BiVACOR

What BiVACOR does

BiVACOR is a clinical-stage medical device company developing the BiVACOR Total Artificial Heart (TAH), a titanium-constructed biventricular rotary blood pump based on centrifugal pump and magnetic levitation (MAGLEV) technologies. The device's central design innovation is a single magnetically levitated dual-sided rotor that simultaneously pumps blood to the systemic and pulmonary circulations, replacing both ventricles of a failing heart. The system includes an implantable TAH, an external controller with adaptive closed-loop operation, and a rechargeable battery pack that supports untethered mobility. The device is designed as a bridge-to-transplant therapy for patients with end-stage biventricular heart failure or univentricular failure where LVAD support is unsuitable; with fewer than 6,000 donor hearts available globally per year and an estimated 100,000 US patients immediately eligible for mechanical circulatory support, the addressable clinical gap is substantial.

BiVACOR is pre-revenue and conducts its business through FDA-approved Early Feasibility Studies and research grant partnerships rather than commercial sales. Revenue inputs today are limited to grant funding — including a $13 million award from Australia's Medical Research Future Fund and NIH/NHLBI funding (R44HL137454) — and equity capital raised across multiple Series B tranches totaling roughly $40M since 2021. The company has executed first-in-human implantation (July 9, 2024, Baylor St. Luke's Medical Center), bridged all five initial EFS patients to transplant, and received FDA Breakthrough Device Designation in May 2025 followed by FDA TAP Program acceptance in August 2025, with the FDA approving expansion of the EFS to 15 additional patients.

The company operates from Huntington Beach, California (corporate headquarters), Houston, Texas (clinical operations within the Texas Medical Center), and Gold Coast, Australia (international subsidiary BiVACOR, Pty. Ltd.). Its clinical and scientific partners include the Texas Heart Institute (which holds an equity ownership interest and supplies the National Principal Investigator), Baylor College of Medicine, St. Vincent's Hospital Sydney, NASA Johnson Space Center, and Queensland University of Technology. The senior leadership team combines founder-inventor Daniel Timms, PhD (CTO), CMO William Cohn, MD (134 US patents, former J&J MedTech VP), CEO Jim Dillon, and Chairman Raymond W. Cohen — a configuration typical of a venture-backed clinical-stage company preparing to scale toward PMA submission and commercialization.

Name

BiVACOR

Legal name

BiVACOR, Inc.

Website

https://bivacor.com

Company type

Private

Founded year

2008

Operating status

Operating

Headcount range

11–50 employees

Short description

BiVACOR is a clinical-stage medical device company developing a magnetically levitated Total Artificial Heart as a bridge-to-transplant solution for patients with severe biventricular heart failure. It is pre-revenue, operating through FDA Early Feasibility Studies and grant-funded research partnerships.

Ownership category

akta.pro rank

Product category

Total Artificial Heart (Mechanical Circulatory Support)

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

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

akta.pro secondary industry

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

Keywords

• Total artificial heart
• Mechanical circulatory support
• Magnetic levitation pump
• Bridge-to-transplant device
• Biventricular heart replacement

Headquarters

HQ city

Houston

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales, Others

Revenue model

1. Total Artificial Heart Device Sales: BiVACOR generates revenue through the sale of its Total Artificial Heart (TAH) devices to healthcare providers and hospital systems for use in clinical settings and ultimately commercial sales following regulatory approval. The device is currently in clinical trials (FDA Early Feasibility Study) and has received FDA Breakthrough Device Designation.
2. Clinical Trial and Research Partnerships: The company receives funding through research grants and clinical trial partnerships with medical institutions (Texas Heart Institute, National Institutes of Health, Australian government programs) to support development and commercialization.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

BiVACOR designs and manufactures the BiVACOR Total Artificial Heart (TAH), a titanium-constructed electro-mechanical rotary blood pump using magnetic levitation (MAGLEV) technology. The device features a single moving part — a magnetically suspended dual-sided rotor — that simultaneously pumps blood to both systemic and pulmonary circulations, replacing both ventricles of a failing heart. It is being developed as a long-term bridge-to-transplant solution for patients with end-stage biventricular heart failure, with an external controller and rechargeable battery system for portable, untethered patient use.

Product overview

BiVACOR is a clinical-stage medical device company with a single unified product: the BiVACOR Total Artificial Heart (TAH). This titanium-constructed electro-mechanical rotary blood pump represents a paradigm shift in artificial heart design, utilizing magnetic levitation (MAGLEV) technology with only one moving part—a magnetically suspended dual-sided rotor. The device simultaneously pumps blood to both the systemic (body) and pulmonary (lung) circulations, replacing the function of both ventricles. The system comprises the implantable TAH device, an external controller, and a rechargeable battery system for untethered operation. Currently undergoing FDA-approved first-in-human Early Feasibility Study as a bridge-to-transplant solution for patients with severe biventricular heart failure.

