Picard Medical / SynCardia Advances Emperor Total Artificial Heart Program with Successful Next-Generation Preclinical Implant Studies

— Independent dual motor ventricular design demonstrates stable full circulatory support across all study procedures — 

— Advancing second-generation Emperor TAH development toward a fully implantable system —

TUCSON, Ariz., June 02, 2026 (GLOBE NEWSWIRE) -- Picard Medical, Inc. (NYSE American: 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.

About Picard Medical and SynCardia

Picard Medical, Inc. is the parent company of SynCardia Systems, LLC (“SynCardia”), the Tucson, Arizona–based leader with the only commercially available total artificial heart technology for patients with end-stage heart failure. SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart (“STAH”), an implantable system that assumes the full functions of a failing or failed human heart. It is the first artificial heart approved by both the FDA and Health Canada, and it remains the only commercially available artificial heart in the United States and Canada. With more than 2,100 implants performed at hospitals across 27 countries, the STAH is the most widely used and extensively studied artificial heart in the world. For additional information about Picard Medical, please visit www.picardmedical.com or review the Company’s filings with the U.S. Securities and Exchange Commission at www.sec.gov.

Forward-Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Forward-looking statements can often be identified by words such as “continue,” “goal,” “advance,” “intended,” and “designed to,” and similar expressions, and various or negatives of these words. These statements include, but are not limited to, statements regarding supporting clinical partners, advancing development of our next generation fully implantable total artificial heart platform, and the expected benefits of the Emperor TAH. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. Additional information about the Company, including risk factors that may affect the Company’s business, financial condition, and results of operations, is contained in the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available free of charge on the SEC’s website at http://www.sec.gov and on the Company’s investor relations website at https://picardmedical.com/.

Contact:

Investors
Eric Ribner
Managing Director
LifeSci Advisors LLC
eric@lifesciadvisors.com

Picard Medical, Inc./SynCardia Systems, LLC
IR@picardmedical.com

General/Media
Brittany Lanza
blanza@syncardia.com


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