EBR Systems (ASX:EBR) has secured priority review determination from the Therapeutic Goods Administration for its innovative WiSE cardiac resynchronisation therapy system.
The regulatory breakthrough slashes the expected evaluation period from 225 working days to approximately 150, clearing an accelerated path for the device’s inclusion on the Australian Register of Therapeutic Goods.
The WiSE System represents a paradigm shift in cardiac rhythm management, functioning as the world’s only wireless endocardial pacing technology.
Approximately the size of a grain of rice, the device is specifically engineered for heart failure patients who have failed to respond to, or are ineligible for, conventional lead-based treatments. By eliminating the need for coronary sinus leads—historically a primary source of clinical complications and reliability issues—the WiSE System enables more anatomically precise stimulation from within the heart’s left ventricle.
Following the TGA’s decision, EBR Systems intends to lodge its formal ARTG application imminently.
This follows a commercial launch in the United States, where the device received FDA approval in April 2025.
EBR CEO John McCutcheon noted that the TGA’s recognition reflects the system’s potential to address a high unmet clinical need for seriously debilitating conditions.
If approved, the accelerated timeline will ensure that Australian heart failure patients gain earlier access to this wireless pacing alternative.
At the time of reporting, EBR Systems’ share price was $0.64.