EBR Systems, Inc. · ASX:EBR
EBR Systems — Investor Presentation (May 2023)
27 slides from EBR Systems's investor presentation, May 22, 2023
Slide 1: SOLVE-CRT Pivotal Trial Top-line Data
For personal use only SOLVE-CRT Pivotal Trial Top-line Data May 2023 1
Slide 2: Achievement of a significant milestone
Achievement of a significant milestone For personal use only Culmination of over a decade of planning, research and development 2023 Positive results released 2022 FDA approves wireless pacemakers as co- implant in SOLVE-CRT 2020 FDA approves post- 2018 COVID trial redesign World first totally 2016
Slide 3: Pivotal SOLVE-CRT trial overview
Pivotal SOLVE-CRT trial overview For personal use only Trial design to provide clinical data to support a PMA application to the FDA Trial design and goals Multi-phase trial completed Purpose: Assess the safety and effectiveness of the WiSE device COMPLETE COMPLETE1 COMPLETE Design: International, m
Slide 4: Efficacy endpoint met
Efficacy endpoint met For personal use only WiSE device confirmed to significantly improve heart function in patients compared to benchmark Primary efficacy endpoint (% ΔLVESV1) Primary efficacy endpoint met p = 0.003† P -16.4% decrease in left ventricular end systolic volume at 0 6 months compared
Slide 5: Safety endpoint met
Safety endpoint met For personal use only WiSE device considerably exceeds the primary safety endpoint with minimal patients experiencing device or procedure-related complications Freedom from type I complications (%) Primary safety endpoint met p < 0.001† 100 P 80.9% freedom from type I complicatio
Slide 6: Supported by clinicians and patients
Supported by clinicians and patients For personal use only Trusted by leading healthcare professionals and demonstrated success in patients Professor Prash Sanders Brian Oakley Director of Cardiac Electrophysiology and Scout leader and avid Melbourne FC fan, Pacing at the Royal Adelaide Hospital una
Slide 7: Journey from here
Journey from here For personal use only EBR continues to achieve significant value catalysts and pave the way to future value creation 2024+ ❑ Submit Clinical Module for PMA application to the FDA 2023 ❑ Submit Final Module including ✓ SOLVE-CRT 6 Month follow up transmitter upgrades completed for f
Slide 8: Market opportunity
Market opportunity For personal use only EBR estimates to have an initial addressable market of ~US$2.5bn at commercial launch, with further opportunities to expand WiSE into other patient groups Initial Addressable Market Expansion Opportunity Target Patient Groups: New patient groups, indications
Slide 9: Attractive investment opportunity
Attractive investment opportunity For personal use only EBR is focused on executing its clear and targeted commercialisation strategy to deliver shareholder value De-risked pathways to market High value market opportunity Value upside Positive results Well funded Large markets Unique solution Re-rat
Slide 10: Appendix: HRS conference presentation
For personal use only Appendix HRS conference presentation
Slide 11: Safety and Efficacy of a Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure
For personal use only Safety and Efficacy of a Leadless Ultrasound-Based Cardiac Resynchronization System in Heart Failure The SOLVE-CRT Study Results Jagmeet P. Singh MD, DPhil; Christopher A. Rinaldi MBBS, MRCP; Prashanthan Sanders MBBS, PhD; Spencer H. Kubo MD; Simon James MD; Imran K. Niazi MD;
Slide 12: Background
Background For personal use only • Despite the well-established role of CRT in heart failure, major limitations of CRT include: o High incidence of unsuccessful coronary sinus (CS) lead placement o Upgrading ICDs in high-risk patients o High rates of CRT non-responders (30-50%) • The WiSE® CRT Syste
Slide 13: The WiSE CRT System
