Title: Chief Financial Officer, Chief Administrative
    Officer, Treasurer and Secretary

 

 

 

 

 

 

 

 

 

 

 

Signature Page to

First Amendment to the 2013 Long-Term Incentive Plan

 

 

 

Exhibit 99.1

 

NYSE MKT: NSPR September 2015

 
 

Forward Looking Statements 2 This presentation 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 sa le 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 t o 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.

 
 

3 An emerging medical device company developing and commercializing advanced technology for interventional cardiology and other vascular procedures InspireMD NYSE MKT: NSPR Stock Price (9/4/15): $0.19 52 Week Range: $0.18 - $2.44 Average Volume: 1,122K Shares Outstanding (9/4/15): 78 M Market Capitalization (9/4/15): $15 M Analyst Coverage: Cowen Group: Josh Jennings Empire Asset Management: Cathy Reese Total Cash (6/30/15): $9.8 M US Headquarters: Boston, MA International Headquarters: Tel Aviv, Israel # of Employees (9/4/2015): 46

 
 

Investment Highlights 4 • 2015 return to revenue growth driven by the full launch of carotid platform through strategic distribution partnership with Penumbra, Inc. • Operating and financial realignment inline with development and growth initiatives. • Advancing into highly valued Neuro and Peripheral markets to leverage MicroNet technology into high growth segments. • Expanding collaboration activities on multiple MicroNet technology applications. Effectively Executing a “Neck Up” Interventional Strategy

 
 

5

 
 

6 Leadership: Significant Track Records of Success EXECUTIVE TEAM BOARD OF DIRECTORS Alan Milinazzo, President, CEO & Director • Medtronic • Boston Scientific Craig Shore, CFO • Pfizer • General Electric Dr. James Barry, COO • Boston Scientific • Howmedica Division of Pfizer Eli Bar, CTO • Nicast Gwen Bame, VP Corporate Development • Boston Scientific • Covidien David Blossom, VP Global Marketing & Strategy • Boston Scientific • Covidien Dr. Sol Barer, Chairman • Former Chairman and CEO, Celgene Alan Milinazzo, President, CEO & Director • Medtronic • Boston Scientific Dr. James Barry • SVP Corporate Technology Development at Boston Scientific • Howmedica Division of Pfizer Michael Berman • Pres. Boston Scientific/Scimed • Founder, Velocimed and Lutonix James Loughlin • KPMG • Celgene Audit Chair Paul Stuka • Founder, Osiris • Fidelity Management and Research Dr. Campbell Rogers • CMO, Heartflow • CSO, Cordis/JNJ • Associate Professor, Harvard School of Medicine

 
 

Technology: MicroNet ™ 7 Proprietary MicroNet Mesh for Embolic Prevention and Flow Diversion MicroNet Platform Ultra thin PET enhances clinical benefit of scaffold devices • Provides revascularization benefit • MicroNet acts as safety net by offering greater surface area coverage to prevent large debris flow • Mesh configuration allows perfusion to vessel wall • Made of a single fiber from a biocompatible polymer, widely used in medical implantations

 
 

Large Addressable Markets 8 Expanding the MicroNet ™ Platform MGuard ™ x $1.7B Market x CE Mark Cleared x Coronary AMI, SVG CGuard ™ x $500M Market x CE Mark Cleared x Carotid NVGuard x $125M Flow Diversion Market x $550M Aneurysm Market x 2016E CE Mark Planned Submission for Flow Diverter x Neurovascular PVGuard x $1.7B Market x 2017E CE Mark Planned Submission x Peripheral

 
 

Carotid Market Opportunity 9 An Enhanced Minimally Invasive Solution • Standard of care: Open surgery: Carotid EndArterectomy (CEA) • Current stents have not improved on CEA stroke rates (CREST) • Mesh covered stent category has the potential to convert CEA to CAS • CARENET 30 - day and 6 - mo data show CGuard better than previous technology/therapy • PARADIGM physician - initiated trial validated benefits of CGuard in an all - comer population • Immediate commercial opportunity with new Strategic Partner Penumbra ROW $200 US $300 Global Carotid Market : $ 500M Source: JMP Securities, 2014

