Q3 2026 Commercial Update

• Q3 implant volumes were below forecast, attributed to commercial strategy realignment
• FDA completed inspection of new manufacturing facility with two observations
• EBR expects Q3 revenue in the range of US$2.43M to US$2.53M
• CMS finalized increased Medicare reimbursement for eligible WiSE procedures
• FDA agreed no immediate field corrective action needed for echo-induced pacing issue

EBR Systems, Inc. reported a Q3 2026 commercial update, noting that implant volumes were below prior forecasts, particularly in September. The company attributes this to commercial leadership transitions, refocused commercial execution strategy, and additional field training requirements. The realignment of the U.S. commercial organization, including the promotion of Michael Sot to Director of U.S. Sales, is expected to strengthen U.S. commercial execution. The FDA completed its pre-approval inspection of the new Santa Clara manufacturing facility, noting two observations. EBR expects to report revenue in the range of US$2.43M to US$2.53M for Q3 2026. The facility achieved ISO 13485 certification and has the potential to manufacture 9,600 systems annually, representing ~US$607.6M in revenue. The final tranche of the A$150 million capital raising closed in August.

EBR expects Q3 2026 revenue in the range of US$2.43M to US$2.53M.

EBR expects the refocused commercial strategy, expanded field team, increased Medicare reimbursement, and new manufacturing facility to support the next phase of U.S. commercial adoption.