InspireMD Inc. · NASDAQ:NSPR
InspireMD — Investor Presentation (April 2024)
31 slides from InspireMD's investor presentation, April 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: Poised to Transform the Carotid Intervention Market
Investment Highlights : Poised to Transform the Carotid Intervention Market CMS Coverage Expanded to Include Standard Risk and CGuard EPS Stent Platform Utilizing Proprietary Asymptomatic Reimbursement MicroNet™ Technology Highly differentiated platform for treatment of carotid artery Enables stent-
Slide 4: Cardiovascular Procedures: The Endovascular Revolution is Nearly Complete
Cardiovascular Procedures: The Endovascular Revolution is Nearly Complete 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 En
Slide 5: CMS Final National Coverage Determination, October 11, 2023
CMS Final National Coverage Determination, October 11, 2023 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 individuals pre
Slide 6: Potential Multi-Billion Dollar Market Opportunity
Potential Multi-Billion Dollar Market Opportunity MicroNetTM covered CGuardTM stent platform could become the new gold standard Carotid procedures today are Carotid procedures tomorrow could be ◆ Current Treated (1) Global Market: primarily surgical mostly minimally invasive with CGuard™ → $1.3 bill
Slide 7: 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 approach (TCAR vs. CAS) Tandem Stroke Company an
Slide 8: Problem: Neurovascular Events After Carotid Procedure; 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 9: Our Solution: CGuard Stent with Proprietary MicroNet Technology
OUR SOLUTION: CGuardTM Stent with Proprietary MicroNetTM Technology1 Mesh-covered stent offers superior plaque coverage when compared to conventional stents Protruding VS. plaque/thrombus MicroNetTM sealing plaque/ between struts thrombus against vessel wall Conventional Open Cell Stent (1St GEN): C
Slide 10: Stent Cell Sizes
Stent Cell 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
Slide 11: 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 11
Slide 12: Unmatched Foundational Data
Unmatched Foundational Data Company and Products Overview 12
Slide 13: 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 14: Well-Established Evidence in the Peer Reviewed Literature
Well-Established Evidence in the Peer Reviewed Literature 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 CGuard
Slide 15: Clinical Evidence Highlights
Clinical Evidence 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 Neur
Slide 16: Comparative Clinical Evidence: CARMEN Meta-Analysis
Comparative Clinical Evidence: CARMEN Meta-Analysis ▪ Meta-analysis of 112 studies, 68K+ CAS patients (all devices) ▪ Improvements from second- generation stents (SGS) relative to first-generation stents (FGS), but important differences exist amongst the SGS ▪ CGuard’s MicroNet drives improvement in
Slide 17: US Regulatory Pathway
US Regulatory Pathway Company and Products Overview 17
Slide 18: PMA Trial Design (C-GUARDIANS)
PMA Trial Design (C-GUARDIANS) FDA Trial Performance Goal – 11.6% (vs European Clinical Trials’ Mean Performance 1.32% @ 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 • Prima
Slide 19: C-GUARDIANS: 30-Day Major Adverse Events
C-GUARDIANS: 30-Day Major Adverse Events Results presented at VEITH - 2023 Event rate in % (n) ITT (N=316) Per Protocol^ Death, Stroke or MI* 0.95% (3) 0.63% (2) Death# 0.32% (1) 0.00% (0) Any stroke# 0.95% (3) 0.63% (2) Major Stroke# 0.32% (1) 0.00% (0) Minor Stroke# 0.63% (2) 0.63% (2) MI# 0.00% (
Slide 20: TCAR
TCAR Company and Products Overview 20
Slide 21: Transcarotid Arterial Revascularization (TCAR): Direct Carotid Access with Reverse Flow
Transcarotid Arterial Revascularization (TCAR): Direct Carotid Access with Reverse Flow InspireMD combines SwitchGuard NPS with Best-in-Class CGuard Implant 1. Transient flow reversal combined with sustained embolic prevention in transcervical revascularization of symptomatic and highly-emboligenic
Slide 22: SwitchGuard NPS (TCAR)
SwitchGuard NPS (TCAR) TCAR Market Opportunity 80CM >2,800 TCAR-trained physicians in the U.S.1 >25,000 TCAR procedures ($177M) performed in the U.S. in 2023, double- digit growth projected1,2 InspireMD’s C-GUARDIANS II TCAR trial anticipated to commence H2 2024; Potential clearance in H1 2026 1 SIL
Slide 23: Corporate
Corporate Company and Products Overview 23
Slide 24: Roadmap / Milestones
Roadmap / Milestones Key Value Drivers • SwitchGuard NPS Approval + Launch • FDA PMA Submission (Module II, III and IV) • CGuard Prime PMA Approval for CAS • Scale US Operations • Initiation of CGUARDIANS II (TCAR) study and TCAR • Approval China • Acute Stroke EFS- Tandem Lesions • U.S. Commercial
Slide 25: Commercial Footprint
• Active selling in more than 30 countries Commercial Footprint • Over 50,000 systems sold • Average CAS Market share of 25% Signed agreement with Chinese distributor. Working toward distribution Investigational Device Exemption (IDE) trial enrollment completed Q2 Exploring expansion 2023; potential
Slide 26: 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 27: Robust Intellectual Property Portfolio
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, P.A
Slide 28: Board of Directors
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 var
Slide 29: 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 30: Summary Financials
Summary Financials March 19, 2024 NASDAQ Capital Markets NSPR Stock Price $2.31 Average 3 Month Volume 29.0K Shares Outstanding 23.4M Shares Outstanding with Prefunded Warrants 38.7M Market Capitalization with Prefunded Warrants $89.3M Cash Balance - Dec. 31, 2023 $39.0M Debt $0M Company and Product
Slide 31: Nasdaq: NSPR
NASDAQ Nasdaq: =NSPR NSPR