EBR Systems (ASX:EBR) Completes First US Commercial Implants of WiSE CRT System
Operational Achievements
EBR Systems has successfully completed the first commercial US implants of its WiSE CRT System following recent FDA approval. The procedures were conducted at St. David’s Medical Centre and the Cleveland Clinic, addressing key indications such as Previously Untreatable and High-Risk Upgrade. These early implantations support the company’s US$3.6bn Total Available Market estimate.
Future Outlook
The company is on track to initiate its limited market release (LMR) and begin reimbursement add-on payments in October 2025. The LMR will focus on selected high-volume and strategically important institutions, aiming to develop clinician advocacy and facilitate wider adoption into 2026.
Executive Comments
John McCutcheon, EBR Systems’ President & Chief Executive Officer, stated, “Seeing the WiSE System in clinical use, helping heart failure patients with leadless LVEP, is truly gratifying. I’m incredibly proud of our team and honoured to be working with these incredible physicians to improve patients’ lives.”
Motley Fool contributor Kiarra Jackson has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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