How EBR Systems Plans to Revolutionize Heart Failure Treatment with WiSE CRT
EBR Systems has secured FDA approval for its pioneering leadless WiSE CRT System and obtained key Medicare reimbursement endorsements, setting the stage for its commercial rollout. The company also completed a significant capital raise to support its market expansion.
- FDA approval granted for WiSE CRT System, the first leadless left ventricular pacing device
- First commercial implants completed at leading US medical centers
- Medicare NTAP and preliminary TPT reimbursement approvals effective October 2025
- A$75.9 million capital raise completed to fund commercialization efforts
- Q2 2025 net loss of $12 million amid early sales and increased SG&A expenses
A Breakthrough in Cardiac Pacing
EBR Systems, a Silicon Valley-based medical device innovator, has reached a pivotal milestone with the FDA’s approval of its WiSE Cardiac Resynchronization Therapy (CRT) System. This device is the world’s first leadless solution designed specifically for left ventricular endocardial pacing, a significant advancement for heart failure patients who cannot benefit from traditional lead-based pacemakers.
The WiSE system eliminates the need for leads, which have historically been a major source of complications and device failures in cardiac rhythm management. By delivering wireless stimulation directly inside the heart, EBR aims to improve patient outcomes and reduce procedural risks.
Early Commercial Adoption and Strategic Rollout
Following FDA approval in April 2025, EBR successfully completed its first commercial implants at prestigious US medical centers including St. David's Medical Centre and the Cleveland Clinic. These initial cases, conducted ahead of anticipated reimbursement add-ons, demonstrate the clinical importance and demand for the WiSE system among physicians treating complex heart failure cases.
The company plans a phased commercial rollout starting in late 2025, focusing initially on high-volume centers to gather real-world experience and build adoption momentum. A full commercial launch is targeted for 2026, leveraging insights from the limited market release.
Medicare Reimbursement – A Crucial Commercial Catalyst
EBR secured critical reimbursement approvals from the US Centers for Medicare & Medicaid Services (CMS). The New Technology Add-On Payment (NTAP) program will provide inpatient Medicare reimbursement at the maximum rate starting October 2025, significantly lowering financial barriers for hospitals and patients.
Additionally, preliminary approval was obtained for the Transitional Pass-Through (TPT) reimbursement, which supports outpatient adoption by providing Medicare coverage for procedures performed outside hospital inpatient settings. These reimbursement pathways are expected to accelerate market penetration and support sustainable commercial growth.
Financial Position and Capital Raising
To underpin its commercialization strategy, EBR completed a substantial capital raise totaling A$75.9 million during Q2 2025, comprising an institutional placement and a heavily oversubscribed Security Purchase Plan. This infusion bolsters the company’s cash position to US$87.2 million, providing runway into early 2027 based on current projections.
Despite these advances, EBR reported a net loss of $12 million for Q2 2025, reflecting increased selling, general and administrative expenses associated with scaling commercial operations, partially offset by reduced research and development costs. Revenue remains nascent at $170,000, derived from initial US and UK sales.
Looking Ahead – Opportunities and Challenges
EBR’s path forward hinges on successful expansion of its sales force, continued regulatory compliance including FDA-mandated post-marketing studies, and effective engagement with payors to secure reimbursement. The company’s breakthrough device designation and Medicare reimbursement approvals provide a strong foundation, but market adoption will require overcoming competitive pressures and demonstrating sustained clinical benefits.
International commercialization efforts remain contingent on regulatory approvals and reimbursement frameworks in key markets such as Australia, the UK, and the EU.
Bottom Line?
EBR Systems is poised at a critical inflection point, balancing promising commercial momentum with the challenges of scaling a novel medical technology in a competitive and regulated market.
Questions in the middle?
- How will the results of the FDA-mandated post-marketing study impact WiSE’s long-term market acceptance?
- What is the timeline and likelihood for securing full outpatient reimbursement under the TPT program?
- How quickly can EBR expand its sales footprint to achieve meaningful revenue growth beyond initial implants?
