Brio Health Solutions

What Brio Health Solutions does

BrioHealth Solutions, Inc. is a privately held medical device company founded in 2008 and headquartered in Burlington, Massachusetts, developing the BrioVAD System, a Left Ventricular Assist System (LVAS) for patients with advanced heart failure. The company's core product is an implantable, fully magnetically levitated blood pump paired with two lightweight external patient-worn components (a controller and a battery). Key engineering differentiators include a smaller pump footprint enabled by magnetic levitation, a novel thin and flexible driveline intended to reduce driveline-associated infections, and an advanced blood flow pathway designed to minimize hemolysis and thrombosis. The BrioVAD Pump is the same platform used internationally in the CH-VAD System, which has been implanted in more than 350 patients outside the US under parent CH Biomedical, Inc.

The business is currently pre-revenue. The BrioVAD System is an investigational device limited by federal law to investigational use and is not approved by the FDA for commercial sale. Distribution is therefore restricted to clinical trial sites. The company is conducting the INNOVATE Trial — a prospective, randomized, controlled, multi-center non-inferiority study comparing the BrioVAD System to Abbott's HeartMate 3 — across up to 60 leading US medical centers. Patient enrollment began in November 2024 after FDA IDE approval in May 2024, and the FDA cleared the Pivotal Phase in August 2025. In April 2026 the FDA granted conditional approval for the Brio4Kids pediatric trial, expanding the platform to school-age children. Strategic clinical partners include University of Michigan (Dr. Francis Pagani, National PI), Emory University (Dr. Mani Daneshmand), and Cincinnati Children's Hospital Medical Center (Dr. Angela Lorts).

Revenue model upon FDA approval will be hardware sales of the BrioVAD System to hospitals and cardiac surgery centers treating advanced heart failure patients — a US population of approximately 650,000 with a 75% five-year mortality rate and only ~4,000 heart transplants performed annually. The company has no commercial sales today and supports its investigational footprint through a clinical trial-based go-to-market motion, field-based clinical consultants, a dedicated clinician hotline, and the BrioUniverse online training portal. No external funding rounds or institutional investors are disclosed in the available materials.

Name

Brio Health Solutions

Legal name

BrioHealth Solutions, Inc.

Website

https://briohealthsolutions.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

51–100 employees

Short description

BrioHealth Solutions is a private Burlington, MA-based medical device company developing the BrioVAD System, a fully magnetically levitated left ventricular assist device for advanced heart failure patients. The investigational system is currently in the FDA Pivotal INNOVATE Trial and Brio4Kids pediatric study, with no commercial revenue.

Ownership category

akta.pro rank

Product category

Ventricular Assist Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Mechanical Circulatory Support (VAD, IABP, ECMO) (HLAHAFAG)

akta.pro secondary industry

Cardiac Assist & Heart Failure Therapies (Implantables, Neuromodulation) (HLAHAFAL)

Keywords

• Ventricular assist devices
• Left ventricular assist system
• Advanced heart failure treatment
• Magnetically levitated pump
• Mechanical circulatory support

Headquarters

HQ city

Burlington

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. BrioVAD System (Pre-commercial): The BrioVAD System is currently an investigational device not approved for commercial use by the FDA. The company is in the clinical trial phase (INNOVATE Trial) and has not yet begun commercial revenue generation. Upon FDA approval, the company will generate revenue through sale of the BrioVAD System to hospitals and healthcare providers for treatment of advanced heart failure patients.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels7 records

Core offering

BrioHealth Solutions develops the BrioVAD System, a fully magnetically levitated Left Ventricular Assist System (LVAS) for patients with advanced heart failure. The system consists of an implantable BrioVAD Pump and two lightweight patient-worn external components (controller and battery). The device is investigational, currently limited to clinical trial use under the INNOVATE Trial and Brio4Kids Trial, with FDA approval for commercial use still pending.

Product overview

BrioHealth Solutions offers a unified product portfolio centered on the BrioVAD System, a Left Ventricular Assist System (LVAS) for advanced heart failure. The core offering includes the implantable BrioVAD Pump with fully magnetically levitated technology and two lightweight external patient-worn components. This is supported by two clinical trials (INNOVATE Trial for adult patients and Brio4Kids Trial for pediatric patients) and the BrioUniverse training platform. The BrioVAD Pump is the same technology used internationally in the CH-VAD System. All products are investigational and limited by federal law to clinical trial use.

Differentiator

Problem solved

Functional benefit

Brands

• BrioVAD: Left Ventricular Assist System (LVAS) - an investigational ventricular assist device designed for patients with advanced heart failure. Features fully magnetically levitated pump and lightweight external components.

Products and services

• BrioVAD System Investigational Left Ventricular Assist System (LVAS) consisting of an implantable BrioVAD Pump with a fully magnetically levitated rotor and two lightweight patient-worn external components (controller and battery). Designed to provide long-term mechanical circulatory support for patients with advanced, refractory left ventricular heart failure (bridge to transplant, destination therapy, or bridge to recovery). Currently restricted to investigational use in clinical trials (INNOVATE Trial for adults and Brio4Kids Trial for pediatric patients) and not yet approved for commercial sale by the FDA.

