EBR Systems (EBR) 44th Annual J.P. Morgan Healthcare Conference summary

Market opportunity and product differentiation

• Introduced the only leadless pacemaker for left ventricular pacing, addressing a critical gap in cardiac resynchronization therapy and offering a unique, complementary solution with no direct competition.

• FDA approval and reimbursement secured, with a disciplined commercial rollout and manufacturing scale-up underway.

• The total addressable market (TAM) in the U.S. is estimated at $5.8 billion, with a recent price update to $55,000 per system.

• Leadless upgrades and high-risk upgrades are the fastest-growing segments, driven by the shift from lead-based to leadless systems.

• The system is compatible with both lead-based and leadless devices, enabling modular therapy for complex patient needs.

Industry trends and competitive landscape

• The cardiac rhythm management market is shifting rapidly toward leadless systems, with major incumbents like Medtronic, Abbott, and Boston Scientific expanding their leadless portfolios.

• Leadless pacemakers now account for 50% of the U.S. pacemaker market, with projections for full adoption in the coming years.

• EBR’s system is the only one capable of providing leadless left ventricular pacing, filling a gap not addressed by competitors.

• The modularity of the system allows for combination therapies, improving outcomes for patients with complex needs.

Commercialization and financial performance

• Limited market release began in Q4 2025, with a focus on high-volume, early-adopter centers and a cautious, sequential expansion strategy.

• Eight sales territories established, with plans for gradual expansion as traction increases.

• Early revenue reached $1.5 million for the year, with cases doubling from Q3 to Q4 and 22 contracts signed by year-end.

• Reimbursement programs (TPT and NTAP) provide up to $63,300 per procedure, supporting a high average selling price.

• Participation in Medicare’s TCET program accelerates national coverage, reducing the typical multi-year wait for new device reimbursement.