EBR Systems, Inc. (ASX: EBR) (“EBR Systems”, “the Company”), developer of the world’s only left ventricular wireless cardiac pacing device for heart failure, is pleased to report the recent publication of two studies reporting on new, unapproved, clinical applications of the WiSE® System in patients suffering from heart failure.
Application 1: WiSE® used to deliver Totally Leadless LBBAP/CSP
Totally leadless cardiac resynchronisation therapy (CRT) achieved by pairing WiSE with a leadless pacemaker has been reported previously, [Carabelli, 2021] as has the use of WiSE to deliver left bundle branch area pacing (LBBAP) or conduction system pacing (CSP) paired with a conventional, lead-based pacemaker. [Elliott, 2022]
Now a recent study published in HeartRhythm Case Reports has examined the possibility of delivering Totally Leadless LBBAP/CSP by pairing with a leadless pacemaker. [Deschamps, 2025]
Author of the study, Prof. Pascal Defaye, Head of Arrhythmia Department at Grenoble Alpes University Hospital, Grenoble, France, said:
"Although combinations of leadless pacemakers and WiSE have been previously described to achieve totally leadless CRT, we were pleased to publish the first reported case series of totally leadless CRT combining WiSE-guided left bundle branch area pacing (LBBAP) with leadless pacemakers. WiSE is remarkable in that it can be paired with leadless pacemakers and it can access the left bundle branch from the left ventricle to achieve conduction system pacing (CSP)."
Application 2: WiSE® used to deliver CRT as an option to treat non-responder patients
Treatment of non-responder patients using WiSE has also been previously reported, [Sidhu, 2020] but a new study published in the Journal of Interventional Cardiac Electrophysiology pools data from three previously published studies. [Wijesuriya, 2025] The study’s goal was to demonstrate whether leadless CRT Is a viable second-line option for this high-risk patient population.
Author of the study, Prof. Christopher A. Rinaldi, Kings College, Guy’s and St Thomas’s NHS Foundation, London, UK, said:
"A significant number of patients do not respond to conventional CRT where the lead must be placed epicardially. This study provides further evidence that utilising WiSE to deliver leadless left ventricular endocardial pacing can lead to improved efficacy in patients who have not responded to conventional lead-based CRT."
Further applications of WiSE are now being Investigated
At this point in time, EBR Systems does not include either of the abovementioned applications in the Company’s total available market (TAM) calculations, as they are not approved in the United States.
EBR Systems is pleased that investigators will continue to evaluate additional new applications of WiSE in two upcoming clinical studies:
- The TLC-AU Study: A feasibility study into utilising the WiSE System along with a leadless pacemaker to achieve totally leadless CRT as a frontline therapy
- The ACCESS-CRT Study: a feasibility study further investigating leadless conduction system pacing with WiSE
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]