Suzhou CH Biomedical Recognized as Jiangsu Province Unicorn Enterprise, Advances Global Ambitions with BrioVAD Clinical Trial in the U.S.

A unicorn company refers to a company that has entered a high-growth period through technological innovation, with outstanding comprehensive benefits, strong core competitiveness, significant industry influence, and high capital market valuation.As a typical representative of new quality productivity, unicorn companies are a powerful engine driving regional economic transformation, upgrading, and innovative development. Their continuous growth is of great significance for achieving high-level technological self-reliance and promoting high-quality regional development. This honor not only highly affirms BrioHealth Solutions' continuous innovation capability in the artificial heart field but also highlights its leading position in the artificial heart industry.

Artificial heart is a high-tech medical device with extremely high R&D difficulty, and is one of the symbols of a country's advanced medical device technology level. Since its establishment in 2008, BrioHealth Solutions has been committed to the research, production, and sales of ventricular assist devices (also known as "VAD," or "artificial heart") with breakthrough technologies. With years of technical accumulation and original innovation, BrioHealth Solutions successfully developed and launched CH-VAD, a globally leading fully magnetically levitated artificial heart.^®VAD (Model: CH-VAD) has complete independent intellectual property rights built from the underlying core technology, and it is technologically advanced with global patent protection. Moreover, it has reached an internationally leading level in various key performance indicators for evaluating artificial hearts.

Cifu^®The outstanding potential of VAD has also been highly recognized by the international medical community. In April this year,At the annual meeting of the International Society for Heart and Lung Transplantation (ISHLT 2024), Fuwai Hospital's single-center Cifu^®Clinical Results of 50 VAD Implants Stun Debut; May,The research findings were published in the prestigious international cardiothoracic surgery journal, "The Journal of Heart and Lung Transplantation.", this is the first time China has published clinical research results on implantable ventricular assist devices (VAD) in this journal, and it is also the first time that research results of China-produced medical devices have been published in this magazine; In September, at the 18th European Mechanical Circulatory Support Summit (EUMS),BrioHealth Solutions^®The research findings on the multi-center clinical application of VAD at Beijing Anzhen Hospital and other centers have once again drawn significant attention from the international medical community, showcasing the excellent level of LVAD clinical application in China and the outstanding performance of China's self-developed fully magnetically levitated LVAD.！

In addition, based on BrioHealth Solutions^®VAD's Excellent Blood Compatibility: BrioHealth Solutions Successfully Develops BrioVAD Through Multiple Technological Innovations^®The left ventricular assist system has achieved portability of the external components, and the overall performance of the system has been further improved.This year, BrioVAD^®The milestone INNOVATE clinical trial has received IDE approval from the U.S. FDA, becoming the first active implantable medical device in China to gain FDA approval for clinical trials, setting a precedent for China's artificial heart industry entering U.S. clinical trials.。

In the future, BrioHealth Solutions will continue to promote innovation and development in the artificial heart field, benefiting a wider range of patients with end-stage heart failure globally through the most cutting-edge scientific and technological achievements.