Picard Medical, Inc.
Picard Medical, Inc. is a U.S.-based medical technology holding company whose operating business is conducted through SynCardia. The company develops, manufactures, and sells the SynCardia Total Artificial Heart, an FDA-approved implantable device used to temporarily replace both ventricles of the heart in patients with advanced heart failure.
Fiscal year 2025 · change from previous year
Development 2024–2025
Business
Share of revenueFDA-approved implantable heart replacement devices used as a bridge to transplant.
Rental of external Freedom drivers that power the implanted heart system.
Required training for transplant centers before first-time deployment of the system.
Support services for centers and patients using the SynCardia platform.
Products
Reported · share of revenue- Products96.1 %
- Rentals3.9 %
Source: 10-K FY2025, revenue the company reports per product line (SEC XBRL). Shares are of the lines shown and add up to 100 %.
Customers
Customers are specialized transplant centers and hospital programs that treat patients with advanced heart failure and need a bridge-to-transplant solution. The buying decision is driven by clinical need, regulatory approval, surgeon and center readiness, and the ability to support implantation, driver use, and patient management. The company also serves centers outside the U.S. where the device is available under special exemptions or compassionate use pathways.
Buy the implantable TAH, driver rentals, and training to treat bridge-to-transplant patients.
Use the system under special exemptions or compassionate use for selected patients.
Purchase support services and device-related infrastructure to run the therapy.
Use ongoing support tied to implanted patients and center operations.
Strategy
Picard Medical's strategy is centered on SynCardia and the next generation of total artificial heart technology. Management also describes a broader plan to build a cardiovascular medical technology portfolio through acquisition, development, or in-licensing of approved or near-approved assets.
Improves usability, outcomes, and long-term competitiveness of the platform.
Reduces dependence on a single product and broadens future growth options.
Patent protection supports differentiation and barriers to entry.
Geography
The company is headquartered in the United States, where the SynCardia TAH is commercially approved and sold. It also has a global footprint through use in multiple countries under special exemptions or compassionate use, which broadens the addressable market but adds regulatory and access complexity.
Risks
The business is highly concentrated in a single commercial product and depends on a narrow set of specialized customers, so adoption, reimbursement, and clinical acceptance are important to growth. As a medical device company, it also faces regulatory, manufacturing, and product-liability risks, while international use depends on country-specific access pathways. The company has also disclosed reliance on external financing, which is common for early-stage medtech businesses with long development cycles.
The company has relied on external capital to fund operations and growth.
Exposure: Operating runway
Most business activity depends on one FDA-approved heart system.
Exposure: SynCardia TAH
Sales depend on approval status, special exemptions, and hospital economics.
Exposure: U.S. and international access
Implantable devices require consistent production quality and traceability.
Exposure: Device manufacturing
Transplant centers must be trained and willing to deploy a complex device.
Exposure: Transplant centers
Accounting
Judgemental itemsDifferent delivery obligations can shift timing between periods.
Impact: Affects quarterly comparability and reported revenue mix
Specialized medical devices can require write-downs if demand or usage changes.
Impact: Affects cost of revenues and gross loss
Fair value changes can create non-cash gains or losses.
Impact: Affects earnings volatility
Common in early-stage financing structures and can be significant.
Impact: Affects operating expenses and financing-related costs
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Last updated: 24/09/2026