2025 Activity Report and Form 10-K submission
Key points
- FDA approval for the WiSE® CRT System on 11 April 2025
- First U.S. commercial implants successfully completed in June 2025
- U.S. reimbursement pathway established with CMS allowing a US$63,300 contract price
Full summary
EBR Systems, Inc. (ASX: 'EBR', 'EBR Systems', or the 'Company'), developer of the world's only wireless cardiac pacing device for heart failure, released its Annual Activity Report and Form 10-K submission for the year ended 31 December 2025. Key highlights include: FDA approval for the WiSE® CRT System on 11 April 2025, enabling the start of U.S. commercial launch with first implants in June 2025; establishment of dedicated reimbursement pathways in both inpatient and outpatient settings, providing a strong foundation to support adoption as the company scales; strong commercial momentum through 2H 2025, including 30 total commercial implants across pilot phase and Limited Market Release by year end, with 2025 revenue of US$1.6m/ A$2.4m; commencement of the WiSE-UP post-approval study and the TLC-AU feasibility study; and a successful A$79.5m capital raise completed in Q2 2025, providing the company well-capitalised through to initial commercialisation.
Guidance
EBR Systems reported 2025 revenue of US$1.6m/ A$2.4m, with the company well-capitalised through to initial commercialisation, holding cash, cash equivalents, and marketable securities of US$54.2m/ A$81.1m as of 31 December 2025.
Outlook
EBR Systems enters 2026 focused on disciplined commercial execution, broadening physician access, and continuing to generate clinical evidence to support long-term growth. The company is proud of the team's execution during this pivotal year and remains committed to delivering this differentiated therapy to patients who need improved CRT outcomes.
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