EBR Systems said yesterday that it raised $50 million to back a clinical trial for the wireless cardiac pacemaker it’s developing after winning CE Mark approval for a second-generation wireless transmitter.
EBR’s device, which it calls wireless stimulation endocardially or Wise, uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted in the right ventricle, which it uses 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 $50 million funding round was led by Australian private equity shops M.H. Carnegie and Brandon Capital Partners, joined by prior backers Split Rock Partners, Ascension Ventures and Dr. Thomas Fogarty’s Emergent Medical Partners.
The funds are earmarked for the Solve-CRT U.S. pivotal trial for Wise, for which the FDA granted an investigational device exemption in September 2016.
“We are pleased to have the support of such a solid syndicate of investors and look forward to definitively proving the clinical effectiveness of wireless pacing in Solve-CRT,” chairman & CEO Allan Will said in prepared remarks.
“The Wise CRT system has enabled me to successfully treat many patients who had previously failed treatment with conventional CRT devices,” added Dr. Tim Betts of Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital. “Without Wise, these heart failure patients would be relegated to progressive deterioration of their condition and repeated hospitalizations. The second-generation system has allowed me to transform a two-day or two-admission procedure into a single procedure treatment, minimizing hospital stay and allowing the patient to experience the benefits of CRT immediately.”
“We are pleased to lead this financing that will enable what we believe will be a landmark study in cardiac rhythm management. The Solve-CRT study provides hope for countless heart failure patients who have no promising therapeutic alternatives,” noted Brandon Capital Partners managing director Chris Nave.
“As a former pacemaker engineer and seasoned industry investor, I am excited to back EBR Systems and its Wise CRT system for wireless endocardial stimulation. I am convinced that wireless pacing represents the future of cardiac pacing and that EBR Systems is at the forefront of this critical technology,” M.H. Carnegie partner Trevor Moody said.
EBR won CE Mark approval in the European Union in October 2015 for the WiSE device, based on the 39-patient Select-LV trial in patients who either could not undergo traditional cardiac resynchronization therapy or failed to respond to it.