Quantifiable outcome

• More than 350 patients treated with the BrioVAD Pump outside the US
• +3 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Five partnerships are on record, tiered core.

• University of MichigancoreStrategic or Co-development PartnerUniversity of Michigan, specifically Dr. Francis D. Pagani, MD, PhD (Otto Gago MD Endowed Professor in Cardiac Surgery), serves as the National Principal Investigator for the INNOVATE Trial. Dr. Pagani provides strategic guidance on clinical trial design and execution, contributing significant expertise in mechanical circulatory support to the development of the BrioVAD System.
• Cincinnati Children's Hospital Medical CentercoreStrategic or Co-development PartnerCincinnati Children's Hospital Medical Center, with Dr. Angela Lorts as National Principal Investigator, is conducting the Brio4Kids Trial evaluating the BrioVAD System in pediatric patients with advanced heart failure. This addresses the significant unmet need for durable LVAD options in school-age children.
• Emory University School of MedicinecoreStrategic or Co-development PartnerEmory University, with Dr. Mani Daneshmand (Andrew J. McKelvey Professor, Director - Thoracic Transplant and MCS Surgery), is a participating center in the INNOVATE Trial, contributing to the clinical evaluation of the BrioVAD System for advanced heart failure patients.
• Abbott (HeartMate 3)coreStrategic or Co-development PartnerThe INNOVATE Trial is a non-inferiority study evaluating the BrioVAD System relative to the HeartMate 3 (HM3) LVAS by Abbott, which is the only FDA-approved durable ventricular assist system currently available in the US. The trial design compares safety and effectiveness against this benchmark technology.
• CH Biomedical, Inc.coreStrategic or Co-development PartnerCH Biomedical, Inc. is the parent company of BrioHealth Solutions. The BrioVAD Pump is the same pump used in the CH-VAD System, which has been commercialized in China and used in over 350 patients outside the US. The technology platform and intellectual property are shared between the entities.

Scale indicators8 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Abbott: Abbott markets HeartMate 3, the only FDA-approved durable LVAD in the US and the direct comparator in BrioHealth's INNOVATE Trial. Abbott is the dominant incumbent in mechanical circulatory support and represents both the benchmark and primary competitive threat for BrioVAD upon potential approval.
• Medtronic: Medtronic previously commercialized the HeartWare HVAD, a centrifugal LVAD, and remains a major player in cardiac surgery and heart failure devices. Although Medtronic stopped global distribution of HVAD in 2021, the company is a structurally relevant incumbent in mechanical circulatory support.
• Abiomed (Johnson & Johnson MedTech): Abiomed (now J&J MedTech) markets the Impella family of percutaneous ventricular assist devices used in cardiogenic shock and high-risk PCI. While Impella provides temporary rather than durable support, J&J/Abiomed is a structurally relevant incumbent in mechanical circulatory support and cardiac surgery decision-making.
• LivaNova (TandemLife): LivaNova's TandemLife portfolio includes temporary mechanical circulatory support products (e.g., ProtekDuo, TandemHeart) used in cardiogenic shock and advanced heart failure. It competes indirectly in the same clinical decision pathways for advanced heart failure patients.

Direct peers

• CH Biomedical, Inc. CH Biomedical is the parent entity of BrioHealth Solutions and the international commercializer of the CH-VAD System, which uses the same BrioVAD Pump. The two entities share IP, leadership, and the underlying device platform, making CH Biomedical the closest operational peer.
• Berlin Heart: Berlin Heart is a specialized mechanical circulatory support manufacturer focused on pediatric and adult VADs (e.g., EXCOR Pediatric VAD). It is a relevant peer because it competes in durable VAD therapy, including the underserved pediatric segment BrioHealth targets with Brio4Kids.

Emerging players

• SynCardia Systems: SynCardia manufactures the SynCardia Total Artificial Heart, a mechanical circulatory support device for end-stage heart failure patients awaiting transplant. It addresses the same advanced heart failure population targeted by BrioVAD via an alternative mechanical support modality.
• CorWave: CorWave is developing a next-generation LVAD using a wave membrane pump technology aimed at reducing complications associated with current durable LVADs. It is an emerging peer in the durable LVAD competitive set with similar target indications to BrioVAD.
• FineHeart: FineHeart is developing the FLOWMAKER, a fully implantable, intraventricular mechanical circulatory support device for advanced heart failure. It targets the same advanced heart failure population as BrioVAD with an emerging alternative to current durable LVADs.

Regional players

• Evaheart, Inc. Evaheart is a Japanese-developed centrifugal LVAD with CE marking and clinical use in Asia/Europe. It is a regional durable LVAD peer with comparable technology class (continuous-flow pump) and overlapping advanced heart failure indication.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/briovad
• LinkedInlinkedin.com/company/BrioHealthSolutions
• YouTubeyoutube.com/channel/UCvm6Nehyl84Y

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Brio Health Solutions