– Successful heart transplant case following an implanted SynCardia total artificial heart reported at hospital with one of the largest heart transplant programs in the country -TUCSON, Ariz., Feb. 12, 2026 (GLOBE NEWSWIRE) — Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, today announced that University of California, San Francisco (UCSF) Health has successfully performed its first heart transplant in a patient who had previously been supported with the SynCardia Total Artificial Heart, marking an important clinical milestone in the treatment of advanced biventricular heart failure. UCSF Health is the U.S. News & World Report 2025-2026 top-ranked hospital in California. UCSF announced in a press release yesterday that a 37-year-old patient from California’s Central Valley was admitted to UCSF in August 2025 with end-stage heart failure. Within weeks, surgeons implanted the SynCardia Total Artificial Heart (STAH) manufactured by Picard Medical Inc., through its wholly owned subsidiary SynCardia Systems LLC. It was the fifth patient that UCSF Health had implanted with a SynCardia Total Artificial Heart. The six-hour procedure took place at the Helen Diller Medical Center at Parnassus Heights. The patient was then discharged and three months later, the patient successfully underwent heart transplantation. The announcement stated that the patient continues to recover well and looks forward to returning home to care for his young daughter with renewed strength and health. The procedures were performed by cardiac surgeon Amy Fiedler, M.D., Surgical Director of the Heart Transplant and Mechanical Circulatory Support Program, and Jason W. Smith, M.D., Chief of Cardiac Surgery and Lung Transplantation. UCSF has one of the largest heart transplant programs in the country and, in Northern CA, has the only active program that fully implants the mechanical heart. Patrick NJ Schnegelsberg, Chief Executive Officer of Picard Medical Inc., commented, “This fifth case at UCSF highlights the continued clinical adoption of the SynCardia Total Artificial Heart at leading transplant centers and now has a corresponding successful heart transplantation. For patients in advanced biventricular failure, time is critical. The ability to stabilize and sustain these patients, so that they are also healthy enough for surgery until a suitable donor heart becomes available is central to our mission.” Picard Medical Inc is also advancing development of the Emperor TAH, a fully implantable next generation device designed to expand access to long-term mechanical circulatory support without the need for external pneumatic drivers. About UCSF Health UCSF Health is recognized worldwide for its innovative patient care, reflecting the latest medical knowledge, advanced technologies and pioneering research. It includes the flagship UCSF Medical Center, which is among the nation’s top specialty hospitals, as well as UCSF Benioff Children Hospitals with campuses in San Francisco and Oakland; two community hospitals, UCSF Health Stanyan Hospital and UCSF Health Hyde Hospital; Langley Porter Psychiatric Hospital; UCSF Benioff Children Physicians; and the UCSF Faculty Practice. UCSF Health UCSF Medical Center ranks among the country’s top specialty hospitals for adult care, according to U.S. News and World Report, and is best in the San Francisco Metro Area in Cardiology, Heart and Vascular Surgery. UCSF Health excels in numerous complex cardiology procedures and conditions and received the highest rating, High Performing, for aortic valve surgery, as well as specialty care for heart arrhythmias, heart attacks, heart failure, and pacemaker implantation. These hospitals serve as the academic medical center of the University of California, San Francisco, which is world renowned for its graduate level health sciences education and biomedical research. UCSF Health maintains affiliations with hospitals and health organizations throughout the Bay Area. For more information, visit https://ucsfhealth.org. 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 SynCardia Total Artificial Heart 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. Contact: InvestorsEric RibnerManaging DirectorLifeSci Advisors LLCeric@lifesciadvisors.com Picard Medical, Inc./SynCardia Systems, LLCIR@picardmedical.com General/MediaBrittany Lanzablanza@syncardia.com
Tag: SynCardia
Picard Medical/ SynCardia to Present at European Mechanical Circulatory Support Summit and International Course on Mechanical Circulatory Support and New Technologies in Heart Failure
TUCSON, Ariz., Feb. 10, 2026 (GLOBE NEWSWIRE) — Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, today announced that Dr. Andre Simon, Vice President of Clinical Affairs will attend and present data on the fully implantable Emperor Total Artificial Heart (TAH) at the upcoming 19th EUMS (European Mechanical Circulatory Support Summit) & 11th International Course on Mechanical Circulatory Support (MCS) and New Technologies in Advanced Heart Failure (HF) congress, being held February 15th – 18th, 2026 in Barcelona, Spain.