® The WiSE CRT System For personal use only CO-IMPLANT DEVICE Existing pacemaker, ICD or CRT provides RV pacing RECEIVER ELECTRODE Implanted endocardially, this Electrode converts ultrasound into electrical energy to pace the LV BATTERY Implanted subcutaneously at the left mid-axillary line, powers
Slide 14: Receiver Electrode Implant Procedure
Receiver Electrode Implant Procedure For personal use only Retrograde Aortic Approach Anchoring Secure Attachment Transseptal Approach Endothelializes for a low risk of thromboembolic events
Slide 15: SOLVE-CRT Study
SOLVE-CRT Study For personal use only Objective: Pivotal study to assess the safety and effectiveness of the WiSE® CRT System Design: International, multi-center, 3-part study: (i) Roll-in, (ii) Randomized, and (iii) Single-arm Study Population: Patients indicated for CRT and ⎻ Previously untreatabl
Slide 16: SOLVE-CRT Study Design
SOLVE-CRT Study Design For personal use only NR = Non responder PU = Previously untreatable HRU = High risk upgrade
Slide 17: Primary and Secondary Endpoints
Primary and Secondary Endpoints For personal use only • Primary Safety Endpoint: Freedom from Type I complications at 6 months compared to a Performance Goal of 70% ⎻ Type I: Device or procedure-related complications • Primary Efficacy Endpoint: Decrease in LVESV at 6 months compared to a Performanc
Slide 18: Baseline Characteristics
Baseline Characteristics For personal use only n/N (%) Safety Population or Mean ± SD Female 42/183 (23.0) Age at enrollment (Years) 68.1 ± 10.28 Left ventricular ejection fraction 30.0 ± 8.3 Co-implant device: -CRT-D 113/183 (61.7) -CRT-P 9/183 (4.9) -ICD 42/183 (23.0) -Pacemaker 15/183 (8.2) Prior
Slide 19: Primary Safety Endpoint
Primary Safety Endpoint For personal use only Participants, n Freedom from Type I Complications (%) Type I Complications Type I 35 (19.1%) (%) Study device system event 12 (6.6%) p < 0.001† Receiver Electrode not anchored 7 (3.8%) No BiV capture 3 (1.6%) Transmitter revision 1 (0.5%) Ventricular tac
Slide 20: Primary Efficacy Endpoint
Primary Efficacy Endpoint For personal use only Primary Endpoint Additional Evidence of Reverse Remodeling % ΔLVESV LVESV (ml) LVEDV (ml) LVEF (%) p = 0.003† p < 0.001‡ p < 0.001‡ p < 0.001‡ Mean ∆ = -25.1 Mean ∆ = -25.4 Mean ∆ = 5.2 95% CI (-32.4, -17.9) 95% CI (-28.4, -22.5) 95% CI (4.7, 5.7) 36.3
Slide 21: Secondary Endpoints
Secondary Endpoints For personal use only Change in QRS (ms) Mean ∆ = -39.3 95% CI (-44.5, -34.2)
Slide 22: Limitations & Strengths
Limitations & Strengths For personal use only Limitations Strengths • COVID impact on protocol • Multi-center • Non-randomized part was open- • Prospective label with no control group • Blinded Echo Core Lab • Short follow-up duration • Independent Clinical Events Committee
Slide 23: Conclusions
Conclusions For personal use only The pivotal SOLVE-CRT study has demonstrated that leadless, ultrasound-based endocardial pacing with the WiSE CRT System is: ⎻ Feasible ⎻ Safe ⎻ Clinically efficacious, resulting in reverse remodeling and improvement in functional status
Slide 24: Clinical Implications
Clinical Implications For personal use only • Totally Leadless CRT4 ⎻ Potential pairing with leadless pacemakers • Leadless LBBAP / Conduction System Pacing5 ⎻ Allows for refined targeting 4 Carabelli, et al. (2020) – Europace, 5Elliott, et al. (2022) – Heart Rhythm
Slide 25: Acknowledgements
Acknowledgements For personal use only St. Thomas’ Hosp, UK Liverpool Heart and Naples Community Prince Charles UCSD, US Chest Hosp, UK Hosp, US Hosp, AU • Participants James Cook University Emory Univ, US Centre Cardiologique Canberra Hosp, AU Intermountain Heart Hosp, UK du Nord, EU Institute, US
Slide 26: 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 27: 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] 27