Suzhou CH Biomedical's Sci-Tech Innovation Board IPO Application Accepted by SSE

China Securities News (Wang Lu) -- On December 26, the Shanghai Stock Exchange (SSE) announced that the Sci-Tech Innovation Board IPO application of BrioHealth Solutions (hereinafter referred to as "BrioHealth Solutions") had been accepted.

The prospectus shows that BrioHealth Solutions was founded in 2008 and has long focused on the research, development, and commercialization of fully magnetically levitated ventricular assist devices (hereinafter referred to as artificial hearts). Based on its complete, independently controlled technology and operating entities in China, the United States, and Europe, the company has built a business system covering the mainstream markets worldwide. It has already generated rapidly growing revenue in China and the United States.

In 2024, BrioHealth Solutions' next-generation product, BrioVAD, received FDA approval to initiate a PMA clinical trial in the United States. This marks the first time that an active implantable medical device from China has entered the highest regulatory pathway for clinical trials in the U.S., signifying that Chinese artificial heart enterprises are now capable of competing under the highest international standards. The trial is covered by U.S. Medicare, with an average support of approximately $220,000 per case. Meanwhile, the company's BrioLife study in Europe has entered the ethical approval stage, with plans to begin enrollment in 2026. Efforts are also underway to expand the product’s application for pediatric heart failure indications in Japan and the United States.

As of the date of the prospectus signing, CH-VAD has been implanted in over 670 cases across more than 80 hospitals, with sales revenue rapidly increasing from RMB 8.27 million in 2022 to RMB 67.06 million in 2024.As a global innovative medical device company driving advancements in the treatment of advanced heart failure through breakthrough new technologies, BrioHealth Solutions is accelerating its move into the ranks of global leaders in artificial heart technology by leveraging international R&D, clinical, and quality systems.