SynCardia Systems

What SynCardia Systems does

SynCardia Systems is the privately-held manufacturer of Total Artificial Heart. The SynCardia temporary Total Artificial Heart (TAH) is used as a bridge to transplant, helping them survive until a matching donor heart. becomes available.

Name

SynCardia Systems

Legal name

SynCardia Systems, LLC.

Website

http://www.syncardia.com/

Company type

Public

Founded year

2001

Operating status

Operating

Headcount range

101–250 employees

Short description

SynCardia Systems is a medical technology company.

Ownership category

akta.pro rank

Product category

Total Artificial Heart Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical Appliance and Supplies Manufacturing (339113)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), 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

• Total artificial heart
• Mechanical circulatory support
• Bridge-to-transplant therapy
• Biventricular heart failure devices
• Pneumatic ventricular assist

Headquarters

HQ city

Tucson

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. SynCardia Total Artificial Heart Device Sales: Revenue from the sale of SynCardia Total Artificial Heart ventricles and associated components to transplant centers. Full-year 2025 revenue was $4.94 million, a 12.5% increase year-over-year.
2. Freedom Driver Rental Program: Rental revenue from the Freedom Driver portable system used by eligible patients discharged from hospital while awaiting transplant. Q1 2026 revenue of $1.2M was driven by growth in both product revenue and the Freedom Driver rental program.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels6 records

Core offering

SynCardia Systems develops, manufactures, and sells the SynCardia Total Artificial Heart (STAH), the only FDA- and Health Canada-approved total artificial heart commercially available in the U.S. and Canada. The company offers the device in two ventricle sizes (70cc and 50cc) along with two pneumatic driver systems—the Companion 2 (C2) for in-hospital use and the Freedom Driver for outpatient mobility—and is developing the next-generation fully implantable Emperor Drive System.

Product overview

SynCardia Systems manufactures a unified product ecosystem centered on the SynCardia Total Artificial Heart (STAH), the world's first and only FDA-approved total artificial heart. The portfolio includes two sizes of the artificial heart (70cc and 50cc) and two driver systems: the Companion 2 Driver for in-hospital use and the Freedom Driver for portable outpatient support. The company is developing next-generation platforms including the Emperor Drive System (a fully implantable electromechanical driver) and Unicorn (driver miniaturization), both currently investigational.

Differentiator

Problem solved

Functional benefit

Brands

• SynCardia Total Artificial Heart (STAH): FDA-approved total artificial heart for bridge-to-transplant in patients with end-stage biventricular heart failure
• Companion 2 Driver (C2)
• Freedom Driver
• Emperor

Products and services

• SynCardia Total Artificial Heart (STAH) FDA-approved total artificial heart that replaces both failing ventricles and all four native heart valves for transplant-eligible patients at risk of imminent death from biventricular heart failure. Available in 70cc and 50cc ventricle sizes.
• Companion 2 Driver (C2) In-hospital pneumatic driver system with touchscreen controls that powers the implanted SynCardia Total Artificial Heart following surgery, designed for operating room, ICU, and step-down care settings.
• Freedom Driver Portable pneumatic driver system that powers the SynCardia Total Artificial Heart, allowing eligible patients to be discharged from hospital while awaiting transplant. Battery-powered with backpack and shoulder carry options for patient mobility.
• Emperor Drive System (EDS) Next-generation patent-pending electromechanical actuation platform for the SynCardia Total Artificial Heart, designed to replace external pneumatic drivers and advance toward a fully implantable system. Investigational and not yet approved for commercial sale.

Quantifiable outcome

• Over 2,100 SynCardia Total Artificial Heart implants performed across 27 countries
• +2 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability1 record

Feature4 records

Partnerships

Three partnerships are on record, tiered core.

