Company Profile
BrioHealth Solutions, Inc. is a US-based manufacturer of left ventricular assist devices (LVAD), headquartered in Burlington, Massachusetts. Founded in 2008 by experts in heart failure therapy, the company operates as the US subsidiary of CH Biomedical (Suzhou Tongxin Medical Technology Co., Ltd.), a China-based cardiovascular device company. BrioHealth employs 101–250 people and is led by CEO Chen Chen, Ph.D. The company develops the BrioVAD System with operations across the United States, China, and Europe.
Core Products ＆ Technologies
BrioVAD® Left Ventricular Assist System (LVAS)
• Fully Magnetically Levitated Pump: Compact implantable blood pump with magnetic bearing design, long-blade rotor technology, and optimized blood flow pathway to enhance cardiac output while minimizing hemolysis and thrombosis
• Thin Driveline: Novel driveline design that is significantly thinner and more flexible than existing LVADs, potentially reducing driveline-associated infections and improving patient comfort
• Lightweight External Components: Only two external patient-worn components (controller and battery), designed to enhance mobility and user experience
• Size Advantage: Smaller pump profile than the currently FDA-approved durable LVAD in the US, designed to reduce surgical invasiveness
Market Position ＆ Certifications
BrioHealth holds a development-stage position in the global mechanical circulatory support market, competing with Abbott (HeartMate 3), Medtronic, CARMAT, CorWave, and BiVACOR. Key strengths include:
• 17+ years of cardiovascular device development heritage
• Global clinical footprint: Over 150 patients enrolled in the INNOVATE trial across 34 US sites as of March 2026
• Regulatory progress: FDA IDE approved for INNOVATE pivotal trial (60 sites, 780 subjects); FDA conditional approval for Brio4Kids pediatric trial
• Magnetic levitation technology: Fully magnetically suspended rotor eliminating mechanical wear and enabling long-term durability
• Patient-centric design: Focus on reducing complications and improving quality of life through compact pump and thin driveline engineering
Corporate Timeline
2008 — Founded by heart failure therapy experts; began proprietary BrioVAD technology development
2024 — Officially renamed from CH Biomedical (USA) to BrioHealth Solutions, Inc.
2024 — Received FDA IDE approval to initiate the INNOVATE trial
2024 — Commenced patient enrollment in the INNOVATE trial across US centers
2025 — Completed safety phase enrollment of INNOVATE trial
2025 — Reached one-year milestone and 100th INNOVATE trial enrollment
2026 — Completed 100th BrioVAD System implant (March); FDA approved progression to pivotal phase of INNOVATE trial, expanding to 60 sites and 780 subjects (April 17); FDA conditional approval for Brio4Kids pediatric trial (April 24); enrollment exceeded 150 patients across 34 US sites
Target Markets ＆ Applications
• Advanced Heart Failure (Adult): Long-term mechanical circulatory support for refractory left ventricular heart failure as bridge-to-transplant or destination therapy
• Pediatric Heart Failure: Durable LVAD support for school-age children and adolescents with advanced heart failure 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 US, European, and Asia-Pacific markets
Contact Information
Global Headquarters
Address: Burlington, Massachusetts, USA
Website: www.briohealthsolutions.com
