EBR Systems Secures Final CMS Approval for NTAP Reimbursement of WiSE System.

EBR Systems, Inc. (ASX: EBR) has received final approval from the U.S. Centers for Medicare & Medicaid Services (CMS) for New Technology Add-On Payment (NTAP) reimbursement for its WiSE CRT System, the world’s only wireless cardiac pacing device for heart failure. The NTAP reimbursement will be effective from 1 October 2025, supporting the Company’s initial limited market release. CMS has granted the maximum reimbursement rate of up to US$41,145 per procedure, in addition to standard DRG payments, for Medicare inpatients.

This approval marks a major step in EBR's commercialisation strategy by facilitating early hospital adoption of the innovative device. The NTAP will remain in effect for three years, allowing CMS to gather cost data before potentially transitioning to a fully reimbursed DRG category. The company also anticipates final Transitional Pass-Through (TPT) approval for outpatient procedures before October 2025, further expanding access to the WiSE System.

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