EBR Systems, Inc. news
- EBR Systems’ WiSE™ CRT System is world’s first and only wireless endocardial (inside the heart) left ventricle pacing system for heart failure
- EBR’s AU$110m ASX initial public offering today was strongly supported by new and existing institutional shareholders
- The new capital funds the completion of pivotal study, targeting FDA submission for approval in 2023 followed by rapid U.S. commercial lau
Highlights:
- Dr Evans, Dr Steinhaus and Ms Drexler to join EBR Systems’ Board ahead of the planned A$110m IPO on the Australian Stock Exchange
- Board appointments follow the retirement of Mr Dave Stassen and Dr Leighton Read
- New EBR Systems’ Board consists of Mr Allan Will, Mr John McCutcheon, Dr Christopher Nave, Mr Trevor Moody, Dr Bronwyn Evans, Dr David Steinhaus and Ms Karen Drexler
Published last month in the European Heart Journal, the case report details the successful deployment of the WiSE Electrode implanted in the LV
EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the WiSE CRT System for the treatment of heart failure.
The FDA created this designation and its associated program in 2017 for certain devices providing more effective treatment of life-threatening or irreversibly debilitating diseases or conditions. Under
EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that Professor Pascal Defaye, Head of Rhythmology and Cardiac Stimulation Unit, CHU de Grenoble-Alpes, France, performed the world’s first successful Leadless Left Bundle Branch Area Pacing (LBBAP) implant performed utilizing the WiSE CRT System.
LBBAP pacing has been proposed as a strategy to achieve physiological pacing by utilizing the heart&rs
EBR Systems, Inc., developer of the world`s only wireless cardiac pacing system for heart failure, today announced it has closed $30M in new funding to complete enrollment of its pivotal SOLVE CRT clinical trial and to prepare for commercialization of the WiSE Cardiac Resynchroniza
EBR Systems, Inc., developer of the world`s only wireless cardiac pacing system for heart failure, today announced that the College of the French National Authority for Health (Haute Autorite de Sante, HAS) awarded a Forfait Innovation Package for the company`s WiSE™ Cardiac Resynchronization Therapy (CRT) System. The award, worth up to €1 million, will help treat as many as 40 patients and support the SOLVE CRT global clinical study. It has started enrolling heart failure pa
EBR Systems, Inc., developer of the world`s only wireless cardiac pacing system for heart failure, today announced that Dr. Mary Norine "Minnow" Walsh has become Co-Principal Investigator (Co-PI) of the SOLVE CRT clinical study. The SOLVE CRT (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy) clinical study is a prospective randomized, double blinded pivotal trial intended to assess safety and efficacy of the WiSE (Wireless Stimulation Endocardially)
EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced enrollment of the first patients in the global SOLVE-CRT (Stimulation of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy) clinical trial.
The first patients were enrolled by Prof. Dr. Christian Butter at Immanuel Klinikum Herzzentrum Brandenburg in Bernau, Germany; Dr. Jeffrey Alison at Monash Heart in Clayton, VIC, Australia; Dr.
EBR Systems, Inc., developer of the world’s first and only wireless cardiac pacing system for heart failure, has raised $50 million to conduct the global SOLVE-CRT study. The financing was led by Australian private equity firms M.H. Carnegie & Co. and Brandon Capital Partners and included participation by prior investors Split Rock Partners, Ascension Ventures and Dr. Thomas Fogarty’s Emergent Medical Partners. EBR Systems’ WiSE™