SynCardia Completes First In Vivo Implantations of Next-Generation Emperor Total Artificial Heart
Picard Medical (NYSE American: PMI) announced on November 19, 2025 that SynCardia completed the first in vivo implantations of the fully implantable Emperor Total Artificial Heart (TAH).
The Emperor TAH was implanted in three pre-clinical models, taken off bypass without issues, and provided full, stable blood circulation while operating energy-efficiently and without technical problems. Observed behaviors included stable hemodynamics, physiologic preload sensitivity, and afterload independence consistent with company laboratory goals.
SyndCardia plans additional pre-clinical studies to refine system parameters before further program acceleration.
Picard Medical (NYSE American: PMI) ha annunciato il 19 novembre 2025 che SynCardia ha completato i primi impianti in vivo del Cuore Totale Artificiale Emperor (TAH) completamente impiantabile.
Il TAH Emperor è stato impiantato in tre modelli preclinici, è stato tolto dalla circolazione extracorporea senza problemi e ha garantito una circolazione sanguigna completa e stabile, operando in modo energeticamente efficiente e senza problemi tecnici. Osservati comportamenti comprendevano emodinamica stabile, sensibilità fisiologica al preload e indipendenza dall'afterload, coerenti con gli obiettivi di laboratorio della società.
SynCardia prevede ulteriori studi preclinici per affinare i parametri di sistema prima di accelerare ulteriormente il programma.
Picard Medical (NYSE American: PMI) anunció el 19 de noviembre de 2025 que SynCardia completó las primeras implantaciones in vivo del Emperor Total Artificial Heart (TAH) totalmente implantable.
El Emperor TAH se implantó en tres modelos preclínicos, se desconectó de la circulación extracorpórea sin problemas y proporcionó una circulación sanguínea completa y estable, al tiempo que operaba de forma eficiente energéticamente y sin problemas técnicos. Se observaron comportamientos como hemodinamia estable, sensibilidad fisiológica al preload y independencia respecto al afterload, coherentes con los objetivos de laboratorio de la empresa.
SynCardia planea estudios preclínicos adicionales para refinar los parámetros del sistema antes de acelerar aún más el programa.
Picard Medical (NYSE American: PMI)는 2025년 11월 19일 SynCardia가 완전히 이식 가능한 Emperor 총인공심장(TAH)의 첫 생체 내 이식 작업을 완료했다고 발표했습니다.
Emperor TAH는 세 가지 전임상 모델에 이식되었고, 체외순환에서 이탈되었으며 문제 없이 작동했고, 에너지를 효율적으로 사용하면서도 기술적 문제 없이 완전하고 안정적인 혈액 순환을 제공했습니다. 관찰된 행동으로는 안정된 혈역학, preload에 대한 생리적 민감성, 그리고 afterload에 대한 독립성이 회사 실험실 목표와 일치하는 것으로 나타났습니다.
SynCardia는 시스템 매개변수를 더 다듬기 위한 추가 전임상 연구를 계획하고 있으며, 프로그램의 가속화를 추가로 추진하기 전에 이를 수행할 예정입니다.
Picard Medical (NYSE American: PMI) a annoncé le 19 novembre 2025 que SynCardia a réalisé les premières implantations in vivo du Cœur Total Artificiel Emperor (TAH) entièrement implantable.
Le Emperor TAH a été implanté dans trois modèles précliniques, retiré du circuit de bypass sans problème et a assuré une circulation sanguine complète et stable tout en fonctionnant de manière économe en énergie et sans problèmes techniques. Les comportements observés incluaient une hémodynamique stable, une sensibilité physiologique au preload et une indépendance vis-à-vis de l’afterload, conforme aux objectifs de laboratoire de l’entreprise.
SynCardia prévoit des études précliniques supplémentaires pour affiner les paramètres du système avant d’accélérer davantage le programme.
Picard Medical (NYSE American: PMI) gab am 19. November 2025 bekannt, dass SynCardia die ersten In-vivo-Implantationen des vollständig implantierbaren Emperor Total Artificial Heart (TAH) abgeschlossen hat.
Der Emperor TAH wurde in drei präklinischen Modellen implantiert, vom Bypass ohne Probleme genommen und lieferte eine vollständige, stabile Durchblutung, während er energiesparend und ohne technische Probleme arbeitete. Beobachtete Verhaltensweisen umfassten stabile Hämodynamik, physiologische Preload-Sensitivität und Unabhängigkeit vom Afterload, konsistent mit den Laborzielen des Unternehmens.
