In 2024, BrioHealth Technologies' next-generation BrioVAD became the first Chinese active implantAble medical device approved by the U.S. FDA for IDE clinical trials, entering the highest U.S. regulatory pathway (PMA). By 2025, the INNOVATE trial completed 152 patient implants across 26 top U.S. medical centers, with plans to expand to 60 centers and 780 patients. In 2025, the company ACHieved RMB 213 million in revenue (175.08% YoY growth), with overseas revenue surpassing 50% of total income. The company filed for STAR Market IPO in December 2025 and received inquiry status in early 2026, aiming to raise RMB 1.064 billion. In March 2026, the company formally submitted the Brio4Kids pediatric clinical trial application to the FDA, while the European BrioLife study gained German Ethics Committee approval.
Company Profile (Updated April 2026)
BrioHealth Technologies, Inc. (苏州同心医疗科技股份有限公司) is a global leader in full magnetically levitated (maglev) ventricular assist devices (VAD), headquartered in Suzhou Industrial Park, jiangsu Province, China. Established in 2008 by Dr. Chen Chen, the company has spent over 17 years developing breakthrough technologies for treating end-stage heart failure. BrioHealth Technologies successfully developed CH-VAD (Cifu VAD), china's first implantable full maglev left ventricular assist system with complete independent intellectual property rights, filling a critical gap in China's high-end active implantable medical device sector.
Development History:
- 2008: Founded in Suzhou, focusing on VAD R＆D from the ground up
- 2016: CH-VAD entered China's Innovative Medical Device Special Approval Procedure (Green Channel)
- 2017: First human implantation of CH-VAD performed by Academician Hu Shengshou's team at Fuwai Hospital, pioneering durable VAD clinical use in China
- 2021: CH-VAD conditionally approved by China's NMPA (Registration No.: 国械注准2021312097), becoming China's first approved full maglev implantable artificial heart, valid until November 23, 2026
- 2024: BrioVAD approved by U.S. FDA for IDE clinical trials, the first Chinese active implantable device to enter U.S. clinical trials; first overseas implantation completed in November 2024
- 2025: BrioVAD entered FDA Pivotal Phase trials; revenue reached RMB 213 million; CH-VAD Plus approved by NMPA for market launch
- 2025-2026: Filed for STAR Market IPO (December 2025), accepted for inquiry (early 2026); Brio4Kids pediatric trial application formally submitted to FDA (March 2026)
Core Mission: To advance the treatment of end-stage heart failure through breakthrough full maglev VAD technology, providing patients worldwide with life-saving alternatives to heart transplantation and improving quality of life for those living with implantable heart pumps.
2024-2025 Breakthrough: BrioVAD U.S. FDA Clinical Trials
FDA IDE Approval and INNOVATE Trial (2024-2025)
Regulatory Milestone:
- In 2024, BrioVAD received U.S. FDA Investigational Device Exemption (IDE) approval for Pre-Market Approval (PMA) clinical trials, the highest regulatory pathway for high-risk active implantable devices
- In August 2025, FDA approved BrioVAD to advance from Safety Phase to Pivotal Phase, expanding to 60 clinical centers with up to 780 enrolled patients
- This marked the first time a Chinese active implantable medical device entered U.S. clinical trials, breaking the monopoly of Abbott's HeartMate 3
Clinical Trial Progress (INNOVATE Study):
- Design: Multi-center, prospective, randomized controlled trial comparing BrioVAD head-to-head against Abbott HeartMate 3
- Enrollment: 100 patients enrolled within one year of launch (by end of 2025); 152 total implants across 26 U.S. centers (including control group)
- Target: 60 top-tier U.S. medical centers, 780 total patient implants
- Medicare Coverage: The trial received U.S. Medicare coverage, with approximately USD 220,000 reimbursement per case, enabling revenue generation during clinical trial phase
Global Expansion:
