Dr. Chen Chen of Relis Heart Presents Latest Advances of CH-VAD and BrioVAD® at 2024 EACTS Mechanical Circulatory Support Summit Amid IPO Filing

November 7-9, the 8th EACTS Mechanical Circulatory Support Summit of the European Association for Cardio-Thoracic Surgery (EACTS) was successfully held in Prague, Czech Republic. Dr. Chen Chen, founder of BrioHealth Solutions, Mr. Karl Nelson, Senior Vice President of Clinical Operations, and others were invited to attend this summit.

At this conferenceIndustry UpdatesSegment: Dr. Chen Chen reported on the full magnetic levitation implantable left ventricular assist system, CiFu, independently developed by BrioHealth Solutions.^®VAD (Model: CH-VAD) and BrioVAD^®The latest research and clinical progress. In the report, Dr. Chen Chen focused on CH-VAD and BrioVAD, based on the global development history of VAD technology, particularly the experiences and lessons learned from the early 20th century in the development of VADs using full magnetic levitation and hydrodynamic suspension technologies.^®In evaluating VAD key performance indicatorsAspectThe significant breakthroughs achieved have sparked a热烈反响 in the international community.

Dr. Chen Chen Reports on the Latest Progress in Product Development and Clinical Trials at BrioHealth Solutions

Dr. Chen Chen first explained CH-VAD and BrioVAD^®Breakthroughs in miniaturization and blood pump-related performance. Compared with similar products internationally, CH-VAD and BrioVAD^®Adopted a unique discrete magnetic levitation structure, whichMaximize Blood Pump RotorAt the same time,Further reduced the size of the blood pump, achieving lower implant invasiveness and providingHemocompatibilityAndHemodynamic PerformanceThe improvement laid a foundation. Based on this structure, CH-VAD and BrioVAD^®Through further optimization design in fluid mechanics, especiallyDesign of the central column guide structure and long blade design of the blood pumpAndSecondary Flow Path Design, achieving further development in two key performance areas of the product: hemocompatibility and hemodynamics. Dr. Chen Chen further emphasized that in magnetic levitation VAD technology, the gyroscopic effect is a weak point for the anti-tilt rotation capability of the magnetic levitation rotor. The insufficient critical speed margin of ultra-small full magnetic levitation pumps and poor suspension stability at high flow rates are key challenges in the development of this category of VAD technology. Therefore,Suspension stability is a critical performance indicator that cannot be overlooked in magnetic levitation artificial hearts. The VAD field needs to establish quality standards for magnetic levitation design to prevent arbitrary evaluations of stability. The rotor of a fully magnetic levitation blood pump should be able to suspend in the air and resist tilting movements during rotation.CH-VAD and BrioVAD^®Through multidisciplinary optimization design, the full magnetic levitation blood pump has not only been miniaturized but also enhanced in various other key performance indicators (including hemocompatibility, hemodynamics, suspension stability, etc.), demonstrating the all-around advantages of the blood pump's performance.

In this report, Dr. Chen Chen also emphasized CH-VAD and BiroVAD.^®A brand-new breakthrough in percutaneous cable technology. As the fully magnetically levitated VAD further improves the long-term survival rate and quality of life for patients with advanced heart failure, long-term VAD carriage has become the mainstream application scenario in this field. Meanwhile, infection prevention of percutaneous cables has gradually become a widely concerned long-term adverse event. CH-VAD and BiroVAD^®By adopting micro-electronic circuit technology, the number of leads is minimized while meeting the requirements of full redundancy design, enabling its percutaneous cable to achieveGlobalThe finest, helps to minimize the occurrence of percutaneous cable infections.

The design features and related advantages of this product have been further validated in large-scale clinical applications. In this report, Dr. Chen Chen announced the latest results of CH-VAD in the clinical promotion and application in China. The current results show that the long-term survival outcomes of CH-VAD...Above the level of international large-scale clinical research and INTERMACS data; while serious adverse events such as stroke, gastrointestinal bleeding, and percutaneous cable infection in patientsBelow the level of international large-scale clinical studies and INTERMACS data, consistently demonstrating internationally leading clinical outcomes。

Dr. Chen Chen simultaneously reported on BrioVAD^®INNOVATE Clinical Study in the United StatesThe design scheme and plan, this study will adoptRandomized ControlledThe method to evaluate BrioVAD^®Efficacy and Safety for Treating Refractory Heart Failure

During the summit, Dr. Chen Chen and the team conducted extensive and in-depth exchanges with international VAD industry leaders, receiving high praise from experts around the world, especially European industry leaders. As BrioHealth Solutions accelerates its commercialization in the Chinese market and initiates clinical trials in the United States, the European market has become the next focal point in the company’s global strategic layout. This summit holds positive significance for BrioHealth Solutions in enhancing the global academic influence of its products and expanding into international markets.