Inspiremd Inc. · NASDAQ:NSPR
Inspiremd — Investor Presentation (January 2019)
30 slides from Inspiremd's investor presentation, January 2019
Slide 1: Investor Presentation
INVESTOR PRESENTATION NYSE AMER: NSPR I January 2019 1
Slide 2: Forward Looking Statements
Forward Looking Statements 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-lookin
Slide 3: About InspireMD
About InspireMD InspireMD is a commercial-stage medical device company developing and marketing innovative embolic prevention systems (EPS) that can prevent harmful consequences, with a primary focus on preventing stroke in patients with carotid artery disease (CAD) COMPANY TECHNOLOGY PRODUCTS Propr
Slide 4: Company Highlights
Company Highlights Lead product, CGuard™ A potential paradigm shift in the treatment of carotid artery disease and stroke prevention EPS Highly differentiated with strong KOL support Benefits demonstrated in Seven completed and four ongoing clinical trials multiple trials Demonstrates strong benefit
Slide 5: Leadership
Leadership Significant track records of success James Barry, Ph.D. President and CEO Craig Shore CFO Paul Stuka Chairman Michael Berman Director Campbell Rogers, M.D. Director Thomas Kester Director Sol Barer, Ph.D. Special Advisor to the Board January 2019 I 5
Slide 6: Stroke is the Second Biggest Cause of Death
Stroke is the Second Biggest Cause of Death An estimated 15 million people suffer from stroke annually3 Top 10 Causes of Death Globally, 2016 18 • 5.7 million deaths1 16 14 • 5 million people left permanently 12 10 disabled3 8 • $34 billion associated with stroke 6 4 management in the US alone2 2 0
Slide 7: Stroke Prevalence Increasing Among Young People
Stroke Prevalence Increasing Among Young People Between 1990 and 2013, there was a significant increase in the global prevalence of ischemic stroke among young people aged 20-64 Approximately 85% of all strokes are ischemic strokes, which result from a lack of blood flow to Global Prevalence of Isch
Slide 8: Unmet Need: A Safer Technology for Stroke Prevention in CAD
Unmet Need: A Safer Technology for Stroke Prevention in CAD Surgery vs. Carotid Artery Stenting Carotid Endarterectomy (CEA) Filter Protected Stenting (CAS) “Gold standard”1, but… Patient friendly, long-term durability1, Invasive; risk of surgical complications Non-Invasive; risk of complications •
Slide 9: Embolization Following Carotid Artery Stenting
Embolization Following Carotid Artery Stenting Plaque protrusion through stent struts occurs in up to 65% of conventional carotid stents, depending on plaque morphology/symptomatic status and stent type. The consequence is cerebral embolization, either directly or via additional thrombus formation.
Slide 10: Consequences Range from Neurological Deficit to Stroke
Consequences Range from Neurological Deficit to Stroke Pre-Procedure Post-Procedure Post-intervention showing successful opening of the Pre-intervention showing 90% occlusion of the occluded carotid artery with conventional stenting and an carotid artery and an MRI showing an old white MRI showing m
Slide 11: A Billion Dollar Market Opportunity
A Billion Dollar Market Opportunity Carotid procedures today are Carotid procedures tomorrow could be primarily surgical mostly minimally invasive with CGuard™ • 2.2M diagnosed with carotid artery disease • 2017: ~600,000 patients with high grade carotid stenosis 20% of Market (HGCS) require interve
Slide 12: The InspireMD Solution: CGuard EPS
The InspireMD Solution: CGuard™ EPS Conventional Carotid Stent CGuard™ EPS • The MicroNetTM permanently covers plaque and stops “debris” from passing through the mesh. • Ultrathin PET mesh made of a single 20 micron fibre from a biocompatible polymer - widely used in other medical implants • MicroNe
Slide 13: The InspireMD Solution: CGuard EPS
The InspireMD Solution: CGuard™ EPS Conventional Carotid Stents 1 CGuard™ EPS2 No plaque coverage - leading to plaque protrusions or The MicroNetTM permanently covers plaque and prolapse passing into the vessel lumen prevents “debris” from passing through the mesh. Conventional Carotid Stent CGuard™
Slide 14: Positive CGuard EPS Clinical Experience
Positive CGuard™ EPS Clinical Experience CARENET Clinical Trial (2014) PARADIGM 101 Clinical Trial (2015, 2016, and 2018) 30 Patient Safety and Efficacy clinical trial 101 patient trial evaluating CGuard EPS in unselected, consecutive carotid patients (all-comers) Zero major adverse cardiac or cereb
Slide 15: Independent Clinical Validation
Independent Clinical Validation Independent study conducted in 30 patients with internal carotid artery disease Clinical results (2016) • 100% success in implanting the CGuardTM EPS • No peri- or post-procedural complications • No deaths, major adverse events, minor or major strokes, or new neurolog
Slide 16: Independent Clinical Validation (continued)
