EBR Systems, Inc.

Every once in a while, a breakthrough doesn't just advance medicine—it changes the conversation entirely. SUNNYVALE, Calif., April 17, 2025 /PRNewswire/ -- EBR Systems, Inc. (ASX: EBR) has received FDA approval of the WiSE® System, which marks a significant leap forward in the treatment of heart failure. Unlike conventional CRT, the WiSE System is the first and only to deliver leadless left ventricular endocardial pacing (LVEP), that closely aligns with the heart's natural conduction pathway. The endocardial approach represents a more physiological method of resynchronization and allows electrophysiologists to treat patients that are not able to receive lead-based devices. This advancement offers a pioneering treatment option for patients who have limited access to conventional CRT therapies. Continue Reading Illustration of implanted WiSE System "Recent years have brought significant advancements in leadless pacing for the right heart, but CRT patients were limited to traditional options—until now," said principal investigator Niraj Varma, MD, PhD, FRCP, Professor of Medicine at Cleveland Clinic. "Now, the WiSE System brings a leadless solution to left ventricular pacing, eliminating the biggest limitation of conventional CRT: the lead. This is a game-changer for patients who were previously untreatable due to anatomy or lead failures." Expanding Access to Patients Conventional CRT leaves too many heart failure patients behind. The WiSE System was designed for them. It allows physicians to help these key patient populations: Patients with challenging anatomy where the LV lead could not be implanted Patients with acute or chronic LV lead failure Patients with high procedural risk for LV lead placement Patients with leadless pacemakers* who need CRT, yet are often poor candidates for conventional upgrades In short: WiSE brings CRT to more patients than ever before. Backed by Data. Reimagining Delivery of CRT. The SOLVE-CRT trial has delivered promising results for heart failure patients. The WiSE System offers hope to those who have tried other therapies without success and were told no further options existed—until now. 16.4% reduction in LV end-systolic volume (LVESV)—a key marker of reverse remodeling (p=0.003) Shorter QRS durations by an average of 39ms— an indicator of electrical resynchronization Over 55% improved at least one NYHA class and another 40% remained stable Seamless Integration. The WiSE System syncs with existing pacing devices—pacemakers, ICDs, or CRTs—using a subcutaneous ultrasound Transmitter to power an ultra-compact Electrode implanted in the LV. No leads. No lead navigation. Just endocardial pacing that's more physiologic, from the inside out. Empowering Physicians, Powering Hearts. "We're delighted for the heart failure patients who were not treatable with existing CRT lead-based devices," said John McCutcheon, President and CEO of EBR Systems. "This milestone celebrates the dedication of our team, the support of our shareholders, and empowers electrophysiologists with a vital new tool to help their patients. It marks the culmination of EBR's 22-year pre-commercial phase and the start of our journey as a high-growth, medical device company." For more information about training, patient selection, or clinical support, please contact EBR at . *Medtronic's Micra leadless pacemaker has been qualified for use with WiSE System. Abbott's Aveir leadless pacemaker has not yet been qualified for use with WiSE System, but testing conducted by EBR is in progress. SOURCE EBR Systems WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

The FDA approved its WiSE cardiac resynchronization therapy (CRT) system through the premarket process. Australia-based EBR Systems — which has its U.S. base in Sunnyvale, California — says WiSE is the world’s only wireless cardiac pacing device for heart failure. EBR designed its WiSE system to significantly expand the population of patients who could benefit from CRT. The leadless solution delivers left ventricular pacing, working seamlessly with existing pacemakers, defibrillators or CRT devices that provide right ventricular pacing. The WiSE CRT system is the size of a cooked grain of rice. FDA approval covers adults (at least 22 years of age) indicated for CRT. These patients have an existing implanted right ventricular pacing system and fall into one of two categories. First, patients may have previously had unsuccessful coronary sinus lead implantation or had their implanted lead turned off (known as previously untreatable). The other group had previously implanted pacemakers or defibrillators but have relative contraindications for CS lead or CRT device implantation (high-risk upgrades). EBR says the Medtronic Micra leadless pacemaker qualifies for use with WiSE CRT. It currently has testing underway to get the Abbott Aveir leadless pacemaker approved for use with WiSE, too. The company plans for a limited market release this year, followed by a full rollout in 2026. It also plans to conduct a post-approval study of 320 patients, followed out to five years. “We are thrilled to announce this major milestone for EBR and to share this achievement with our dedicated team, shareholders, partners and stakeholders who have supported us on this journey,” said John McCutcheon, EBR Systems’ president and CEO. “Securing FDA approval for the WiSE CRT system is a transformative moment, marking our transition from clinical development to commercialization. “With FDA approval in hand, EBR is well-positioned to bring our innovative solution to market, delivering real impact to patients and servicing a significant unmet need.”

