SynCardia Total Artificial Heart
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Picard Medical Reports Full Year 2025 Financial Results
Globenewswire· 2026-03-25 11:00
Core Viewpoint - Picard Medical, Inc. experienced a transformational year in 2025, marked by revenue growth, improved operating performance, and a strengthened balance sheet following its public listing and capital raises [1][3]. Financial Results - Total revenue for 2025 was $4.94 million, an increase of 12.5% from $4.39 million in 2024 [4][8]. - Product revenue accounted for $4.75 million, while rental revenue was $0.19 million, driven by the adoption of the SynCardia Total Artificial Heart [4]. - Gross loss was $(0.2) million, with a gross margin of (4.1%), compared to a gross loss of $(0.1) million and a margin of (2.6%) in 2024 [5][8]. - Operating expenses were $13.1 million, a decrease from $13.6 million in 2024, with R&D expenses at $3.0 million and SG&A expenses at $10.0 million [6][8]. - Operating loss was $(13.3) million, slightly improved from $(13.7) million in 2024 [7][8]. - Net loss for the year was $(27.0) million, compared to $(21.1) million in 2024 [9][8]. Liquidity and Capital Resources - Cash, cash equivalents, and restricted cash totaled $11.5 million as of December 31, 2025, a significant increase from $0.1 million at the end of 2024 [10]. - Net cash used in operating activities was $(15.7) million, while net cash provided by financing activities was $27.1 million [10]. Outlook - The company plans to continue investing in commercialization, manufacturing scale, and product development, indicating that additional capital will be required to support operations and execute its business plan [11]. About Picard Medical and SynCardia - Picard Medical, Inc. is the parent company of SynCardia Systems, LLC, which leads in total artificial heart technology for patients with end-stage heart failure. The SynCardia Total Artificial Heart is the first artificial heart approved by both the FDA and Health Canada, with over 2,100 implants performed globally [12].
Picard Medical / SynCardia to Present its Next-Generation Emperor Total Artificial Heart Technology at the American College of Cardiology’s Annual Scientific Session
Globenewswire· 2026-03-20 12:00
Core Insights - The company will present early preclinical data on its next-generation Emperor Total Artificial Heart at the ACC.26 conference in New Orleans from March 28 to March 30, 2026 [1][3] Company Overview - Picard Medical, Inc. is the parent company of SynCardia Systems LLC, which developed the first total artificial heart approved by both the U.S. FDA and Health Canada [1][7] - SynCardia's Total Artificial Heart is the only commercially available artificial heart technology in the U.S. and Canada, with over 2,100 implants performed across 27 countries [7] Product Development - The Emperor Total Artificial Heart is designed as a fully implantable electromechanical system that aims to preserve physiological autoregulation and hemodynamic performance [3][6] - The new system is intended to provide long-term support while improving mobility and quality of life for patients with advanced heart failure [6] Conference Participation - SynCardia will exhibit at booth 2554 during the ACC.26 conference, providing opportunities for attendees to meet with engineering and clinical teams [4][5] - The conference will serve as a platform for discussing the design, development progress, and future clinical direction of the Emperor Total Artificial Heart [5]
Picard Medical / SynCardia Highlight Second Successful Total Artificial Heart Bridge to Transplant at UCSF Health
Globenewswire· 2026-03-19 12:00
Core Insights - The case highlights the successful use of the SynCardia Total Artificial Heart to bridge a young patient with advanced biventricular heart failure to heart transplantation after 119 days of support [1][2][3] Company Overview - Picard Medical, Inc. is the parent company of SynCardia Systems, LLC, which produces the only commercially available total artificial heart technology approved by both the U.S. FDA and Health Canada [5] - The SynCardia Total Artificial Heart is the first artificial heart to receive regulatory approval in both the U.S. and Canada, and it is the most widely used artificial heart globally, with over 2,100 implants performed across 27 countries [5] Industry Context - The successful case at UCSF Health represents the second of five patients who have been bridged to transplantation using the SynCardia Total Artificial Heart, indicating the growing role of total artificial heart therapy in treating patients with severe heart failure [2][3] - The increasing adoption of the SynCardia Total Artificial Heart at leading transplant centers reflects the rising demand for advanced mechanical circulatory support for patients with end-stage heart failure [4]
Picard Medical / SynCardia Announce Successful Four-Year Bridge to Transplant with SynCardia Total Artificial Heart Support
Globenewswire· 2026-03-17 11:00
Core Insights - A 29-year-old patient successfully received a donor heart transplant after being supported for over 1,600 days by the SynCardia Total Artificial Heart, demonstrating the device's effectiveness as a bridge to transplant [1][2]. Company Overview - Picard Medical, Inc. is the parent company of SynCardia Systems, LLC, which produces the SynCardia Total Artificial Heart, the first total artificial heart approved by both the U.S. FDA and Health Canada [5]. - The SynCardia Total Artificial Heart is the only commercially available artificial heart in the U.S. and Canada, with over 2,100 implants performed across 27 countries [5]. Product Functionality - The SynCardia Total Artificial Heart replaces the pumping function of both sides of the heart, maintaining circulation for patients with irreversible biventricular heart failure while they await a donor organ [2][3]. - The device restores circulation and hemodynamic stability by replacing both ventricles and all four native heart valves [3]. Clinical Impact - More than 2,100 implants of the SynCardia Total Artificial Heart have been performed worldwide, with the longest documented support exceeding eight years [4]. - Extended duration support cases continue to inform clinical practice and illustrate the potential for long-term mechanical circulatory support in carefully selected patients [4].
