InspireMD : May 2026 Investor Deck

Published: 2026-05-04 19:37:06 ET NSPR

Published on 05/04/2026 at 07:37 pm EDT

May 2026

Dedicated to advancing the prevention of stroke and treatment of carotid artery disease

MicroNet Mesh-Covered Protection

SmartFit Technology

Deep industry experience and subject matter expertise

Marvin Slosman

Chief Executive Officer

30+ years of medical device

experience, NSPR since 2019

Previous CEO/President of ITAMAR Medical, Ovalum Vascular, Phormax Medical

Prior experience at JNJ, GE Healthcare and Baxter

BS from University of Alabama, MBA from University of Chicago

Shane Gleason

Chief Commercial Officer

20+ years of cardiovascular medical

device experience, NSPR since 2023

Previous CCO of Nuvaira; VP Sales of TriVascular, Cordis and Surmodics

Prior experience at Abbott and Edwards Lifesciences

BS in Engineering Science and Mechanics from Virginia Tech, MBA from University of Maryland

Mike Lawless

Chief Financial Officer

20+ years of financial management, NSPR since 2025

Prior CFO of Lifeward Ltd. and Brooks Life Sciences

Previous leadership experience at Brooks Automation, PerkinElmer, MFS Investment Management

BA in Economics from Swarthmore College, MBA from Tuck School of Business at Dartmouth College

CAROTID ARTERY DISEASE

MicroNetTM covered CGuard® stent platform could become the new gold standard

CEREBRAL ANEURYSMS

CORONARY ARTERY DISEASE

THORACIC/ABDOMINAL AORTIC ANEURYSMS

PERIPHERAL ARTERIAL DISEASE

70% Endo1 77% Endo2 65% Endo3 81% Endo4

45%Endo

>12% CAGR5

70% Endo

Oth 3

2025 2030

Already have been converted to endovascular-first procedures

Converting to endo

1 Bekelis K, Gottlieb DJ, Su Y, et al. Comparison of clipping and coiling in elderly patients with unruptured cerebral aneurysms. J Neurosurg. 2017;126(3):811-818

2 Culler SD, Kugelmass AD, Brown PP, , et al. Trends in Coronary Revascularization Procedures Among Medicare Beneficiaries Between 2008 and 2012. Circulation. 2015;131(4):362-70

3 Beck AW, Sedrakyan A, Mao J, et al. Variations in Abdominal Aortic Aneurysm Care: A Report From the International Consortium of Vascular Registries. Circulation. 2016;134(24):1948-1958

4 Guez, D., Hansberry, D. R., Gonsalves, C. F., Eschelman, D. J., Parker, L., Rao, V. M., & Levin, D. C. Recent Trends in Endovascular and Surgical Treatment of Peripheral Arterial Disease in the Medicare Population. AJR Am J

Roentgenol. 2020 May;214(5):962-966. 5

5. Based on claims data, AcuityMD

CAS/TCAR continues to gain over CEA

US Market Size

30,000

CEA CAS/TCAR

$207

$113

$150

$207

$277

$460

$296

$836M1

$987M

25,000

20,000

15,000

10,000

TCAR coverage

CAS coverage expansion

CREST-2

publication

5,000

expansion

2 3

2022

2023

2024

2025

2026

2027

DRG/CPT data by Facility and HCP

~151K annual carotid intervention claims

Accounts for ~90% of procedures (does not include Kaiser, Gov't/DoD)

12% stent (CAS + TCAR) CAGR over prior three years, modeled to increase to 13% post CREST-2

2025 2030

Stenting Procedure Mix: 50% CAS / 50% TCAR

Based on claims data, AcuityMD

Only ~10-15% of diagnosed patients treated annually

~160,000

35k

CAS

35k

TCAR

90k

CEA

Expanding Treatment Population

CMS coverage expansion broadens eligible treatment population

Annual U.S. Procedures

~1,000,000

Untreated U.S. Diagnosed Patients

2025

2030

~200,000

Annual U.S. Procedures

70k CAS

70k TCAR

60k CEA

Growth of Carotid Stenting

CREST-2 validates revascularization benefits

Access to next generation solutions - CGuard Prime

de Weerd M. et al. Prevalence of asymptomatic carotid artery stenosis in the general population. Stroke. 2010;41:1294-1297.

Rockman CB. et al. Carotid artery disease: epidemiology and screening. Journal of Vascular Surgery. 2010.

Naylor AR. Management of asymptomatic carotid stenosis. Lancet Neurology. 2022;21:355-366.

Based on claims data, AcuityMD

Momentum. Expansion. Acceleration.

