Picard Medical

What Picard Medical does

Picard Medical, Inc. (NYSE American: PMI) is the publicly traded parent company of SynCardia Systems, LLC, a Tucson, Arizona-based mechanical heart replacement technology company founded in 2001 by Dr. Jack Copeland, Richard Smith, and Dr. Marvin Slepian to carry forward the legacy of CardioWest and the pioneering Jarvik-7 design. Picard Medical acquired SynCardia on September 30, 2021 and completed its IPO on NYSE American on September 2, 2025. SynCardia's flagship product is the SynCardia Total Artificial Heart (STAH) — a pneumatically driven total artificial heart that replaces both ventricles and all four native heart valves, available in 70cc and 50cc sizes to serve both adult and smaller-stature patients including women and pediatric candidates, and the only commercially available total artificial heart approved by both the U.S. FDA and Health Canada.

The STAH is powered by hospital-based Companion 2 Driver Systems for inpatient care and the portable Freedom Portable Driver System that enables patient mobility and discharge while awaiting a donor heart transplant. SynCardia has performed more than 2,100 implants across 27 countries over three decades of clinical use, including a world-record patient supported for over eight years (Serbia, implanted 2017). Picard Medical is developing a next-generation fully implantable, electromechanically actuated successor — the Emperor Total Artificial Heart — featuring an independent dual motor ventricular design that eliminates external pneumatic drivers; this platform is currently in preclinical development with first-in-animal studies completed November 2025, second-generation acute in vivo studies completed June 2026, and a target clinical study launch in 2028.

Picard Medical generates revenue primarily through one-time hardware sales of the STAH to certified U.S. and Canadian heart transplant centers (96% of 2025 revenue, $4.75M of $4.94M), supplemented by a recurring rental model on the Freedom Portable Driver ($0.19M in 2025; pricing-adjusted in Q1 2026). The company distributes exclusively through a direct enterprise field sales motion led by a Head of Global Sales and Clinical Education, supported by Senior Clinical Specialists who conduct sponsored surgical training programs, KOL engagement, and account-level procedural readiness at high-volume centers including Banner Health, UCSF Health, Texas Children's Hospital, Cedars-Sinai, HonorHealth, Mayo Clinic Arizona, and Houston Methodist. Products are approved for sale in the U.S. and Canada only, though implants have been performed across 27 countries.

Name

Picard Medical

Legal name

Picard Medical, Inc.

Website

https://picardmedical.com

Company type

Public

Founded year

2021

Operating status

Operating

Headcount range

1–10 employees

Short description

Picard Medical (NYSE American: PMI) is the publicly traded parent of SynCardia Systems, which develops and commercializes the SynCardia Total Artificial Heart — the only FDA- and Health Canada-approved total artificial heart — and companion driver systems for bridge-to-transplant patients at certified U.S. and Canadian heart transplant centers.

Ownership category

akta.pro rank

Product category

Total Artificial Heart Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)

SIC

Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

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

Keywords

• Artificial heart devices
• Mechanical circulatory support
• Total artificial heart
• Bridge to transplant
• Cardiac medical devices

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

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

Revenue model

1. SynCardia Total Artificial Heart (STAH) Product Sales: One-time sales of the SynCardia Total Artificial Heart implant system to hospitals and transplant centers. Product revenue was $4.75 million in 2025, representing 96% of total revenue.
2. Freedom Driver Rental Program: Recurring rental income from leasing the Freedom Portable Driver to patients awaiting donor heart transplant. Rental revenue was $0.19 million in 2025 and grew to $0.2 million in Q1 2026 (vs. $7,000 in Q1 2025) following pricing adjustments.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels12 records

Core offering

Picard Medical develops, manufactures, and commercializes the SynCardia Total Artificial Heart (STAH) — the only commercially available total artificial heart approved by both the FDA and Health Canada — through its wholly owned subsidiary SynCardia Systems, LLC. The STAH replaces both ventricles and all four native heart valves and is available in 70cc and 50cc sizes, supported by the Companion 2 Driver System for inpatient use and the Freedom Portable Driver System for home mobility while patients await donor heart transplantation. The company also has the next-generation Emperor Total Artificial Heart, a fully implantable, motor-driven platform under preclinical development.

