SUNNYVALE –– EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, has closed $30 million in new funding to complete enrollment of its pivotal SOLVE CRT clinical trial and to prepare for commercialization of the WiSE Cardiac Resynchronization Therapy (CRT) System.
This financing was led by Australian private equity firms Brandon Capital Partners and M.H. Carnegie & Co. and included participation by prior investors Split Rock Partners, Ascension Ventures, and Dr. Thomas Fogarty’s Emergent Medical Partners, among others.
The company also announced that John McCutcheon has joined EBR Systems as President and CEO. John brings more than three decades of experience as a medical device executive and has extensive background in clinical studies and commercialization. Prior to EBR, John served as the President and CEO of Ceterix Orthopaedics and Emphasys Medical.
SOLVE CRT is EBR’s multi-center, randomized, double blinded, prospective international study intended to assess safety and efficacy of the WiSE™ (Wireless Stimulation Endocardially) pacing technology in support of U.S. Food and Drug Administration (FDA) premarket approval (PMA) application. The study is enrolling 350 heart failure patients who have failed to respond to, or are otherwise unable to receive, conventional CRT. It is expected to complete enrollment in 2020.
“We are encouraged by the results and patient benefit shown in previous studies using the WiSE™ System and as such, we are excited to be continuing to support EBR Systems to bring this important technology to the market,” said Dr Chris Nave PhD, Managing Partner at Brandon Capital Partners. “EBR’s technology promises to revolutionize cardiac resynchronization therapy.”
“I’m delighted to join the fantastic team at EBR Systems to bring the unique WiSE System to the market and help improve patient outcomes,” said John McCutcheon, President and CEO of EBR Systems. “I look forward to guiding the organization through the crucial next steps of completing the study, gaining regulatory approvals, scaling manufacturing, and beyond.”