InspireMD Inc. · NASDAQ:NSPR
InspireMD — Investor Presentation (September 2023)
33 slides from InspireMD's investor presentation, September 2023
Slide 1: Sustained Embolic Protection
Sustained Embolic Protection
Slide 2: Disclaimers
Disclaimers Forward Looking Statement 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. For
Slide 3: Investment Highlights: Transformational Market Drivers
Investment Highlights : Transformational Market Drivers CGuard EPS Stent Platform utilizing Proprietary Expanding Commercial Footprint MicroNet™ Technology Double-digit market share in 30 served countries (34% in Italy) Highly differentiated platform for treatment of carotid artery Over 40,000 stent
Slide 4: Transformational May 2023 Financing Up To $113.6 Million
Transformational May 2023 Financing Up To $113.6 Million To advance the company towards potential US approval and launch of CGuard EPS and other value-creating milestones • $42.2 million upfront funding • $71.4 million tied to the achievement of four milestones ($17.9 million each) each expiring upo
Slide 5: Endovascular Procedures: Landscape and InspireMD Potential
Endovascular Procedures: Landscape and InspireMD Potential CEREBRAL CORONARY THORACIC/ABDOMINAL PERIPHERAL CAROTID ARTERY ANEURYSMS ARTERY DISEASE AORTIC ANEURYSMS ARTERIAL DISEASE DISEASE5 AWAITING CONVERSION TO ENDO 30% Surgical1 23% Surgical2 35% Surgical3 19% Surgical4 Surgical Endo 77% Endo2 70
Slide 6: Approaches to Treating Carotid Artery Disease
Approaches to Treating Carotid Artery Disease 155,000 Procedures Annually Surgical Approach Carotid Artery Stenting (CAS) (20%) Carotid Endarterectomy (CEA) (70%) TCAR (10%) Conventional Approach (Bare Stent) Risk of complications: Risk of complications: Myocardial infarction risk1 (heart attack) Pr
Slide 7: The Problem: Risk of Embolism Following Conventional Carotid Stenting
THE PROBLEM: Risk of Embolism Following Conventional Carotid Stenting (1st Generation Stents) 2 Approximately 2/3 of neurovascular events (stroke, TIA) occur after the procedure takes place. Pre-Procedure Post-Procedure with Conventional Stent 90% occlusion of MRI of a pre-existing white Successful
Slide 8: Our Solution: Proprietary MicroNet Technology
OUR SOLUTION: Proprietary MicroNetTM Technology1 New mesh covered stent offers superior plaque coverage when compared to conventional stent approaches Protruding VS. plaque/thrombus MicroNetTM sealing plaque/ between struts thrombus against vessel wall Conventional Open Cell Stent (1St GEN): CGuard
Slide 9: Pore Sizes Diameters
Pore Sizes Diameters Area Comparison (mm2) CGUARD™ CASPER® *165µ 375µ 500µ 1050µ 1900µ Closed cell stent Open cell stent ACCULINK™ WallStent™ * Bench test results may not necessarily be indicative of clinical performance. Stent images approximately at scale but not exact * Average in lesion at expan
Slide 10: Our Solution: The CGuard EPS
PROBLEM: Approximately 2/3 of neurovascular events (stroke, TIA) occur after the carotid surgery procedure takes place2. How to preserve the flexibility of an open-celled stent while building in embolic protection? OUR SOLUTION: The CGuard EPS The only stent platform available with our patented Micr
Slide 11: wQAT1200/NE vod
se wQAT1200/NE vod Gojoayaoos 34)
Slide 12: A picture is worth a thousand words
A picture is worth a thousand words … 90% occlusion CGuard Stent 90% occlusion CGuard Stent Company and Products Overview 12
Slide 13: Potential Multi Billion Dollar Market Opportunity
Potential Multi Billion Dollar Market Opportunity MicroNetTM covered CGuardTM stent platform could become the new gold standard WW carotid procedures today are ◆ Current Treated Global Market: Carotid procedures tomorrow could be → $1.3 billion (1) primarily surgical mostly minimally invasive with C
Slide 14: Long-Term Stent Performance is the Cornerstone of Our Focus
Long-Term Stent Performance is the Cornerstone of Our Focus, Regardless of Delivery Platform CGuard EPS with its novel MicroNet mesh covering is a best-in-class implant that has demonstrated superior patient outcomes compared to both surgery and first-generation stents ✓ Well position to capitalized
Slide 15: Unmatched Superior Foundational Data
Unmatched Superior Foundational Data Company and Products Overview 15
Slide 16: CGuard EPS Yields Superior Clinical Outcomes
CGuard™ EPS Yields Superior Clinical Outcomes When compared with Conventional Stents and Surgery (CEA), CGuard trends Superior 30 Day DSM (Death, Stroke, Myocardial Infarction) • No stent related major stroke and 11 minor strokes to date with CGuard in 1,873 patients 6.00% (10) in 9 studies (0.6%) 5
