EBR Systems, Inc.

EBR is a U.S.-based medical device company that developed the WiSE CRT System ("WiSE"), an implantable cardiac pacing system. WiSE provides stimulation to endocardial heart tissue to correct heart rhythm conditions without requiring leads. This implantable device is part of a cardiac resynchronization therapy ("CRT") that offers endocardial heart tissue stimulation without the complications associated with traditional lead-based systems. Traditional cardiac rhythm management ("CRM") systems use leads to conduct electricity from an implantable pulse generator ("IPG") to electrodes that deliver therapeutic electric pulses to heart tissue. Leads are a critical part of most CRM systems but are a primary shortcoming and a leading cause of device failure. EBR initially developed WiSE for use with another implanted pacemaker to provide CRT to patients unable to receive CRT from a traditional lead-based system or who are at high risk of complications from an upgrade procedure. WiSE CRT technology is designed for patients who have not had success with conventional CRT or face high complication risks. By eliminating lead requirements for left ventricular pacing, WiSE CRT offers a new approach to cardiac pacing. On April 11, 2025, EBR received notification that the Center for Devices and Radiological Health ("CDRH") of the Food and Drug Administration ("FDA") approved WiSE for commercial distribution in the U.S. for adult patients at least 22 years of age who are indicated for CRT, have an existing or are eligible for an implanted right ventricular pacing system, and fall into one of two categories: 1) "previously untreatable" patients where previous coronary sinus ("CS") lead implantation was unsuccessful, or an implanted lead has been turned off; or 2) "high risk upgrades" for patients with previously implanted pacemakers or Implantable Cardioverter-Defibrillators ("ICDs") where standard CRT upgrade is not advisable due to known relative contraindications for CS lead or CRT device implantation.