Differentiator

Problem solved

Functional benefit

Products and services

• BiVACOR Total Artificial Heart (TAH) The BiVACOR TAH is a titanium-constructed electro-mechanical rotary blood pump with a single moving part — a magnetically levitated dual-sided rotor — that pumps blood to both systemic and pulmonary circulations, replacing both ventricles of a failing heart. It is being developed as a bridge-to-transplant solution for patients with end-stage biventricular heart failure or univentricular failure not suitable for LVAD support, and includes a portable external controller and rechargeable battery system for untethered operation.

Quantifiable outcome

• All 5 patients in FDA Early Feasibility Study successfully bridged to donor heart transplant
• +3 more outcomes

Named customers3 records

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Seven partnerships are on record, tiered flagship, core and minor.

• Texas Heart InstituteflagshipStrategic or Co-development PartnerClinical trial partner for first-in-human implantation; The Texas Heart Institute has an equity ownership interest in BiVACOR. Dr. Joseph Rogers serves as National Principal Investigator on the research.
• Baylor St. Luke's Medical CentercoreImplementation/ SI/ Consulting PartnerFirst-in-human implantation site located in the Texas Medical Center; joint venture between Baylor College of Medicine and St. Luke's Health.
• Baylor College of MedicinecoreImplementation/ SI/ Consulting PartnerAcademic medical partner and joint owner of Baylor St. Luke's Medical Center; Dr. William Cohn is a tenured professor of surgery.
• St. Vincent's Hospital SydneycoreImplementation/ SI/ Consulting PartnerFirst Australian implantation site; successfully completed first TAH implantation in Australia on November 22, 2024.
• NASA Johnson Space CentercoreTechnology or IntegrationNASA's Johnson Space Center partnered with BiVACOR to improve the robustness and reliability of the Total Artificial Heart system, providing risk analysis expertise.
• Queensland University of TechnologycoreStrategic or Co-development PartnerDr. Timms is an alumnus; university collaborated on TAH research and development; Prince Charles Hospital Foundation also supported research.
• Griffith UniversityminorStrategic or Co-development PartnerBiVACOR established operations at Gold Coast Health Park (GCHKP) to collaborate with Griffith University.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• CorWave: CorWave is developing a next-generation left ventricular assist device using a unique wave-membrane pump technology. It competes in mechanical circulatory support with innovation aimed at reducing complications, making it an emerging comparable in MCS device development.
• MagAssist: MagAssist (China) is developing magnetically levitated ventricular assist and ECMO devices using similar MAGLEV rotor technology as BiVACOR. While focused on VADs rather than a full TAH, the overlap in core magnetic levitation pump technology makes it a relevant technical comparable.
• Cleveland Heart: Cleveland Heart is developing a continuous-flow total artificial heart targeting the same bridge-to-transplant and destination-therapy indications as BiVACOR. It represents an early-stage U.S. competitor in the TAH space.
• Leviticus Cardio: Leviticus Cardio is developing a wireless VAD system that eliminates the percutaneous driveline—a long-standing source of infection in MCS devices. Its driveline-free approach addresses one of the same patient-mobility limitations that BiVACOR's portable external controller is designed to mitigate.
• Calon Cardio: Calon Cardio is a UK-based spin-out developing a miniaturized ventricular assist device (miniVAD) targeting less invasive MCS. Its smaller-form-factor approach overlaps with BiVACOR's emphasis on compact, patient-friendly mechanical circulatory support.

Direct peers

• Carmat: Carmat (France) has developed the Aeson Total Artificial Heart, which received CE mark in Europe and is in clinical trials. Carmat is the most advanced non-U.S. TAH developer and competes with BiVACOR in the same clinical use case globally.
• SynCardia Systems: SynCardia is the only FDA-approved Total Artificial Heart on the market, using a pneumatic volume-displacement design. It is BiVACOR's closest direct competitor, occupying the same bridge-to-transplant clinical niche that BiVACOR is currently advancing into.

Broad incumbents

• Medtronic: Medtronic previously commercialized the HVAD system (withdrawn from market in 2021) and remains a major incumbent in cardiac surgery and mechanical circulatory support. Its broad cardiac surgery portfolio makes it a comparable incumbent for hospital-system sales and reimbursement dynamics.
• Abbott: Abbott markets the HeartMate 3 left ventricular assist device (LVAD), the dominant mechanical circulatory support device in clinical use today. As a broad medtech incumbent, Abbott is the principal alternative therapy for end-stage heart failure patients that BiVACOR targets.

Regional players

• Evaheart: Evaheart (Japan) has developed a continuous-flow left ventricular assist device, primarily commercialized in Japan and Asia. It is a regional peer in the mechanical circulatory support category addressing the same patient population.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds5 records

Investors4 records

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M&A

Investments

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

Frequently asked questions about BiVACOR