Highlights

  • First patient implanted in the Australian TLC-AU feasibility study evaluating totally leadless CRT.
  • Study examines combined use of the WiSE System and a leadless pacemaker for de novo CRT cases.
  • Trial outcome may expand EBR’s addressable CRT market by targeting newly diagnosed patients.

EBR Systems, Inc. (ASX:EBR) announced the successful first enrolment and implant of its WiSE® System in the Totally Leadless Cardiac Resynchronisation Therapy (TLC-AU) study. The first procedure was carried out on 11 December at the Princess Alexandra Hospital in Brisbane by electrophysiologist Dr Paul Gould.

The implant involved combining EBR’s WiSE System with the Abbott Aveir™ DR leadless pacemaker, forming part of a feasibility trial exploring a fully leadless approach to CRT. The announcement marks an important milestone as the company assesses WiSE’s potential application beyond upgrade cases.

Expanding the Scope of Leadless CRT
While the WiSE System is already included in FDA-approved labelling for patients with an existing leadless pacemaker who develop pacing-induced heart failure requiring CRT, the TLC-AU study aims to take this further. It will focus on newly diagnosed heart failure patients requiring CRT—referred to as de novo patients.

This patient category represents about 75% of the overall CRT market. By evaluating a leadless pacemaker paired with the WiSE System at the first point of CRT treatment, EBR is examining whether the technology can broaden its therapeutic scope and become applicable at the initial stage of treatment.

Study Design and Objectives
Sponsored by EBR Systems, the TLC-AU study is structured as a single-arm, prospective, multi-centre feasibility trial. The study intends to enrol between 20 and 40 participants across up to five Australian clinical centres. It includes patients receiving CRT for the first time as well as those upgraded from existing intracardiac pacemakers.

Each enrolled participant will be monitored for six months.

  • Primary objective: Evaluate the safety and efficacy of co-implanting the WiSE CRT System with an intracardiac pacemaker to achieve totally leadless CRT.
  • Secondary objective: Assess clinical response at six months compared with baseline for patients receiving therapy through the combined system.

Procedural Significance
The first implant sheds light on how future therapeutic pathways might incorporate fully leadless CRT configurations. By generating clinical evidence in a newly diagnosed patient group, the TLC-AU study may define potential use cases for broader adoption within the CRT landscape.

Share Price Snapshot
EBR was trading 1.93% higher at AUD 0.922 per share as of 12 December 2025.