EBR Systems secures comprehensive reimbursement for WiSE CRT System

EBR Systems, developer of the world's only wireless endocardial cardiac pacing device, has received final CMS approval for Transitional Pass-Through (TPT) reimbursement for its WiSE CRT System. Effective October 1, 2025, this TPT status, alongside the previously approved New Technology Add-On Payment (NTAP) for inpatient use, provides comprehensive Medicare reimbursement for both outpatient and inpatient settings. TPT payments will align with a $63,300 average sales price, covering the cost of the WiSE system and reducing financial barriers for hospitals.

This dual reimbursement strategy addresses a $3.6bn total addressable market in the US, including patients with acute lead failure, high-risk upgrades, and chronic lead failure. EBR Systems, an ASX-listed company since 2021, aims to leverage this market opportunity with a disciplined commercialization strategy, focusing on high-volume US sites and supported by its new state-of-the-art 51,000 sq ft manufacturing facility in Santa Clara, California, expected to be fully operational by H1 2026. The company’s WiSE technology is protected by over 97 issued patents globally.