EBR Systems, Inc. · ASX:EBR
EBR Systems — Investor Presentation (May 2023)
20 slides from EBR Systems's investor presentation, May 29, 2023
Slide 1: Investor Presentation May 2023
For personal use only Investor Presentation May 2023 1
Slide 2: 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 High value market opportunity De-risked pathways to market Value upside Unique solution Large markets Positive results Well funded Re-rat
Slide 3: Traditional pacemakers are suboptimal
Traditional pacemakers are suboptimal For personal use only Traditional pacemakers use wires to deliver energy to the heart, which can lead to many problems Coronary Sinus limits Can migrate and LV lead placement sometimes fracture locations RIGHT ATRIUM LEAD Pathway for pathogens to Difficult to pl
Slide 4: EBR has a wireless solution for heart failure patients
EBR has a wireless solution for heart failure patients For personal use only WiSE® is the only wireless device that can deliver cardiac resynchronisation therapy (CRT) Wireless Cardiac Rhythm Management Landscape1 • There are a few wireless products in the market CRT Bradycardia Defibrillation • Pat
Slide 5: Advantages of WiSE
Advantages of WiSE® For personal use only WiSE® addresses the shortcomings of traditional pacemakers Wireless Eliminates lead complications such as placement difficulty, blood clots, unintended nerve stimulation, dislodgement, extraction and repositioning. Endocardial Delivers pacing directly to the
Slide 6: US$2.5bn initial addressable market
US$2.5bn initial addressable market For personal use only At commercial launch, EBR estimates to have an addressable market of ~US$2.5bn initially Target Patient Groups Initial Addressable Market (US$) Acute Lead Failure $0.3bn Unable to implant CRT wire in a new CRT patient $0.4bn Chronic Lead Fail
Slide 7: Market Expansion
Market Expansion For personal use only TOTALLY LEADLESS CRT • Pair WiSE with a leadless RV pacemaker to achieve totally leadless CRT • Increased adoption of leadless pacemakers expands the need for WiSE ⎻ Approximately 30% of these patients will need CRT within 4 years ⎻ WiSE provides only means to
Slide 8: No direct competitors
No direct competitors For personal use only No other players are known to be developing wireless left ventricular (LV) pacing technology for CRT Right ventricle/Right atrium Left ventricle WiSE® fills the gap Currently the only leadless solution globally for LV pacing including CRT. Other wireless p
Slide 9: 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 10: 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 11: 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 12: 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 13: WiSE device update
WiSE device update For personal use only EBR is implementing a transmitter solution with no impact expected to PMA approval WiSE transmitter update Solution PMA submission • Ongoing technical assessments identified ✓ Identified a design solution ✓ Final PMA module to the FDA planned for a potential
Slide 14: Strong working relationship with the FDA
Strong working relationship with the FDA For personal use only Proven track record of successful engagement underpins confidence for final FDA approval processes 2016 2019 2020 2022 FDA granted FDA granted FDA approved trial FDA approved leadless Investigational Device Breakthrough Device re-design
Slide 15: US sales and distribution platform
US sales and distribution platform For personal use only EBR will leverage its established partnerships and presence in the US to drive initial sales growth Clinical trial sites to drive initial sales Specialist sales force established • Targeting ~45 US sites that have participated in previous • Ex
Slide 16: 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 17: Growth capital facility with Runway Growth Capital
Growth capital facility with Runway Growth Capital For personal use only Flexibility Capital risk mitigation Subsequent tranches can be Positive trial results unlock 2nd forgone in favour of equity finance tranche of funding US$50m Growth Capital Facility Protects from uncertainty Minimises dilution
Slide 18: 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 Final Module including transmitter upgrades 2023 ❑ Additional sub-studies published ✓ SOLVE-CRT 6 Month follow up using SOLVE dataset completed for fi
Slide 19: 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 20: 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] 20