Key Highlights

  • Application to list the WiSE System on the Australian Register of Therapeutic Goods was lodged with the TGA
  • The TGA granted the WiSE System a Priority Review Determination in April 2026
  • The WiSE implant, comparable in size to a large rice grain, paces the left ventricle without leads
  • EBR expects to offer Australian patients who failed to benefit from lead-based CRT a leadless pacing option

EBR Systems, Inc. (ASX:EBR) announced on 20 October 2026 that it has formally submitted an application to Australia's Therapeutic Goods Administration (TGA) for inclusion of its WiSE System on the Australian Register of Therapeutic Goods, known as the ARTG. The Santa Clara, California-based company develops wireless cardiac pacing technology for heart failure. It expects the TGA to handle the application through the Priority Review Determination it granted in April 2026, a status that shortens the target time for evaluation. The WiSE System is currently available for sale only in the United States.

The ARTG Application

EBR described the submission as the next regulatory step toward potential market entry in Australia. Subject to TGA approval, entry would extend the company's commercial footprint beyond the United States. The filing draws on the WiSE System's approval from the US Food and Drug Administration (FDA). President and Chief Executive John McCutcheon said the filing also rests on the company's clinical data, and that EBR anticipates working with the TGA during the Priority Review and, depending on the regulator's assessment, making WiSE available to Australian patients.

How Priority Review Works

The TGA's Priority Review pathway is intended to fast-track assessment of breakthrough medical devices aimed at life-threatening or seriously debilitating conditions that carry a high unmet clinical need. Under that pathway, an application moves to the front of the queue, which is expected to shorten the target evaluation period. EBR stated that the timing and outcome of the TGA's assessment remain subject to the regulator's review and cannot be guaranteed. The determination was granted to the WiSE System in April 2026, before this submission.

The WiSE System

WiSE stands for Wireless Stimulation Endocardially, a patented, proprietary technology that EBR developed to remove the need for cardiac pacing leads. The first product is designed to eliminate coronary sinus leads when pacing the left ventricle of heart failure patients who require cardiac resynchronisation therapy (CRT). The implant is comparable in size to a large grain of rice, and EBR's website lists a body length of 9.2 mm and a volume of 0.05 cc. EBR notes that pacing companies have pursued stimulation of the left ventricle from inside the heart for years, because the inside is thought to be a potentially more anatomically correct location, and that WiSE could do away with the left ventricular pacing wire placed on the heart's outer surface. EBR says future products may extend wireless endocardial stimulation to bradycardia and other non-cardiac uses. In most markets, WiSE remains an investigational device.

The US Approval Behind the Filing

EBR reported in its May 2025 quarterly update that it received notice on 11 April 2025 that the FDA had completed its review of the premarket approval application and approved the WiSE CRT System for commercial distribution in the United States. The approval covers adults aged at least 22 who need CRT and have an existing or eligible right ventricular pacing system, including patients whose coronary sinus lead implant failed or whose lead was turned off, and patients with earlier pacemakers or defibrillators who are not suited to a standard CRT upgrade. SOLVE-CRT was the pivotal trial.

Australian Use and Listing Structure

Were the WiSE System added to the ARTG, EBR expects to give Australian clinicians a leadless left-ventricular pacing option for heart failure patients who failed to benefit from conventional lead-based CRT. EBR Systems, Inc. holds ARBN 654 147 127, and its ASX-traded securities are CHESS Depositary Interests (CDIs). The CDIs are issued in reliance on Regulation S of the US Securities Act, so holders cannot transfer them into the United States, or to a US person, unless the resale is registered or an exemption is available. The board's Routine Disclosure Committee authorised the disclosure.

Wrapping Up

EBR Systems (ASX:EBR) has lodged an application with the TGA to list the WiSE System on the ARTG, with assessment expected under the Priority Review Determination of April 2026. The filing builds on FDA approval notified on 11 April 2025 and on clinical data. The implant is comparable in size to a large rice grain, is available for sale only in the United States, and would be offered to Australian patients who did not benefit from lead-based CRT.