2026 H1 2027 H2 2027 TAILWINDS

Q2 2026 - CGUARDIANS III Trial

Enrollment begins

Q3 2026 - CGuard® Enters the U.S. Market

Restores core U.S. commercial availability

H2 2026 - CGuard® Prime 80 for TCAR Doubles addressable U.S. market

CAS CAS + TCAR stenting

Enhanced CGuard® Prime configuration

A delivery system designed to match the performance of the CGuard stent

SwitchGuard NPS for TCAR

Expands value capture across the full TCAR procedure

Positions $NSPR as the leading carotid intervention platform company

Broadens addressable market across CAS, TCAR, and NPS

Long-term growth and durable platform differentiation

CMS Coverage Expanded

Standard Risk and Asymptomatic Reimbursement

Enables stent-first approach to carotid revascularization

Landmark Clinical Evidence

CREST-2 Validates Revascularization Benefit

Reinforces role of carotid stenting in the

market

Unmatched Clinical Evidence Short and Long-Term Results

Ten clinical trials completed with >2,000 patients presented or published including two pivotal trials reinforced by recent CGUARDIANS II results

Benefits are independent of access method

CAS

Transfemoral/ Transradial

We are positioned to capitalize on the ongoing paradigm shift toward a "stent first" approach and away from surgery

TCAR

Transcarotid

CGuard® Prime

Tandem Lesions

Stroke/Neuro

90% occlusion

Stenting

CGuard® Stent

Surgical Endarterectomy

CGuard Prime Dual Layer Design

CGuard Prime is designed to prevent embolization by securing carotid plaque behind its MicroNet mesh, preventing prolapse through the stent struts while maintaining blood flow to the external carotid artery.

CGuard Prime has the smallest pore size of any approved carotid stent (150-180 μm)*

CGuard

Conventional carotid stents vs CGuard® Prime dual layer design

Conventional Carotid Stent

Unmatched Foundational Data and Evidence

CGUARDIANS III

CGuard Prime 80cm w/ proprietary

SwitchGuardTM NPS for TCAR

IDE Approved, 103 patient target enrollment

Enrollment Begins Q2 2026

C-GUARDIANS

CGuard® Prime 135cm w/commercially available EPDs (NAV6 and MOMA)

1-year primary endpoint results published (1.93% MAE rate)

PMA Approved June 2025

Completed

CGUARDIANS II

CGuard Prime 80cm w/ commercially

available NPS (Enroute) for TCAR

50 patient target enrollment complete

Completed

30-Day Death/Stroke/MI (DSMI) rates, compared to other carotid trials

CGUARDIANS 30-day outcomes

30-day DSMI (multiple FDA trials)

Intention to Treat

Per Protocol1,2

8.30%

4.80%

5.40%

5.80%

5.20%

5.10%

3.50%

2.30%

0.95%

30-day DSMI

0.95% (3)

0.63% (2)

Death

0.32% (1)

0.0% (0)

Stroke

0.95% (3)

0.63% (2)

0.00% (0)

0.0% (0)

SAPPHIRE ARCHeR MAVERIC BEACH PROTECT CREST- CAS (Standard

Risk)

CREST- CEA (Standard Risk)

ROADSTER PERFORMANCE 2 C-GUARDIANS

Demonstrates the lowest 30-day DSMI rates of any FDA approval/clearance trial for carotid intervention (CAS or TCAR)

Trial includes independent event adjudication

0.95% event rate consistent with 1.03% 30-day event rate from >1350 patients in peer-reviewed, published studies of real-world use, supporting the CGuard Stent as a front-line therapeutic option for carotid revascularization

Kaplan-Meier estimate for all 1-year endpoints

Per Protocol Analysis excludes 15 patients with Major Protocol Deviations

Yadav JS, et al, N Engl J Med 2004;351:1493-501. Gray WA, et al, J Vasc Surg. 2006 Aug;44(2):258-68. Higashida RT, et al, Stroke. 2010 Feb;41(2):e102-9. White CJ, et al, CCI 2006 Apr;67(4):503-12. Iyer SS, et al, J Am Coll Cardiol. 2008 Jan 29;51(4):427-34. Matsumura JS, et al, J Vasc Surg. 2012 Apr;55(4):968-976.e5. SSED Premarket Approval Application (PMA)

Number: P040012/SO34. Kwolek CJ, et al, J Vasc Surg. 2015 Nov;62(5):1227-34. W. Gray VIVA 2023 14

365-Day Death/Stroke/MI (DSMI) rates, compared to other carotid trials

CGUARDIANS 365-day

365-day (multiple FDA trials)

Intention to Treat

Per Protocol1,2

12.20%

Primary Endpoint: 30-day Death, Stroke, or MI + Ipsilateral Stroke between

31 and 365 days

1.93% (6)

1.70% (5)

0.98% (3)

1.01% (3)

9.60%

8.90%

7.10%

5.90%

6.60%

3.40%

2.80%

1.93%

Target Lesion Revascularization (TLR) through 365 days.

