EBR : Annual Report to Stockholders

Contents

• 2 Chairman's Letter

• 3 CEO's Letter

• 4 Operational Highlights

• 6 Operational Review 2021

• 9 WiSE® Technology Overview

• 23 Initial Addressable Market

• 24 Directors' Report and Financial Statements

• - 31 December 2021

• 25 Remuneration Report

• 30 Board of Directors

EBR Systems ARBN 654 147 127

• 33 Consolidated Balance Sheets

• 34 Consolidated Statements of Operations and Comprehensive Loss

• 35 Consolidated Statements of Stockholders' Equity (Deficit)

• 36 Consolidated Statements of Cash Flows

• 38 Notes to Consolidated Financial Statements

• 60 Independent Auditor's Report

• 62 Shareholder Information

• 69 Corporate Directory

EBR Systems is driven to deliver superior treatment for millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective and reliable therapies using wireless cardiac stimulation.

Letter from the Executive Chair

On behalf of the Board of Directors and management of EBR Systems, Inc ( ), I am excited to present EBR's first public annual report for the 2021 financial year.

EBR is focused on the development of WiSE® - the world's first and only inside-the-heart leadless cardiac pacing device for heart failure. Most patients with heart failure require a treatment called cardiac resynchronisation therapy (CRT), to stimulate the left ventricle and coordinate the beating of the left and right sides of the heart. Traditional CRT devices use leads (wires) to deliver energy to the heart; however, many patients are unable to receive effective CRT because their anatomy or disease prevents the use of leads. Our WiSE® device provides an alternative solution by providing leadless CRT to patients who would otherwise suffer poor prognosis. In 2022, we received FDA approval for the inclusion of other commercially available leadless pacemakers in the SOLVE-CRT pivotal trial which increased our initial addressable market by ~US$400m, taking us to a US$2.5bn1 annual addressable market in 2024.

EBR made headway late last year with its admission to the official list of the Australian Securities Exchange (ASX) on 24 November 2021. This was underpinned by a successful A$110m Initial Public Offering (IPO), which was strongly supported by our earlier venture investors including M.H Carnegie & Co, Brandon Capital and superfunds Australian Super, HESTA, Hostplus and Statewide Super, who collectively contributed more than A$30m. We received significant investor interest and were pleased to welcome a host of other institutional and retail shareholders to the register. The funds raised will be allocated towards the Company's SOLVE-CRT pivotal trial, pursuing FDA approval, and to support commercialisation of WiSE® in the U.S. and other initial target markets.

The market has indeed been turbulent since we became public. Nonetheless, we have remained resilient and continue to be on track to meet our goals as outlined in the prospectus, with the Company rapidly embracing virtual and remote working practises operationally. The pandemic has had no material impact on SOLVE-CRT pivotal trial recruitment, which is still scheduled to complete by the first half of 2022. EBR is led by a highly experienced management team with significant expertise in the development, scale and commercialisation of medical device technologies. I have the highest confidence in this team's ability to advance WiSE® from development through to commercialisation and ultimately help patients suffering from heart failure.

Currently, our key focus areas are completing the SOLVE-CRT pivotal trial, research and development, and preparing for commercialisation. We continue to expand and establish our internal sales force with the aim of targeting high volume CRT procedure sites in the US and key target markets. This will be supported by the relationships we have fostered with clinical sites who have historically participated in our clinical trials. In addition to this, we have a comprehensive regulatory strategy and have a well-established and open line of communication with the FDA with priority review of regulatory submissions due to our Breakthrough Device Designation.

I would like to take this opportunity to thank my fellow Board members, our CEO and President John McCutcheon, and the entire EBR Systems team for their continuous devotion and determination. We also welcomed three new Board members in 2021: Dr Bronwyn Evans, Dr David Steinhaus and Ms Karen Drexler, who bring a wealth of clinical and commercial experience across the healthcare industry, which are of significant value to EBR. Their guidance and leadership will be critical as EBR embarks on its next growth phase. I would like to finally thank our shareholders, for their extensive and ongoing support. We look forward providing further updates on the Company's progress.

Yours sincerely,

ALLAN WILL

Executive Chair, EBR Systems Inc.

1. Other pages in this document contain references to EBR Systems' initial addressable market pre-FDA approval for the inclusion of other leadless pacemakers, which is US$2.1bn annually.

Letter from the CEO

Last year was a defining year in EBR Systems, Inc's (EBR) trajectory, with its transformation from a private company to a publicly listed company on the Australian Stock Exchange. I feel privileged to lead the Company during such an exciting and pivotal period, and I am committed to see WiSE® through to becoming an accessible, commercially available product for people who are unable to receive effective cardiac resynchronisation therapy (CRT). The first clinical trial for WiSE® was conducted in 2011 and today we are conducting our final pivotal study and are well positioned to commercialise our proprietary technology by the end of 2023.

During the year, our operating expenses reached US$22.8m, an increase of US$2.2m compared to the prior year. This was underpinned by an increase in field expenses to continue the SOLVE-CRT pivotal trial and to increase the number of clinical sites participating in the trial. We ended the year with a cash position of US$78.2m, strengthened significantly by the IPO.

Our key focus has been progressing the SOLVE-CRT pivotal trial. The randomised phase (first phase) of the SOLVE-CRT pivotal trial was completed in 2020 and the single-arm phase (second phase) is currently recruiting patients and is set to finish enrolment for interim analysis by the first half of 2022. Previous clinical trials of WiSE® exceeded the efficacy and safety performance goals set for the current pivotal trial, and the FDA has provided extensive guidance with regards to the trial design, de-risking the clinical and regulatory pathways to commercialisation.

Our current initial addressable market is US$2.5bn1 annually, which we estimate will grow to approximately US$7.1bn by expanding the use of WiSE® into other patient groups and geographies. To support this growth potential, EBR continued its collaboration on two other, investigator-initiated clinical projects which may lead the way to expanded indications.

The first is the Totally Leadless CRT trial which pairs WiSE® with a leadless intracardiac pacemaker, and the second is the Achieving Conduction System Activation with Left Ventricular Septal Endocardial Leadless Pacing (ACCESS-CRT) study which will evaluate the ability to activate the heart's native conduction system with WiSE®. These additional studies address patient groups outside the current core focus of lead failures and upgrades, which pave the way for WiSE® to become a de-novo treatment option for heart failure patients.

On top of this, we strengthened our management team with the appointment of Mr Michael Hendricksen as Chief Operating Officer, Mr Steve Sandweg as Chief Commercial Officer and the promotion of Ms Madhuri Bhat to Chief Regulatory Officer. I am extremely proud of the team's achievements over 2021 and I believe the senior management team is best placed to deliver on our goals and drive clinical development and commercialisation activities forward.

I would like to thank the Board, for their ongoing counsel, the EBR team, for their hard work and dedication, and our shareholders for their optimism and support. We are committed to building a sustainable company that delivers better and safe treatment options for patients.

Yours sincerely,

JOHN McCUTCHEON

President & CEO, EBR Systems Inc.

1. Other pages in this document contain references to EBR Systems' initial addressable market pre-FDA approval for the inclusion of other leadless pacemakers, which is US$2.1bn annually.