In December 2025, BrioHealth reACHed the 100th BrioVAD implant milestone and received FDA approval to proceed to the pivotal phase of the INNOVATE trial. In July 2025, the company completed a strategic funding round of over USD 100 million led by HongShan and Gaorong Ventures. In April 2026, the company announced FDA conditional approval for the Brio4Kids pediatric heart failure trial, with enrollment expected to commence in mid-2026. Over 350 patients have been treated internationally with BrioVAD pump technology prior to US trials.
Company Profile (Updated April 2026)
BrioHealth Solutions, Inc. is a global medical device company developing next-generation ventricular assist devices (VADs) for patients with advanced heart failure. Originally founded as CH Biomedical in 2008 by a team of scientific and technological experts with overseas experience, the company officially rebranded to BrioHealth Solutions in January 2024. Headquartered in Burlington, Massachusetts, USA, the company operates a wholly-owned subsidiary and parent company, BrioHealth Technologies (formerly CH Biomedical), in Suzhou Industrial Park, jiangsu Province, China.
Development History:
- 2008: Founded as CH Biomedical, Inc. (CHB) in Suzhou, china
- 2017: First-in-human implantation of the CH-VAD in China under compassionate use
- 2021: CH-VAD received NMPA approval for marketing in China
- January 2024: Rebranded from CH Biomedical (USA) to BrioHealth Solutions, Inc.
- May 2024: Received FDA IDE approval to begin the INNOVATE trial
- November 2024: Enrolled first patients in the INNOVATE trial in the US
- July 2025: Completed strategic funding round of over USD 100 million
- December 2025: Reached 100th BrioVAD implant; FDA approved pivotal phase of INNOVATE trial
- April 2026: Announced FDA conditional approval for Brio4Kids pediatric heart failure trial
Core Mission: To become the global leader in innovative solutions for advanced and persistent heart failure, delivering extraordinary medical technologies that restore, extend, and enhance lives.
Core Technology: BrioVAD System
Product Description
The BrioVAD System is an innovative, fully magnetically levitated centrifugal flow LVAD designed to treat advanced, refractory left ventricular heart failure.
Key Technical Features:
- Fully Magnetically Levitated Rotor: Eliminates mechanical bearings, reducing blood trauma
- 20% Smaller Pump Size: Compared to HeartMate 3, enabling less invasive implantation
- Narrower, More Flexible Driveline: Designed to reduce driveline infections, dramatically thinner than current systems
- Lower Rotor Spinning Speed: Potentially reduces hemolysis while maintaining adequate flow
- Single-Battery System: Provides up to 12 hours of power
- Only Two External Components: Simplified peripheral design
- Identical Pump and Percutaneous Lead: BrioVAD and CH-VAD share the same pump and lead
Clinical Evidence - CH-VAD (China)
- International Experience: Over 350 patients treated with BrioVAD Pump outside the US
- China Experience: Over 300 patients implanted with CH-VAD across China
INNOVATE Clinical Trial
The INNOVATE Trial is a prospective, randomized, controlled, multi-center, non-inferiority trial comparing the BrioVAD System to the HeartMate 3 (Abbott).
