EBR Systems (EBR) Investor presentation summary

Investment highlights

• Only fully leadless CRT device, WISE System, with no direct competitors and complementary to other pacemakers.

• FDA PMA approval received in April 2025, supported by breakthrough device designation and strong clinical data.

• Premium reimbursement secured: CMS approval for NTAP and TPT at $63,300, and first technology accepted in TCET program.

• Large initial addressable US market of $5.8bn, targeting patients with limited or no other options.

• Clear commercial strategy with experienced team, manufacturing expansion underway, and full transition to new facility by end of H2 2026.

Major milestones

• Achieved world's first leadless CRT and LBBAP, with key regulatory and clinical milestones from 2018 to 2025.

• SOLVE-CRT enrollment completed in 2022, results released in 2023, and published in JAMA Cardiology in 2024.

• Passed FDA facility inspection and received FDA approval in early 2025.

• NTAP and TPT reimbursement approvals in mid-2025, with limited market release initiated in October 2025.

• First commercial US patient and first TLC-AU implant completed in 2025.

Market opportunity

• Cardiac rhythm management market valued at $18.4bn globally, with CRT segment at $5.6bn.

• WISE System addresses lead-related complications, offering a safer, leadless alternative.

• Rapid adoption of leadless devices, with WISE enabling totally leadless CRT upgrades.

• US total addressable market of $5.8bn, including high-risk upgrades and lead failures.

• Fastest growing segment: leadless upgrades for patients with high risk for conventional CRT.