Independent Clinical Validation (continued) The Iron-Guard Registry • Physician initiated • 12 large Italian medical centers • 200 patients Clinical Results • 100% success in implanting the CGuard EPS • No major adverse cerebrovascular cardiac events at 30 days “The IRON-Guard Registry shows promisi
Slide 17: CGuard EPS vs Conventional Stents and Surgery
CGuard™ EPS vs Conventional Stents and Surgery 30 day MACCE results (Major and Minor Adverse Cardiac and Cerebral Events) • CGuardTM EPS has a superior profile 6.00% versus historical data on both conventional 5.20% (3) carotid stents and surgery 5.00% 4.50% (3) • CGuard™ is a next-generation stent
Slide 18: A Leading Vascular Surgeon's View
A Leading Vascular Surgeon’s View “The CGuard™, in comparison to other [carotid] stents, even in comparison to other mesh covered stents, is a very easy to use device. Very simple, you take it off the shelf and you use it and that’s it.” ” “Patient risks associated with stenting using CGuard™ are fa
Slide 19: CGuard EPS - Accelerating Sales Growth
CGuard™ EPS - Accelerating Sales Growth Growth continues to accelerate for 2018/2017 Year End Sales in USD Sept. YTD Sales in USD 2,500,000 2,500,000 2,268,345 2,000,000 1,922,000 2,000,000 72% Growth 68% Growth 1,500,000 1,500,000 1,315,000 1,147,000 1,000,000 1,000,000 500,000 500,000 0 0 Year End
Slide 20: Accelerating CGuard Sales Growth: Italy
Accelerating CGuard™ Sales Growth: Italy Italy CGuard sales in USD Italy Sept. YTD 2017 and 2018 CGuard sales in USD 600,000 556,000 600,000 53% Growth 500,000 511,000 500,000 21% Growth 423,000 400,000 59% Growth 365,000 400,000 300,000 300,000 229,000 200,000 200,000 100,000 100,000 0 0 Sept. YTD
Slide 21: Accelerating CGuard Sales Growth: Germany
Accelerating CGuard™ Sales Growth: Germany Sept. YTD in USD 700,000 602,000 600,000 156% Growth 500,000 New Distributor in Q2 2017 400,000 300,000 Growth Trend is 236,000 accelerating 200,000 100,000 0 Sept. YTD 2017 Sept. YTD 2018 January 2019 I 21
Slide 22: Accelerating CGuard Sales Growth: Poland
Accelerating CGuard™ Sales Growth: Poland Sept. YTD in USD 200,000 179,000 180,000 New Distributor in 160,000 184% Growth Q2 2017 140,000 New Growth Trendin is 120,000 Q2accelerating 2017 100,000 80,000 Growth Trend is 63,000 60,000 accelerating 40,000 20,000 0 Sept. YTD 2017 Sept. YTD 2018 January
Slide 23: Addressable Stroke Prevention Device Market
Addressable Stroke Prevention Device Market 13mn people 2.2mn people ~600,000 received Untapped market: At Plus roughly globally with high with HGS surgical/stent least 1.6mn patients 10mn people who grade carotid diagnosed treatment could be helped by are undiagnosed stenosis (HGS) CGuard EPS 2017:
Slide 24: Commercial Strategy
Commercial Strategy Transition Vascular Surgeons to CGuardTM Transition current users of conventional carotid stents Advisory boards, surgeon specific clinical registries, centers of to CGuardTM EPS excellence Communication of CGuard™ EPS clinical data Publish, present, and communicate data demonstr
Slide 25: CGuard EPS Product Development
CGuard™ EPS Product Development • Pre-IDE FDA submission for CGuard™ EPS February 2017 • Formal FDA meeting held April 2017 US FDA • 9 months of pre-clinical work required to file IDE application to begin a US clinical trial • CGuard continuous improvements (including COGs) Innovative Pipeline • 5F
Slide 26: Recent/Upcoming Anticipated Milestones
Recent/Upcoming Anticipated Milestones Continued clinical trial/registry results Establish Centers of CGuard approval in Excellence Approval in Australia Brazil H12018 H22018 H12019 MID2019 H22019 CGuard approval and CGuard U.S. IDE launch in Mexico submission Continued market execution and revenue
Slide 27: Intellectual Property Portfolio
Intellectual Property Portfolio PATENT RIGHTS ISSUED ALLOWED PENDING USA 12 1 7 Rest of World 36 2 22 Proprietary platform technology supported by a robust intellectual property portfolio Continue to strengthen and broaden patent protection globally to enable future pipeline products January 2019 I
Slide 28: Summary Financials
Summary Financials NYSE AMER NSPR Stock Price (1/4/19): $0.17 Average three month daily trading volume: 1.9 M Shares outstanding (12/31/18): 38.4 M Shares Outstanding Including full conversion of preferred shares and prefunded warrants 44.7 M (12/31/18): Market Capitalization including full conversi
Slide 29: Summary
Summary Focused on the deadly and catastrophic problem of stroke that is estimated to cost the healthcare system more than $34BB annually in the US alone The current addressable market for CGuard TM EPS is estimated to be $1BB with the potential to further expand into the 1.6MM patient population wh
Slide 30: James Barry, Ph.D., President and CEO; Craig Shore, CFO
James Barry, Ph.D., President and CEO Craig Shore, CFO 888.776.6804 888.776.6804 [email protected] [email protected]