EBR Systems, Inc. · ASX:EBR
EBR Systems — Investor Presentation (April 2025)
18 slides from EBR Systems's investor presentation, Apr 14, 2025
Slide 1: FDA PMA Approval Webinar
For personal use only FDA PMA Approval Webinar John McCutcheon, President & CEO Pharoah Garma, Chief Regulatory Officer Erik Strandberg, Chief Commercial Officer April 15, 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 FDA approved Clear commercial Unique solution Large markets Positive results strategy in place No competition as
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 Resynchroni
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 ventricle(1) Right ventricle / atrium(1) WiSE CRT System fills the gap The only leadless solution for left ventricle (LV) pacing O
Slide 7: FDA Approval of WiSE CRT System
FDA Approval of WiSE CRT System EBR has successfully advanced the WiSE CRT System to FDA approval, having received an approval letter authorising commercial marketing For personal use only Final PMA process timeline Final PMA Day 100 Interactive module Meeting review submitted Sep-24 Jan-25 Apr-25 J
Slide 8: Approved Indications Support US$3.6bn TAM
Approved Indications Support US$3.6bn TAM The FDA has approved the WiSE CRT System with the expected indications For personal use only The WiSE CRT System is indicated for adult patients who are at least 22 years of age, are indicated for cardiac resynchronization therapy (CRT), have an existing imp
Slide 9: Post-approval Study
Post-approval Study EBR will undertake a post-approval study to help assure continued safety and effectiveness For personal use only Post-approval study summary Primary end point and additional data Primary endpoint: Rate of serious adverse events (SAEs) Prospective, real-world, observational occurr
Slide 10: Commercialisation pathway
Commercialisation pathway Successful FDA approval follows positive pivotal trial results and strong track record with the FDA with focus now shifting to commercialisation activities For personal use only US reimbursement & commercialisation EBR is now focused on ramping up commercial activity, focus
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: 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(1) For personal use only High Risk Upgrades - Leadless • Patients with a leadless right Acute Lead Failure ventricle pacemaker can only $0.77bn $0.41bn Unable to implant CRT wire in a n
Slide 13: Reimbursement System
Reimbursement System The reimbursement system in the US is a function of coding and coverage to determine the amount paid for a procedure For personal use only Coding Coverage Payment Coding allows uniformity in claims submission for a specific service – “The Will they pay for it? How much will they
Slide 14: WiSE Reimbursement
WiSE Reimbursement EBR has multiple pathways for WiSE Reimbursement For personal use only Medicare Coverage Medicare In-patient Payment Medicare Out-patient Payment Transitional Coverage of Emerging New Technology Add-On Payment (NTAP) Transitional Pass-Through (TPT) Technologies (TCET) - Active dis
Slide 15: 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 16: 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 17: Thank you
For personal use only Thank you 17
Slide 18: 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