 
 

Carotid Solution 10 Emerging Market Opportunity CGuard ™ Embolic Prevention System Combines stent and embolic protection in a single device • CE marked • Self - expanding nitinol stent • Global market valued at $500M* • Strong CARENET FIM data released 9/14 and 1/15 • Impressive all - comer data from PARADIGM presented 5/15 • Full launch planned for Q4 2015 *Source : JMP Securities, 2014

 
 

Positive CGuard™ Clinical Experience 11 * FIM , First in Man CARENET ( CAR otid E mbolic protection using micro NET ) FIM* Clinical Trial • 30 Patient Safety and Efficacy clinical trial • Prospective, multi - center, multispecialty, non - randomized single arm study • DWMRI follow ups at 48hrs and 30 days for “ gold - standard ” neurological analysis CARENET Highlights: 30 day Results • Achieved primary end point • 100% procedural success • Zero MACCE at 30 days • 50% fewer new ischemic lesions compared to historical non - mesh carotid artery stenting data • Average lesion volume per patient 10 times smaller compared to historical non - mesh carotid artery stenting data CARENET Highlights: 6 mo Results • 3.6% MACCE rate at 6 months (Comparative data 8.09%) • 6 month ultrasound analysis was indicative of healthy healing without restenosis concern with patent external and internal carotid arteries

 
 

Positive CGuard™ Clinical Experience 12 * FIM , First in Man PARADIGM ( P rospective evaluation of A ll - comer pe rR cutaneous c A roti D revascularization I n symptomatic and increased - risk asymptomatic carotid artery stenosis using C G uard TM M esh - covered embolic prevention system) Physician I nitiated All - Comers Study • Objective: To evaluate feasibility and outcome of routine anti - embolic stent system in unselected, consecutive carotid patients (all - comers) • Investigator - independent neurological and angiographic evaluation • 71 CGuard devices placed in 68 pts • Device success: 100%; Procedure success: 100% • MACCE (Death/stroke/MI) @ 48 hr: 0% @ 30 day: 0% • Conclusions: • “> 90% all - comer carotid artery stenosis pts, including >50% symptomatic pts, can be treated using CGuard .”

 
 

Strategic Distribution Partnership 13 • Founded in 2005 as a Neurovascular company with a clinically - driven product development strategy • Reputation as the innovation leader in the neurovascular field • Extending success beyond stroke into the periphery and neurosurgical markets • Track record of consistent, profitable growth (S 1 just filed) • Management team with decades of vascular experience • Entering carotid market to complement their stroke portfolio Rationale: Predictable, Sustainable & Profitable Revenue Growth

 
 

- 200 400 600 800 1,000 1,200 1,400 1,600 1,800 Q1 Q2 Q3 Q4 2012 2013 2014 2015 Commercial Profile 14 Revenue Growth Driven by CGuard ™ RX • Late September 2015: Full Total Systems Solution Launch • Key European Territories Targeted • Opportunity to Increase Number of Target Territories Note: Revenue in $000

 
 

Robust Pipeline 15 Commercial • CE Mark Cleared • 12 - month MASTER I, II MicroNet ™ Platform Technology MGuard ™ Coronary EPS NVGuard ™ Neurovascular* RGuard™ Renal *  CGuard ™ RX Carotid PVGuard™ Peripheral * MGuard ™ Drug Eluting *  * Planning & Development Phase Commercial • CE Mark Cleared • CARENET Trial • PARADIGM all - comer study • CGuard FDA IDE protocol in draft form • Penumbra Strategic Partnership 2017E CE Mark Planned Submission CE Mark Planned Submission, Subject to Strategic Partner Support Exploring Market Opportunities: • Flow Diverter • Intra - Cranial Stent 2016E CE Mark Planned Submission for Flow Diverter Exploring Market Opportunity Expanding Indications with MicroNet ™

 
 

