- CEO
- John Graham McCutcheon
- Full Time Employees
- 89
- Sector
- Healthcare
- Industry
- Medical - Devices
- Address
- 480 Oakmead Parkway Sunnyvale CA United States of America 94085
- IPO Date
- Aug 31, 2023
- Business
- EBR Systems, Inc. (EBRCZ) develops and commercializes leadless cardiac pacing technologies for treating heart rhythm disorders, particularly heart failure patients requiring cardiac resynchronization therapy (CRT). The company offers the WiSE CRT System, the world's first FDA-approved leadless endocardial pacing solution that delivers wireless stimulation directly to the left ventricle using an implantable device the size of a grain of rice; this system eliminates the need for coronary sinus leads and associated complications, working in conjunction with conventional pacemakers or defibrillators to provide physiologic pacing. EBR Systems targets patients ineligible for or non-responsive to traditional CRT, serving high-volume cardiac centers in the United States with plans for broader commercial rollout; it operates primarily in the cardiac rhythm management segment of the medical device industry.
Founded in 2003 and headquartered in Sunnyvale, California, the company conducts research, development, manufacturing, and commercialization from its U.S. facilities, including subsidiaries in Australia and the United Kingdom for clinical trials and intellectual property activities.
In April 2025, EBR Systems received U.S. FDA premarket approval for the WiSE CRT System following a successful pre-approval inspection with no observations; the company entered CMS's Transitional Coverage for Emerging Technologies (TCET) pathway and secured proposals for maximum New Technology Add-On Payment (NTAP) reimbursement at 65% of device costs for inpatient procedures and Transitional Pass-Through (TPT) for outpatient starting October 2025. EBR Systems completed a A$55.9 million institutional placement in May 2025 to fund commercialization, including scaling manufacturing and sales capabilities ahead of a limited market release in late 2025 and full distribution in 2026; it also signed an 11-year lease for a 51,000 sq. ft. manufacturing facility in Santa Clara, California, with transition planned for H1 2026. The pivotal SOLVE-CRT study results were published in JAMA Cardiology, supporting the system's efficacy, while Q3 2025 updates confirmed eight new U.S. purchasing agreements and 14 physicians trained.