Inspiremd Inc. · NASDAQ:NSPR
Inspiremd — Investor Presentation (June 2024)
32 slides from Inspiremd's investor presentation, Jun 24, 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-f
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: 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 billi
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 approach (TCAR vs. CAS) Tandem Stroke Company an
Slide 7: Problem and 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 8: 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 9: Stent Cell Sizes
Stent Cell Sizes Area Comparison (mm2) CGuard RoadSaverTM *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 10: A Picture is Worth a Thousand Words
A Picture is Worth a Thousand Words… VS Surgical Endarterectomy 90% occlusion CGuard Stent Stenting Company and Products Overview 10
Slide 11: Unmatched Foundational Data and Evidence
Unmatched Foundational Data and Evidence Company and Products Overview 11
Slide 12: PMA Trial Design (C-GUARDIANS)
PMA Trial Design (C-GUARDIANS) Prospective, multicenter international single-arm clinical trial • Pivotal study objective: to evaluate the safety and efficacy of the CGuard Carotid Stent System in the treatment of carotid artery stenosis • Primary Endpoint: Composite of DSMI through 30 days or ipsil
Slide 13: C-GUARDIANS: 30-Day Safety Outcomes
C-GUARDIANS: 30-Day Safety Outcomes 30-Day Death/Stroke/MI (DSMI) rates, compared to other carotid trials CGUARDIANS 30-day outcomes 30-day DSMI (multiple FDA trials) Intention Per 8.30% to Treat Protocol1,2 30-day DSMI 0.95% (3) 0.63% (2) 5.80% 5.80% 5.40% 5.10% 4.80% Death 0.32% (1) 0.0% (0) 3.50%
Slide 14: C-GUARDIANS: 1-Year Safety and Effectiveness Outcomes
C-GUARDIANS: 1-Year Safety and Effectiveness Outcomes Composite event rate of 30-Day Death/Stroke/MI (DSMI) or Ipsilateral stroke between days 31-365 CGUARDIANS 1-Year outcomes 30-day DSMI or Ipsilateral Stroke to 1-Year Intention to Treat Per Protocol1,2 12.20% Primary Endpoint: 30-day Death, Strok
Slide 15: Safety Comparison: InspireMD vs. Silk Road vs. Contego Medical
Safety Comparison: InspireMD vs. Silk Road vs. Contego Medical 30-day Major Adverse Events (DSMI) with independent adjudication. C-GUARDIANS U.S. Pivotal Trial ROADSTER U.S. Pivotal Trial PERFORMANCE II U.S. Pivotal Trial Intent to Treat (n=316) Intent to Treat (n=141) Intent to Treat (n=305) Death,
Slide 16: CARMEN Meta-Analysis (112 Studies, 68K Patients)
CARMEN Meta-Analysis (112 Studies, 68K Patients)1 30-day and 12-month event rates by stent type (random-effect model) Terumo Gore Event FGS SGS RoadSaver/ ▪ Improvements from second- Casper (not marketed) CGuard generation stents (SGS) 30-day Stroke [%] relative to first-generation (95% CI) 3.01 (2.
Slide 17: Randomized DW-MRI Study Comparing CGuard and Acculink
Randomized DW-MRI Study Comparing CGuard and Acculink Demonstrates the Neuroprotective Effect of MicroNet DW-MRI number of cerebral lesions: 45 with CGuard vs 82 with Acculink (p= 0.03) DW-MRI total volume of cerebral lesions: 18,212 mm3 with CGuard vs 3,930 mm3 with Acculink Filters with Macroscopi
Slide 18: TCAR
TCAR Company and Products Overview 18
Slide 19: 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 20: SwitchGuard NPS (TCAR) Market Opportunity
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 CGUARDIANS II TCAR trial anticipated to commence H2 2024; Potential clearance in H1 2026 1 SILK
Slide 21: The Promise of TCAR with CGuard
The Promise of TCAR with CGuard DW MRI study of recently symptomatic patients- Professor Nacho Leal at LINC 2024 • “Transcarotid Flow Reversal and MicroNET Covered Stent for Carotid Revascularization in Recently Symptomatic Patients: A DW MRI-Based Prospective Evaluation” • 15 recently-symptomatic (
Slide 22: Corporate
Corporate Company and Products Overview 22
Slide 23: 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 24: 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 25: Executive Leadership Team
Executive Leadership Team Deep industry experience and subject matter expertise Marvin Slosman Shane Gleason Craig Shore Andrea Tommosoli Chief Executive Officer Chief Commercial Officer Chief Financial Officer Chief Operating Officer • 30+ years medical device • 20+ years cardiovascular • 25+ years
Slide 26: Executive Leadership Team (continued)
Executive Leadership Team (continued) Deep industry experience and subject matter expertise Peter Ligotti Dr Patrick Verta Amir Kohen Cheryl Tal EVP and General Manager EVP Clinical & Medical Affairs SVP Finance & HR VP Quality & Regulatory Affairs • 30+ years medical device • 25+ years medical devi
Slide 27: 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 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: 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 30: 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 31: Summary Financials
Summary Financials June 11, 2024 NASDAQ Capital Markets NSPR Stock Price $2.68 Average 3 Month Volume 34.9K Shares Outstanding 25.1M Shares Outstanding with Prefunded Warrants 38.9M Market Capitalization with Prefunded Warrants $104.2M Cash Balance - March 31, 2024 $34.0M Debt $0M Company and Produc
Slide 32: Nasdaq: NSPR
NASDAQ Nasdaq: =NSPR NSPR