• EBR Systems

  Participated · Equity · Apr 2015

  EBR Systems is a Sunnyvale, Calif.-based developer of the WiSE (Wireless Stimulation Endocardially) wireless cardiac pacing technology designed to eliminate the need for cardiac pacing leads. Its initial product aims to remove the need for coronary sinus leads to stimulate the left ventricle in heart failure patients who require cardiac resynchronization therapy (CRT). The company plans future products to address wireless endocardial stimulation for bradycardia and other non-cardiac indications. EBR is conducting the SOLVE CRT multi-center, randomized, double-blinded, prospective international study to assess safety and efficacy of WiSE in support of a U.S. FDA premarket approval (PMA) application. The SOLVE CRT study is enrolling 350 heart failure patients who have failed to respond to, or cannot receive, conventional CRT and was expected to complete enrollment in 2020. EBR intends to use the recently raised funds to complete SOLVE CRT enrollment and to prepare for commercialization of the WiSE CRT System. Leadership noted in the article includes President and CEO John McCutcheon and Executive Chairman Allan Will (former Chairman and CEO). EBR Systems develops the WiSE (Wireless Stimulation Endocardially) wireless cardiac pacing system that implants a tiny electrode directly in the left ventricle to pace heart failure patients who have failed or cannot receive conventional CRT. The system aims to eliminate the need for coronary sinus leads and their associated complications by providing endocardial pacing via a rice-grain-sized implant. The company raised $50 million to conduct the SOLVE-CRT pivotal trial intended to establish safety and efficacy in support of U.S. Food and Drug Administration approval. Separately, EBR received CE Mark approval for its second-generation wireless transmitter, which is half the size of the first-generation device, extends battery life and enables a simpler, less-invasive implantation; initial cases were performed at four European clinical centers. Future products are planned to address wireless endocardial stimulation for bradycardia and other non-cardiac indications. The company's wireless pacing system is not currently available for commercial sale in the United States. EBR Systems is a Sunnyvale, CA-based developer of a wireless cardiac pacing system designed to eliminate the need for cardiac pacing leads. Its initial product eliminates the need for coronary sinus leads to stimulate the left ventricle in heart failure patients requiring CRT. Future product plans include wireless endocardial stimulation for bradycardia and applications in other non-cardiac indications. The company’s system is not yet available for commercial sale and is subject to obtaining a CE mark for Europe and U.S. IDE approval for clinical study. Led by Chairman and CEO Allan Will, EBR intends to use the recent funding for clinical studies and regulatory filings and has commitments toward a second-quarter closing. EBR Systems develops a new-style pacemaker and other cardiac pacing devices. The company raised a $35 million third round of financing to advance its product toward clinical trials. Delphi Ventures led the round, with existing investors De Novo Ventures, Frazier Healthcare Ventures, Split Rock Partners and SV Life Sciences participating. The Sunnyvale, Calif.-based company had previously raised $27 million across its first two rounds. The new capital is intended to support clinical testing and regulatory steps for its pacing device.

No current team members are available.