Picard Medical Inc's Business Segments

General Picard Medical, Inc. (PMI), incorporated in Delaware in 2021, is a holding company that owns 100% of SynCardia Systems, LLC. SynCardia manufactures and sells the only FDA and Health Canada approved Total Artificial Heart (TAH), which fully replaces the function of a failing human heart. Over 2,100 SynCardia TAHs have been implanted in patients across 27 countries as a bridge to heart transplantation for individuals with end-stage biventricular heart failure. The SynCardia TAH system comprises implantable artificial ventricles, external pneumatic drivers (the Companion 2 Driver for hospital use and the Freedom Driver for home use), and drivelines connecting the implant to the drivers. The system replaces both ventricles and all four heart valves to provide immediate cardiac output. PMI is developing the Emperor TAH, a next-generation fully implantable artificial heart with an internal driver system, currently undergoing non-clinical testing. PMI’s strategy includes expanding clinical use through label expansion, pursuing international regulatory approvals such as the CE Mark in the European Union and potential pathways in China, improving manufacturing efficiency, and advancing next-generation pneumatic driver technology, including the Unicorn driver. The SynCardia TAH is reimbursed under CMS guidelines and is the only commercially approved TAH in the United States and Canada, competing with other mechanical circulatory support devices such as left ventricular assist devices (LVADs) and extracorporeal membrane oxygenation (ECMO) systems.

The Company operates in a single operating and reportable segment. The chief operating decision maker (CODM), comprising the Chief Executive Officer, Chief Financial Officer, and Chief Operating Officer, evaluates the Company's financial information and resources on a consolidated basis. Segment financial information reported internally to the CODM includes revenue by product and rentals, cost of revenues by product and rentals, and gross profit or loss. Gross profit or loss is the primary measure used by the CODM to assess segment performance and allocate resources. The CODM also reviews revenue disaggregated by geography. There are no segment operating expenses disclosed separately beyond those in the consolidated statements of operations and comprehensive loss. Segment assets are reported as total assets on the consolidated balance sheets.