EBR Systems, Inc. has successfully completed the 183-patient interim enrolment in the pivotal SOLVE-CRT IDE ("SOLVE") trial of WiSE®. Following the 6-month follow up of the last patient, EBR expects to release headline results in First Quarter 2023. The SOLVE trial is evaluating the safety and efficacy of the WiSE® System in up to 300 patients with acute lead failures, chronic lead failures, high-risk upgrades and leadless upgrades.

The primary endpoints for the SOLVE trial are: Efficacy endpoint: >9.3% improvement in heart function measured by a reduction in left ventricular end systolic volume Safety endpoint: <30% of patients with device or procedure-related complications Outcomes from previous clinical trials of WiSE® have exceeded the efficacy and safety endpoints set for the SOLVE trial, de-risking the clinical pathway. In addition, EBR has engaged extensively with the FDA, including being awarded Breakthrough Device Designation which provides greater access to the FDA and initial payment coverage. This combination of factors underpins EBR's confidence in the of WiSE®.

EBR is targeting pre-market approval (PMA) submission for US Food and Drug Administration (FDA) approval in 2H 2023. The Company estimates an initial annual addressable market of USD 2.5 billion for WiSE®. To highlight the significance of this market size - assuming a $1.5 billion initial addressable market in the US in 2024 and an average selling price of USD 35,000, just ~10% of the market share will generate potential sales of ~$150 million in the first year of commercialisation.

EBR plans to launch in Australia and key European markets as well, further unlocking revenue potential and shareholder value.