Dr. Chen Chen of CH Biomedical Presents Latest Advances of CH-VAD® and BrioVAD® at EUMS 2024 and Submits IPO Prospectus
BrioHealth Solutions
Ventricular Assist Device Developer and Manufacturer
September 11-14, the 18th European Mechanical Circulatory Support Summit (EUMS) was successfully held in Hanover, Germany. The summit is an internationally leading academic exchange platform in the field of advanced heart failure, showcasing technological innovations, setting best practice standards, and promoting multidisciplinary diagnosis and treatment strategies. This year's summit aimed to highlight best practices, adopt an interdisciplinary approach, ensure an international perspective, encourage intervention strategies, promote interactive participation, and drive innovation. Dr. Chen Chen, founder of BrioHealth Solutions, and Mr. Karl Nelson, Senior Vice President of Clinical Operations, were invited to attend the conference.
At this conferenceVAD UPDATESSession: Dr. Chen Chen reported on BrioHealth Solutions' independently developed fully magnetically levitated implantable left ventricular assist system - CiFU.®VAD (Model: CH-VAD)®）and BrioVAD®The latest R&D and clinical progress has attracted widespread attention and high praise from the international community.
Figure 1: Dr. Chen Chen delivering a presentation at the EUMS 2024 Summit
At the meeting, Dr. Chen Chen introduced the company's core product, Cifu, in detail.®VADand BiroVAD®The original innovative development process (Fig. 2, Fig. 3), the product was first prototyped in 2011 and announced at the American Society for Artificial Internal Organs annual meeting, underwent several multidisciplinary optimization iterations and was finalized in 2015. BrioHealth Solutions®VADand BiroVAD®InMagnetic suspension structure, hydrodynamic design, percutaneous cable designand other aspects, with multiple globally pioneering technologies, and inHemocompatibility, Hemodynamics, Implant Invasiveness, Anti-Infectivity, Portability and ReliabilityThese critical performance indicators for evaluating artificial hearts have demonstrated international leadership (Figures 4 to 6).
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As an expert in magnetic levitation VAD with international reputation, Dr. Chen Chen focused on elaborating the technical standards of full magnetic levitation at this conference. Dr. Chen Chen stated that CiFU...®VAD and BiroVAD®The design follows the internationally widely recognized ISO 14839-3 international standard for mechanical vibration, which requires a stability margin assessment for vibrations in rotating machinery equipped with active magnetic bearings; meanwhile, it suggests that quality standards for magnetic suspension design need to be established in the VAD field to eliminate arbitrary choices, explainingThe rotor of a fully magnetically levitated blood pump should be able to suspend in the air and resist tilting movements during rotation.。
Note: The peak angular velocity is 12.57 rad/sec, corresponding to the rotational speed of the upper body during the swing of professional golfers.
At the same time, Dr. Chen Chen announced the CiFu®Main outcomes of VAD in clinical promotion and application in China. By actively promoting the internationally leading concept of full-process management and multidisciplinary collaboration, and in compliance with post-marketing follow-up and regulatory requirements, as of September 1, 2024, BrioHealth Solutions' CiFU®VADUsed in a total of 314 cases in China. Through the use of Kaplan-Meier survival analysis, patients1-year, 2-year, 3-year survival ratesRespectively87.2%, 85.2%, 82.4% (Figure 8)，Above the level of international large-scale clinical trials and INTERMACS data. Patients had stroke (Figure 9), gastrointestinal bleeding (Figure 10), percutaneous cable infection (Figure 11), etc.KeyThe incidence of adverse events was lower thanInternational Large-Scale Clinical Trials and INTERMACS Data Levels。
Figure 8: Kaplan-Meier Survival
Figure 9: Freedom from First Stroke
Figure 10: Freedom from First GI Bleeding
Figure 11: Freedom from First Driveline Infection
Dr. Chen Chen introduced the upcoming BrioVAD in sync.®The design and plan of the INNOVATE clinical study in the United States, which will use a randomized controlled method to evaluate BrioVAD®Efficacy and Safety for the Treatment of Refractory Heart Failure
During the conference, Dr. Chen Chen and Mr. Karl Nelson had extensive exchanges and discussions with international VAD industry leaders.
In 2020, BrioHealth Solutions became the first Chinese implantable VAD company invited to attend the European Mechanical Circulatory Support Summit, and has since continuously reported on the company's product development and application progress at the conference. In November 2021, the CH-VAD®VAD becomes the first domestically produced artificial heart approved for marketing in China, marking the entry of China's end-stage heart failure treatment into the era of artificial hearts; In February 2024, BrioVAD®Received IDE approval from the U.S. FDA, becoming the first active implantable medical device produced in China to be approved by the FDA for clinical trials. With the product's internationally leading performance in key metrics, BrioHealth Solutions has successively entered new milestones in its operations in both China and the U.S., which will further accelerate the company’s expansion into European and other overseas markets.
