Recently, BrioHealth Solutions, Inc., a wholly-owned subsidiary of BrioHealth in the United States, announced that its independently developed fully magnetic levitation left ventricular assist device, BrioVAD, has formally received approval from FDA to advance to the Pivotal Phase of its clinical trial following the successful completion of the Safety Phase of the INNOVATE clinical trial in the United States. The FDA has approved expanding the clinical research centers to 60 sites, with a cumulative enrollment of up to 780 subjects (including those enrolled during the Safety Phase).

Dr. Francis D. Pagani, Otto Gago Chair Professor of Cardiac Surgery at the University of Michigan and lead investigator of the clinical trial, stated: “With the successful completion of the Safety Phase, we are pleased to advance into the Pivotal Phase of the INNOVATE clinical trial. Our ultimate goal is to provide clinicians with an advanced treatment option for the thousands of patients currently affected by advanced heart failure.”

Dr. Chen Chen, founder of BrioHealth, shared his excitement about this progress: “It brings us one step closer to our mission of becoming a global leader in innovative solutions for advanced and persistent heart failure, as we continually break the boundaries of what is possible. We are thrilled to advance the INNOVATE clinical trial, which will now expand to 60 clinical partner centers to evaluate both short-term and long-term efficacy.”

The FDA's approval of the INNOVATE clinical trial to advance into the Pivotal Phase not only signifies FDA recognition of BrioVAD's design, feasibility, and preliminary clinical performance, but also demonstrates BrioHealth's capability and expertise to continuously advance clinical development under the world's most stringent regulatory framework. This milestone marks the first time China's high-end medical device industry has break through the world's highest regulatory barriers with innovative technologies, propelling it further into the global innovation arena for high-end medical devices.

About the BrioVAD® System

Main Components of the BrioVAD® Left Ventricular Assist System

The BrioVAD® system is a durable left ventricular assist device (LVAD) designed to provide full-flow support for long-term use in heart failure patients. It consists of an implantable blood pump and external components. Unlike the only FDA-approved durable LVAD currently available in the U.S., the BrioVAD® features an innovative discrete magnetic levitation design that combines a compact pump body with a larger impeller, thereby minimizing surgical trauma. Additionally, the BrioVAD® employs a novel percutaneous cable that is thinner and more flexible, aimed at reducing the risk of infection.

The distinctive magnetic levitation structure and large-diameter impeller of the BrioVAD® pump provide a foundation for optimized internal flow paths. This advanced flow path design enhances blood compatibility and improves hemodynamic performance, ultimately lowering the risk of severe complications.

The external components of the BrioVAD® system are uniquely designed to improve user experience and patient quality of life. Patients only need to carry two components daily, significantly enhancing convenience and comfort.

About the INNOVATE Clinical Trial

The INNOVATE trial is a prospective, random controlled, open-label, multi-center pivotal study designed to assess the safety and effectiveness of the BrioVAD® system in patients with advanced, refractory heart failure needing either short-term or long-term mechanical circulatory support. In this study, participants will be randomly assigned in a 2:1 ratio to receive either the BrioVAD® system or the HeartMate 3. The primary endpoints are survival free from disabling stroke and pump replacement at both 6 months and 24 months. Secondary endpoints include evaluating adverse events, cardiac function, and quality of life in heart failure patients. The trial will also investigate whether implantation of the BrioVAD® can reduce the total number of hospital days during the follow-up period. Approximately 800 patients will be enrolled across leading medical centers in the United States. For more information, visit www.theinnovatetrial.com.