BrioHealth Solutions

BrioHealth Technologies, Inc. ("BRIOHEALTH" for short) was founded in 2008. It is committed to the research and development, production, and sales of ventricular assist devices (also known as "VAD," or "artificial heart") with breakthrough technology. By continuously providing excellent services to professional medical teams and patients, it aims to help a wider range of heart failure patients and their families worldwide regain a healthy and happy life, becoming a technology company leading the global artificial heart industry's progress. Ventricular assist devices are one of the benchmarks reflecting a country’s high-end medical device technological level, integrating a large number of cutting-edge technologies from fields such as mechanics, electronics, software control, fluid mechanics, and biomedical engineering, as well as advanced international medical device development management and manufacturing experience. After more than a decade of development, based on its technological accumulation in the fully magnetically levitated VAD field, BRIOHEALTH's independently developed CiFu® Implantable Left Ventricular Assist System (referred to as "CiFu® VAD") became China’s first fully magnetically levitated VAD with complete independent intellectual property rights to be approved for marketing. At the same time, with the latest breakthroughs in key performance indicators of this product, BRIOHEALTH has gained an international reputation as a technological innovator, consistently demonstrating its strength as a global technology and market leader. BRIOHEALTH has completed core patent layouts for this product in China, the United States, Europe, Japan, and other countries and regions, laying the foundation for the company’s global commercialization strategy. Additionally, the company has received support from key projects under the National High-Tech Research and Development Program (863 Program) during the "Eleventh Five-Year Plan," independent sub-projects under the "Twelfth Five-Year Plan" 863 Program, key special projects under the "Thirteenth Five-Year Plan" National Key R&D Program, and multiple provincial and municipal science and technology program projects, establishing independent intellectual property rights starting from fundamental patents. The company is dedicated to promoting continuous innovation in the VAD industry globally by synergizing professional resources. BRIOHEALTH has built a global R&D platform with multidisciplinary optimization design capabilities, incorporating usability engineering and DFM product design concepts; created a sophisticated manufacturing system with deep technical expertise; established a quality management system covering the entire lifecycle of medical devices according to China GMP, ISO13485, and U.S. FDA quality standards; and is leading the creation of an internationally advanced VAD clinical application support system. The establishment of a high-barrier technology platform and standard systems has laid a solid foundation for BRIOHEALTH's sustainable development in the Chinese and global markets, making it a new-generation leader in the global VAD industry.