TAMPA, Fla., April 24, 2024 /PRNewswire/ -- Valcare Medical, Inc., a leading innovator in transcatheter-based mitral solutions, today announced a comprehensive corporate restructure aimed at accelerating the company's plans to initiate the AMEND clinical studies following the recent company acquisition by TechWald Holding S.p.A. As part of the restructuring, TechWald has appointed Steve Sandweg to serve as Chief Executive Officer. Sandweg brings a successful 25-year history in the medical device space having worked for both Fortune 500 and startup companies in the cardiovascular and structural heart space. Sandweg most recently served as Chief Commercial Officer for EBR Systems, Inc, developer of the world's only wireless cardiac pacing system for heart failure. Prior to that, Sandweg worked for Keystone Heart where he served as General Manager, and Direct Flow Medical serving as Director, US Clinical Field Operations. Sandweg began his cardiovascular and structural heart career with Medtronic Corp. in 2006 where he held positions of increasing responsibility with Medtronic's peripheral vascular, coronary, and structural heart business units. While with Medtronic, Sandweg played a key role in helping execute several strategic product launches including Endeavor and Resolute, the company's first drug eluting stents and Corevalve/EVOLUT, the company's first transcatheter aortic valve devices. "I'm excited and honored to be joining such a remarkably talented team," Sandweg said. "The TechWald acquisition and corporate restructure offer a unique opportunity for us to increase focus and accelerate performance. Following the success of our 17 patient first in human experience in which the AMEND implant demonstrated positive clinical efficacy out to 6 months, we are eager to now begin enrolling patients in the AMEND Plus European pilot study and look forward to initiating our FDA early feasibility study in the US next year." In addition to the appointment of Sandweg, the company also appointed a new Board of Directors led by Executive Board Chair, Chris Richardson. Richardson has over 30 years of experience in the medical device industry, and an extensive record of successfully leading medtech startups from clinical study phase through regulatory approval, commercial launch, and acquisition. Richardson currently serves as CEO for SafeHeal™, a leading innovator in the field of digestive surgery and developer of the Colovac device. Prior to that, Richardson served as President and CEO of Keystone Heart which was acquired by Venus Medtech in 2018. He also served as International President and Chief Commercial Officer of Direct Flow Medical, a transcatheter aortic valve company, and General Manager of Evalve (MitraClip), which was acquired by Abbott Vascular in 2009. "We're fortunate to have Steve come on board at this important stage in Valcare's development," said Chris Richardson. "Steve has the experience and operational track record the company needs at this time to execute on its ambitious plan to transform the standard of care for patients suffering from severe mitral regurgitation." Valcare's AMEND mitral valve repair device is an innovative, clinically proven, D-shaped, semi-rigid closed ring with proprietary anchoring capabilities. AMEND is designed to provide clinical standard-of-care surgical treatment via a transcatheter-based procedure. The AMEND platform also serves as the foundation for Valcare's future mitral replacement and tricuspid repair solutions. The AMEND device is limited to investigational use and is not commercially available. For more information, contact: [email protected] About Valcare Medical: Valcare Medical is dedicated to providing innovative minimally invasive technologies for the treatment of mitral regurgitation. SOURCE Valcare Medical