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Highlights

  • EBR’s WiSE® leadless cardiac pacing system successfully implanted in first U.S. commercial patients post-FDA approval.

  • Reimbursement payments for inpatient and outpatient use expected to begin October 2025.

  • Limited Market Release (LMR) to focus on high-volume institutions, laying foundation for broader adoption.

EBR Systems, Inc. (ASX:EBR) has announced the successful completion of the first commercial U.S. implantations of its WiSE® cardiac resynchronization therapy (CRT) system, following recent approval by the U.S. Food and Drug Administration (FDA). The update marks a significant commercial milestone for the company and has boosted investor sentiment, with EBR shares climbing over 6% to AUD 1.18 on 6 June.

The initial implantations were performed at St. David's Medical Centre and the Cleveland Clinic, two prominent institutions participating in the pilot release phase of the WiSE system. These early procedures were carried out ahead of expected reimbursement timelines.

The WiSE CRT system is the world’s only wireless left ventricular pacing technology designed to address heart failure in patients who are unsuitable for conventional CRT due to limitations with coronary sinus (CS) leads or those at high risk from existing lead-based systems. The early commercial use cases highlighted by EBR include patients with non-functional CS leads and those with pacing-induced heart failure from Micra® leadless pacemakers—two core segments within EBR’s estimated US$3.6 billion Total Addressable Market (TAM).

In parallel with these successful implantations, EBR is preparing for the initiation of its Limited Market Release (LMR) in October 2025. This next phase will target select high-volume and strategically important institutions, aiming to build clinician advocacy and demonstrate clinical benefits in real-world scenarios. The LMR is expected to continue into 2026, serving as a springboard for broader adoption and commercial scale-up.

The company also reiterated that reimbursement add-on payments are expected to begin in October 2025, covering both inpatient (NTAP1) and outpatient (TPT1) scenarios.