EBR Systems, Inc. · ASX:EBR
EBR Systems — Bell Potter Healthcare Conference 2023
16 slides from EBR Systems's conference presentation, Nov 15, 2023
Slide 1: Bell Potter Healthcare Conference Presentation
For personal use only Bell Potter Healthcare Conference Presentation November 2023 1
Slide 2: Disclaimer
Disclaimer For personal use only The material contained in this document is a presentation of general information about may differ materially from what is expressed in this presentation. the activities of EBR Systems, Inc. (ASX:EBR) (ARBN 654 147 127) and its subsidiaries (“EBR”) current as at the d
Slide 3: Traditional pacemakers are suboptimal
Traditional pacemakers are suboptimal For personal use only Traditional pacemakers use wires or leads to deliver energy to the heart, which can lead to many problems Coronary Sinus limits Can migrate and Left Ventricle (LV) lead sometimes fracture placement locations RIGHT ATRIUM LEAD Pathway for pa
Slide 4: EBR has a wireless solution for heart failure patients
EBR has a wireless solution for heart failure patients For personal use only EBR’s WiSE CRT System is the only wireless device that can deliver cardiac resynchronisation therapy Left ventricle Right ventricle/atrium WiSE CRT System fills the gap Currently the only leadless solution globally for LV p
Slide 5: Pivotal SOLVE-CRT Study meets all endpoints
Pivotal SOLVE-CRT Study meets all endpoints For personal use only Positive results confirm WiSE CRT System as a highly effective treatment option for patients with heart failure Primary efficacy endpoint met Primary safety endpoint met -16.4% Decrease in left ventricular end systolic volume 80.9% Pa
Slide 6: Randomised sub-analysis supports primary results
Randomised sub-analysis supports primary results For personal use only The WiSE CRT System demonstrates clinically and statistically significant evidence of reverse remodelling and electrical response within previously untreatable and high-risk patients LVESV (%) LVEDV (%) LVEF (%) QRS (ms) † ‡ † p
Slide 7: Clear regulatory pathway
Clear regulatory pathway For personal use only EBR’s track record of successful engagement underpins confidence for FDA approval process 2019 2020 2022 2023+ FDA granted FDA approved trial re- FDA approved Clear pathway to Breakthrough Device design of pivotal leadless pacemakers approval with modul
Slide 8: Focused commercialisation strategy
Focused commercialisation strategy For personal use only EBR will leverage its established partnerships and presence in the US to drive initial sales growth, targeting initial sales in H1 2025 Clinical trial sites to drive initial sales Specialist sales force established • CRT market is concentrated
Slide 9: US$2.6bn initial addressable market
US$2.6bn initial addressable market For personal use only At commercial launch, EBR estimates to have an initial addressable market of ~US$2.6bn Leadless Upgrades Acute Lead Failure • Patients with a leadless right ventricle pacemaker can only upgrade with WiSE Unable to implant CRT wire in a new CR
Slide 10: Totally Leadless CRT is a growth market
Totally Leadless CRT is a growth market For personal use only The Totally Leadless CRT (TLC) market has the potential to grow by an additional US$4.2bn Upgrading dual chamber leadless TLC as first-line therapy WiSE CRT System used in conjunction with the WiSE CRT System $0.4bn used in conjunction wi
Slide 11: Market expansion opportunity
Market expansion opportunity For personal use only The WiSE CRT System can be expanded for use in other patient groups, indications and geographies, increasing EBR’s market opportunity and underpinning future growth Initial addressable market • Acute Lead Failure US$2.6bn • Chronic Lead Failure • Hi
Slide 12: Product development
Product development For personal use only EBR is developing a new rechargeable battery that will support WiSE CRT System in becoming a first- line therapy option and treat a broader suite of patients Background EBR is developing a rechargeable battery and wireless charging system based on feedback f
Slide 13: Clinical development: totally leadless CRT
Clinical development: totally leadless CRT For personal use only EBR is currently progressing planning activities for studies to expand indications Totally leadless CRT • WiSE CRT System can pair with a leadless RV pacemaker to achieve totally leadless CRT • Increased adoption of leadless pacemakers
Slide 14: Upcoming milestones
Upcoming milestones For personal use only EBR continues to achieve significant value catalysts and pave the way to future value creation 2023 2024 2025+ ü SOLVE-CRT 6 Month follow up q Submit Final PMA Module including transmitter upgrades q Commercial launch in the US completed for final patient in
Slide 15: Investment highlights
Investment highlights For personal use only EBR is focused on executing its clear and targeted commercialisation strategy to deliver shareholder value High value market opportunity De-risked pathways to market Expert leadership Unique solution Large markets Positive results Focused strategy Strong t
Slide 16: Contact Us
For personal use only Contact Us Company John McCutcheon President & CEO P: +1 408 720 1906 E: [email protected] Investors Dean Dribbin Vesparum Capital P: +61 3 8582 4800 E: [email protected] 16