Sunnyvale, California; 6 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, today announced that management will be participating at the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum on Thursday, November 20, 2025 at The Westin Grand Central in New York, NY and the first patient has now been enrolled in the WiSE® System Utilization & Performance (WiSE-UP) Study.
The WiSE-UP post-approval study enrols commercially-treated patients to gather real-world evidence for the WiSE left ventricular endocardial pacing system.
Key Highlights:
• The first two patients have now been enrolled in the WiSE-UP post-approval study by Dr Devi Nair from St Bernards Heart & Vascular Center, Arkansas
• The EBR-sponsored study will evaluate real-world outcomes for heart failure patients receiving the FDAapproved WiSE® System for cardiac resynchronization therapy (CRT)
• The study will follow more than 300 patients across 50 US centers over a five-year period, and will generate both short- and long-term performance metrics
The first two patients in the WiSE-UP Study were treated at the St Bernards Heart & Vascular Center, Arkansas, on Tuesday 4 November 2025 (US time) by globally-respected electrophysiologist Dr Devi Nair. This achievement marks a significant milestone in the advancement of CRT for heart failure patients.
The WiSE-UP Study, sponsored by EBR Systems, is a prospective observational study designed to evaluate real-world outcomes for heart failure patients receiving the FDA-approved WiSE System utilising left ventricular endocardial pacing (LVEP) for CRT. The study will follow more than 300 commercial patients across 50 centers over a five-year period and will generate both short- and long-term performance metrics.
"It was an honour to lead the team performing the first WiSE System implant as part of the WiSE-UP Study,” said Devi Nair, MD, FACC, FHRS, Electrophysiologist at St. Bernards Heart & Vascular Center. “Our entire team is proud to contribute to this important study, which we believe will further demonstrate the benefits of left ventricular endocardial pacing for patients with heart failure. We look forward to continuing our collaboration with EBR Systems as we work together to advance innovation in cardiac resynchronization therapy and improve patient outcomes.”
Niraj Varma, MD, PhD, FRCP, Professor of Medicine at the Cleveland Clinic and the National Principal Investigator for the study said: "The launch of the WiSE-UP Study marks an exciting moment in cardiac resynchronization therapy. This study will evaluate the application of left ventricular endocardial pacing in real world practice, capture important clinical outcomes over time, and assess sustained therapeutic impact of the WiSE System. I am proud to lead this initiative that will continue to develop the standards of care for heart failure patients."
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]
