- The disease
- Heart failure is a condition in which the heart cannot pump enough blood to meet the body's needs. In some patients, the two lower chambers of the heart beat out of sync, which worsens pump function. Cardiac resynchronization therapy (CRT) uses electrical signals to coordinate the heartbeat across both chambers. CRT is delivered through leads — thin wires threaded through blood vessels and into the heart — but placing those leads can be difficult or impossible in a subset of patients.
- What the asset is trying to do
- The WiSE CRT System is an implantable cardiac device that delivers resynchronization therapy wirelessly, without a lead placed in the left ventricle (the heart's main pumping chamber). An ultrasound transmitter implanted under the ribs sends energy to a small receiver electrode fixed to the left ventricle wall, which then delivers the pacing signal. The two trials listed (per ClinicalTrials.gov NCT06561932 and NCT05451797) study the WiSE CRT System in combination with a separate intracardiac pacemaker, aiming to achieve a fully leadless CRT configuration.
- What the trial is measuring, and why it matters
- The primary endpoint for the lead feasibility trial (NCT06561932) is (per ClinicalTrials.gov NCT06561932). CRT trials commonly assess whether the device successfully resynchronizes the ventricles and whether patients experience improvements in heart function or symptoms, though the specific endpoints for this study should be confirmed from the registry record. Secondary endpoints are listed separately below.
- Efficacy benchmarks in this setting
- In conventional lead-based CRT, pivotal trials have reported response rates (typically defined as a clinically meaningful improvement in a composite of symptoms, function, or hospitalisation) in approximately 60-70% of appropriately selected patients, with reductions in all-cause mortality and heart failure hospitalisation observed versus medical therapy alone (per Cleland et al, New England Journal of Medicine 2005, CARE-HF trial; and Abraham et al, New England Journal of Medicine 2002, MIRACLE trial). The WiSE CRT System's early-stage feasibility data are not statistically comparable to these pivotal trial outcomes, as study populations, endpoints, and design differ.
- Commercial context
- EBR Systems disclosed commercial activity in a quarterly activities report dated 8 April 2026, describing growth in commercial cases during Q1 2026 (per ASX announcement 8 April 2026). The WiSE CRT System has received CE Mark approval in Europe and FDA approval in the United States for specific indicated populations; the exact scope of those approvals should be confirmed from the relevant regulatory agency records. details on disclosed deal comparables, manufacturing arrangements, or the asset's standing relative to other pipeline assets within EBR Systems.