Highlights

  • EBR Systems completed 40 commercial WiSE implants in Q3 CY2026, compared with 46 in the preceding quarter.
  • Preliminary quarterly revenue is expected between USD 2.43 million and USD 2.53 million.
  • The company is restructuring its US commercial operations to increase implant activity at existing hospitals.
  • Higher Medicare reimbursement rates and manufacturing milestones support the next stage of commercial development.

EBR Systems (ASX:EBR), a US-based medical technology company developing wireless cardiac pacing systems, reported weaker commercial implant activity for the September 2026 quarter. The company is implementing changes to its United States sales operations while progressing regulatory, reimbursement and manufacturing activities supporting its WiSE cardiac resynchronisation therapy system.

The commercial update released on 12 October 2026 highlighted a slowdown in implant procedures, particularly during September, alongside efforts to improve hospital utilisation and strengthen the company's commercial infrastructure.

WiSE Implant Volumes Decline During September Quarter

EBR Systems (ASX:EBR) reported 40 commercial WiSE implants during Q3 CY2026, compared with 46 implants in Q2 CY2026.

The quarterly reduction was concentrated in September, when procedural activity slowed during changes to commercial leadership, field training and sales operations.

The company has now completed 157 commercial implants since beginning its pilot and limited market release programs.

EBR also reported preliminary, unaudited revenue expectations of USD 2.43 million to USD 2.53 million for Q3 CY2026, compared with approximately USD 2.6 million in Q2 CY2026.

The preliminary figures remain subject to final accounting adjustments and should not be interpreted as completed financial results.

The softer implant activity indicates that expanding hospital access has not yet translated into consistently increasing quarterly procedure volumes.

US Sales Restructuring Focuses on Existing Hospitals

EBR Systems (ASX:EBR) has revised its US commercial strategy to concentrate on increasing the frequency of WiSE procedures at hospitals already using the technology.

Previously, the company's commercial expansion involved activating new hospital accounts, training physicians and establishing purchasing agreements.

Under the revised approach, EBR intends to prioritise deeper utilisation of existing facilities rather than maintaining the same pace of hospital additions.

Chief executive John McCutcheon has assumed direct oversight of the commercial organisation following changes to its leadership structure.

Michael Sot has been appointed Director of US Sales, while recruitment for additional commercial leadership and field positions continues.

During Q3 CY2026, EBR reported 40 active hospitals, with approximately half having completed at least three WiSE procedures.

The company also secured five additional purchasing agreements, bringing its total contracted hospital accounts to 57.

A further 10 physicians completed training during the quarter, increasing the number of trained implanters to 100.

The operational changes are intended to improve procedure scheduling, hospital engagement and repeat usage. However, their effectiveness will depend on subsequent implant volumes.

Medicare Reimbursement Changes Support Commercial Framework

EBR Systems (ASX:EBR) achieved an important reimbursement milestone following changes to US Medicare inpatient payment arrangements.

From 1 October 2026, revised Medicare rates increased base reimbursement for eligible WiSE procedures by approximately 58% and 93%, depending on the applicable diagnosis-related group.

The changes followed the reassignment of eligible procedures to Medicare Severity Diagnosis-Related Groups 228 and 229.

Eligible procedures may also qualify for a New Technology Add-on Payment of up to USD 41,145.

Including the maximum applicable add-on payment, total Medicare reimbursement could reach approximately USD 77,839 or USD 66,566, depending on the relevant payment classification.

Actual reimbursement depends on hospital-specific adjustments, patient eligibility and applicable payment rules.

Although the revised rates may reduce financial barriers for hospitals, they do not guarantee increased procedure volumes or company revenue.

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Santa Clara Manufacturing Facility Advances Regulatory Process

EBR Systems (ASX:EBR) continued progressing the regulatory qualification of its new manufacturing facility in Santa Clara, California.

The facility obtained ISO 13485 certification during September 2026, demonstrating compliance with recognised medical device quality management requirements.

The US Food and Drug Administration also completed a pre-approval inspection of the facility, identifying two observations requiring corrective responses.

As of 12 October 2026, final FDA authorisation of the new manufacturing facility remained pending.

EBR is targeting completion of the regulatory process before the end of CY2026, subject to the FDA's assessment.

The facility is designed to support expanded production capacity as commercial demand develops.

However, potential manufacturing capacity should not be equated with confirmed sales or future revenue.

WiSE Technology and Additional Regulatory Activities

The WiSE System is designed to deliver leadless left ventricular pacing for selected heart failure patients requiring cardiac resynchronisation therapy.

The technology uses an implanted electrode that receives energy wirelessly through ultrasound, allowing pacing without a conventional left ventricular lead.

EBR Systems (ASX:EBR) received US FDA premarket approval for WiSE in April 2025 and has subsequently focused on commercial adoption.

The company is also preparing a regulatory submission addressing device labelling associated with a previously identified echocardiography-related pacing risk and its mitigation.

During the September quarter, EBR commercially introduced its WiSE Coupler accessory to assist device positioning during implantation.

These developments form part of the company's ongoing product support, manufacturing and regulatory activities.

Key Insights

EBR Systems (ASX:EBR) reported weaker implant volumes in Q3 CY2026, prompting changes to its US commercial strategy.

While Medicare reimbursement improvements and manufacturing milestones represent progress, the company's immediate challenge remains increasing WiSE utilisation across contracted hospitals.

As of 12 October 2026, key operational developments include the implementation of its revised sales strategy, regulatory progress at Santa Clara and the conversion of existing hospital accounts into more consistent procedure activity.