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8-K - 8-K - InspireMD, Inc.s101618_8k.htm
EX-99.3 - EXHIBIT 99.3 - InspireMD, Inc.s101618_ex99-3.htm
EX-99.1 - IEXHIBIT 99.1 - InspireMD, Inc.s101618_ex99-1.htm

 

Exhibit 99.2

NYSE MKT: NSPR August 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 control of InspireMD, Inc. (the “Company”), 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 the Company’s 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 the Company’s products, (iv) intense competition in the medical device industry from much larger, multi-national companies, (v) product liability claims, (vi) product malfunctions, (vii) the Company’s limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payorsfor the Company’s products, (ix) the Company’s efforts to successfully obtain and maintain intellectual property protection covering its products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) the Company’s reliance on single suppliers for certain product components, (xii) the fact that the Company will need to raise additional capital to meet its business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain, (xiii) the fact that the Company conducts business in multiple foreign jurisdictions, exposing it 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 and (xiv) the escalation of hostilities in Israel, which could impair the Company’s ability to manufacture its products. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements are set forth in the Company’s filings with the Securities and Exchange Commission, including the Company’s Transition Report on Form 10-K/T and its quarterly reports on Form 10-Q. Investors and security holders are urged to read these reports free of charge on the Securities and Exchange Commission’s web site at 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 (8/3/15): $0.28 52 Week Range: $0.18 -$2.57 Average Volume: 1,248K Shares Outstanding (8/3/15): 78 M Market Capitalization (8/3/15): $21.8 M Analyst Coverage: Cowen Group:Josh Jennings Empire Asset Management: Cathy Reese Total Cash (8/3015): $9.8 M US Headquarters: Boston, MA International Headquarters: Tel Aviv, Israel # of Employees (8/3/2015): 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 Neuroand Peripheral markets to leverage MicroNettechnology into high growth segments. • Expanding collaboration activities on multiple MicroNettechnology applications.

 
 

5 Leadership: Significant Track Records of Success EXECUTIVETEAM 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

 
 

6

 
 

Technology: MicroNet™ 7 Beyond Stenting: MicroNetMesh for Embolic Prevention MicroNetPlatform Combines stent and embolic protection in a single device • Stent platform provides revascularization benefit • MicroNetthen 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 xCE Mark Cleared xCoronary AMI, SVG CGuard™ x$500M Market xCE Mark Cleared xCarotid NVGuard x$125M Flow Diversion Market x$550M Aneurysm Market x2016E CE Mark Planned Submission for Flow Diverter xNeurovascular PVGuard x$1.7B Market x2017E CE Mark Planned Submission xPeripheral

 
 

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 CGuardin an all-comer population • Immediate commercial opportunity with revenue ramp throughout 2015 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 • Stent platform provides revascularization benefits • MicroNetacts as safety net by offering greater plaque scaffolding to prevent prolapse related to late embolization • CE marked • Self-expanding nitinolstent • Global market valued at $500M* • Strong CARENET FIM data released 9/14 and 1/15 • Impressive all-comer data from PARADIGM presented 5/15 • First commercial orders (LMR) received Q4 2014 *Source: JMP Securities, 2014

 
 

Positive CGuard™ Clinical Experience 11 * FIM , First in Man CARENET (CARotidEmbolic protection using microNET) 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 Announced at TCT 2014 • 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 moResults Announced at LINC 2015 and EuroPCR2015 • 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 (Prospective evaluation of All-comer perRcutaneous cArotiD revascularization In symptomatic and increased-risk asymptomatic carotid artery stenosis using CGuard TM Mesh-covered embolic prevention system) PhysicianInitiatedAll-ComersStudy • 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 CGuarddevices 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.” • “Endovascular revascularization with routine use of the CGuard in an unselected patient population is extremely safe” • “Use of the CGuard enables endovascular reconstruction of the diseased carotid artery across a wide lesion spectrum in absence of clinical complications.”

 
 

Commercial Profile 13 Revenue Growth Driven by CGuard™ RX - 200 400 600 800 1,000 1,200 1,400 1,600 1,800 Q1 Q2 Q3 Q4 2012 2013 2014 2015

 
 

Strategic Distribution Partnership 14 • 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 • Management team with decades of vascular experience • Entering carotid market to complement their stroke portfolio Rationale: Predictable, Sustainable & Profitable Revenue Growth

 
 

Coronary MGuard™ EPS 15 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%) • MGuardclinical 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—Vol293, No. 9 1063 Gregg W. Stone

 
 

16 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 D e a t h ( % ) HR: 0.14 [95% CI: 0.02, 1.15] P=0.03 1.9% 0.3%

 
 

Robust Pipeline 17 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 • CGuardFDA 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 18 Innovation Leads Growth • Current designs have sub-optimal trackabilityand in vessel flexibility • MicroNetmeets need to simultaneously manage thrombosis of the aneurysmal sac while preserving the patency of the adjacent small vessels Source: MRG NeuroReport, Ev3 Revenue Data 2014 Competitive Landscape: Relatively Fewer Players with Limited Innovation Product Company Approval Pipeline Medtronic/Covidien CE Mark / FDA 2011 Surpass Stryker CEMark 2011 Silk BaltExtrusion CE Mark 2008 The Flow Diversion System The preferred solution for unrupturedaneurysm treatment

 
 

NVGuard™ Neurovascular 19 Differentiation Yields Increased Utility Our Significant Advantage Over Existing Flow Diverters • MicroNetaperture & 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 neuroendovasculardisease 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 “Devices in the European neurovascular device market will face significant competition from emerging treatments, such as INR flow diversion” Source: MRG

 
 

PVGuard™ Peripheral 20 The Embolic Prevention System A new stent category as the preferred solution for peripheral intervention • Current stents not specifically designed for embolic protection • Mesh covered stent category emerging as immediate opportunity • Strong global growth profile with increased clinical complexity Source: MRG 2013/2014,ReportLinker Market Landscape2014 Company EU Market Share Abbott Laboratories 15% Boston Scientific 15% C. R. Bard 12% W.L. Gore 10% Covidien 9.5% Cordis 7% Enabling a New Solution: Peripheral Embolic Protection

 
 

2015E 2016E 2017E R&D/Clin/Reg Corporate Operational Commercial Target Milestones 21 Support & Execute on Growth Initiatives Strategic Partnership : Penumbra Strategic Partnership V Strategic Partnership IV DES Estimated CE Mark Achieve Targeted COGS NVGuardCE Mark Submission CGuard RX Launch NVGuardEstimated CE Mark CGuard FDA IDE Submission CARENET I 6M FU DES Pre Clinical PVGuard CE Mark Submission DES CE Mark Submission * CGuradRX Full Launch with Penumbra *Subject to Strategic Partner Support MOH Russia MGuardPrime

 
 

Investment Summary 22 • 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 Neuroand Peripheral markets to leverage MicroNettechnology into high growth segments. • Expanding collaboration activities on multiple MicroNettechnology applications.

 
 

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