InspireMD Inc. · NASDAQ:NSPR
InspireMD — Investor Presentation (February 2024)
33 slides from InspireMD's investor presentation, February 2024
Slide 1: CGuard EPS Carotid Stent Platform for Sustained Embolic Protection
CGuard EPS Carotid Stent Platform for Sustained Embolic Protection Nasdaq: NSPR
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 48,000 stent
Slide 4: CMS Final National Coverage Determination, October 11, 2023
CMS Final National Coverage Determination, October 11, 2023 In summary, this final decision memorandum, which affects NCD 20.7 sections B4 and D, revises Medicare coverage for Percutaneous Transluminal Angioplasty (PTA) of the carotid arteries concurrent with stenting by: 1 Expanding coverage to ind
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: Long-Term Stent Performance is the Cornerstone of Our Focus
Long-Term Stent Performance is the Cornerstone of Our Focus Delivery Platform Agnostic CGuard EPS ✓ Well positioned to capitalize on the ongoing paradigm shift toward a “stent first” approach and away from surgery CAS ✓ Agnostic to stent TCAR delivery platform (TCAR vs. CAS) Tandem Stroke Company an
Slide 7: 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 Carotid procedures tomorrow could be ◆ Current Treated (1) Global Market: primarily surgical mostly minimally invasive with CGuard™ → $1.3 b
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
Pore Sizes 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 expanded state
Slide 10: Problem and 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: Unmatched Superior Foundational Data
Unmatched Superior Foundational Data Company and Products Overview 13
Slide 14: 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 DSMI (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%)
Slide 15: 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 16: Clinical Support Highlights
Clinical Support Highlights 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 superiority in Neuro
Slide 17: 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: ▪ CGuard’s MicroNet drives improvement both in event reduction (due to improved scaffolding) and restenosis
Slide 18: US Regulatory Pathway
US Regulatory Pathway Company and Products Overview 18
Slide 19: PMA Trial Design (CGuardians I)
PMA Trial Design (CGuardians I) 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 • Pri
Slide 20: CGuardians I: 30-day Major Adverse Events
CGuardians I: 30-day Major Adverse Events Results presented at VIVA23 Event rate in % (n) ITT (N=316) Per Protocol^ Death, Stroke or MI* 0.95% (3) 0.63% (2) Death# 0.32% (1) 0.% (0) Any stroke# 0.95% (3) 0.63% (2) Major Stroke# 0.63% (2) 0.32% (1) Minor Stroke# 0.32% (1) 0.32% (1) MI# 0.0% (0) 0.0%
Slide 21: TCAR
TCAR Company and Products Overview 21
Slide 22: TCAR Procedure: Reverse Flow
TCAR Procedure: Reverse Flow Contrast port (1) Guidewire Clamping (ligation) 80CM Aspiration port Stent pull back device (1) SwitchGuard NPS serves Trans carotid (TCAR) Opportunity with Best-in-Class CGuard Implant 1. Transient flow reversal combined with sustained embolic prevention in transcervica
Slide 23: SwitchGuard NPS (TCAR)
SwitchGuard NPS (TCAR) TCAR Market Opportunity 80CM >2,600 TCAR-trained physicians in the U.S.1 >24,000 TCAR procedures ($170M) projected in the U.S. in 2023, strong double-digit growth projected1,2 InspireMD’s C-GUARDIANS II TCAR trial anticipated to commence mid-2024; Potential clearance in H2 202
Slide 24: Roadmap + Milestones
Roadmap + Milestones Company and Products Overview 24
Slide 25: Our Advancement Roadmap / Milestones
Our Advancement Roadmap / Milestones Our Expected Key Value Drivers and Strategic Pathways • FDA PMA Submission (Modules II, III and IV) • FDA PMA Approval of CGuard Prime ✓ USA Trial Enrollment Complete • Initiation of C-GUARDIANS II (TCAR) study • FDA 510K Clearance of SwitchGuard NPS Kit • Inclus
Slide 26: Corporate
Corporate Company and Products Overview 26
Slide 27: 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 28: 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 29: Commercial Footprint
• Active selling in more than 30 countries Commercial Footprint • Over 45,000 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 30: Our Robust Intellectual Property Portfolio
Our Robust Intellectual Property Portfolio Proprietary platform technology supported by IP Patent Rights Issued Pending USA 19 6 Rest of World 40 17 InspireMD will continue to strengthen and broaden its patent protection globally to enable future pipeline products IP Counsel: Kligler and Associates,
Slide 31: 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 32: Summary Financials
Summary Financials February 9, 2024 NASDAQ Capital Markets NSPR Stock Price $2.75 Average 3 Month Volume 36.8K Shares Outstanding 23.5M Shares Outstanding with Prefunded Warrants 38.7M Market Capitalization with Prefunded Warrants $106.4M Cash Balance - Sept. 30, 2023 $43.0M Debt $0M Company and Pro
Slide 33: NASDAQ Nasdaq: = NSPR NSPR
NASDAQ Nasdaq: =NSPR NSPR