Inspiremd Inc. · NASDAQ:NSPR
Inspiremd — VIVA23 (November 2023)
21 slides from Inspiremd's conference presentation, Nov 1, 2023
Slide 1: 30-Day Results of the C-GUARDIANS Pivotal Trial of the CGuard Carotid Stent System
30-Day Results of the | GUARDIANS Pivotal Trial of the C-Guard Carotid Stent System The‘@.GUARDIANS Trial D. Christopher Metzger, MD — OhioHealth Riverside Methodist Hospital Columbus, Ohio, USA On Behalf of the C-GUARDIANS Investigators YOVAOG
Slide 2: Disclosure Statement of Financial Interest
Disclosure Statement of Financial Interest Symposia Honoraria & Proctor Fees: « Abbott, Endologix Symposia Honoraria: ¢ Boston Scientific, Medtronic, Penumbra, Shockwave VIVA Board Member National PI/Co-PI: * C-GUARDIANS, CONFIDENCE, SAPPHIRE WW, CANOPY, PERFORMANCE 3 Stock Options: INSPIREMD Resear
Slide 3: Background
Background ¢ Goal is carotid artery stenting (CAS) performed at /ow risk of peri-procedural stroke « More recent CAS trials have shown significant improvement in results, with 30-day stroke and death rates of ~2-3.5%* * US : CMS requires use of embolic protection devices, which decrease but do not c
Slide 4: POST-CAS Strokes: Advantage for a Micro-Mesh Stent Design?
POST-CAS Strokes: Advantage for a Micro-Mesh Stent Design? Approximately 2/3 of Events Occur AFTER the CAS Procedure 40-80% of CAS embolic events aré Bost procedural D. Christopher Metzger, MD
Slide 5: Stroke Prevention Strategy: MicroNet Technology
Stroke Prevention Strategy: MicroNet Technology Microtet™ sealing plaqueh plaqueftf@mous. thrombus against vessel wal peigpetveen struts row CGuard Stent System (3" GEN): Conventional Open Cell Stent (1St GEN): Stents are covered in MicroNet Bare or dual layer approach, with plaque protrusion risk A
Slide 6: "Pore Size" Comparisons of Carotid Stents
“Pore Size” Comparisons of Carotid Stents Area Comparison (mm?) Open Cell D. Christopher Metzger, MD
Slide 7: Theoretic Advantages of CGuard Stent
Theoretic Advantages of CGuard Stent ¢ Maximized conformability suitable for more carotid anatomies (“open —cell’ stent with proprietary “Smart Fit” auto-taper technology) * Coupled with maximized scaffolding and plaque coverage with smallest pore size and free cell area of available carotid stents
Slide 8: 9x30 mm
—_—__———> 9x30 mm d = D. Christopher Metzger, MD
Slide 9: C-GUARDIANS US Pivotal IDE Trial
C-GUARDIANS US Pivotal IDE Trial Disclaimers: ¢ CE Mark Approved Europe 2015 * INVESTIGATIONAL Only in US «In C-GUARDIANS IDE Trial (enrollment completed), and allowed as part of ongoing CREST 2 trial « Results presented today are 30- day results, although the. primary endpoint for thé trial is a 1-
Slide 10: Slide 10
Slide 11: Other Key Study Personnel
Other Key Study Personnel bemoan = PD DAR®
Slide 12: Investigative sites in the US and Europe
25 investigative sites in the US and Europe + Ascension Seton Heart (UT Austin) + Asklepios Hospital St Georg + Avera Heart Hospital (NC Heart) * Ballad Wellmont Holston Valley + Baylor Plano + Brookwood Baptist * Cleveland Clinic + Columbia Medical Center + Imland Klinik Rendsburg + John Paul II Ho
Slide 13: Study Patients
Study Patients « Patients < 80 years of age at high risk for carotid endarterectomy « Asymptomatic = 80%, symptomatic = 50% stenosis ¢ Pre-specified 25% of population symptomatic per FDA * All patients had pre-CAS carotid duplex and CTA/MRA ¢ All patients were approved by screening committee (2 appr
Slide 14: Study Visits and Evaluations
Study Visits and Evaluations > entre Ww 7 66002
Slide 15: Patient Demographics
Age (mean + SD) % Symptomatic % Male Diabetes Mellitus Hypertension Dyslipidemia CAD COPD Current Smoker PVD D. Christopher Metzger, MD Patient Demographics
Slide 16: Embolic Protection Utilized
Embolic Protection Utilized MoMA Proximal embolic protection Both (Nav6 and MoMa) 24 None D. Christopher Metzger, MD
Slide 17: C-GUARDIANS 30-day Results
C-GUARDIANS 30-day Results Cc > a= * Hierarchical: patient count (each patient first occurrence of the most serious event). # Non-hierarchical: event count (multiple events in each patient are counted individually). 2 Gaciigmner Mise MA) \ SS" " A VOV2®®
Slide 18: C-Guardians: 30-day Major Adverse Events
C-Guardians: 30-day Major Adverse Events The CEC independently adjudicated all neurological, cardiac events: ¢1 major fatal stroke on post procedural day 10 after all DAPT stopped contrary to per protocol requirements. ¢ 1 major stroke. (NIHSS 2, post procedure). NIHSS 1, CDU patent 30 days, NIHSS 0
Slide 19: C-Guardians: 30-day Major Adverse Events
C-Guardians: 30-day Major Adverse Events Event rate in % (n) ITT (N=316) Per Protocol” Death, Stroke or MI” Death* 0.32% (1) Any stroke* 0.95% (3) 0.63% (2) Major Stroke* 0.63% (2) 0.32% Minor Stroke* 0.32% (1) 0.32% (1) Mit 0.0% (0 0.0% Death or any stroke” Som Gare Death or major stroke” 0.63% (2)
Slide 20: Conclusions
Conclusions « In the C-GUARDIANS IDE Pivotal trial of patients at high risk for carotid endarterectomy with obstructive carotid disease (25% symptomatic), treatment with carotid artery stenting with the CGuard carotid stent system with embolic protection had a low incidence of stroke, death, or MI p
Slide 21: Thank You for Your Attention!
Thank You for Your Attention! D. Christopher Metzger, MD