Inspiremd Inc. · NASDAQ:NSPR
Inspiremd — Investor Presentation (January 2023)
30 slides from Inspiremd's investor presentation, January 2023
Slide 1: Sustained Embolic Protection
Sustained Embolic Protection Investor Presentation I January 2023
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: Our Leadership
Our Leadership Marvin L. Slosman Craig Shore Andrea Tommasoli President and CEO Chief Financial Officer SVP Global Sales & Marketing Roei Samuri Tamar Nativ Juan Rigla, M.D., Ph.D VP Operations Medical Director VP QA & RA Company and Products Overview 3
Slide 4: Scientific Advisory Board (Multidisciplinary KOL's)
Scientific Advisory Board (Multidisciplinary KOL’s) 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 O
Slide 5: Summary Financials
Summary Financials January 17, 2023 NASDAQ Capital Market NSPR Stock Price $1.15 Average 3 Month Volume 29.3K Shares Outstanding 8.3M Market Capitalization $9.6M Cash Balance – September 30, 2022 $21.0 Debt $0M Company and Products Overview 5
Slide 6: Investment Highlights
Investment Highlights 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 35,406 stents sold through September 30, 2022 dis
Slide 7: Our Advancement Roadmap / Milestones
Our Advancement Roadmap / Milestones Our Expected Key Value Drivers and Strategic Pathways • U.S. Commercial Launch • FDA PMA Submission / Approval • China Commercial Launch • SwitchGuard (TCAR) Launch • Japan Regulatory Approval • USA Trial Enrollment Complete • Preparation for U.S. Launch • USA Tr
Slide 8: InspireMD Pipeline
InspireMD Pipeline Development/New Indications Regulatory / Clinical Pathway Commercial Stage Trans Femoral CAS: Gen 1 CGuardTM EPS Carotid Stent System Ongoing Trans Femoral CAS: Next Gen 2023 New CGuard Prime Delivery System Trans Carotid CAS: TCAR New SwitchGuard Accessory Device 2024 New Short S
Slide 9: 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 10: Unmet Clinical Need
Unmet Clinical Need Company and Products Overview 10
Slide 11: THE PROBLEM: Risks with Existing Approaches to CAD
THE PROBLEM: Risks with Existing Approaches to CAD Conventional approaches come with risks Carotid Endarterectomy (CEA) Carotid Artery Stenting (CAS) Surgical Approach Conventional Approach (Bare Stent) Risk of complications: Risk of complications: Myocardial infarction risk1 (heart attack) Procedur
Slide 12: THE PROBLEM: Risk of Embolism Following Conventional Carotid Stenting
THE PROBLEM: Risk of Embolism Following Conventional Carotid Stenting MRI reveals post-procedural cerebral embolization Pre-Procedure Post-Procedure with Conventional Stent 90% occlusion of MRI of a pre-existing white Successful MRI reveals new multiple micro-infarcts the carotid artery matter infar
Slide 13: Our Solution
Our Solution Company and Products Overview 13
Slide 14: OUR SOLUTION: The CGuard EPS
OUR SOLUTION: The CGuard EPS The only stent platform available with our patented MicroNet mesh technology Stent- Nitinol (NiTi): • The CGuard framework is manufactured from a 3mm Nitinol tube • This tubing is used for all CGuard stent designs (Ø 6-10 mm, L=20,30,40,60mm) • The tubing is laser cut in
Slide 15: 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 16: 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 16
Slide 17: A picture is worth a thousand words …
A picture is worth a thousand words … Thrombus Burden Stroke CGuard Stent Angio Post Stented Vessel Company and Products Overview 17
Slide 18: 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 19: 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 DSM (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%) 5
Slide 20: Clinical Data Foundation: Evolution to Standard of Care
Clinical Data Foundation: Evolution to Standard of Care YEAR STUDY PUBLICATION HIGHLIGHTS CGUARD'S STANDING (known & anticipated) Journal 2015 CARENET Safety, Efficacy & Neuroprotection over other stents data JACC 2016 PARADIGM All comers population; Excellent clinical results ◎ CGuard evaluated as
Slide 21: Clinical Support Highlights / Call out
Clinical Support Highlights / Call out 2015-2022 PARADIGM + Extend CARENET Trial Randomized Control Trial Opened CARENET study First in Man Study- Randomized Trial; CGuard inclusion criteria all Demonstrated Safety, vs. Conventional Stent comers. Efficacy, & Concluded the safety and (Acculink); Neur
Slide 22: U.S. Market and Regulatory Pathway
U.S. Market and Regulatory Pathway FDA Trial Performance Goal – 11.6% v Real World Performance 1.32% (w/ 1 Yr) U.S. Market Opportunity* $809M* Size: 155K High Grade Carotid Artery Stenosis (HGCS) interventions estimated in 2023 Opportunity: The addressable market is estimated to be approximately $80
Slide 23: SwitchGuard and CGuard Prime
SwitchGuard and CGuard Prime TCAR Delivery System will Facilitate Accelerating Conversion from Surgery to Stenting 80 Company and Products Overview 23
Slide 24: Market Opportunity
Market Opportunity Company and Products Overview 24
Slide 25: Potential Multi Billion Dollar Market Opportunity
Potential Multi Billion Dollar Market Opportunity Our MicroNetTM covered stents like CGuardTM could become the new gold standard WW carotid procedures today are ◆ Current Treated Global Market: Carotid procedures tomorrow could be → $1.3 billion (1) primarily surgical mostly minimally invasive with
Slide 26: Commercial Footprint
Commercial Footprint Signed agreement with Chinese distributor. Working toward distribution U.S. Market Investigation Device Exemption (IDE) approval September 2020; Exploring expansion US trial initiated Q3 2021 opportunities Taiwan, Japan, and Korea Current Markets Registration Work Underway • Act
Slide 27: Corporate
Corporate Company and Products Overview 27
Slide 28: Our Robust Intellectual Property Portfolio
Our Robust Intellectual Property Portfolio Proprietary platform technology supported by IP Patent Rights Issued Pending USA 16 6 Rest of World 42 11 InspireMD will continue to strengthen and broaden its patent protection globally to enable future pipeline products IP Counsel: Kligler and Associates,
Slide 29: 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 30: NASDAQ = NSPR
INSPIREM9 NASDAQ = NSPR