SynCardia Systems, LLC - Total Artificial Heart Technology Pioneer

Company Overview (Updated April 2026)

SynCardia Systems, LLC is a leading cardiac device company headquartered in Tucson, Arizona. Founded in 2001, the company was acquired by Picard Medical, Inc. (NYSE: PMI) on September 30, 2021. SynCardia is the maker of the world's first and only commercially available total artificial heart approved by both the U.S. Food and Drug Administration (FDA) and Health Canada.

Mission: To provide life-sustaining total cardiac replacement therapy for patients with end-stage biventricular heart failure, enabling them to survive until a donor heart becomes available, while advancing next-generation fully implantable artificial heart technologies.

Corporate History

Founding and Development (2001-2004)

- 2001: Company founded in Tucson, Arizona

- 2004: SynCardia Total Artificial Heart received FDA approval as a bridge to transplant device following pivotal trial demonstrating 79% successful bridge rate

- 2008: CMS (Centers for Medicare & Medicaid Services) coverage approved

Acquisition by Picard Medical (2021)

- September 30, 2021: Acquired by Picard Medical, Inc. (then Hunniwell Picard I, LLC) for $15.5 million

- Strategic Rationale: Picard Medical became the publicly traded parent company focused on advancing SynCardia's technology and next-generation development

- December 2025: Parent company Picard Medical completed IPO on NYSE American under ticker PMI

Core Technology: SynCardia Total Artificial Heart (TAH)

Device Design and Function

The SynCardia Total Artificial Heart is a pneumatically driven, biventricular, orthotopic, pulsatile device:

- Weight: 160 grams

- Displacement: 400 mL

- Materials: Two polyurethane ventricle chambers with biocompatible material featuring anti-fatigue and anti-thrombosis properties (over 1 billion cycle anti-fatigue performance)

- Valves: Four mechanical valves (Medtronic Hall, 27 mm inflow, 25 mm outflow) directing blood flow

- Drive System: Percutaneous drivelines connected to external pneumatic drivers provide air and vacuum Pulses to mobilize diaphragms within left and right ventricles

- Flow Capacity: 6-9 L/min at filling pressures less than 10 mmHg

- Autoregulation: Automatically balances blood output between left and right sides with Starling-like response to increased venous return

Clinical Indications

Approved for:

- Biventricular failure as bridge to transplantation

- Left ventricular failure with prior mechanical heart valves

- Severe anatomical damage (ventricular septal defect, atrioventricular disruption)

- Intractable malignant arrhythmias

- Massive ventricular thrombus

- Cardiac allograft failure

- Hypertrophic or restrictive cardiomyopathy

- Complex congenital heart disease

- LVAD failure (increasingly utilized, ~20% of recent implants)

Clinical Performance (2026 Data)

Global Utilization:

- Total Implants: Over 2,100 performed worldwide

- Geographic Reach: 27+ countries across North America, Europe, Middle East, Asia-Pacific

- Clinical Centers: More than 100 implanting centers globally

Outcomes (FDA Pivotal Trial and Contemporary Data):

- Bridge-to-Transplant Success: 70-80% in INTERMACS Status 1 patients (sickest "crash and burn" cohort)

- One-Year Post-Transplant Survival: 80-86% among those successfully bridged

- Quality of Life Improvement (2026 THT Data):

- 95% of patients improved from NYHA Class IV to Class I-II

- 35% average increase in quality of life scores at 6 months

- Significant reduction in anxiety and depression scores

Extended Support Cases:

- Longest documented support: Over 8 years on device

- Longest support exceeding 1 year: 47+ patients, with 72% undergoing transplantation

- Recent case (March 2026): 29-year-old patient supported for 1,636 days (4.5 years) before successful transplant

Patient Selection Criteria

- Body surface area >1.7 m²

- Anteroposterior chest diameter >10 cm at level of 10th vertebral body

- Biventricular failure not amenable to isolated LVAD support

- Generally excludes cirrhosis, chronic dialysis dependency, or psychosocial factors precluding transplant

