Market Alert: US Sets Tariff Floor at 15% – Potentially Rising to 50% from 01 August 2025
EBR Systems Inc. (ASX: EBR) has successfully completed the first commercial US implants of its groundbreaking WiSE CRT system—the only FDA-approved wireless cardiac resynchronization therapy device. The implants were performed at St. David’s Medical Centre and the Cleveland Clinic, addressing patients previously untreatable due to non-functional CS leads or pacing-induced heart failure. These early procedures validate the clinical importance of leadless left ventricular endocardial pacing (LVEP).
The company anticipates initiating its Limited Market Release (LMR) in October 2025 alongside expected reimbursement add-on payments (NTAP and TPT). The LMR will target select high-volume institutions to drive clinician adoption and wider rollout into 2026. The WiSE technology offers a more anatomically natural stimulation method, potentially improving outcomes for heart failure patients. With a total addressable market estimated at US$3.6 billion, this milestone marks a major step in EBR’s commercial journey and cardiac therapy innovation.
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Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.