Company Profile
BrioHealth Technologies, Inc. (Chinese: 苏州同心医疗科技股份有限公司) is a China-based manufacturer of implantable ventricular assist devices (VAD), headquartered in Suzhou Industrial Park, Jiangsu. Founded on 25 July 2008 by Dr. Chen Chen, the company is led by its founder serving as Chairman and Chief Technology Officer. Dr. Chen is the controlling shareholder with 30.9508% voting rights through direct ownership and concerted action agreements. The company employs 103 R＆D staff (as of June 2025) and operates global subsidiaries in the United States, Hong Kong, and Europe. It filed for an IPO on the Shanghai Stock Exchange STAR Market on 26 December 2025, seeking to raise RMB 1.064 billion.
Core Products ＆ Technologies
Maglev Left Ventricular Assist Systems
• CH-VAD: China's first NMPA-approved fully magnetically levitated implantable artificial heart (November 2021); over 670 clinical implants across 80+ hospitals in China
• CH-VAD Plus: Iterative upgrade of CH-VAD with enhanced performance; NMPA approved
• BrioVAD: Next-generation fully magnetically levitated LVAD for global markets; FDA IDE approved (2024) with CMS reimbursement coverage (~USD 220,000 per case); CE-marking pathway initiated in Europe
• BrioVAD 2.0: Next-generation implantable artificial heart under development with multiple technical breakthroughs achieved
Clinical Trial Portfolio
• INNOVATE Trial (US): Prospective, multicenter, open-label, non-inferiority pivotal trial for BrioVAD against Abbott HeartMate 3; 34 sites activated with 150+ patients enrolled; FDA approved progression to pivotal phase in April 2026, expanding to 60 sites and 780 subjects
• BrioLife (Europe): Pre-market clinical study application submitted in Germany, Austria, and the Netherlands; German ethics committee approved; clinical trial agreements signed with 2 centers
• Brio4Kids (US/Japan): Prospective, multicenter, single-arm pediatric trial planned at 7 US and 2 Japanese pediatric cardiac centers; 25–65 patients targeted; FDA conditionally approved April 2026; enrollment expected to commence mid-2026
Market Position ＆ Certifications
BrioHealth Technologies holds a pioneering position in China's artificial heart market, competing with Abbott (HeartMate 3), Medtronic, CARMAT, CorWave, BiVACOR, and CoreHeart Medical. Key strengths include:
• 17+ years of VAD R＆D heritage
• First-mover advantage: First domestically developed and NMPA-approved fully magnetically levitated artificial heart in China; one of only two fully magnetically levitated LVADs globally recognized by regulators and international academia (alongside Abbott HeartMate 3)
• Global regulatory progress: First Chinese active implantable medical device to receive FDA IDE approval for US clinical trials; CMS reimbursement established for trial-stage revenue generation
• Technology leadership: Proprietary full magnetic levitation eliminating mechanical wear; long-blade rotor design optimizing blood flow and minimizing hemolysis
• Global subsidiary network: US entity BrioHealth Solutions, Inc. (2009); Hong Kong entity BrioHealth Technologies (HK) Limited (2025); European entity BrioHealth B.V., Amsterdam (2025)
Corporate Timeline
2008 — Founded in Suzhou Industrial Park by Dr. Chen Chen
2009 — Established US subsidiary BrioHealth Solutions, Inc. in Delaware
2021 — CH-VAD received NMPA approval, becoming China's first fully magnetically levitated artificial heart
2024 — BrioVAD received FDA IDE approval; first patient enrolled in INNOVATE US trial; CMS established reimbursement coverage
2025 — Annual revenue reached RMB 213 million (up 175.08% YoY); overseas trial revenue reached RMB 107 million (50.51% of total); STAR Market IPO application accepted on December 26; CH-VAD Plus received NMPA approval; completed E-round financing of RMB 465 million; established Hong Kong and European subsidiaries
2026 — Updated IPO prospectus in April; FDA approved INNOVATE trial pivotal phase expansion (60 sites, 780 subjects) and conditionally approved Brio4Kids pediatric trial; cumulative INNOVATE enrollment exceeded 150 patients across 34 US sites
Target Markets ＆ Applications
• Advanced Heart Failure (Adult): Long-term mechanical circulatory support as bridge-to-transplant or destination therapy for refractory left ventricular failure
• Pediatric Heart Failure: Durable VAD support for school-age children and adolescents through the Brio4Kids trial
• Transplant Bridge: Short-term and long-term support for patients awaiting cardiac transplantation
• Destination Therapy: Permanent mechanical support for patients ineligible for heart transplant
• Global Expansion: Clinical and commercial development across China, the United States, Europe, and Japan
Contact Information
Global Headquarters
Address: Room 301, Building NW-07, Suzhou Nanopolis, No. 99 Jinji Lake Avenue, Suzhou Industrial Park, Jiangsu 215123, China
Phone: +86 512 6295 6271
Email: ir@briohealthtech.com
Website: www.briohealthtech.com
