EBR Price sensitive 19 Mar 2026, 8:21 AM

2025 Activity Report and Form 10-K submission

EBR Systems Inc

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.

Summary generated by a large language model. Please interpret with care.

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