Picard Medical (PMI) Registration filing summary

Company overview and business model

• Operates as a holding company with 100% ownership of SynCardia, a medical technology firm producing the only FDA and Health Canada approved Total Artificial Heart (TAH) for end-stage heart failure patients.

• Over 2,100 SynCardia TAHs have been implanted in 27 countries; the device is an established bridge to heart transplantation.

• Developing next-generation products, including the fully implantable Emperor TAH and advanced pneumatic driver technologies.

• Revenue streams include sales of TAHs, rental of Freedom Drivers, and training/certification services for transplant centers.

• U.S. reimbursement is primarily through CMS DRG 001, with additional coverage from private insurers; international expansion is ongoing.

Financial performance and metrics

• FY2025 revenues were $4.9M, up 13% from FY2024, with U.S. sales growth offsetting declines in Europe and other regions.

• FY2025 net loss was $27.0M, compared to $21.1M in FY2024; gross loss for FY2025 was $0.2M.

• Q1 2026 revenues increased 85% year-over-year to $1.15M, but net loss widened to $7.6M.

• Operating cash outflows for FY2025 were $15.7M; cash and equivalents at year-end were $7.5M.

• Auditor's report includes a going concern warning due to recurring losses and negative cash flows.

Use of proceeds and capital allocation

• No proceeds from resale of shares by selling stockholders; potential proceeds of up to $1.87M from warrant exercises, to be used for general corporate purposes.

• Recent capital raised through IPO ($19.6M gross), senior secured notes ($15M), and follow-on offerings ($5M gross in May 2026).

• Ongoing investments in R&D for next-generation devices and regulatory approvals.