SAPPHIRE* ARCHeR MAVERIC BEACH PROTECT CREST CAS

(Standard Risk)

CREST CEA

(Standard Risk)

PERFORMANCE 2 C-GUARDIANS

Demonstrates the lowest primary endpoint event rates of any FDA approval/clearance trial for CAS

Trial includes independent event adjudication

1.93% event rate consistent with 1.99% 1-year event rate from >1100 patients in peer-reviewed, published studies of real-world use, supporting the CGuard Stent as a front-line therapeutic option for carotid revascularization

Kaplan-Meier estimate for all 1-year endpoints

Per Protocol Analysis excludes 15 patients with Major Protocol Deviations

SAPPHIRE one-year primary endpoint also included Death/MI from 31-365 days

976.e5. SSED Premarket Approval Application (PMA) Number: P040012/SO34. Kwolek CJ, et al, J Vasc Surg. 2015 Nov;62(5):1227-34. Langhof, LINC 2024 15

CGuard commercially available in Europe since 2015 (CE Mark)

Study

Year

DS 30-Day % (n)

DSMI 30-Day % (n)

CARENET

2015

0.0%(0)

PARADIGM

2016

101

0.0%(0)

CASANA

2017

1.22%(1)

WISSGOTT I

2017

0.0%(0)

IRONGUARD I

2018

200

2.50%(5)

WISSGOTT II

2019

0.0%(0)

IRONGUARD 2

2020

733

0.5%(4)

1.09%(8)

GREEK Study

2021

103

0.0%(0)

SIBERIA

2021

0.0%(0)

Total

1,359

0.80%(11)

1.03%(14)

1. Schofer, J. et al. JACC Cardiovasc. Interv. 2015; 2) Casana, R. et al. Eur. J. Vasc. Endovasc. 2017; 3) Musialek, P. et al. Interv. Cardiol. 2016

Wissgott, C. et al. Int. Soc. Endovasc. Spec. 2017; 5) Speziale, F. et al. EuroIntervention 2018; 6) Wissgott, C. et al. J Endovasc Ther. 2019

7. Sirignano, P et al. Cardiovascular Interventions 2020;8) Tigkiropoulos, K. et al. Journal of EndoTherapy 2021; 9) Karpenko, A. et al JACC Cardiovasc. Interv. 2021

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 reduction (due to less metal burden)

Event

FGS

SGS

Terumo RoadSaver/ Casper

Gore

(not marketed)

CGuard

30-day Stroke [%]

3.01

0.60

0.50

2.89

0.54

(95% CI)

(2.63-3.38)

(0.28-0.92)

(0.0-1.15)

(1.03-4.76)

(0.17-0.92)

30-day Death / Stroke / MI [%]

4.11

1.30

1.33

4.82

1.08

(95% CI)

(3.65-4.56)

(0.64-1.96)

(0.0-2.66)

(2.44-7.2)

(0.55-1.60)

12-month Ipsilateral Stroke [%]

3.51

0.7

0.26

3.1

0.38

(95% CI)

(2.52-4.50)

(0.0-1.47)

(0.0-1.27)

(1.11-5.1)

(0.0-0.9)

12-month Restenosis [%]

3.97

3.38

7.16

4.83

0.34

(95% CI)

(0.28-5.14)

(1.39-5.37)

(4.45-9.86)

(2.36-7.29)

(0.0-0.82)

12-month Ipsilateral Stroke / Restenosis [%] (95% CI)

8.15

(6.34-9.93)

5.12

(2.14-8.10)

7.86

(5.04-10.68)

7.93

(4.82-11.04)

0.73

(0.0-1.44)

1. Clinical Outcomes of Second- versus First-Generation Carotid Stents: A Systematic Review and Meta-Analysis, J. Clin. Med. 2022, 11

Any Perioperative Stroke or Death Plus Ipsilateral Stroke Thereafter up to 4 Years

Med Alone 6.0%

CAS + Med 2.8%

A Systematic Review and Meta-Analysis, J. Clin. Med. 2022, 11

Stroke and death (S/D) out to 4-years was 6.0% for medical therapy and 2.8% when CAS was added

Absolute difference of 3.2% favoring CAS was significant

Only 31 people with high-grade asymptomatic carotid stenosis needed to be treated to prevent a primary event at 4 years

Note- No primary events happened on the day of the procedure- what is left behind matters!

S/D out to 4-years was 5.3% for medical therapy and 3.7% when CEA was added

Absolute difference of 1.6% favoring CEA was not significant

1. Clinical Outcomes of Second- versus First-Generation Carotid Stents:

TCAR

Preliminary results from first 36 TCAR patients | presented at Charing Cross Symposium 2026

Study Overview

Multicenter, single-arm pivotal U.S. trial evaluating CGuard® Prime (80cm) with TCAR using ENROUTE Transcarotid Neuroprotection System

50 patients enrolled (target complete)

High surgical risk population (≥50% symptomatic / ≥80% asymptomatic stenosis)

Principal Investigators & Study Leadership

Patrick Muck, MD - Co-National Principal Investigator

Patrick Geraghty, MD - Co-National Principal Investigator

11 U.S. investigational sites

Preliminary Data (First 36 Patients)

100% Acute Device Success

97% Technical Success

Strong performance across complex lesion types

30-DAY CLINICAL OUTCOMES (SECONDARY ENDPOINTS)

DEATH

STROKE

0% 0%

MYOCARDIAL STENT INFARCTION THROMBOSIS

DEVICE-RELATED SAE's

Zero major adverse events at 30 days in the first 36 TCAR patients treated with CGuard Prime (80cm) and the ENROUTE Neuroprotection System

Disclaimer

InspireMD Inc. published this content on May 04, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 04, 2026 at 23:36 UTC.