EBR Systems Reports Q4 Revenue Between US$870K–US$935K with 18 WiSE Implants

Commercial Momentum Builds

EBR Systems, the ASX-listed developer of the WiSE System, the world’s only wireless cardiac pacing device for heart failure, has reported a significant surge in commercial activity during the fourth quarter of fiscal 2025. The company successfully implanted the WiSE System in 18 patients in Q4, doubling the number from the previous quarter and bringing the total to 30 implants since the pilot phase began. This growth reflects increasing physician familiarity and expanding hospital readiness to adopt this novel technology.

Alongside the implants, EBR signed nine new purchase agreements with target centres and trained 11 additional physicians, bringing the total trained to 33. These developments underpin the company’s Limited Market Release strategy, which is gaining traction in key US hospitals, including the Louis Stokes Cleveland Veterans Affairs Medical Center, where complex cases are benefiting from the WiSE System’s unique wireless, leadless approach.

Clinical Trials Advance

EBR also marked important clinical milestones with the commencement of two pivotal studies. The WiSE-UP post-approval study began enrolling patients to evaluate real-world outcomes of the FDA-approved system, aiming to follow over 300 patients across 50 centres over five years. Early enrolments have already taken place at respected institutions such as St. Bernards Heart & Vascular Center and Naples Comprehensive Health.

Meanwhile, the Totally Leadless CRT (TLC-AU) feasibility study launched in December with the first patient implanted in Brisbane, Australia. This study explores the combination of the WiSE System with a leadless right ventricular pacemaker, potentially expanding the device’s applicability to a broader patient population, including those receiving cardiac resynchronisation therapy for the first time.

Preliminary Financial Outlook

EBR provided preliminary, unaudited revenue guidance for Q4 2025, expecting between US$870,000 and US$935,000, with full-year 2025 revenue forecast between US$1.55 million and US$1.62 million. While these figures are subject to final audit adjustments, they indicate a positive trajectory for the company’s commercialisation efforts. Management emphasised disciplined execution and continued investment in evidence-building to support broader adoption of the WiSE System.

Investor engagement remained robust, with EBR’s leadership presenting at multiple healthcare and investor conferences across Australia and the US, complemented by roadshows in Brisbane, Sydney, and Melbourne. This active communication strategy aims to maintain market confidence as the company transitions from pilot phases to wider commercialisation.

Looking Ahead

EBR Systems is positioning itself at the forefront of cardiac pacing innovation by addressing longstanding challenges associated with traditional lead-based devices. The company’s progress in both commercial uptake and clinical validation suggests a growing acceptance of wireless pacing technology. However, the path to widespread adoption will depend on continued clinical data, reimbursement developments, and scaling physician training.