InspireMD Inc. · NASDAQ:NSPR
InspireMD — Investor Presentation (May 2023)
29 slides from InspireMD's investor presentation, May 23, 2023
Slide 1: Sustained Embolic Protection
Sustained Embolic Protection Investor Presentation I May 2023
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: 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 30% Surgical1 23% Surgical2 35% Surgical3 19% Surgical4 Surgical Endo 77% Endo2 70% Endo1 35% 65% Endo3 81% En
Slide 5: 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) 1st generation Risk of complications: Risk of complications: Myocardial infarction risk1 (h
Slide 6: 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 7: 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 8: Scaffolding - Stent Cell Diameters
Scaffolding- Stent Cell Diameters Area Comparison (mm2) CGUARD™ Competitor A *165µ 375µ 500µ 1050µ 1900µ Closed cell stent Open cell stent Competitor B Competitor C * Bench test results may not necessarily be indicative of clinical performance. Stent images approximately at scale but not exact * Ave
Slide 9: 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 9
Slide 10: 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 primarily surgical → $1.3 billion (1) mostly minimally invasive with C
Slide 11: Unmatched Foundational Data
Unmatched Foundational Data Company and Products Overview 11
Slide 12: 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 strokes and 11 minor strokes to date with CGuard in 1,873 patients 6.00% (10) in 9 studies (0.6%)
Slide 13: 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 14: 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 15: Clinical Support Highlights / Call out
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 16: CARMEN Meta-Analysis (112 Studies, 68K Patients)
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: ▪ Roadsaver limits 30-day events but shows restenosis similar to FGS ▪ Gore performs similarly to FGS ▪ CGua
Slide 17: US IDE Trial
US IDE Trial Company and Products Overview 17
Slide 18: PMA Trial Design
PMA Trial Design FDA Trial Performance Goal – 11.6% vs European Clinical Trials’ 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: Sympt
Slide 19: Roadmap + Milestones
Roadmap + Milestones Company and Products Overview 19
Slide 20: 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 21: TCAR
TCAR Company and Products Overview 21
Slide 22: TCAR Procedure: Reverse Flow
TCAR Procedure : Reverse Flow Contrast port Guidewire Clamping (ligation) 80CM Aspiration port Stent pull back device Reverse flow through surgical CCA clamping and use of CGuard Prime +SwitchGuard 22
Slide 23: Corporate
Corporate Company and Products Overview 23
Slide 24: 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 25: Scientific Advisory Board (Multidisciplinary KOLs)
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 26: Commercial CGuard Footprint
• Active selling CGuard in more than 30 countries Commercial CGuard Footprint • Over 40K stents sold to date Signed agreement with Chinese distributor. Working toward distribution U.S. Market Investigation Device Exemption (IDE) approval September 2020; Exploring expansion US trial initiated Q3 2021
Slide 27: 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 28: Summary Financials
Summary Financials May 22, 2023 NASDAQ Capital Markets NSPR Stock Price $1.90 Average 3 Month Volume 83.5K Shares Outstanding 18.6M Shares Outstanding with Prefunded Warrants 34.2M Market Capitalization with Prefunded Warrants $65M Cash Balance - March 31, 2023* $12.9M Debt $0M * Post financing May
Slide 29: NASDAQ = NSPR
INSPIREMO NASDAQ = NSPR