Next-Generation Development: Emperor TAH

Technology Overview

The Emperor Total Artificial Heart is a next-generation, fully implantable electromechanical artificial heart system:

- Design: Fully implantable with no external hardware (transcutaneous energy transfer)

- Objective: Preserve physiological autoregulation and hemodynamic performance of current SynCardia TAH while enabling destination therapy (2+ years support as alternative to transplant)

- Development Status: Preclinical phase with animal studies ongoing

- Future Goal: Long-term destination therapy for patients ineligible for transplantation

Scientific Presentations (2026)

ACC.26 (New Orleans, March 2026):

- Poster: "The Emperor Total Artificial Heart: A Fully Implantable, Autoregulating Solution for Advanced Heart Failure"

- Presenter: Duffy Elmer, Engineering Project Manager

ISHLT 2026 (Toronto, April 2026):

- Poster: "The Emperor Total Artificial Heart: A Fully Implantable Solution for End Stage Heart Failure"

- Presenter: Andre R. Simon, Vice President of Clinical Affairs

- Booth 409 exhibition

Clinical Research and Recent Cases (2026)

UCSF Health Success Cases

- Case 2 (March 2026): Male in his twenties with advanced biventricular heart failure received SynCardia TAH November 15, 2025; successfully bridged to transplant after 119 days (March 14, 2026)

- Program Status: Five patients successfully bridged to transplantation at UCSF Health

Four-Year Bridge Case (March 2026)

- Patient: 29-year-old male

- Implant Date: September 2, 2021

- Support Duration: 1,636 days (4.5 years) on SynCardia TAH

- Transplant Date: February 24, 2026

- Significance: Demonstrates ability to sustain patients for extended periods while awaiting donor organs

Chinese Joint Venture: NewHeart Medical

- Partner: NewHeart Medical (SynCardia's Chinese joint venture subsidiary)

- Leadership: Tiger Zhu, CEO

- Focus: Industrial transformation and market development for total artificial heart technology in China

Adverse Events and Risk Profile

Common Adverse Events (per 100 patient-months):

- Infection: 15.8

- Ischemic stroke: 4.6

- Mediastinal bleeding requiring reoperation: 3.5

- Gastrointestinal bleeding: 4.3

Stroke Management:

- Ischemic stroke occurs in approximately 8-11% of patients

- Mechanical thrombectomy has been successfully performed in SynCardia patients within 6 hours of symptom onset without hemorrhagic complications

Leadership Team

SynCardia Leadership

Vice President of Clinical Affairs: Andre R. Simon, MD

- Leads clinical data presentations at international conferences (ISHLT, ACC, EUMS)

- Oversees clinical research and evidence generation

Engineering Project Manager (Emperor TAH): Duffy Elmer

- Presented Emperor TAH preclinical data at ACC.26

china CEO (NewHeart Medical): Tiger Zhu

- Oversees China operations and market development

Parent Company Leadership (Picard Medical):

- Patrick NJ SchnegelSBErg, CEO

- Bernard Skaggs, CFO

- Matthew Schuster, COO

- Dr. Frank Tinker, CTO

Company Information

Corporate Details

Legal Name: SynCardia Systems, LLC

Founded: 2001

Headquarters: Tucson, Arizona, USA

Parent Company: Picard Medical, Inc. (NYSE American: PMI, acquired September 2021)

Status: Operating subsidiary of public company

Industry: Medical Devices - Cardiac Surgery / Artificial Organs / Mechanical Circulatory Support

Regulatory Milestones: FDA approved 2004 (bridge to transplant); Health Canada approved; CE Mark (European Union)

Contact Information

Media/PR: Brittany Lanza | blanza@syncardia.com

Parent Company IR: Eric Ribner, LifeSci Advisors | eric@lifesciadvisors.com

Website: www.syncardia.com

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