Picard Medical, Inc., parent company of SynCardia Systems, LLC, announced the publication of an independent commentary in Artificial Organs examining its next-generation Emperor platform. The platform combines the Emperor Drive with the SynCardia Total Artificial Heart (STAH) and aims to advance mechanical heart replacement technology. The commentary, authored by Aakash M. Shah, M.D., reviews the history of total artificial heart development and highlights Picard Medical's recent preclinical studies as a milestone toward a fully implantable artificial heart.

The article discusses the latest series of acute large-animal implant studies evaluating the Emperor platform. As previously announced, three implant procedures were completed successfully, with the device providing stable full circulatory support, demonstrating physiologic autoregulatory behavior, and experiencing no device-related intraoperative failures. The commentary emphasizes the platform's independent dual-motor architecture, which enables independent control of the systemic and pulmonary circulations, closely replicating physiologic cardiac function without an external pneumatic driver.

Richard Fang, Ph.D., Interim Chief Executive Officer and Chairman of Picard Medical, stated that the independent commentary places the Emperor platform within the broader context of decades-long efforts to develop a practical, fully implantable artificial heart. He noted that while significant work remains, the successful acute implant studies represent an encouraging preclinical milestone. The company remains focused on engineering, preclinical, and regulatory work to advance the Emperor platform toward human clinical evaluation.

The commentary also reviews SynCardia's more than two decades of clinical experience in total artificial heart therapy, noting that the STAH remains the only commercially available total artificial heart approved in both the United States and Canada. Within Picard Medical's development program, the next-generation platform integrates the Emperor Drive, an electromechanical drive system under development, with the STAH. The design builds upon the proven pumping principles of the STAH while aiming to provide independent control of systemic and pulmonary circulations.

The article concludes that continued advances in total artificial heart technology have the potential to expand treatment options for patients with advanced biventricular heart failure who may not receive a donor heart due to ineligibility or supply shortages. The publication clarifies that the commentary is intended as a news update for its readership and does not constitute an endorsement of Picard Medical.

Picard Medical, Inc. reported an 85% year-over-year increase in revenue and an improved gross margin of 28% from year-end 2025, driven by a 116% increase in U.S. revenue. The company, parent of SynCardia Systems, LLC, released the details in a pre-recorded presentation ahead of its 2026 Annual Meeting of Stockholders scheduled for July 17, 2026. The presentation outlines business performance, product development progress, and manufacturing initiatives.

Richard Fang, Ph.D., Interim Chief Executive Officer and Chairman of the Board, highlighted the company's commitment to advancing a fully implantable total artificial heart while supporting current technologies. He noted strong first-quarter financial performance and continued innovation in the next-generation Emperor platform.

Financial and Operational Highlights

The company emphasized steady financial milestones and ongoing manufacturing optimization initiatives aimed at strengthening quality control, improving supply chain resilience, and reducing production costs.

Emperor Platform Development

Picard Medical provided an update on its Emperor platform, which builds on the SynCardia Total Artificial Heart architecture. The Emperor Drive System is a new electromechanical actuation platform designed to eliminate the external pneumatic driver used with current products. The initial configuration retains an external controller and battery, with a roadmap toward a fully implantable system using wireless power transfer.

Development milestones include the pursuit of FDA Breakthrough Device designation, continued preclinical studies, and a planned Investigational Device Exemption submission in 2028. The company intends to begin clinical study activities in 2029, with the scope and design determined in consultation with the FDA.

2026 Annual Meeting Details

The 2026 Annual Meeting of Stockholders will be held virtually on July 17, 2026, at 6:00 p.m. Eastern Time. Proposals to be considered include the election of directors, amendments to the capital structure, ratification of the independent registered public accounting firm, and advisory votes on executive compensation. Stockholders of record as of the applicable record date are eligible to vote by internet, telephone, or during the virtual meeting.