EBR Systems (ASX: EBR) has secured Priority Review Determination from the Therapeutic Goods Administration (TGA) for its WiSE cardiac resynchronisation therapy (CRT) system, opening an accelerated path toward Australian market entry.
The decision shortens the expected evaluation period for the WiSE System from the standard 225 working days to about 150 working days and positions the company to seek earlier inclusion on the Australian Register of Therapeutic Goods (ARTG).
EBR intends to submit its ARTG inclusion application in the near term, with approval expected to support earlier access in Australia for heart failure patients who have not benefited from conventional lead-based cardiac resynchronisation therapy.
The TGA milestone adds to a period of regulatory and commercial progress for the company, following US Food and Drug Administration (FDA) approval of the WiSE System in April 2025 and the early stages of US commercial activity and revenue generation.
Australian Review Moves to Faster Track
EBR lodged its submission with the TGA on 12 March 2026 and believes the regulator’s decision reflects the WiSE System’s potential to address a serious condition with a high unmet clinical need.
The grant represents a significant regulatory milestone because it should allow the device to reach the Australian market sooner than would otherwise be expected under the standard review timetable.
That review pathway is intended for breakthrough medical devices targeting life-threatening or seriously debilitating conditions, which EBR said fits the clinical setting for the WiSE System.
Chief executive officer John McCutcheon called the determination “an important step in expanding access to the WiSE System beyond the US [that] reflects the technology’s potential to meet a significant need for heart failure patients in Australia.”
Patients with Limited Options Targeted
EBR describes WiSE as the world’s only wireless endocardial pacing system in clinical use for stimulating the left ventricle of the heart.
The device is designed for heart failure patients requiring cardiac resynchronisation therapy.
It aims to eliminate the need for coronary sinus leads, which have historically been a major source of complications, effectiveness issues, and reliability problems in cardiac rhythm disease management.
WiSE offers a leadless pacing option for patients who cannot receive or do not respond to conventional lead-based therapy, giving it a differentiated position in the market.
The implant itself is roughly the size of a large grain of rice, and enables pacing inside the heart’s left ventricle, which is seen as a potentially superior and more anatomically correct stimulation location.
US Approval Supports Global Expansion
EBR expects the FDA approval secured in April 2025 to provide the foundation for its Australian Priority Review submission and support its push to broaden commercial access beyond the US.
Mr McCutcheon said the combination of FDA approval, early US commercial momentum, and growing clinical validation left the company well placed to work through the Australian review process.
If WiSE is added to the ARTG, EBR would gain an earlier route into the Australian market at a time when it is already building its commercial footprint in the US.
The Australian review therefore represents not just a regulatory milestone but a further step in broadening access to its wireless cardiac pacing technology across markets.
