EBR Systems submits TGA ARTG application for WiSE System
EBR Systems has submitted its application to the Therapeutic Goods Administration (TGA) for inclusion of the WiSE® System on the Australian Register of Therapeutic Goods (ARTG), announced on 20 October 2026. The application is expected to be assessed under the Priority Review Determination granted in April 2026, which is expected to reduce the target evaluation period through front-of-queue prioritisation.
The submission is the next regulatory step towards potential market entry in Australia. Subject to TGA approval, that would expand the company’s commercial footprint beyond the U.S.
Key highlights from the announcement:
- Formal TGA application submitted for inclusion of the WiSE System on the ARTG
- Assessment expected under the Priority Review Determination granted in April 2026
- Potential Australian market entry, subject to TGA approval
- If approved, inclusion would support earlier access for Australian heart failure patients who have failed to benefit from conventional therapies
John McCutcheon, President & Chief Executive Officer
“Submitting our ARTG application is an important step towards making the WiSE System available to patients outside the U.S….”
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What Priority Review means for investors
Understanding the Priority Review pathway
The Priority Review pathway is designed to accelerate the evaluation of breakthrough medical devices that address life-threatening or seriously debilitating conditions where there is a high unmet clinical need. The ARTG is the register on which a therapeutic device is included for supply in Australia.
Under this pathway, the target evaluation period is expected to be reduced by providing front-of-queue prioritisation. The timing and outcome of the TGA’s assessment remain subject to the TGA’s review and cannot be guaranteed, and the announcement does not disclose a specific timeline.
The Priority Review Determination cut the target Australian evaluation window from 225 to approximately 150 working days, though it does not guarantee approval or fix a decision date.
| Step | Status | Detail |
|---|---|---|
| Priority Review Determination | Granted | April 2026 |
| ARTG application | Submitted | 20 October 2026 |
| TGA assessment | Pending | Timing and outcome cannot be guaranteed |
Why the WiSE System application is supported
The application is supported by the WiSE System’s U.S. Food and Drug Administration (FDA) approval. According to Mr McCutcheon, it is also supported by the company’s clinical data.
Supporting evidence continues to build, with real-world implant data from the first 100 US commercial procedures presented at the APHRS 2026 meeting, showing acute QRS reduction regardless of electrode location.
If the WiSE System is included on the ARTG, EBR expects to be able to offer Australian clinicians and heart failure patients a leadless left-ventricular pacing option. This is aimed specifically at those who have failed to benefit from conventional lead-based Cardiac Resynchronisation Therapy (CRT).
EBR describes its WiSE technology as the world’s only wireless, endocardial (inside the heart) pacing system in clinical use for stimulating the heart’s left ventricle. The implant is roughly the size of a large grain of rice.
The company notes that WiSE is an investigational device in most markets and is currently only available for sale in the US.
Next steps for EBR Systems
The next milestone is the outcome of the TGA’s assessment. Mr McCutcheon said the company looks forward to “working with the TGA through the Priority Review process and, subject to its assessment, to making WiSE available to Australian patients.”
The announcement does not disclose commercial plans or revenue guidance for Australia. Investors may wish to watch:
- Progress of the TGA assessment
- Inclusion of the WiSE System on the ARTG
- Any resulting Australian commercialisation update
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