The Sunnyvale, Calif.-based company is developing the Wise wireless pacemaker, designed to use a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle to synchronize the left and right ventricles. The system is designed to eliminate the need for a left ventricular lead by allowing the operating physician to place the stimulation “pellet” in a patient-specific location inside the left ventricle.
The new funding is earmarked for completing enrollment in its pivotal Solve CRT trial and preparations for commercialization, EBR said. Australian private equity shops Brandon Capital Partners and M.H. Carnegie led the round, joined by previous backers Split Rock Partners, Ascension Ventures, Emergent Medical Partners and others.
The FDA approved the Solve-CRT study back in September 2016. The randomized, double blinded pivotal trial is designed to compare treatment with the Wise device to a sham procedure in which the device is implanted but not activated in patients who failed to respond to or are otherwise unable to receive conventional cardiac resynchronization therapy, according to ClinicalTrials.gov.
The primary safety outcome is freedom from procedure- and device-related complications at six months, including electrode dislodgement, migration or malfunction; vascular complications from the procedure; transmitter/battery pocket complications; and stroke/transient ischemic attack. Solve-CRT has three primary endpoints, all at six months: mean change in left ventricular end systolic volume; the percentage of subjects with an improvement of greater than 15% in LVESV; and a composite improvement measure using the New York Heart Assn. scale, quality of life, heart failure events and death.
“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,” Brandon Capital managing partner Chris Nave said in prepared remarks. “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 McCutcheon, whose resume also includes a stint as CEO at Emphasys Medical. “I look forward to guiding the organization through the crucial next steps of completing the study, gaining regulatory approvals, scaling manufacturing, and beyond.”
Former EBR CEO Allan Will will stay on as chairman and “remains actively involved with advancing the business,” EBR said. Smith & Nephew (NYSE:SNN) paid $50 million for Ceterix early this year. Pulmonx bought Emphasys Medical in May 2009.