First implant in the Totally Leadless CRT (TLC-AU) Study
EBR Systems, Inc. (ASX:EBR)
Key Highlights
• First patient enrolment and implant in the Totally Leadless CRT (TLC-AU) study by Dr Paul Gould from the Princess Alexandra Hospital, Brisbane
• TLC-AU is a feasibility study into using the WiSE® System alongside a leadless pacemaker to achieve totally leadless CRT
• The study represents a significant strategic milestone as EBR evaluates WiSE as a potential first-line therapy for treating newly diagnosed heart failure patients
• TLC-AU could meaningfully expand EBR’s addressable market
Sunnyvale, California; 12 December 2025: EBR Systems, Inc., developer of the world’s only wireless cardiac pacing device for heart failure, announces the first enrolment and implant of the WiSE System into a patient in the Totally Leadless CRT (TLC-AU) study.
The procedure, performed on Thursday 11 December (Australian time), was undertaken at the Princess Alexandra Hospital in Brisbane, Australia, by respected electrophysiologist Dr Paul Gould. The WiSE System was implanted alongside an Abbott Aveir™ DR leadless pacemaker.
Totally Leadless CRT, pairing EBR’s WiSE System with a leadless right ventricle pacemaker, has been previously published1 , and is already included in the FDA-approved labelling for patients with an existing leadless pacemaker who subsequently develop pacing-induced heart failure and require an upgrade to CRT.
The TLC-AU study will build on this previous published experience by treating newly diagnosed heart failure patients requiring CRT. These de novo patients will receive a leadless pacemaker and the WiSE System. De novo patients account for around 75% of the CRT market, meaning this indication has the potential to significantly expand EBR’s total addressable market and establishing WiSE as a potential first-line option for patients requiring CRT.
John McCutcheon, President & CEO of EBR Systems, said: “The first implant in the TLC-AU Study is a significant milestone for EBR, marking our entry into the much larger frontline CRT market. TLC-AU allows us to build on the FDAlabelled upgrade indication and generate the evidence needed to position WiSE CRT as a fully leadless alternative for patients requiring resynchronisation therapy. As leadless pacing rapidly becomes standard of care, advancing a totally leadless CRT solution strengthens EBR’s leadership in the next major evolution of heart-failure treatment.”
Dr Paul Gould, MBBS, FRACP, FCANZ, Principal Investigator for the study said: “It was a privilege to lead the team completing the first Totally Leadless CRT implant in this feasibility study. The team at Princess Alexandra Hospital was proud to contribute to this important milestone and to support the evaluation of a totally leadless cardiac resynchronisation option for heart failure patients. We believe this study will provide valuable insights into the role that Totally Leadless CRT may play in expanding treatment options for suitable patients in the future.”
To read the full announcement, please click here
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
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