EBR Systems, Inc. · ASX:EBR
EBR Systems — Investor Presentation (March 2025)
20 slides from EBR Systems's investor presentation, Mar 25, 2025
Slide 1: Investor Presentation
For personal use only Investor Presentation John McCutcheon (President & CEO) March 2025 ASX:EBR
Slide 2: Disclaimer
Disclaimer The material contained in this document is a presentation of general information about the activities of EBR Systems, Inc. (ASX:EBR) (ARBN 654 147 127) and its subsidiaries (“EBR”) current as at the date of this presentation. It should be read in conjunction with EBR’s periodic and contin
Slide 3: Investment highlights
Investment highlights Developer of the world’s first and only leadless pacemaker for heart failure For personal use only High value market opportunity Pathways to market Defined Strategy Clear pathway to FDA Clear commercial Unique solution Large markets Positive results approval strategy in place N
Slide 4: Cardiac Rhythm Management Market
Cardiac Rhythm Management Market Three key segments driving growth in the global cardiac rhythm management market For personal use only Worldwide CRM Market (~US$13.6bn)1 Implantable Pulse Generator $4.8bn $4.7bn Right atrium lead $4.0bn Left ventricle lead Right ventricle lead Cardiac Resynchronisa
Slide 5: Traditional CRT systems are suboptimal
Traditional CRT systems are suboptimal Traditional CRT systems use wires or leads to deliver energy to the heart, which can lead to many problems. For personal use only Leads can migrate and LV lead must be placed sometimes fracture outside the heart to avoid blood clots Leads can become a way for C
Slide 6: EBR has a wireless solution for the heart
EBR has a wireless solution for the heart EBR’s WiSE CRT System is the only wireless device that can deliver cardiac resynchronisation therapy For personal use only Left ventricle1 Right ventricle / atrium1 WiSE CRT System fills the gap The only leadless solution for left ventricle (LV) pacing Other
Slide 7: Pivotal SOLVE-CRT Study met all endpoints
Pivotal SOLVE-CRT Study met all endpoints Positive results confirm WiSE CRT System as a highly effective treatment option for patients with heart failure1 For personal use only Primary efficacy endpoint met Primary safety endpoint met Decrease in left ventricular end systolic volume -16.4% (vs. -9.3
Slide 8: Strong Support from Global Key Opinion Leaders
Strong Support from Global Key Opinion Leaders For personal use only Jagmeet P. Singh M.D., Ph.D. Prash Sanders, MBBS, PhD, FHRS Timothy Betts, MD, MBChB, FRCP Cardiologist & Electrophysiologist, Harvard Cardiologist & Electrophysiologist, Cardiologist & Electrophysiologist Medical School, Universit
Slide 9: Commercialisation pathway
Commercialisation pathway Positive pivotal trial results and strong track record with the FDA provide a clear pathway to approval and commercialisation For personal use only US reimbursement & commercialisation FDA approval process underpinned by positive pivotal trial results and a track record of
Slide 10: Favourable US market dynamics
Favourable US market dynamics Market dynamics in the US support initial adoption of the WiSE CRT System For personal use only Market validation • Support of Key Opinion Leaders (KOLs) • Unmet need underscored by FDA Breakthrough Device designation • CRT market is highly concentrated - targeting high
Slide 11: Initial commercialisation strategy
Initial commercialisation strategy EBR will leverage its established partnerships and presence in the US to drive initial sales growth For personal use only Commercial Leadership LMR Supports Adoption and Direct, specialist sales Advocacy force to execute plan • EBR is expanding and optimizing its •
Slide 12: Expanding manufacturing capabilities
Expanding manufacturing capabilities EBR has secured a new state-of-the-art facility at favourable terms to support long-term commercial growth and scale For personal use only Significant Facility Expansion: • New 11-year lease secured for 51,000 sq ft (4,751 sqm) facility • Expansion of manufacturi
Slide 13: US$3.6bn initial addressable market
US$3.6bn initial addressable market At commercial launch, EBR estimates an initial addressable market of ~US$3.6bn For personal use only Leadless Upgrades • Patients with a leadless right Acute Lead Failure ventricle pacemaker can only $0.77bn $0.41bn Unable to implant CRT wire in a new upgrade with
Slide 14: Totally Leadless CRT grows the market
Totally Leadless CRT grows the market Continued global growth and adoption of leadless RV pacemakers significantly expands EBR’s market opportunity For personal use only Global Leadless RV Pacemaker Market Revenue and Unit Growth (US$m) (thousands) $1,400 1H 2025: Boston Scientific EMPOWER expected
Slide 15: Long term growth strategy
Long term growth strategy Long term growth opportunity targeting new patient groups, indications and geographies For personal use only Pursue new indications Product development Expand internationally Progress clinical studies to expand Grow addressable market Launch in select OUS1 markets as indica
Slide 16: Clinical development: Totally Leadless CRT
Clinical development: Totally Leadless CRT EBR is actively progressing activities to initiate studies to support expanded indication For personal use only Commercial benefits • Increased adoption of leadless pacemakers expands the need for WiSE, including upgrading dual chamber leadless pacemakers •
Slide 17: Product development: Rechargeable battery
Product development: Rechargeable battery EBR is developing a new rechargeable battery that will support the WiSE CRT System in becoming a first-line therapy option and treat a broader suite of patients For personal use only Commercial benefits • Drives higher uptake by removing barriers to adoption
Slide 18: Upcoming milestones
Upcoming milestones EBR continues to achieve significant value catalysts and pave the way to future value creation For personal use only Delivered Near term Next steps ü Headline data released at Heart Rhythm q FDA approval in the US q Expand manufacturing facility Society conference q Expected on o
Slide 19: Summary
Summary EBR remains driven to deliver superior treatment for patients suffering from cardiac rhythm diseases For personal use only Developer of the world’s first and only leadless pacemaker for heart failure EBR’s WiSE® CRT System has no direct competitors and is complementary to other pacemaker tec
Slide 20: Thank you
For personal use only Thank you 20