• TGA grants Priority Review Determination for EBR's WiSE System
• Accelerated pathway toward inclusion on the Australian Register of Therapeutic Goods
• Supports earlier access to a leadless pacing option for heart failure patients in Australia

EBR Systems, Inc. (ASX: 'EBR'), the developer of the world's only wireless cardiac pacing device for heart failure, has announced that the Therapeutic Goods Administration (TGA) has granted Priority Review Determination for the WiSE System. This represents a significant regulatory milestone for the company, positioning EBR to achieve market entry in Australia sooner than would otherwise be expected, complementing its existing U.S. commercialization. The TGA's 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. EBR's WiSE System is expected to be assessed within an accelerated timeframe, with the evaluation period reduced from the standard 225 working days to approximately 150 working days. EBR intends to submit its application for inclusion on the ARTG (Australian Register of Therapeutic Goods) within the near future. Inclusion on the ARTG will support earlier access in Australia to a leadless pacing option for heart failure patients who have failed to benefit from conventional lead-based Cardiac Resynchronization Therapy (CRT). This follows the company's U.S. Food and Drug Administration (FDA) approval for the WiSE System in April 2025, which provided a strong foundation for the TGA Priority Review Determination submission.

EBR Systems expects to generate early revenue from the commercialization of the WiSE System in the U.S. and Australia, following the TGA's Priority Review Determination and the company's planned ARTG inclusion application.

With FDA approval secured, early U.S. commercial momentum building, and growing clinical validation, EBR believes the WiSE System is well positioned to offer a differentiated leadless CRT option for heart failure patients in Australia who cannot receive or do not respond to conventional lead-based therapy.