As a technology company focused on developing innovative solutions for advanced heart failure,BrioHealth Solutions announced today that the milestone clinical trial, INNOVATE study, has received FDA Investigational Device Exemption (IDE) approval and can conditionally begin patient recruitment.

This study will evaluate the efficacy and safety of the novel full magnetic levitation left ventricular assist system, BrioVAD™, independently developed by BrioHealth Solutions, for treating refractory heart failure. Meanwhile, BrioHealth Solutions has held its first investigator meeting and initiated relevant work at U.S. clinical trial centers.

BrioVAD™ Left Ventricular Assist System can provide short-term or long-term circulatory support for patients with advanced heart failure. Building on the excellent hemocompatibility of the existing product CH-VAD, this system achieves portability of external components through multiple technological innovations, with overall system performance further enhanced. This advanced technology is dedicated to helping patients overcome the challenges of heart failure and regain a high-quality life. Meanwhile, the INNOVATE study will adopt a randomized controlled design to compare and evaluate BrioVAD™ with previously FDA-approved products.

Francis D. Pagani, M.D., Ph.D., the current president of U.S. INTERMACS, Otto Gago Professor of Cardiac Surgery at the University of Michigan, and the principal investigator of this clinical trial, stated: "The FDA approval of the INNOVATE study is a landmark step, indicating that clinicians and patients with advanced heart failure will have more treatment options. The entry of the BrioVAD™ system into clinical evaluation represents a significant advancement in the field of heart failure, as countless patients each year face untreatable conditions and continue to suffer from this severely debilitating disease."

Dr. Chen Chen, CEO of BrioHealth Solutions, stated: "Achieving this key milestone is truly exciting for us. Our goal is to provide patient-centered solutions for end-stage heart failure patients and their families. The innovative BrioVAD™ has been designed and developed to achieve superior blood compatibility, featuring compact and lightweight external components to help patients overcome the challenges of heart failure and regain a vibrant quality of life."

This progress of BrioHealth Solutions has set a precedent for China's artificial heart industry to enter clinical trials in the United States, making the company one of the very few pioneers in China's entire medical device field to conduct clinical trials in the U.S.