Product overview

Picard Medical, Inc. (NYSE American: PMI) is a single-product-platform medical device company whose offering is built around one core implantable therapy — the SynCardia Total Artificial Heart (STAH), the only commercially available total artificial heart approved by both the FDA and Health Canada — supported by two named companion driver systems that power the implant in different care settings: the hospital-based Companion 2 Driver System and the portable Freedom Portable Driver System, which together let patients regain mobility while awaiting a donor heart. The STAH is offered in two size variants (70 cc and 50 cc) to address a broader patient population. Layered on top of this established platform, Picard Medical is developing the Emperor Total Artificial Heart, a next-generation, fully implantable, motor-driven successor designed to eliminate the need for external pneumatic drivers and enable long-term mechanical circulatory support; this is currently in preclinical development with a target 2028 clinical study launch.

Differentiator

Problem solved

Functional benefit

Brands

• SynCardia: Wholly owned subsidiary brand and trade name for the Company's total artificial heart technology business, including the SynCardia Total Artificial Heart (STAH) and the next-generation Emperor Total Artificial Heart platform.
• SynCardia Total Artificial Heart (STAH)
• Emperor Total Artificial Heart

Products and services

• SynCardia Total Artificial Heart (STAH) The only commercially available total artificial heart approved by both the FDA and Health Canada. Replaces both ventricles and all four native heart valves to assume the full functions of a failing human heart, indicated as a bridge to transplant for patients with end-stage biventricular failure. Available in 70cc and 50cc sizes, with more than 2,100 implants performed across 27 countries.
• Emperor Total Artificial Heart SynCardia's next-generation, fully implantable, motor-driven (electromechanically actuated) total artificial heart platform designed to eliminate external pneumatic drivers and enable long-term mechanical circulatory support. Currently in preclinical development, targeting a 2028 clinical study launch.
• Companion 2 Driver System Hospital-based pneumatic driver that powers and monitors the implanted SynCardia Total Artificial Heart while patients are in a clinical setting awaiting donor heart transplantation.
• Freedom Portable Driver System Portable pneumatic driver that enables patients supported by the SynCardia Total Artificial Heart to leave the hospital, regain mobility, and await a donor heart at home; commercialized through a recurring rental revenue program.
• FDA-Cleared Accessory for SynCardia Total Artificial Heart FDA-cleared accessory for the SynCardia Total Artificial Heart, rolled out by Picard Medical in January 2026 to support the STAH platform.

Quantifiable outcome

• More than 2,100 STAH implants performed across 27 countries worldwide
• +6 more outcomes

Named customers9 records

Segments4 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

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

• Hydrix ServicescoreStrategic or Co-development Partner · 5 January 2026SynCardia Systems (a Picard Medical subsidiary) entered into a development collaboration agreement with Hydrix Services on January 5, 2026, to advance the Emperor, SynCardia's next-generation fully implantable total artificial heart. Hydrix will perform development work through the end of 2026 as the 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's CEO noted the collaboration may allow the company to benefit from Australian R&D tax incentives of approximately 43% of eligible expenditure.
• Banner HealthflagshipStrategic or Co-development PartnerBanner Health has performed more than 50 SynCardia Total Artificial Heart implants, one of the busiest programs globally. The program is led by Francisco Arabia, M.D., at Banner University Medical Center Phoenix and is part of its broader advanced heart failure and transplant services. Banner receives referrals from medical centers worldwide and contributes to the development of clinical practices across patient selection, surgical technique, and post-implant management. Picard Medical publicly recognized Banner Health's leadership role in the advancement of total artificial heart technology in April 2026.
• University of Arizona / Banner University Medical Center TucsoncoreStrategic or Co-development PartnerAcademic and clinical research collaboration partner. Picard Medical / SynCardia conducted successful acute in vivo implant studies of the Emperor Total Artificial Heart platform at the University of Arizona and Banner University Medical Center Tucson. Dr. Andre Simon (VP of Clinical Affairs at SynCardia) and the surgical teams collaborated on the studies, generating data supporting continued preclinical and translational development.
• LifeSci Advisors (Eric Ribner)minorGTM or Marketing PartnerLifeSci Advisors LLC serves as Picard Medical's Investor Relations firm of record. Eric Ribner (Managing Director at LifeSci Advisors) is the IR contact ([email protected]) and is the named IR contact on Picard Medical press releases, SEC filings, and the investor relations website. LifeSci Events also hosts Picard Medical's virtual annual business update webcasts.
• H.C. Wainwright & Co.minorGTM or Marketing PartnerH.C. Wainwright & Co. hosts the Annual Global Investment Conference at which Picard Medical CEO Patrick NJ Schnegelsberg presented in-person at the Lotte New York Palace Hotel on September 10, 2025. H.C. Wainwright analyst Yi Chen, Ph.D., CFA provides analyst coverage of Picard Medical (PMI).
• The Mullings Group Companies / DragonflyminorGTM or Marketing PartnerTwo-part interview series featuring Picard Medical CEO Patrick NJ Schnegelsberg, hosted by Joe Mullings (Chairman and CEO of The Mullings Group Companies). Filmed, edited, and produced by Dragonfly (a TMG Company). The Mullings Group is a premier global executive search firm specialized in MedTech, HealthTech, and Life Sciences, with more than 9,000 placements across 900+ companies globally.
• Arizona Bioindustry Association (AZBio)minorOthersPicard Medical / SynCardia is a member of AZBio, Arizona's biotechnology trade association. CEO Patrick NJ Schnegelsberg was elected to the AZBio Board of Directors in December 2025 (term extending through December 2028). The Company participates in AZBio programming including the "Voice of the Patient" event during AZ Tech Week.
• BTV – Business Television / BTV The AgencyminorGTM or Marketing PartnerBTV – Business Television featured the SynCardia Total Artificial Heart in a segment airing on FOX Business News (Saturday, March 14, 2026 at 5:00 p.m. EST), highlighting clinical use and next-generation Emperor development. BTV The Agency is a B2B TV production and digital marketing agency serving publicly traded and financial companies, with distribution across Bloomberg, CNBC, FOX Business News, and leading financial platforms.
• DeviceTalksminorGTM or Marketing PartnerDeviceTalks hosted a webinar on the Emperor Fully Implantable Total Artificial Heart featuring Picard Medical / SynCardia.
• Continental Stock Transfer & Trust CompanyminorOthersContinental Stock Transfer & Trust Company serves as Picard Medical's transfer agent for common stock traded on NYSE American under ticker PMI.
• MaloneBailey, LLPminorOthersMaloneBailey, LLP serves as Picard Medical's independent registered public accounting firm.

