Picard Medical Inc (PMI) is a medical device company that manufactures and commercializes the SynCardia Total Artificial Heart (TAH), the only total artificial heart approved and commercially available in the United States as a bridge to heart transplant. Revenue comes from sales of TAH implant kits, rental of pneumatic Freedom Drivers for ambulatory patients, and training and certification services required before a transplant center may deploy the system. PMI sells to a concentrated customer base of heart transplant centers, hospitals, surgeons, and their distributors. As of the 10-K filed 2026-03-30, over 2,100 SynCardia TAHs have been implanted across 27 countries. PMI operates from a manufacturing site in Tucson, AZ and reported net losses of $27.0 million and $21.1 million for the years ended December 31, 2025 and December 31, 2024, respectively. Total revenues increased 13% for the year ended December 31, 2025 versus the prior year, driven by a $1.0 million increase in U.S. sales, partially offset by declines in Europe and rest-of-world.

Revenue model

Transactional product revenue from sales of TAH Kit 70cc and TAH Kit 50cc implant systems to hospitals; rental revenue from Freedom Drivers used by ambulatory patients; and service revenue from mandatory training and certification of transplant centers before first deployment of the SynCardia TAH.

Products and services

SynCardia TAH System: implant with left and right artificial ventricles replacing both ventricles and all four heart valves; TAH Kit 70cc and TAH Kit 50cc; Companion 2 Driver (C2 Driver) for in-hospital pneumatic power; Freedom Driver for portable in-home use; Companion Cart Hospital (Cart); Companion Caddy. In development: Emperor TAH, a next-generation fully implantable artificial heart with an internal driver system, targeting FDA approval submission as early as 2028.

Customers and end markets

Heart transplant centers, hospitals, cardiothoracic surgeons, and their distributors. Customer concentration is material, with a limited number of transplant centers representing the primary buyer base. End market is end-stage biventricular heart failure patients who are candidates for heart transplant. Implantation is covered under CMS National Coverage Determination 20.9.1 and reimbursed under DRG 001 in the U.S.

Value-chain role

Manufacturer and direct commercial seller of a highly manual, complex medical device system. PMI relies on single- or limited-source suppliers for critical components including valves and drive parts. Manufacturing is concentrated at one site in Tucson, AZ. PMI also provides required training and certification services to transplant centers, creating a procedural onboarding step before centers may use the product commercially.

Geographic exposure

Primary market is the United States. International sales include countries where the SynCardia TAH is available under special exemptions or compassionate use, with markets including France, Germany, Australia, United Kingdom, Canada, Italy, Turkey, Kuwait, and Saudi Arabia, among others across 27 countries total as of the 10-K filed 2026-03-30. For the year ended December 31, 2025, U.S. sales increased by $1.0 million while Europe sales declined by $0.4 million and rest-of-world sales declined by $0.1 million.

Competitors

Other total artificial heart manufacturers (unnamed in filing), Ventricular assist device (VAD) manufacturers offering alternative therapies

Source: SEC 10-K, filed 2026-03-30

Industry: Surgical & Medical Instruments & Apparatus