- ClinicalTrials.gov ID: NCT06310031
- National Principal Investigator: Dr. Francis D. Pagani, M.D., Ph.D., University of Michigan
- Trial Phases: Safety phase completed December 2025; pivotal phase approved December 2025
- Planned Sites: Up to 60 clinical partner sites in the US
- First US Implant: University of Michigan, February 2025
Brio4Kids Pediatric Trial
- Indication: Pediatric heart failure
- Status: FDA conditional approval announced April 2026
- Expected Enrollment: Mid-2026
- Initial Data Anticipated: Q4 2026
Market Context and Competition
Market Opportunity
- Cardiac Assist Devices Market: Valued at USD 2.89 billion in 2024, projected to reach USD 6.23 billion by 2032 (CAGR 13.70%)
- LVAD Market Segment: Projected to reach USD 2.24 billion by 2033
- US LVAD Implants: Approximately 3,000 patients receive LVADs annually in the US, surpassing heart transplants
- Heart Failure Burden: Among 6 million Americans with heart failure, thousands await transplants or are ineligible
Competitive Landscape
- Abbott HeartMate 3: Currently the only FDA-approved LVAD for both short-term and long-term treatment in the US; market leader
- BrioHealth Solutions (BrioVAD): INNOVATE trial ongoing; 100+ implants; smaller pump, narrower driveline, simplified peripherals
- CorWave (France): CorWave LVAD using undulating discoidal wave membrane technology
- FineHeart (France): FlowMaker - fully implantAble cardiac output accelerator
- BiVACOR: Total artificial heart (TAH) with magnetically levitated rotor
- Magenta Medical (Israel): Elevate - percutaneous LVAD, ＂world's smallest heart pump＂
Funding and Financials
Funding History
- July 2025 Strategic Round: Over USD 100 million raised
- Lead Investors: HongShan and Gaorong Ventures
- Other Participants: Neovision Capital, China Growth Capital
- Total Funding Raised: USD 100 million+
- Estimated Annual Revenue: Approximately USD 39.4 million (ZoomInfo estimate)
- Employees: Approximately 31 staff at US subsidiary; larger workforce at Suzhou parent company
Company Information and Leadership
Corporate Overview
- Company Full Name: BrioHealth Solutions, Inc.
- Former Name: CH Biomedical (USA), Inc.
- Founded: 2008
- US Headquarters: Burlington, Massachusetts, USA
- China Headquarters: Suzhou Industrial Park, Jiangsu Province, China (BrioHealth Technologies)
- Company Type: Private venture-backed company
- Industry: Medical Devices - Cardiovascular / Heart Failure / Mechanical Circulatory Support
- Core Values: Integrity, Truth, Respect, Excellence
Leadership Team
CEO: Chen Chen, Ph.D.
- Led the company through rebranding, FDA IDE approval, and INNOVATE trial initiation
- Vision: ＂Our mission to become the global leader in innovative solutions for advanced and persistent heart failure is one step closer.＂
COO and Senior VP of R&D: Justin Callaway
- Oversees US organization expansion and technology development
VP of Clinical and Field Services: Pranesh ThirUKkonda
- Contact: pranesh.thirukkonda@briohealth.com
National Principal Investigator (INNOVATE Trial): Dr. Francis D. Pagani, M.D., Ph.D.
- Otto Gago MD Endowed Professor in Cardiac Surgery at the University of Michigan
2026 Outlook and Strategic Focus
Future Development Priorities
- INNOVATE Trial Completion: Expand to up to 60 clinical sites; complete pivotal phase toward FDA approval
- Brio4Kids Trial Launch: Commence pediatric heart failure trial enrollment in mid-2026; initial data by Q4 2026
- Global Market Expansion: Leverage CH-VAD approval in China and CE/MHRA pathways for international growth
- Product Innovation: Continue refining BrioVAD peripherals and exploring next-generation pump designs
- Commercialization ReADINess: Build manufacturing capacity and clinical support infrastructure ahead of FDA approval
- Competitive Positioning: Differentiate against HeartMate 3 through smaller pump, reduced driveline infections, and simplified management
Contact Information
US Headquarters
- Address: Burlington, Massachusetts, USA
- Website: www.briohealthsolutions.com
- LinkedIn: @BrioHealthSolutions
- Twitter/X: @BrioVAD
China Headquarters
- Address: NW-07-301, Nanopolis, 99 Jinjihu Avenue, Suzhou Industrial Park, Jiangsu 215123, China
- Telephone: +86-0512-62956270; +86-021-52650586
- Fax: +86-0512-62956271
- Email: info@briohealthtech.com
- Website: us.chbiomedical.com
Keywords: BrioHealth Solutions, BrioVAD, CH Biomedical, LVAD, left ventricular assist device, ventricular assist device, magnetically levitated, HeartMate 3, INNOVATE trial, FDA IDE, heart failure, cardiac assist device, Burlington, Massachusetts, Suzhou, China, Chen Chen, Francis Pagani, CH-VAD, full MagLev, pediatric heart failure, Brio4Kids, implantable heart pump, driveline, hemocompatibility, destination therapy, bridge to transplant, bridge to recovery, NCT06310031, University of Michigan, Emory Healthcare, cardiovascular device, mechanical circulatory support
