Key Highlights:
- EBR secured CMS approval for NTAP reimbursement for inpatient use of the WiSE CRT System, effective 1 October 2025, establishing a reimbursement pathway for the novel WiSE CRT System for Medicare inpatients
- CMS approval was also received for TPT reimbursement for outpatient settings, completing a comprehensive Medicare pathway across inpatient and outpatient care
- Case volume tripled from Q2 to Q3 2025 with the WiSE System successfully implanted in a total of 12 commercial patients during the pilot launch phase between FDA approval and 30 September 2025
- EBR recorded US$0.512 million of revenue in Q3 2025, up 201% from Q2 2025
- Limited Market Release preparations advanced during Q3 2025, with 8 additional purchasing agreements signed and 14 physicians trained ready to support adoption of WiSE
- EBR holds cash, cash equivalents, restricted cash marketable securities of US$73.0m / A$110.4m1 as at 30 September 2025
Sunnyvale, California; 13 November 2025: EBR Systems, Inc. (ASX: “EBR”, “EBR Systems”, or the “Company”), developer of the world’s only wireless cardiac pacing device for heart failure, is pleased to release its Quarterly Activity Report and Form 10-Q submission for the September quarter (“Q3 2025”).
CMS approval of NTAP reimbursement for inpatient use
During the quarter, Centers for Medicare & Medicaid Services ("CMS") confirmed New Technology Add-on Payment ("NTAP") for inpatient use of the WiSE CRT System ("WiSE"). The program commenced on 1 October 2025 and provides an add-on reimbursement at the maximum level of up to US$41,145 per eligible case, paid in addition to the relevant Diagnosis-Related Group ("DRG"). CMS has set this level based on an average WiSE selling price of US$63,300 and will remain in place for three years while claims data are collected. The Company plans to petition CMS during the second year to move WiSE procedures to a DRG that fully covers the device and procedure, which is the usual pathway for durable reimbursement. In the near term, NTAP narrows the funding gap for hospitals, gives budgeting certainty to capital and value analysis committees, and aligns with the timing of Limited Market Release activities.
CMS approval of TPT reimbursement for outpatient use
CMS also approved Transitional Pass Through ("TPT") reimbursement for outpatient cases, effective 1 October 2025 and in place for three years. The agency assigned HCPCS code C1740, which provides a separate payment outside the Ambulatory Payment Classification for eligible procedures. The intent of TPT is to support hospital adoption of technologies that deliver substantial clinical improvement but are not yet fully costed within standard payment rates. Practical implications include clearer coding and billing workflows for finance teams and improved predictability for supply chain and scheduling. Taken together with the inpatient decision, TPT completes the reimbursement framework across care settings and strengthens the business case for centres to adopt WiSE in both admitted and day procedure environments.
John McCutcheon, EBR Systems’ President & Chief Executive Officer said:
“During the September quarter we secured the remaining elements of the United States Medicare payment pathway for WiSE CRT, with CMS confirming New Technology Add-on Payment for inpatient cases and Transitional Pass Through for outpatient procedures, both effective 1 October 2025. These decisions provide hospitals with clear funding arrangements across care settings and support the commencement of our Limited Market Release. We completed our twelfth United States commercial implant and continued to build utilisation at targeted centres. Manufacturing expansion in Santa Clara, California, which is intended to support scaling, remains on track to be completed in 2026. Our focus remains on consistent execution and patient outcomes, and I thank our clinicians, employees, partners and shareholders for their continued support.”
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About us:
About EBR Systems
Silicon Valley-based EBR Systems (ASX: EBR) is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications, effectiveness and reliability issues in cardiac rhythm disease management. The initial product is designed to eliminate the need for coronary sinus leads to stimulate the left ventricle in heart failure patients requiring Cardiac Resynchronisation Therapy (CRT). Future products potentially address wireless endocardial stimulation for bradycardia and other non-cardiac indications.
About the WiSE Technology
EBR Systems’ WiSE technology is the world’s only wireless, endocardial (inside the heart) pacing system in clinical use for stimulating the heart’s left ventricle. This has long been a goal of cardiac pacing companies since internal stimulation of the left ventricle is thought to be a potentially superior, more anatomically correct pacing location. WiSE technology enables cardiac pacing of the left ventricle with a novel cardiac implant that is roughly the size of a large grain of rice. The need for a pacing wire on the outside of the heart’s left ventricle – and the attendant problems – are potentially eliminated. WiSE is an investigational device in most markets and is currently only available for sale in the US.
Contact details:
Andrew Shute
EBR Systems, Inc. (ASX:EBR)
Chief Corporate Development Officer
[email protected]
www.ebrsystemsinc.com
Investor relations
Julia Maguire
The Capital Network
[email protected]