Picard Medical, Inc. (NYSE:PMI) (the "Company" or "Picard Medical"), parent company of SynCardia Systems LLC, maker of the world's first and only total artificial heart approved by both the U.S. FDA and Health Canada, today announced the successful completion of an acute in vivo implant study series using the Company's next-generation Emperor Total Artificial Heart ("Emperor TAH" or "Emperor") Platform at the University of Arizona and Banner University Medical Center in Tucson.

The animal study evaluated the latest iteration of the Emperor TAH, an electromechanically actuated system designed to build upon the established blood-contacting architecture and extensive clinical experience of the SynCardia Total Artificial Heart ("STAH") while advancing patient mobility and supporting the future development of a fully implantable artificial heart system.

Initial preclinical data from the first-generation Emperor TAH, completed in late 2025, were subsequently presented at the American College of Cardiology and at the International Society for Heart & Lung Transplantation 2026 conferences. Compared to the previous generation device, the latest iteration incorporates an independent dual motor ventricular system enabling side-specific control of systemic and pulmonary circulation. The system is designed to support physiologic responsiveness while preserving the underlying pumping principles and autoregulatory characteristics of the STAH.

Three acute implant procedures were successfully completed. Across all study procedures, the Emperor TAH demonstrated stable hemodynamic support with observations consistent with physiologic autoregulatory behavior. No device-related intraoperative failures were observed.

"This animal study demonstrated the Emperor's capability to provide stable full circulatory support in a large animal model and generated important data supporting continued preclinical and translational development activities," said Andre Simon, MD-PhD, Vice President of Clinical Affairs.

"The independent ventricular architecture operated as intended under study conditions," said Matthew Schuster, Chief Operating Officer of Picard Medical and inventor of the Emperor. "These studies further validated the design and will support ongoing system optimization and future testing."

"These studies mark another important milestone toward our goal of a fully implantable artificial heart," said Patrick Schnegelsberg, Chief Executive Officer of Picard Medical. "The Emperor TAH is designed to build on decades of clinical experience from the SynCardia platform, with the goal of improving patient mobility and quality of life."

The studies were conducted in collaboration with researchers and surgical teams at The University of Arizona and Banner University Medical Center Tucson.

The Emperor TAH is being developed as a fully implantable artificial heart platform intended to provide long-term circulatory support for patients with advanced biventricular heart failure without the need for external pneumatic drivers. The Emperor TAH is currently under development and has not received FDA approval or clearance.