Neurovascular Market Opportunity 16 Innovation Leads Growth • Current designs have sub - optimal trackability and in vessel flexibility: metal on metal devices • MicroNet has proven flow diversion effect with ultra low profile and improves device flexiblity to improve device deliverability Source: MRG Neuro Report, Ev3 Revenue Data 2014 Competitive Landscape: Relatively Fewer Players with Limited Innovation Product Company Approval Pipeline Medtronic/Covidien CE Mark / FDA 2011 Surpass Stryker CE Mark 2011 Silk Balt Extrusion CE Mark 2008 Flow Diversion For Unruptured Brain Aneurysms Next Generation Combination Technology

 
 

NVGuard ™ Neurovascular 17 Differentiation Yields Increased Utility Our Significant Advantage Over Existing Flow Diverters • MicroNet aperture & size • Low metal to artery ratio • Can be placed in side branches and bifurcations, which is impossible with current technology Total Aneurysm Market Value: $946M • Aneurysm Therapy (all types): $550M • Aneurysms account for 74% of neuroendovascular disease states • Estimated that flow diverters can treat 25% of all aneurysms • Wide - neck Aneurysm Procedures: $350M • Non - coil neurovascular products: estimated 12% CAGR from 2010 - 2016 Advanced neurovascular technologies are highly valued as the market segment expands with improved device performance Source: MRG

 
 

Neurovascular Market 18 • Medtronic acquires Medina Medical for $150 million • Stryker Acquires Surpass Medical for $135 million • Covidien Acquires Chestnut Medical for $150 million * * Based on milestones achieved as part of structured deal High Strategic interest with attractive valuations

 
 

Intellectual Property Portfolio 19 Continue to strengthen and broaden patent protection globally. Progress over the last year imparts important rights on existing products and technologies and will enable future pipeline products Source: MRG PATENT RIGHTS Issued Allowed Pending US 2 2 10 Rest of World (ROW) 13 1 15

 
 

2015E 2016E 2017E R&D/ Clin / Reg Corporate Operational Commercial Target Milestones 20 Support & Execute on Growth Initiatives Strategic Partnership : Penumbra Strategic Partnership V Strategic Partnership IV DES Estimated CE Mark Achieve Targeted COGS NVGuard CE Mark Submission CGuard RX Launch NVGuard Estimated CE Mark CGuard FDA IDE Submission CARENET I 6M FU DES Pre Clinical PVGuard CE Mark Submission DES CE Mark Submission * CGurad RX Full Launch with Penumbra *Subject to Strategic Partner Support MOH Russia MGuard Prime

 
 

Investment Highlights 21 • 2015 return to revenue growth driven by the full launch of carotid platform through strategic distribution partnership with Penumbra, Inc. • Operating and financial realignment inline with development and growth initiatives. • Advancing into highly valued Neuro and Peripheral markets to leverage MicroNet technology into high growth segments. • Expanding collaboration activities on multiple MicroNet technology applications. Effectively Executing a “Neck Up” Interventional Strategy

 
 

Alan Milinazzo , CEO (888) 776 - 6804 alanm@ inspiremd.com Craig Shore, CFO (888) 776 - 6804 craigs@inspiremd.com

 
 

Coronary MGuard ™ EPS 23 Improving AMI Patient Outcomes • Current stents not specifically designed for AMI • Distal embolization occurs in up to 73% of cases* • Majority of AMI market is outside of the U.S . (~ 60%) • MGuard clinical experience including two randomized trials MASTER I and MASTER II with data showing sustained mortality rates • Coronary market to be pursued with strategic partner support Source: Health Research International, (June 2012 ) | *JAMA , March 2, 2005 — Vol 293, No. 9 1063 Gregg W. Stone

 
 

24 MASTER I & II Pooled: All Cause Mortality at 30 days (743 patients) 0 5 10 15 20 25 30 Time in Days BMS/DES (n=371) MGuard (n=372) 5 4 3 2 1 0 Death (%) HR: 0.14 [95% CI: 0.02, 1.15] P=0.03 1.9% 0.3%

 
 

 

 

 

 

 

 

Exhibit 99.2

 

 

 

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, CGuard TM Embolic Prevention System for the treatment of carotid artery disease, and MGuard TM 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 (CGuard TM ), 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