Slide 17: Carotid Solution: Our Well Studied Mesh-Covered Technology
Carotid Solution: Our Well Studied Mesh-Covered Technology CLI NI CAL RESEARCH I N TER VEN TI ON S FOR H YPER TEN SI ON AN D STROK E EuroIntervention 2018;13:1714-1720 published online More than Thirty-day results from prospective multi-specialty evaluation of carotid artery stenting using the CGuar
Slide 18: Clinical Data Foundation: Evolution to Standard of Care
Clinical Data Foundation: Evolution to Standard of Care YEAR STUDY PUBLICATION HIGHLIGHTS CGUARD'S STANDING (known & anticipated) Journal 2015 CARENET Safety, Efficacy & Neuroprotection over other stents data JACC 2016 PARADIGM All comers population; Excellent clinical results ◎ CGuard evaluated as
Slide 19: Clinical Support Highlights
Clinical Support Highlights / Call out 2015-2022 PARADIGM + Extend CARENET Trial Randomized Control Trial Opened CARENET study First in Man Study- CGuard vs. Conventional inclusion criteria all Demonstrated Safety, Stent (Abbott Acculink) comers. Efficacy, & Concluded the safety and CGuard superiori
Slide 20: CARMEN Meta-Analysis (112 Studies, 68K Patients)
(1) CARMEN Meta-Analysis (112 Studies, 68K Patients) ▪ Improvements from second-generation stents (SGS) relative to first-generation stents (FGS), but important differences exist amongst the SGS: ▪ CGuard’s MicroNet drives improvement both in event reduction (due to improved scaffolding) and resteno
Slide 21: US Regulatory Pathway
US Regulatory Pathway Company and Products Overview 21
Slide 22: PMA Trial Design
PMA Trial Design FDA Trial Performance Goal – 11.6% vs European Clinical Trials’ Mean Performance 1.32% (w/ 1 Yr) • Pivotal study objective evaluate the safety and efficacy of the CGuard™ Carotid Stent System in the treatment of carotid artery stenosis • Intent to Treat Protocol • Primary Endpoint:
Slide 23: TCAR
TCAR Company and Products Overview 23
Slide 24: TCAR Procedure: Reverse Flow
TCAR Procedure: Reverse Flow Contrast port (1) Guidewire Clamping (ligation) 80CM Aspiration port Stent pull back device ▪ CGuard evidence suggests plaque sealing improving TCAR outcomes in symptomatic patients (1) SwitchGuard NPS serves Trans carotid (TCAR) Opportunity with Best-in-Class CGuard Imp
Slide 25: Roadmap + Milestones
Roadmap + Milestones Company and Products Overview 25
Slide 26: Our Advancement Roadmap / Milestones
Our Advancement Roadmap / Milestones Our Expected Key Value Drivers and Strategic Pathways • FDA PMA Approval • FDA PMA Submission • SwitchGuard (TCAR) Launch (U.S. + EU) ✓ USA Trial Enrollment Complete • Acute Stroke (NGuard) Pivotal • U.S. Commercial Launch • Inclusion of CGuard Prime • China Regu
Slide 27: Corporate
Corporate Company and Products Overview 27
Slide 28: Our Board of Directors
Our Board of Directors Mr. Slosman has over 30 years of experience in the medical device industry with focused leadership in commercialization and Marvin L. Slosman international market development in both public and privately held companies. He has had senior management roles President and CEO in a
Slide 29: Scientific Advisory Board
Scientific Advisory Board (Multidisciplinary KOLs) Kenneth Rosenfield, M.D. Adnan H. Siddiqui, M.D. Ph.D Chris Metzger , M.D. Sean Lyden, M.D. Interventional Professor, Vice Chairman of the Medical Director Vascular Surgeon Department of Neurosurgery Cardiologist Cardiologist Company and Products Ov
Slide 30: Commercial Footprint
• Active selling in more than 30 countries Commercial Footprint • Over 40,000 systems sold • Average CAS Market share of 25% Signed agreement with Chinese distributor. Working toward distribution U.S. Market Investigation Device Exemption (IDE) approval September 2020; Exploring expansion US trial i
Slide 31: Our Robust Intellectual Property Portfolio
Our Robust Intellectual Property Portfolio Proprietary platform technology supported by IP Patent Rights Issued Pending USA 16 6 Rest of World 42 11 InspireMD will continue to strengthen and broaden its patent protection globally to enable future pipeline products IP Counsel: Kligler and Associates,
Slide 32: Summary Financials
Summary Financials August 7, 2023 NASDAQ Capital Markets NSPR Stock Price $3.10 Average 3 Month Volume 136.3K Shares Outstanding 21.1M Shares Outstanding with Prefunded Warrants 36.8M Market Capitalization with Prefunded Warrants $113.9M Cash Balance - June 30, 2023* $47.0M Debt $0M * Includes ~$37.
Slide 33: NASDAQ = NSPR
INSPIREM9 NASDAQ = NSPR