Business · Companies · 2 hrs ago
EBR shifts US sales focus after 40 WiSE implants in Q3
EBR Systems sells WiSE, a wireless cardiac pacing system for people with heart failure.
In the September quarter of 2026, it completed 40 commercial implants in the United States, down from 46 in the previous quarter.
The company is slowing the pace of opening new hospital sites and focusing instead on more procedures at hospitals already using WiSE, along with physician training and support.
By September 30, 40 hospitals had been activated, and 100 physicians had been trained to implant the system.
A new manufacturing facility in Santa Clara received ISO 13485 certification, and the US Food and Drug Administration completed a pre-approval inspection; EBR expects approval of the site by the end of 2026.
Increased Medicare inpatient reimbursement for eligible WiSE procedures took effect on October 1.
CEO John McCutcheon is overseeing the sales team while EBR searches for a new commercial leader, and the company says it aims for more consistent sales execution through the fourth quarter and into 2027.
EBR Systems completed 40 commercial WiSE implants in the third quarter of 2026 and refocused its US sales strategy.
The implants brought the total across its pilot phase and Limited Market Release to 157.
The company is prioritising more procedures and deeper use of WiSE at activated hospitals, while moderating new site activations.
By September 30, 40 hospitals had been activated and 100 physicians had been trained to implant the system.
EBR’s Santa Clara manufacturing facility received ISO 13485 certification, and the FDA completed its pre-approval inspection.
- Who
- EBR Systems, which makes the WiSE wireless cardiac pacing system.
- What
- It completed 40 commercial implants in Q3 and refocused its US sales strategy.
- When
- The September quarter of 2026.
- Where
- The United States; the new manufacturing facility is in Santa Clara.
- Why
- EBR is focusing on deeper use at activated hospitals, more frequent procedures and physician training.
This story does not have two clearly opposing sides.
Q3 commercial implant volumes were below the prior two quarters,
I take responsibility for that, and I believe these are temporary corrections that will put EBR on a stronger path to success.
The team is focused on deeper utilisation within activated accounts, strengthening field training and support, and increasing procedural frequency,
EBR completed the final tranche of a $150 million capital raising.
EBR had activated 40 hospitals, including 20 that had completed three or more WiSE implants.
Increased Medicare inpatient reimbursement for eligible WiSE procedures took effect.
- Commercial implants in Q3 CY26
- 40
- Total implants across pilot phase and Limited Market Release
- 157
- Activated hospitals by September 30
- 40
- Trained physicians by September 30
- 100
- New Santa Clara facility
- ISO 13485 certified; FDA pre-approval inspection completed
Sources
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