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 unique, with no direct competition and is complementary to other leadless devices.

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

• Well-capitalised with US $66.0m in cash and short-term investments as of 31 December 2024.

Product innovation and clinical results

• WISE CRT System is the only wireless device delivering CRT, overcoming limitations of traditional lead-based systems.

• Protected by over 97 issued patents globally, offering strong competitive protection.

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

• Positive results in high-risk patients who failed conventional CRT, with complication rates decreasing over time.

• Strong endorsements from global key opinion leaders highlight clinical impact and future potential.

Regulatory and commercialisation pathway

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

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

• US market dynamics support adoption: concentrated CRT market, low hospital adoption barriers, and reimbursement pathways established.

• Target US average selling price for WISE CRT System is US $45,000, with reimbursement via NTAP and TPT schemes.