SUNNYVALE, Calif.--(BUSINESS WIRE)--EBR Systems, Inc., developer of the world’s first and only wireless cardiac pacing system for heart failure, has raised $20 million for clinical studies and regulatory filings, including commitments toward a second quarter closing. Led by Dr. Thomas Fogarty’s Emergent Medical Partners, the financing includes current venture investors Split Rock Partners, SV Life Sciences, Delphi Ventures and St. Paul Venture Capital. In addition to institutional and private investors, the financing included participation by a cardiovascular corporate strategic investor. Private investors participating in this financing include Dr. Fogarty and Stephen Mahle, former president of Medtronic’s Cardiac Rhythm Management division, among others.
EBR Systems is using the funds to build on promising European clinical work; obtain CE Mark for the company’s proprietary wireless pacing system; obtain approval for a U.S. IDE (Investigational Device Exemption) clinical study; and complete development of its second generation system that is smaller and more energy efficient.
The main focus is clinical work demonstrating product safety and effectiveness in heart failure patients who have not responded to conventional Cardiac Resynchronization Therapy (CRT). Conventional CRT devices can improve left ventricular function and reduce morbidity and mortality in patients with cardiac synchronization problems. However, wires used to deliver pacing pulses to the left ventricle can break or otherwise fail, leading to complications in roughly 12% of cases.
In addition, approximately 30% of patients receiving conventional CRT do not respond to the therapy. A major reason is limitations on where wire leads can be placed in the heart’s venous anatomy. EBR’s wireless technology eliminates the need for leads and lets the physician place the endocardial technology at the most optimal site inside the left ventricle where it can be most effective. Data from multiple sources strongly suggests this can benefit patients and is a major advance in left ventricular stimulation.
“I’ve been a physician for 55 years and am confident EBR Systems’ wireless technology is the future of cardiac pacing,” said renowned cardiovascular surgeon and former Stanford medical professor Thomas Fogarty, M.D., who holds more than 150 patents and is recipient of the Presidential National Medal of Technology and Innovation and the Lemelson-MIT Award for Invention and Innovation. “Wireless pacing enables stimulation of any site inside the heart. That degree of precision and flexibility is a huge advantage over lead-based systems requiring wires. Numerous studies make it clear that the decades-old approach of wired leads has many limitations.
“This technology also has huge potential implications for bradycardia, which is an abnormally slow heart rate. We can finally stimulate the left ventricle----- which is the best location---- instead of settling for the right ventricle. All the data we’ve seen indicates this can be a significant advance in treatment.”
David Milne, managing partner of SV Life Sciences, said, “Nearly $3.5 billion dollars are spent annually on CRT devices worldwide. Unfortunately, roughly one-third of the procedures fail to provide the patient with any benefit. That’s more than one billion dollars of devices wasted each year, with a lot of patients getting zero benefit. EBR Systems’ technology may dramatically change that by offering potentially superior efficacy, dramatic cost savings, and hope for patients who have previously failed conventional therapy.”
“We are pleased to have the support of some of medical technology’s most successful investors and the strong validation provided by our corporate investor. We look forward to further demonstrating the clinical effectiveness of our wireless pacing in the coming months,” said Allan Will, Chairman and CEO of EBR Systems.
About EBR Systems
EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless endocardial pacing. The company’s patented, proprietary technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management. The Company’s initial product eliminates the need for coronary sinus leads to stimulate the left ventricle in heart failure patients requiring CRT. Future products will address wireless endocardial stimulation for bradycardia, and other non-cardiac indications.
The Company’s wireless pacing system is not currently available for commercial sale. The system is subject to the company obtaining a CE mark for sale in Europe and approval for a U.S. IDE (Investigational Device Exemption) clinical study.
About Heart Failure and Cardiac Resynchronization Therapy (CRT)
Heart failure affects more than five million Americans and 22 million people worldwide and is the most costly disease in the US, estimated at more than $40 billion annually and growing. CRT is a treatment for heart failure that uses an implantable pacemaker to improve the pumping efficiency of the heart by synchronizing the left and right ventricles of the heart. Studies have demonstrated successful CRT therapy improves symptoms and reduces hospitalizations and mortality.