- Europe: BrioLife study submitted in Germany, Austria, and Netherlands; German Ethics Committee approval obtained; 2 centers signed clinical trial agreements
- Pediatric Expansion (Brio4Kids): In March 2026, formally submitted FDA clinical trial application for pediatric late-stage heart failure indication, with planned joint U.S.-Japan studies under the HBD framework
Core Products and Technology
CH-VAD / CH-VAD Plus (Cifu VAD System)
China's First Full Maglev Artificial Heart:
- Technology: Proprietary discrete maglev structure with optimized hemodynamic design, minimizing blood cell damage while ensuring efficient pumping
- Global Advantage: One of only two full maglev VADs approved by regulators and recognized by international academia globally (alongside Abbott HeartMate 3)
- Infection Prevention: Features an ultra-thin percutaneous cable design, significantly reducing infection risk at the driveline exit site
- Clinical Performance: Real-world multi-center follow-up studies demonstrate favorable blood compatibility and device reliability, with outcomes exceeding international benchmarks
- First Patient: The first CH-VAD implant patient survived 7 years with the device before successfully transitioning to heart transplant
- Commercialization: Approved for market in November 2021; implemented in over 100 hospitals across China with cumulative implants exceeding 750 cases by 2025
- CH-VAD Plus: Iterative version with enhanced features, approved by NMPA for market launch
BrioVAD System (Next Generation)
- Design: Smaller pump body with larger impeller, reducing surgical trauma while maintaining full maglev technology
- Advanced Driveline: Thinner, more flexible percutaneous cable design for improved patient comfort and reduced infection risk
- Patient Experience: External components optimized so patients only need to wear two components daily, improving mobility and quality of life
- Regulatory Status: FDA IDE approved (2024); Pivotal Phase ongoing (2025-2026); first overseas revenue generated in 2025
Financial Performance (2022-2025)
2025 Annual Results
BrioHealth Technologies Overall:
- Total Revenue: RMB 213 million (approximately USD 29.4 million), up 175.08% year-on-year
- Domestic Revenue: CH-VAD products and accessories reached RMB 105 million, up 100% from 2023
- Overseas Revenue: BrioVAD products and accessories reached RMB 107 million, up over 10x from 2024, accounting for 50.51% of total revenue
- BrioVAD Gross Margin: 72.28%
Historical Performance:
- 2022: Revenue RMB 8.61 million; Net loss RMB 189 million
- 2023: Revenue RMB 50.45 million; Net loss RMB 306 million
- 2024: Revenue RMB 77.35 million; Net loss RMB 372 million
- 2025: Revenue RMB 213 million; Net loss RMB 374 million
- Operating Cash Flow: Net cash used in operating activities was RMB -319 million in 2025
- Cumulative Losses (2022-2025): Over RMB 1.2 billion, reflecting typical high-R＆D medical device commercialization phase
IPO and Financing
- STAR Market IPO: Filed December 26, 2025; inquiry status reached in early 2026
- Planned Fundraising: RMB 1.064 billion
- Fund Allocation: Primarily for BrioVAD global clinical trials and registration, production base construction, next-generation LVAS R＆D, and working capital
Company Leadership and Structure
Corporate Governance
Founder & Controlling Shareholder: Dr. Chen Chen (陈琛博士)
- Holds combined voting rights of approximately 30.95%
- Led the company from founding through FDA breakthrough and IPO filing
Key Investors:
- Boyang Group (百洋集团, via Huizhu Boyang, Boyang Zhuxin, Boyang Group, and Puti Medical): 16.73% stake
- Sequoia China (红杉中国): 8.53% stake
- Blue Sail Medical (蓝帆医疗, via Jiwei Medical and Zhong Shuqiao): 5.15% stake
- Lingdao (领dao): 4.11% stake
- Gaorong Ventures (高榕创投): 3.89% stake
- Fenxiang (分享): 3.87% stake
R＆D Team:
- 103 R＆D personnel as of June 2025
- Dual R＆D structure: China team focuses on core technology and clinical support; U.S. team handles FDA-standard product development and overseas clinical/registration affairs
