InspireMD Inc. · NASDAQ:NSPR
InspireMD — Non-Deal Roadshow (November 2019)
25 slides from InspireMD's roadshow presentation, November 2019
Slide 1: InspireMD
InspireMD James Barry, Ph.D. President and CEO I November 2019 1
Slide 2: Disclaimers
Disclaimers 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 ar
Slide 3: About InspireMD
About InspireMD InspireMD is a commercial-stage medical device company focused on stroke prevention for patients with carotid artery disease and other vascular diseases utilizing an integrated embolic protection technology COMPANY TECHNOLOGY PRODUCTS NYSE AMER: NSPR Proprietary MicroNet™ Commercial:
Slide 4: Company Highlights
Company Highlights Enabling a paradigm shift (CAS) in the treatment of carotid artery disease and stroke prevention CGuard™ EPS Breakthrough platform: Highly differentiated, with strong support from leading clinicians MicroNetTM technology that is elegantly simple, propriety and easily leveraged to
Slide 5: 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 • 6.2 million deaths1 Top 10 Causes of Death Globally, 20166 • 5 million people left permanently disabled3 18 16 • $34 billion associated with stroke management in 14 the US alone2 12 • ~ 85% of a
Slide 6: 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 7: Current Treatments for Carotid Artery Disease
Current Treatments for Carotid Artery Disease Surgery (Carotid Endardarectomy) (CEA) vs. Conventional Carotid Stents (CAS) 1CREST Trial: N Engl J Med 2010;363:11-23 September 2019 7
Slide 8: 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 9: 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 10: 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 11: 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 12: 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 13: Positive CGuard EPS Clinical Experience
Positive CGuard™ EPS Clinical Experience PARADIGM 101 and PARADIGM Extend Clinical Trials (2015, CARENET Clinical Trial (2014) 2016, 2018, and 2019) 30 Patient Safety and Efficacy clinical trial 402 patients, 436 devices ongoing registry evaluating CGuard EPS in unselected, consecutive carotid patie
Slide 14: Analysis of Published Carotid Stent Trial Data
Analysis of Published Carotid Stent Trial Data Musialek – Presentation at the 2019 Joint Congress of the World Heart Federation and the European Society of Cardiology, Paris FR November 2019 I 14
Slide 15: Analysis of Published Next Generation Carotid Device Trial Data
Analysis of Published Next Generation Carotid Device Trial Data* ** *Musialek – Presentation at the 2019 Joint Congress of the World Heart Federation and the European Society of Cardiology, Paris FR November 2019 I 15 **Stabile et. al. 1-year results, J. Cardio. Surg. (submitted)
Slide 16: 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) 6.00% • CGuardTM EPS has a superior profile 5.20% (3) versus historical data on both conventional 5.00% 4.50% (3) carotid stents and surgery 4.00% • CGuard™ is a next-generation
Slide 17: 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 18: Commercial Strategy
Commercial Strategy Transition Vascular Surgeons to CGuardTM Transition current users of carotid stents to CGuardTM EPS Advisory boards, surgeon specific clinical registries, centers of excellence Continued communication of CGuard™ EPS clinical data Publish, present, and communicate data demonstrati
Slide 19: CGuard EPS Product Development
CGuard™ EPS Product Development • IDE FDA submission for CGuard™ EPS July 2019 • Additional request from FDA for information in support of application August 2019 US FDA • Working closely with FDA to resolve additional requests for information • Critical step in commencing human trial in the USA • C
Slide 20: 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 21: Intellectual Property Portfolio
Intellectual Property Portfolio PATENT RIGHTS ISSUED ALLOWED PENDING USA 13 2 6 Rest of World 47 0 19 Proprietary platform technology supported by a robust intellectual property portfolio Continue to strengthen and broaden patent protection globally to enable future pipeline products November 2019 I
Slide 22: 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 November 2019 I 22
Slide 23: Summary Financials
Summary Financials NYSE AMERICAN NSPR Stock Price (10/31/19): $1.13 Average last month daily trading volume: 242 K Shares outstanding (10/31/19): 3.6 M Shares outstanding including full conversion of preferred shares and prefunded warrants 4.9 M (10/31/19): Market capitalization including full conve
Slide 24: 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 25: InspireMD
inspireMD