- 01WiSE implants fell to 40 from 46 quarter-on-quarter.
- 02EBR prioritises repeat use at existing US hospitals.
- 03Higher Medicare rates and a new plant could support 9,600 systems yearly.
EBR Systems (ASX: EBR) is refocusing its US commercial strategy after completing 40 WiSE wireless cardiac pacing implants in the September quarter, down from 46 in the previous quarter.
The medical technology group has now completed 157 implants across its pilot phase and limited market release, although September procedures were approximately half the monthly average recorded in July and August.
Preliminary unaudited third-quarter revenue is expected between US$2.43 million and US$2.53m, compared with US$2.6m in the June quarter, subject to closing adjustments.
EBR is prioritising repeat procedures at existing hospitals over rapid new-site activation while progressing expanded manufacturing capacity and improved Medicare reimbursement in the US.
Commercial Focus Shifts
President and chief executive officer John McCutcheon has assumed direct responsibility for the commercial organisation following leadership changes intended to improve execution.
The group promoted Michael Sot to director of US sales and is recruiting additional personnel, including a chief commercial officer, while strengthening field training and case support.
By quarter-end, EBR had activated 40 hospitals, including 20 that had performed at least three WiSE implants, and secured five additional purchasing contracts to lift its total to 57.
A further 10 physicians completed training during the quarter, bringing the number trained to implant the WiSE System to 100.
“The team is focused on deeper utilisation within activated accounts, strengthening field training and support, and increasing procedural frequency,” Mr McCutcheon said.
“These changes take time to flow through to case volumes, but we believe they provide the right foundation for more consistent commercial execution as we move through Q4 and into 2027.”
Increased Reimbursement Rates
From 1 October, revised US Medicare inpatient reimbursement rates increased base payments for eligible WiSE procedures by approximately 58% or 93%, depending on the applicable payment group.
With the maximum available new technology add-on payment of US$41,145, total Medicare reimbursement could reach approximately US$77,839 or US$66,566, although actual payments depend on hospital circumstances, case details, and eligibility.
EBR’s new Santa Clara manufacturing facility achieved International Organisation for Standardisation (ISO) 13485 certification, while the Food and Drug Administration completed its pre-approval inspection with two observations.
The FDA agreed that EBR’s completed cybersecurity risk assessment did not warrant an immediate WiSE field corrective action or recall.
Once authorised, the expanded plant has potential annual capacity of 9,600 systems, which EBR equates to approximately US$607.6m in revenue.
WiSE Regulatory Submission
EBR also plans a fourth-quarter regulatory submission to update WiSE labelling around the previously identified echo-induced pacing risk and its mitigations.
During the September quarter, the group commercially launched its WiSE Coupler accessory to assist catheter positioning and stabilisation during implantation.
The final tranche of EBR’s A$150 million capital raising closed in August, providing funding for commercial expansion and manufacturing scale-up.
EBR expects to provide fuller quarterly operating and financial details around 10 November as it seeks to improve implant frequency and field execution heading into 2027.
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