SynCardia plant zusätzliche präklinische Studien, um Systemparameter zu verfeinern, bevor das Programm weiter beschleunigt wird.
بيكار ميديكال (بورصة نيويورك الأمريكية: PMI) أعلنت في 19 نوفمبر 2025 أن SynCardia أتمت أولى عمليات الزرع الحية لـ قلب Emperor الاصطناعي الكلي (TAH) القابل للزراعة بشكل كامل.
تم زرع Emperor TAH في ثلاثة نماذج قبل السريرية، وأُسحب من جهاز الدورة خارجياً بدون مشاكل، ووفّر دورة دموية كاملة ومستقرة بينما كان يعمل بتوفير للطاقة وبلا مشاكل تقنية. شملت الملاحظات استقراراً ديناميكياً في الضغط الدموي، وحساسية preload الفيزيولوجية، واستقلالية عن afterload متوافقة مع أهداف مختبر الشركة.
تخطط SynCardia لإجراء دراسات قبل السريرية إضافية لتحسين معلمات النظام قبل تسريع البرنامج أكثر.
- First in vivo implantations completed in 3 pre-clinical models
- Devices taken off bypass without issues
- Observed stable hemodynamics and physiologic preload sensitivity
- Device operated energy-efficiently and without technical problems
- Results are from pre-clinical acute models, not human trials
- Additional pre-clinical studies required before clinical translation
Insights
Successful first in vivo implants in three pre-clinical models show the Emperor TAH met lab goals and demonstrated physiologic function on
Picard Medical and its SynCardia affiliate completed first in vivo implantations of the fully implantable Emperor Total Artificial Heart in three pre-clinical models and removed each model from bypass without issues. The device delivered full, stable circulation, operated without technical problems, and met stated laboratory performance goals, indicating the system produced stable hemodynamics, preload sensitivity, and afterload independence consistent with the Frank–Starling response.
The key dependencies are additional pre-clinical studies and refinement of system parameters, which the company states it will continue. The results reported are acute and pre-clinical only; longer observation and formal regulatory study designs remain necessary to establish safety and effectiveness over time. Watch for subsequent pre-clinical study endpoints and protocol milestones, and any announced transition to chronic studies or regulatory submissions over the next 12–24 months.
Significant milestone reached in advancing a driverless total artificial heart, strengthening Picard Medicals leadership in total artificial heart technology
TUCSON, Ariz., Nov. 19, 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 it has successfully completed the first in vivo implantations of the fully implantable Emperor Total Artificial Heart (TAH). The positive outcomes observed following the implantations mark a major milestone in the development of the Emperor platform as the next-generation successor to the clinically proven, FDA-approved SynCardia Total Artificial Heart (“STAH”).
Patrick NJ Schnegelsberg, CEO of Picard Medical, stated, “We are excited by these initial data. The successful completion of these first implantations brings SynCardia back to the forefront of innovation in total artificial heart technology. This milestone strengthens our position as the global leader in total artificial hearts and is yet another step that validates the potential of the Emperor platform.”
The Emperor TAH was successfully implanted in three pre-clinical models, and each model was taken off bypass without any issues. Throughout the observation periods, the device provided full and stable blood circulation, used energy efficiently, and operated without technical problems. The Emperor TAH performed in a way that closely mirrors how a natural human heart works. It produced stable hemodynamics (steady, controlled blood flow), showed physiologic preload sensitivity (the pump output increased naturally as more blood entered the device), and maintained afterload independence (consistent pumping performance even as systemic vascular resistance changed). These behaviors reflect the Frank Starling response, the natural mechanism by which the heart adjusts its pumping strength based on how much blood fills it. All results were consistent with Picard Medicals laboratory performance goals for the Emperor platform.
“Our very positive experience with implanting the next-generation TAH in three separate in vivo models confirms that the Emperor platform is progressing as designed and confirms its potential to become a fully implantable alternative to heart transplantation,” added Andre R. Simon, MD, PhD, FRCS, Vice President of Medical Affairs. “The performance characteristics observed in each of these acute experiments validate key engineering choices and support continued program acceleration for this novel device which could be an even further improvement to a patient’s quality of life.”
SynCardia will continue with additional pre-clinical studies to refine the final system parameters. The Emperor platform is designed to expand the total artificial heart market by delivering a fully implantable system with improved performance, energy efficiency, and patient usability.
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:
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
FAQ
What did Picard Medical (PMI) announce on November 19, 2025 about the Emperor TAH?
How did the Emperor TAH perform in the November 19, 2025 pre-clinical implantations for PMI?
Does the November 19, 2025 Emperor TAH announcement mean PMI has human trial approval?
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