3.5亿！创新械企超额完成两轮融资

Core Viewpoint - EBR Systems has successfully completed a significant financing round, raising nearly $50 million to support the commercialization of its WiSE™ wireless cardiac resynchronization therapy (CRT) system, which has recently received FDA approval and is set to transform heart failure treatment [2][4][12]. Financing Overview - EBR Systems announced the completion of its Share Purchase Plan (SPP) on June 18, 2025, raising approximately $13 million (about AUD 20 million), significantly exceeding the initial target of AUD 6 million [2][3]. - The total financing from this round, combined with a previous institutional placement of $36.1 million (approximately AUD 55.9 million), brings the total to nearly $50 million (about AUD 75.9 million) [4][12]. Product Development and Market Entry - The WiSE CRT system is the first and only FDA-approved wireless left ventricular endocardial pacing device for heart failure-related cardiac resynchronization therapy [4][5]. - The system's design eliminates the need for multiple leads, reducing complications associated with traditional CRT devices, thus expanding the potential patient population [5][11]. - EBR Systems has initiated its limited market release (LMR) following the first commercial implant of the WiSE system in the U.S. in June 2025 [9][12]. Reimbursement and Commercialization Strategy - EBR is actively working on establishing a reimbursement mechanism, having applied for inclusion in the Transitional Pass-Through Payment (TPT) program, expected to take effect in October 2025 [10][12]. - The company is also seeking to have the WiSE CRT system included in the New Technology Add-On Payment (NTAP) list, which would facilitate broader adoption in hospitals [10]. Clinical Impact and Innovation - The WiSE CRT system has shown higher pacing accuracy and better simulation of the heart's natural conduction pathways, improving the quality of life for heart failure patients [11][12]. - The system is particularly beneficial for high-risk patients or those who have failed traditional therapies, providing a new treatment option [11].