SynCardia and Hydrix Enter into Development Collaboration to Advance the Emperor, SynCardia’s Next Generation Total Artificial Heart
TUCSON, Ariz., Jan. 12, 2026 (GLOBE NEWSWIRE) — Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, today announced that on January 5, 2026 SynCardia entered into a development collaboration agreement (the “Agreement”) with Hydrix Services Pty Ltd (“Hydrix”), a wholly owned subsidiary of Hydrix Limited (ASX: HYD), to commence an initial development phase for SynCardia’s next-generation, fully implantable Total Artificial Heart (TAH) technology, known as the Emperor. As a fully implantable TAH, Emperor would eliminate the use of an external driver and offer both greater convenience and increased freedom related to patient mobility. SynCardia selected Hydrix as a development partner based on its proven expertise in complex critical engineering and its strong track record developing regulated medical devices, including mechanical circulatory support systems. The collaboration reflects Picard Medical’s focus on partnering with world-class engineering organizations capable of supporting long-term, high-value development programs for mission-critical, life-sustaining technologies. Patrick N.J. Schnegelsberg, CEO of SynCardia Systems, commented, “Hydrix’s expertise and demonstrated track record in advancing complex cardiovascular technologies will support our shared objective of developing transformative solutions for patients with advanced heart failure. As we advance the Emperor program into its next phase of development, the structure may also allow Picard to benefit from Australian R&D tax incentives of approximately 43% of eligible expenditure, subject to qualification and review.” “We are excited to commence this critical development with SynCardia, a highly regarded global leader in advanced heart replacement technology,” said Gavin Coote, Executive Chairman of Hydrix. “It endorses our capability to deliver complex, medical device development programs for leading international medical technology companies.” Under the agreement, Hydrix will perform development work for Picard and SynCardia through the end of 2026 as a first phase within a broader staged development program for the Emperor. The program is structured as a multi-stage, multi-year effort advancing through defined engineering verification and regulatory milestones with continuation between stages dependent on demonstrated technical progress performance and safety validation regulatory alignment. About Hydrix Limited and Hydrix Services Hydrix Limited (ASX: HYD) is a powerful product innovation company. Hydrix’s purpose is to enhance the health, safety, and well-being of a billion lives. The Company leverages its powerful product innovation capability across three business segments: Services: design, engineer and deliver world-first products and innovation; Ventures: invest in high potential MedTech clients; and Medical: distribute disruptive cardiovascular products. 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 SynCardia Total Artificial Heart 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. 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. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Registration Statement and related prospectus filed in connection with the initial public offering with the SEC. Copies are available on the SEC’s website, http://www.sec.gov. Contact: InvestorsEric RibnerManaging DirectorLifeSci Advisors LLCeric@lifesciadvisors.com Picard Medical, Inc./SynCardia Systems, LLCIR@picardmedical.com General/MediaBrittany Lanzablanza@syncardia.com
Picard Celebrates Patient Living a World-Record of Over Eight Years with the SynCardia Total Artificial Heart
-Picard Medical / SynCardia Systems LLC mark historic milestone as a patient reaches 2,900 days of continuous support with the SynCardia Total Artificial Heart — the longest timeframe in the world ever recorded- TUCSON, Ariz., Dec. 09, 2025 (GLOBE NEWSWIRE) — Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, proudly marks a new milestone in the field of mechanical circulatory support with a patient living over eight years or 2,900 days with a SynCardia™ Total Artificial Heart (STAH), the longest timeframe that a patient has ever lived on an artificial heart. “This achievement shows the life-changing impact of the SynCardia Total Artificial Heart, offering not only a bridge to transplant but also durable long-term support, to support life far beyond the typical time span for patients waiting for a donor heart,” said Patrick NJ Schnegelsberg, Chief Executive Officer of Picard Medical. “In this