Picard Medical / SynCardia Highlight Total Artificial Heart on BTV Program Airing on FOX Business News
Globenewswire· 2026-03-13 10:00
Core Viewpoint - Picard Medical, Inc. is promoting its SynCardia Total Artificial Heart (STAH) technology, which is the first total artificial heart approved by both the U.S. FDA and Health Canada, through a feature on BTV Business Television, highlighting its significance in treating patients with severe heart failure [1][5]. Group 1: Company Overview - Picard Medical, Inc. is the parent company of SynCardia Systems, LLC, which is based in Tucson, Arizona, and is the leader in total artificial heart technology for patients with end-stage heart failure [8]. - The SynCardia Total Artificial Heart (STAH) is the only commercially available artificial heart in the United States and Canada, with over 2,100 implants performed across 27 countries, making it the most widely used and extensively studied artificial heart technology globally [3][8]. Group 2: Technology and Development - The STAH replaces both left and right ventricles and all four heart valves, restoring circulation in patients with severe biventricular heart failure who are at risk of imminent death without mechanical circulatory support [3]. - The company is also developing a next-generation, fully implantable artificial heart platform aimed at improving patient mobility and quality of life by eliminating external pneumatic drivers [4]. Group 3: Market Awareness and Outreach - The upcoming segment on BTV Business Television aims to raise awareness of advanced heart failure therapies, which is increasingly important as the number of patients needing mechanical circulatory support continues to grow [5]. - BTV Business Television has been a long-running investment-focused program that profiles emerging companies and technologies, providing exposure to retail and institutional investors [7].
Picard Medical / SynCardia Showcases Leadership in Total Artificial Heart Therapy at Technology and Heart Failure Therapeutics Conference
Globenewswire· 2026-03-02 13:00
Core Insights - Picard Medical, Inc. is advancing its leadership in artificial heart technology with the SynCardia Total Artificial Heart and the next-generation Emperor system, focusing on not just survival but also quality of life and transplant eligibility [1][2]. Company Overview - Picard Medical, Inc. is the parent company of SynCardia Systems, LLC, which is the only provider of commercially available total artificial heart technology for end-stage heart failure patients [5]. - The SynCardia Total Artificial Heart (STAH) is the first artificial heart approved by both the U.S. FDA and Health Canada, with over 2,100 implants performed globally [5]. Conference Participation - Dr. Andre Simon, Vice President of Clinical Affairs, will present at the Technology and Heart Failure Therapeutics (THT) 2026 conference, showcasing the company's commitment to innovation and education in heart failure therapies [1][2]. - The conference will feature discussions on emerging technologies and clinical data aimed at improving patient outcomes in heart failure management [4]. Presentation Highlights - Dr. Simon's presentations will cover: - The Emperor system's early laboratory and preclinical data, emphasizing its design for improved patient mobility and independence [2]. - Future priorities in total artificial heart therapy, including earlier intervention and organ recovery [3]. - Updated registry analyses demonstrating that outcomes with the STAH extend beyond survival to include functional improvement and quality of life enhancements [3].