• Houston Methodist HospitalcoreStrategic or Co-development Partner · 24 February 2026Picard Medical and SynCardia hosted an invitation-only surgical training program at Houston Methodist Hospital on February 24, 2026, bringing together cardiac surgeons and clinical teams from four Houston-area heart centers for education on SynCardia Total Artificial Heart implantation techniques, patient selection, and clinical best practices. The training combined classroom instruction with hands-on surgical training and is part of Picard's broader strategy to develop centers of excellence and expand adoption of total artificial heart therapy at leading transplant centers nationwide.
• Hydrix ServicescoreStrategic or Co-development Partner · 5 January 2026SynCardia Systems (subsidiary of Picard Medical) entered into a development collaboration agreement with Hydrix Services on January 5, 2026, to advance the Emperor next-generation fully implantable total artificial heart. Hydrix performs development work through the end of 2026 as a first phase of a broader multi-stage, multi-year program. The agreement is structured around defined engineering verification and regulatory milestones, with continuation between stages dependent on technical progress and safety validation. Picard Medical noted the collaboration may allow the company to benefit from Australian R&D tax incentives of approximately 43% of eligible expenditure.
• Picard Medical, Inc. (parent company)coreOthersPicard Medical, Inc. is the parent company and sole owner of SynCardia Systems LLC. SynCardia operates as a wholly owned subsidiary. Picard Medical is publicly traded on NYSE American under ticker symbol PMI. The parent company completed its IPO on September 2, 2025, raising approximately $19.5 million in gross proceeds.

Scale indicators8 records

Recent moves9 records

Expansion highlights5 records

Direct peers

• Carmat: French-listed developer of the Aeson total artificial heart, the only commercially-relevant TAH competitor to SynCardia. Carmat is CE-marked in Europe and competes in the same bridge-to-transplant clinical niche.
• Berlin Heart: Manufacturer of the EXCOR pediatric and adult ventricular assist devices. Competes with SynCardia in the bridge-to-transplant mechanical support category, particularly for smaller-patient anatomies.

Broad incumbents

• Abbott: Owner of HeartMate 3 LVAD, the dominant left-ventricular assist device. Competes with SynCardia in the mechanical circulatory support space but does not offer a total artificial heart — they are the most likely alternative therapy at U.S. transplant centers.
• Abiomed (Johnson & Johnson MedTech): Acquired by J&J in 2022, Abiomed manufactures the Impella family of percutaneous ventricular support devices. Operates in adjacent mechanical circulatory support indications and shares SynCardia's transplant-center customer base.
• Medtronic: Historical developer of the HeartWare HVAD (recalled 2021). Medtronic remains a major player in cardiac surgery, heart valves, and mechanical circulatory support infrastructure and competes for share-of-mind with cardiac surgeons.
• LivaNova: Manufactures the TandemHeart percutaneous ventricular assist system and has historical presence in cardiopulmonary products. Operates in adjacent mechanical circulatory support space with shared hospital customers.
• Edwards Lifesciences: Dominant player in surgical heart valves and transcatheter valve replacement. Competes indirectly for cardiac surgery OR time and budget at transplant centers, and could expand into mechanical circulatory support adjacencies.
• Getinge (Maquet): Provides intra-aortic balloon pumps (IABP), ECMO systems, and operating-room infrastructure used at transplant centers. Competes for mechanical circulatory support share of clinical workflow at the same hospital customers.

Emerging players

• Jarvik Heart: Developer of next-generation continuous-flow total artificial heart and ventricular assist devices. Investigational-stage competitor with a similar long-term goal to SynCardia's Emperor program.

Others

• Fresenius Medical Care: While not a direct TAH competitor, Fresenius operates cardiovascular services adjacent to transplant and advanced heart failure programs and participates in the same hospital ecosystem where SynCardia implants occur.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/SynCardia
• YouTubeyoutube.com/@syncardiaofficial/videos
• Facebookfacebook.com/SynCardia
• LinkedInlinkedin.com/company/syncardia-systems-inc.

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds4 records

Investors2 records

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 SynCardia Systems