Global Market Position and Competition
Market Landscape
Global Heart Failure Burden:
- Over 60 million heart failure patients worldwide; approximately 3.2 million end-stage cases
- China: 13.7 million heart failure patients aged 35+; approximately 1 million end-stage cases
- Only ~8,000 heart transplants performed globally per year, creating massive unmet need for VAD therapy
Primary Competitors
- Abbott (HeartMate 3): Global market leader with over 40,000+ implants and annual sales exceeding USD 1 billion; long-standing monopoly in full maglev VAD segment
- Medtronic: Acquired HeartWare; historical presence in VAD market
- Berlin Heart: Pediatric and adult VAD solutions (Germany)
- CARMAT: Total artificial heart developer (France)
- Core Medical (核心医疗): Domestic competitor with Corheart 6 (smallest commercialized maglev VAD globally); filed STAR Market IPO concurrently
- Yongrenxin (永仁心), Space TaiXin (航天泰心): Other domestic VAD developers
Competitive Advantages
- Technology Leadership: One of only two globally recognized full maglev VADs; proprietary discrete maglev architecture
- Clinical Validation: Only Chinese VAD consistently publishing long-term clinical data on international academic platforms; real-world outcomes exceeding international averages
- Regulatory First-Mover: First Chinese active implantable device to enter FDA's highest regulatory pathway (PMA clinical trials)
- Revenue Diversification: First Chinese VAD company generating substantial overseas revenue during clinical trial phase via U.S. Medicare coverage
- Global Pipeline: Simultaneous development across U.S., Europe, and Japan markets with pediatric expansion
China Market Implementation Cases
Fuwai Hospital, Beijing (2017-2024)
- Milestone: Site of China's first CH-VAD implantation (June 2017) by Academician Hu Shengshou
- Patient Outcome: First patient survived 7 years with CH-VAD before successful heart transplant, demonstrating exceptional long-term reliability
- Clinical Significance: Established the clinical protocol for durable VAD therapy in China
Multi-Center Commercial Implementation (2021-2025)
- Hospital Network: CH-VAD implemented in over 100 hospitals across China
- Cumulative Implants: Exceeded 750 cases by 2025
- Market Share: CH-VAD held 26.9% cumulative implant market share in China as of end-2024
- Patient Services: Company established full lifecycle VAD patient service system covering implantation, management, and follow-up care
2026 Outlook and Strategic Priorities
Global Clinical and Commercial Roadmap
- U.S. Market: Complete BrioVAD INNOVATE Pivotal Phase trial across 60 centers; pursue FDA PMA approval for U.S. market entry
- European Market: Launch BrioLife study enrollment in H1 2026; pursue CE Mark certification
- Pediatric Indication: Advance Brio4Kids trial for pediatric heart failure in U.S. and Japan
- Next-Generation R＆D: Continue development of BrioVAD 2.0 and future LVAS innovations
China Market Expansion
- Accelerate CH-VAD and CH-VAD Plus commercialization with expanded hospital network
- Continue medical education and multidisciplinary training to standardize VAD therapy nationwide
- Leverage STAR Market IPO funding to scale production capacity and reduce costs
Contact Information
Headquarters
Address: Suzhou Industrial Park, Jiangsu Province, China
Investor Relations
STAR Market IPO: Under review by Shanghai Stock Exchange (as of early 2026)
Planned Listing: Shanghai Stock Exchange STAR Market (科创板)
Planned Ticker: To be determined upon approval
Corporate Website: www.briohealthtech.com
Investor Email: ir@briohealthtech.com
Keywords: BrioHealth Technologies, BrioHealth Solutions, 同心医疗, CH-VAD, BrioVAD, Cifu VAD, artificial heart, ventricular assist device, full maglev, heart failure, NMPA, FDA IDE, STAR Market, Suzhou, China, Abbott HeartMate 3, Dr. Chen Chen, Hu Shengshou, Fuwai Hospital, 750 implants, 213 million revenue, 2025, pediatric heart failure, Brio4Kids, Medicare coverage, medical device, IPO, CH-VAD Plus, conditional approval