case, the STAH demonstrates long-term durability and reliability as well as fills a life-saving gap for patients who would otherwise have no viable options. Building on this foundation of long-term success, Picard Medical is now developing the Emperor, its next generation of fully implantable, artificial heart systems to broaden access and provide greater flexibility for long-term support worldwide.” About the Patient A 46-year-old patient, facing end-stage heart failure, received the SynCardia Total Artificial Heart on December 9, 2017 at the Institute for Cardiovascular Diseases, Dedinje hospital (also known as “IVDK Dedinje Hospital”) in Belgrade, Serbia. Today, eight years later, this patient continues to live supported by the SynCardia Total Artificial Heart, reaching more than 2,900 days of extended life, with most of those days spent at home with family and loved ones. The dedication of the medical team at IVDK Dedinje Hospital, combined with SynCardia’s technology, continues to make a profound difference in this patient’s journey. Long-term Success Concentrated in Serbia Serbia continues to lead the world in long-duration support with the SynCardia Total Artificial Heart. The five longest supported patients globally are all from IVDK Dedinje Hospital in Belgrade, with one patient supported for about eight years, another for more than four years, a third for more than three years, and two additional patients each supported for just under three years. These extraordinary cases reflect the strength of the clinical program in the region and the dedication of Serbian cardiac surgeons and transplant teams at IVDK Dedinje Hospital, who have advanced the SynCardia Total Artificial Heart at an exceptional level. 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 SynCardia Total Artificial Heart 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. 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. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Registration Statement and related prospectus filed in connection with the initial public offering with the SEC. Copies are available on the SEC’s website, http://www.sec.gov. Contact: InvestorsEric RibnerManaging DirectorLifeSci Advisors LLCeric@lifesciadvisors.com Picard Medical, Inc./SynCardia Systems, LLCIR@picardmedical.com General/MediaBrittany Lanzablanza@syncardia.com
Picard Medical, Inc. and SynCardia Systems LLC CEO to Present at CSI Focus D-HF 2025 in Frankfurt, Germany
TUCSON, Ariz., Dec. 03, 2025 (GLOBE NEWSWIRE) — Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, today announced that Patrick NJ Schnegelsberg, CEO will attend and present data on the fully implantable Emperor Total Artificial Heart (TAH) at the upcoming CSI Focus D-HF (Device Therapies in Heart Failure) conference, scheduled for December 5th through 6th, 2025 in Frankfurt, Germany.
SynCardia Systems, LLC. 50cc temporary Total Artificial Heart (TAH-t) Now FDA Approved
TUCSON, AZ, March 09, 2020 (GLOBE NEWSWIRE) — With the FDA approval of the SynCardia Systems, LLC 50cc TAH-t system a greater number of cardiac transplant eligible patients at risk of imminent death from biventricular failure now have access to total artificial heart therapy. The 50cc TAH-t is 37.5% smaller […]
SynCardia Announces Promotion of Don Webber to CEO & Appointment of Peter Spadaro as President and CCO
TUCSON, Arizona, April 3, 2019 /PRNewswire/ — SynCardia Systems, LLC, manufacturer of the world’s only clinically-proven and commercially approved total artificial heart, is pleased to announce that Don Webber has been promoted to Chief Executive Officer, and Peter Spadaro has been appointed as the President and Chief Commercial Officer (CCO). Don Webber joined SynCardia in 2018 as […]
SynCardia Announces Promotion of Don Webber to CEO
TUCSON, Ariz., March 7, 2019 /PRNewswire/ — SynCardia Systems, LLC, manufacturer of the world’s only clinically-proven and commercially approved total artificial heart, is pleased to announce that Don Webber has been named Chief Executive Officer (CEO). Mr. Webber joined SynCardia in 2018 as Chief Operating Officer (COO), leading Manufacturing Operations and Engineering, Quality and Supply […]
Italian Boy Becomes Youngest Patient Bridged To Transplant With The SynCardia Total Artificial Heart
The smaller 50cc Total Artificial Heart helped rejuvenate the critically-ill 12-year-old’s vital organs until a matching donor heart became available two weeks later. TUCSON, Ariz.–(BUSINESS WIRE)–A 12-year-old boy at Bambino Gesù Children’s Hospital in Rome, Italy, has become the world’s youngest patient to be bridged to a heart transplant with […]