Scale indicators12 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• CARMAT (Carmat SA): CARMAT is a French medical device company developing the Aeson total artificial heart, the most advanced direct competitor to SynCardia in the total artificial heart category. Both companies target end-stage biventricular heart failure as bridge to transplant with fully implantable systems in development.
• BiVACOR: BiVACOR is developing a total artificial heart using rotary blood-pump technology, with active preclinical and early clinical programs targeting bridge-to-transplant indications comparable to SynCardia. It is one of the closest direct competitors pursuing an FDA-approved fully implantable TAH.
• Berlin Heart: Berlin Heart develops ventricular assist devices (VADs), most notably the EXCOR Pediatric VAD — the only FDA-approved pediatric VAD — making it a direct peer to SynCardia's STAH in the mechanical circulatory support / bridge-to-transplant space.
• Jarvik Heart: Jarvik Heart develops miniaturized ventricular assist devices, including the Jarvik 2000, and its historical Jarvik-7 design is the technological predecessor of the SynCardia TAH. They compete in the long-term mechanical circulatory support market.

Broad incumbents

• Abbott (HeartMate): Abbott's HeartMate 3 left ventricular assist device (LVAD) is the dominant FDA-approved LVAD and a broad incumbent in mechanical circulatory support. While not a TAH, it competes with SynCardia for the same advanced heart failure / bridge-to-transplant patient population.
• Medtronic (Heart Failure): Medtronic's Cardiac Rhythm & Heart Failure business includes HVAD (discontinued) and broader heart failure therapies, overlapping with SynCardia in the mechanical circulatory support category. It is a large incumbent pursuing heart failure treatment via devices and diagnostics.
• Edwards Lifesciences: Edwards Lifesciences is a global leader in heart valves and structural heart disease, including transcatheter aortic and mitral therapies. It is a broad incumbent adjacent to SynCardia in the advanced heart failure and structural heart intervention market.
• Abiomed (Johnson & Johnson MedTech): Abiomed, now part of Johnson & Johnson MedTech, develops the Impella family of percutaneous heart pumps used in cardiogenic shock and high-risk PCI. It is a broad incumbent in mechanical circulatory support that overlaps with SynCardia's heart failure patient population.
• LivaNova: LivaNova is a medical device company with heart valve and cardiopulmonary businesses, including mechanical heart valves and oxygenators used during cardiac surgery. It is a broad incumbent in cardiac surgery markets that intersect with SynCardia's heart failure customer base.

Emerging players

• ReliantHeart: ReliantHeart develops the HeartAssist5 LVAS, a next-generation left ventricular assist device with remote monitoring capabilities. It is an emerging player in the same mechanical circulatory support category as SynCardia's STAH and competes for advanced heart failure patient share.

Market position

Strengths5 records

Weaknesses1 record

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Subsidiaries1 record

Funding overview

Funding rounds2 records

Investors

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

M&A1 record

Investments

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

Frequently asked questions about Picard Medical