Recently, BrioHealth Solutions, an innovator in artificial heart technology, announced that its self-developed fully magnetically levitated implantable left ventricular assist system (abbreviated as"LVAD", commonly known as "artificial heart")BrioVADConducted in the United StatesINNOVATEClinical Trials Reach Key Milestone——From2024Since its launch at the end of the year, it has been successfully completed in just one year.100Example of patient enrollment.

BrioHealth SolutionsINNOVATEThe clinical trial is a multi-center, prospective study, conducted in2024Officially launched in the United States in the year, that year11Completed the first implantation in the month.This clinical trial willBrioVADThe Dominator in the Field of Fully Magnetically Levitated Artificial Hearts——AbbottHeartMate3Proceed“Head-to-Head”Control,Strictly VerifiedBrioVADClinical outcomes in terms of hemocompatibility, hemodynamics, implant invasiveness, and portability of external components. Meanwhile, in this clinical trial, each participant is eligible for U.S. federal Medicare (Medicare) approximately $220,000 in reimbursement support.BrioVAD, as the first and only active implantable medical device from China to receive FDA approval for clinical trials in the United States, marks BrioHealth Solutions' achievement in exporting domestically produced high-end medical devices.Milestone Breakthrough。

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Heart failure is known as“Cancer”According to statistics from the World Health Organization, the number of heart failure patients worldwide exceeds6000Million. Once heart failure is diagnosed,5Annual Mortality Rate50%, comparable to the survival rate of malignant tumors.Heart transplantation is an effective treatment for end-stage heart failure, but the number of heart transplants performed globally each year is only8000Approximately. Therefore, artificial heart implantation has become the only means for large-scale treatment of heart failure.

For Chinese innovative enterprises, successfully going global and entering the international market is a key leap in realizing value imagination.. Unlike in510The K pathway achieves overseas market entry for medium-to-low risk medical devices through performance testing. High-risk implantable devices like artificial hearts must go through a rigorous, phased process to enter the U.S. market.IDEClinical research, completing the safety phase and the confirmatory phase of the trial in sequence,After accumulating sufficient human clinical data,Only withPMA（Pre-Market Approval) pathway approved for marketing,This is also the most stringent, complex, and costly path to market in the U.S. medical device system.OnceThroughThis pathway has been approved.Success, which not only means that the product itself has globalTop-notchTechnologyLevel, which also marks the company's true entry onto the international high-end medical device stage.

BrioHealth Solutions has long been dedicated to the research and development of breakthrough implantable ventricular assist devices and is promoting their industrialization on a global scale.Development.Driven by original innovation and breakthroughs in underlying technology,BrioHealth Solutions Successfully Developed China's First Fully Magnetically Levitated Artificial Heart with Complete Independent Intellectual Property Rights——CH-VAD(Cifu®VAD），Fills the gap in this field in China. As the first fully magnetically levitated artificial heart product in China, CiFU®The core component of the VAD, the blood pump, through an internationally pioneeringSplit Magnetic Levitation StructureCompared with the optimizedFluid Dynamics Design, achieving excellence inBlood Compatibility, Ensuring Efficient Pumping While MaximizingReduceBlood CellsInjury，SignificantReduce adverse events such as pump thrombosis, stroke, and gastrointestinal bleedingTheIncidence RateThereby improving the long-term survival rate of patients and enhancing their quality of life.

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BrioVADIt is BrioHealth Solutions' fully magnetically levitated artificial heart, CiFU.®VADA new generation of products developed on the basis.Through a number of technological innovations,BrioVADThe portability of components such as external batteries and the overall performance improvement of the system have enabled greater benefits in the treatment of end-stage heart failure patients.

2025Year8In the month, after successfully completing the U.S. clinical safety phase study,BrioVADObtainFDAApproval to enter the confirmatory stage, the research center will expand to60Household, Cumulative Enrollment780subjects. This progress reflectsFDAYesBrioVADThe recognition in system design, engineering feasibility, and preliminary clinical performance also demonstrates that BrioHealth Solutions possesses the comprehensive strength to continuously and standardly advance clinical research and development under the highest regulatory standards globally.

BrioVAD System Schematic Diagram

The Principal Investigator of this clinical trial, Department of Cardiac Surgery, University of Michigan Medical SchoolOtto GagoDistinguished ProfessorFrancis D. PaganiThe doctor said:“Each successful implantation gives us a deeper understanding.BrioVADThe full potential of the system, and have expanded more treatment options for patients with advanced heart failure. We are encouraged by the progress achieved so far and will continue to advance relevant scientific research, building a new generation of heart failure treatment framework.”

Dr. Chen Chen, founder of BrioHealth Solutions, stated:“BrioVADSystemINNOVATEClinical Trial Completed100The enrollment of the first patient is an important milestone for our entire team. This achievement would not have been possible without the outstanding commitment of our clinical trial partners, and it also highlightsBrioVADThe system has the potential to expand more effective treatment options for patients with advanced heart failure. This is of great significance to the patients we are committed to serving, meaning that we have taken another big step forward in changing the standard of heart failure treatment.”

As clinical trials proceed steadily and technology continues to break through, BrioHealth Solutions will consistently empower global heart failure treatment with innovation, bringing new hope to more patients with heart failure.