Core Viewpoint - Picard Medical, Inc. has entered into a development collaboration agreement with Hydrix Services Pty Ltd to advance the next-generation fully implantable Total Artificial Heart technology, known as the Emperor, which aims to enhance patient mobility and convenience by eliminating the need for an external driver [1][2]. Company Overview - Picard Medical, Inc. is the parent company of SynCardia Systems, LLC, which is recognized for developing the only commercially available total artificial heart technology for patients with end-stage heart failure. 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 across 27 countries, making it the most widely used artificial heart globally [5]. Collaboration Details - The selection of Hydrix as a development partner is based on its expertise in complex critical engineering and a strong track record in developing regulated medical devices, including mechanical circulatory support systems. This collaboration aligns with Picard Medical's strategy to partner with leading engineering organizations for long-term development of life-sustaining technologies [2][3]. - Under the agreement, Hydrix will conduct development work for Picard and SynCardia through the end of 2026 as part of a multi-stage development program for the Emperor, which will progress through defined engineering verification and regulatory milestones [3]. Financial Incentives - The collaboration may allow Picard to benefit from Australian R&D tax incentives of approximately 43% of eligible expenditure, subject to qualification and review, which could enhance the financial viability of the development program [3]. Hydrix Overview - Hydrix Limited is a product innovation company focused on enhancing health, safety, and well-being through its services in design, engineering, and delivery of innovative medical products. The company operates across three segments: Services, Ventures, and Medical [4].

Core Viewpoint - Picard Medical, Inc. is actively participating in key healthcare conferences, highlighting its leadership in total artificial heart technology and its commitment to advancing medical innovation [1][4]. Group 1: Conference Participation - Picard Medical will attend the 44th Annual J.P. Morgan Healthcare Conference, including events such as LifeSci Advisors' Corporate Access Event and Lifeblood and Goodwin's CEO-Only MedTech Forum [1]. - The Lifeblood and Goodwin's MedTech CEO-Only Forum is scheduled for January 12, 2026, as an invite-only discussion forum in San Francisco, CA [3]. - The LifeSci Advisors 15th Annual Corporate Access Event will take place on January 14, 2026, featuring one-on-one meetings at The Beacon Grand, San Francisco, CA [3]. Group 2: Company Overview - Picard Medical, Inc. is the parent company of SynCardia Systems, LLC, which is recognized for its SynCardia Total Artificial Heart (STAH), the only commercially available total artificial heart technology for patients with end-stage heart failure [4]. - The SynCardia Total Artificial Heart is the first artificial heart approved by both the FDA and Health Canada, and it is the only commercially available artificial heart in the United States and Canada [4]. - 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 [4].

Core Insights - Picard Medical, Inc. is the parent company of SynCardia Systems LLC, which produces the world's first total artificial heart approved by both the U.S. FDA and Health Canada [1][3] - CEO Patrick NJ Schnegelsberg will present data on the Emperor Total Artificial Heart at the CSI Focus D-HF conference in Frankfurt, Germany, on December 6, 2025 [1][2] Company Overview - Picard Medical, Inc. is based in Tucson, Arizona, and is a leader in total artificial heart technology for patients with end-stage heart failure [3] - The SynCardia Total Artificial Heart (STAH) is the only commercially available artificial heart in the U.S. and Canada, having been implanted over 2,100 times across 27 countries, making it the most widely used and studied artificial heart globally [3]

Core Viewpoint - Picard Medical, Inc. will present in vitro data on its fully implantable Emperor Total Artificial Heart at the ISMCS 2025 conference, highlighting advancements in patient mobility and quality of life [1][3]. Group 1: Presentation Details - The presentation is scheduled for December 4, 2025, at 14:05 CET during the Mini Oral Session 3 focused on Hemocompatibility and Heart/Pump Interaction [2]. - The title of the presentation is "The Emperor Total Artificial Heart: A Next Generation, Fully Implantable Total Artificial Heart," and it will be presented by Duffy Elmer, Engineering Project Manager at Picard Medical [2]. Group 2: Product Information - The Emperor Total Artificial Heart features an internal motor-driven design that eliminates the need for an external pneumatic driver, aiming to enhance patient mobility and overall quality of life [3]. - Picard Medical, through its subsidiary SynCardia Systems, is the only company with commercially available total artificial heart technology for patients with end-stage heart failure, having performed over 2,100 implants across 27 countries [5]. Group 3: Event Information - ISMCS 2025 is the 31st annual global congress of the International Society for Mechanical Circulatory Support, bringing together various stakeholders to discuss new clinical research and emerging technologies in mechanical circulatory support [4].

Core Insights - Picard Medical has achieved a significant milestone by successfully completing the first in vivo implantations of the Emperor Total Artificial Heart (TAH), marking a major advancement in total artificial heart technology [1][2] Company Overview - Picard Medical, Inc. is the parent company of SynCardia Systems, LLC, which is recognized as the leader in total artificial heart technology for patients with end-stage heart failure [4] - 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 [4] Product Development - The Emperor TAH was successfully implanted in three pre-clinical models, demonstrating full and stable blood circulation, energy efficiency, and operation without technical issues [2][3] - The device exhibited hemodynamic stability, preload sensitivity, and afterload independence, reflecting the natural functioning of a human heart [2][3] - The positive outcomes from the initial implantations validate the engineering choices made for the Emperor platform and support the acceleration of its development [3] Market Position - The successful development of the Emperor platform strengthens Picard Medical's position as a global leader in total artificial hearts and aims to expand the market by offering a fully implantable system with enhanced performance and usability [2][3]

Core Viewpoint - Picard Medical, Inc. has stated that it is not aware of any undisclosed material changes in its operations or financial condition that would explain the recent volatility in its stock price [1] 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 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] Strategic Focus - The company remains committed to executing its strategic and operational priorities while ensuring compliance with all disclosure obligations under applicable securities laws [2]