On November 25, 2024, BrioHealth Solutions, Inc., the wholly-owned U.S. subsidiary of BrioHealth Solutions, announced the company's independently developedFully Magnetically Levitated Left Ventricular Assist Device BrioVAD^®, the first patient was enrolled in the INNOVATE clinical trial at Emory University Hospital in the United States.

Dr. Chen Chen, founder of BrioHealth Solutions and CEO of BrioHealth Solutions, stated: "We are thrilled to launch the INNOVATE clinical trial. After a long journey of continuous innovation, refinement, and quality optimization, we have breathed life into BrioVAD®. Although progress has been made in the field of ventricular assist devices, there remains an urgent need to enhance device performance and patient outcomes, and BrioHealth Solutions is committed to addressing this gap. The immense enthusiasm displayed by participating centers in advancing the treatment of advanced heart failure through this trial is truly gratifying."

BrioHealth Solutions was founded in 2008. After more than a decade of original innovation, it successfully developed a new generation of ultra-small fully magnetically levitated artificial heart, CiFU® VAD (Model: CH-VAD), which is China's first fully magnetically levitated implantable left ventricular assist device with complete independent intellectual property rights to be approved for marketing by the National Medical Products Administration (NMPA). Currently, over 350 patients in China have received treatment with CH-VAD, demonstrating excellent clinical outcomes. BrioVAD® shares the same implantable blood pump as CH-VAD and, through several technological innovations, has achieved portability of external components and an overall improvement in system performance.

The INNOVATE trial is a prospective, non-blinded, randomized, controlled, multi-center, confirmatory study designed to evaluate the safety and efficacy of the BrioVAD® system in treating advanced, refractory left ventricular heart failure.

Mani Daneshman, MD, Andrew J. McKelvey Distinguished Professor at Emory University School of Medicine and Director of the Emory Heart and Lung Transplant and Mechanical Circulatory Support Program, stated: "The launch of the INNOVATE trial is an important milestone in expanding treatment options for patients with advanced heart failure, and we look forward to seeing how the BrioVAD® system will benefit these patients."

BrioHealth Solutions has officially launched the INNOVATE clinical trial for its BrioVAD® Left Ventricular Assist System in the United States, marking a new milestone in the global heart failure treatment landscape and a solid step forward in the company’s globalization strategy.

About BrioVAD® System

BrioVAD® Left Ventricular Assist System Schematic Diagram

BrioVAD® Left Ventricular Assist System Main Components

BrioVAD® System is a durable VAD capable of providing full-flow support, consisting of an implantable blood pump and external components, designed to offer long-term support for heart failure patients. Compared with the currently only FDA-approved durable VAD in the United States, the BrioVAD® blood pump adopts an innovative discrete magnetic levitation design, achieving the perfect combination of a smaller pump body and a larger impeller, which helps reduce surgical trauma. Additionally, BrioVAD® features an innovative percutaneous cable design; the thinner and softer percutaneous cable helps reduce the risk of associated infections.

The unique magnetic levitation structure and large-diameter impeller of the BrioVAD® blood pump also provide a foundation for optimizing the internal flow path of the pump. Advanced flow path design helps improve the device's hemocompatibility and hemodynamic performance, thereby reducing the risk of severe complications.

The external components of the BrioVAD® system feature several unique designs, allowing patients to wear only two components daily, which helps enhance user experience and quality of life.

About the INNOVATE Clinical Trial

INNOVATE is a prospective, randomized controlled, non-blinded, multi-center, confirmatory clinical trial that will enroll patients with indications for both short-term and long-term mechanical circulatory support. The aim is to evaluate the safety and efficacy of the BrioVAD® system in treating advanced, refractory heart failure. Participants in the trial will be randomized in a 2:1 ratio to receive either the BrioVAD® or the HeartMate 3. The primary endpoint is survival free from disabling stroke and pump replacement at short-term (6 months) and long-term (24 months). Secondary endpoints include assessment of adverse events in heart failure patients, cardiac function, and quality of life. The study will also verify whether implantation of the BrioVAD® can reduce the total number of hospitalization days during the follow-up period. The trial is expected to recruit approximately 800 patients at leading medical centers across the United States.