EBR Systems (EBR) Investor Presentation summary

Investment highlights and market opportunity

• World's first and only leadless pacemaker for heart failure, targeting a US$3.6bn initial addressable market.

• WISE CRT System is the only leadless device delivering CRT, with no direct competition and strong patent protection.

• Cardiac rhythm management market valued at ~US$13.6bn, with CRT, defibrillation, and pacing as key segments.

• Well funded with a pro forma cash balance of ~US$74.2m as of September 2024.

Product differentiation and clinical results

• Traditional CRT systems have limitations due to leads, including migration, infection risk, and placement challenges.

• WISE CRT System is the only wireless solution for left ventricle pacing, compatible with other leadless pacemakers.

• Protected by over 97 issued patents globally.

• SOLVE-CRT pivotal study met all safety and efficacy endpoints, showing significant improvement in heart function and low complication rates.

• Strong support from global key opinion leaders, highlighting the system's ability to treat previously failed patients.

Regulatory and commercialisation pathway

• FDA Breakthrough Device Designation and positive pivotal trial results underpin a clear path to approval.

• FDA approval expected on or before 13 April 2025, with commercial launch planned for H2 2025.

• Targeting high-volume US CRT procedure sites and leveraging KOL support for initial adoption.

• Low hospital adoption barriers, with no capital equipment required and reimbursement available post-approval.

• Direct specialist sales force and manufacturing capabilities in place to meet early demand.