Picard Medical / SynCardia to Participate in Inaugural “Hands-On Training Day” at the Technology and Heart Failure Therapeutics Conference
Globenewswire· 2026-02-26 13:00
Core Insights - Picard Medical, Inc. will participate in the inaugural "Hands-On Training Day" at the THT 2026 conference to enhance education on the SynCardia Total Artificial Heart for advanced heart failure patients [1][2] Company Overview - Picard Medical is the parent company of SynCardia Systems, which produces the only commercially available total artificial heart approved by the U.S. FDA and Health Canada [6] - The SynCardia Total Artificial Heart has been implanted over 2,100 times across 27 countries, making it the most widely used artificial heart globally [6] Training Program Details - The training program will feature interactive, case-based learning aimed at improving multidisciplinary collaboration and patient outcomes in advanced heart failure [2][4] - Clinicians will engage with the technology through hands-on training, focusing on real-world clinical scenarios [3][4] - Senior Clinical Specialists will lead the training, providing direct interaction with the Companion 2 Driver, Freedom Portable Driver, and the SynCardia Total Artificial Heart [3] Conference Information - The THT 2026 conference focuses on advancing heart failure innovation through emerging devices and therapies, bringing together clinicians, researchers, and industry partners [5] - The program includes scientific sessions, case discussions, and hands-on training to foster collaboration and improve patient outcomes [5]
Leading Heart Transplant Centers Convene in Houston for Picard Medical/ SynCardia’s Total Artificial Heart Surgical Training
Globenewswire· 2026-02-23 13:00
Core Viewpoint - Picard Medical, Inc. is hosting an exclusive training program for the SynCardia Total Artificial Heart, aimed at enhancing surgical education and collaboration among leading cardiac centers in the U.S. [1][5] Group 1: Training Initiative - The "SynCardia Total Artificial Heart Training Village" will take place at Houston Methodist Hospital, featuring advanced programs on implantation techniques and clinical best practices [2][5] - The program will be led by Dr. Andre Simon, an expert in mechanical circulatory support, combining classroom instruction with hands-on surgical training [3][4] - The initiative aims to improve patient care for those with advanced heart failure through peer-to-peer surgical education and collaborative discussions [4][5] Group 2: Strategic Goals - The training initiative is part of Picard Medical's broader strategy to develop centers of excellence across the U.S. to expand access to total artificial heart therapy [5][8] - The Houston region is identified as a significant market for advanced heart failure, and the program aims to enhance collaboration among high-volume transplant and mechanical circulatory support programs [5][8] - The company plans additional training initiatives in key markets to increase implant volumes and broaden access to the SynCardia Total Artificial Heart [5][8] Group 3: Company Background - Picard Medical, Inc. is the parent company of SynCardia Systems, which offers the only commercially available total artificial heart technology for end-stage heart failure [8][9] - The SynCardia Total Artificial Heart has been implanted over 2,100 times across 27 countries, making it the most widely used artificial heart globally [9]
Picard Medical/ SynCardia Highlights Successful Bridge-to-Transplant Case at UCSF Health Using the SynCardia Total Artificial Heart
Globenewswire· 2026-02-12 13:30
Core Viewpoint - The successful heart transplant following the use of the SynCardia Total Artificial Heart at UCSF Health marks a significant advancement in treating advanced biventricular heart failure, showcasing the clinical adoption of this technology in leading transplant centers [1][4]. Company Overview - Picard Medical, Inc. is the parent company of SynCardia Systems, LLC, which is the only provider of commercially available total artificial heart technology for patients with end-stage heart failure [6][7]. - The SynCardia Total Artificial Heart (STAH) is the first artificial heart approved by both the U.S. FDA and Health Canada, and it remains the only commercially available artificial heart in the U.S. and Canada [6][7]. Clinical Milestone - UCSF Health successfully performed its first heart transplant on a patient who had been supported by the SynCardia Total Artificial Heart, marking it as the fifth case at UCSF [1][2][4]. - The patient, a 37-year-old from California's Central Valley, was implanted with the STAH in August 2025 and underwent a successful heart transplant three months later [2][3]. Surgical Details - The heart transplant procedures were conducted by Dr. Amy Fiedler and Dr. Jason W. Smith at the Helen Diller Medical Center, which is part of UCSF Health, known for having one of the largest heart transplant programs in the country [3][4]. Future Developments - Picard Medical is advancing the development of the Emperor TAH, a next-generation fully implantable device aimed at expanding access to long-term mechanical circulatory support without the need for external pneumatic drivers [4].
Picard Medical/ SynCardia to Present at European Mechanical Circulatory Support Summit and International Course on Mechanical Circulatory Support and New Technologies in Heart Failure
Globenewswire· 2026-02-10 21:05
Core Insights - Picard Medical, Inc. is set to present data on its fully implantable Emperor Total Artificial Heart at the upcoming 19th EUMS & 11th International Course on MCS and New Technologies in Advanced Heart Failure congress in Barcelona, Spain from February 15-18, 2026 [1][2] Company Overview - Picard Medical, Inc. is the parent company of SynCardia Systems, LLC, which is the only provider of commercially available total artificial heart technology for patients with end-stage heart failure [3] - The SynCardia Total Artificial Heart (STAH) is the first artificial heart approved by both the U.S. FDA and Health Canada, and it remains the only commercially available artificial heart in the United States and Canada [3] - Over 2,100 implants of the SynCardia Total Artificial Heart have been performed in hospitals across 27 countries, making it the most widely used and extensively studied artificial heart globally [3] Event Details - The presentation titled "The Emperor Rises: First In Vitro and In Vivo Evaluation of SynCardia's Electromechanical Total Artificial Heart" will take place on February 16, 2026, from 17:15 to 18:15 Central European Time [2] - The European Mechanical Circulatory Support Summit (EUMS) serves as a leading international forum for advancing mechanical circulatory support and emerging technologies in treating advanced heart failure [2]