Picard Medical (PMI) Registration Filing summary

Company overview and business model

• Manufactures and sells the only FDA- and Health Canada-approved total artificial heart (TAH), with over 2,100 implants in 27 countries as a bridge to heart transplantation for biventricular failure patients.

• Business is conducted through SynCardia Systems, LLC, with plans to expand indications from bridge to transplant (BTT) to bridge to candidacy (BTC) and long-term use, and to develop a fully implantable TAH.

• Product portfolio includes the SynCardia TAH (70cc and 50cc), external drivers (Companion 2 and Freedom Driver), and proprietary materials and manufacturing processes.

• Revenue is generated from product sales, driver rentals, and training/certification services for transplant centers.

Financial performance and metrics

• 2024 revenues were $4.4 million, down 13% from 2023, with a net loss of $21.1 million and an accumulated deficit of $49.8 million as of December 31, 2024.

• Gross loss in 2024 was $112,000, with total operating expenses of $13.6 million, and cash and cash equivalents of $96,000 at year-end.

• Company has a working capital deficit of $25.5 million and total liabilities of $35.8 million as of December 31, 2024.

• Auditor's report includes a going concern warning due to recurring losses and limited liquidity.

Use of proceeds and capital allocation

• Proceeds will fund a $2.85 million investment in a China joint venture, up to $5 million for R&D of a fully implantable system, $1 million for sales/marketing expansion, and $4 million for general operations and working capital.

• Additional proceeds may be used for inventory, driver expansion, and public company transition costs.