EDAP To Launch New Focal One® i Robotic HIFU system at the Upcoming 120th American Urological Association (AUA) Annual Meeting
EDAP TMS SA (Nasdaq: EDAP) announced the launch of their new Focal One i robotic HIFU system at the upcoming 120th American Urological Association Annual Meeting in Las Vegas (April 26-29, 2025). The enhanced system features expanded HIFUsion compatibility, including:
- PSMA PET scans integration
- ExactVu Micro-Ultrasound support
- AI-driven algorithms (Unfold AI and OnQ Prostate)
- Extended capabilities for Koelis 3D biopsy maps and DynaCAD Urology datasets
The system introduces streamlined workflows, onboard video libraries, and enables treatment streaming and recording capabilities. CEO Ryan Rhodes highlighted that the design improvements were based on customer feedback, emphasizing the demand for incorporating latest diagnostic imaging modalities and AI algorithms for personalized procedures. The system's digital interface enables remote proctoring and collaborative procedures, following Cleveland Clinic's successful first remote transatlantic Focal One treatment from Ohio to Abu Dhabi.
EDAP TMS SA (Nasdaq: EDAP) ha annunciato il lancio del nuovo sistema robotico HIFU Focal One i in occasione del 120° Congresso Annuale dell'American Urological Association a Las Vegas (26-29 aprile 2025). Il sistema migliorato offre una maggiore compatibilità con HIFUsion, includendo:
- Integrazione delle scansioni PSMA PET
- Supporto per ExactVu Micro-Ultrasound
- Algoritmi basati su AI (Unfold AI e OnQ Prostate)
- Capacità estese per mappe bioptiche 3D Koelis e dataset DynaCAD Urology
Il sistema introduce flussi di lavoro ottimizzati, librerie video integrate e consente lo streaming e la registrazione dei trattamenti. Il CEO Ryan Rhodes ha sottolineato che i miglioramenti di design derivano dai feedback dei clienti, evidenziando la richiesta di integrare le più recenti modalità di imaging diagnostico e algoritmi AI per procedure personalizzate. L’interfaccia digitale del sistema permette la supervisione remota e procedure collaborative, seguendo il successo del primo trattamento Focal One transatlantico remoto dalla Cleveland Clinic, da Ohio ad Abu Dhabi.
EDAP TMS SA (Nasdaq: EDAP) anunció el lanzamiento de su nuevo sistema robótico HIFU Focal One i en la próxima 120ª Reunión Anual de la Asociación Americana de Urología en Las Vegas (26-29 de abril de 2025). El sistema mejorado cuenta con una mayor compatibilidad con HIFUsion, incluyendo:
- Integración de escaneos PSMA PET
- Soporte para ExactVu Micro-Ultrasound
- Algoritmos impulsados por IA (Unfold AI y OnQ Prostate)
- Capacidades ampliadas para mapas de biopsia 3D Koelis y conjuntos de datos DynaCAD Urology
El sistema introduce flujos de trabajo optimizados, bibliotecas de video integradas y permite la transmisión y grabación de tratamientos. El CEO Ryan Rhodes destacó que las mejoras en el diseño se basaron en la retroalimentación de los clientes, enfatizando la demanda de incorporar las modalidades de imagen diagnóstica más recientes y algoritmos de IA para procedimientos personalizados. La interfaz digital del sistema permite la supervisión remota y procedimientos colaborativos, siguiendo el éxito del primer tratamiento remoto transatlántico Focal One desde la Cleveland Clinic, de Ohio a Abu Dhabi.
EDAP TMS SA (나스닥: EDAP)는 2025년 4월 26일부터 29일까지 라스베가스에서 열리는 제120회 미국비뇨기과학회 연례회의에서 새로운 Focal One i 로봇 HIFU 시스템을 출시한다고 발표했습니다. 향상된 시스템은 확장된 HIFUsion 호환성을 제공하며, 다음을 포함합니다:
- PSMA PET 스캔 통합
- ExactVu 마이크로 초음파 지원
- AI 기반 알고리즘 (Unfold AI 및 OnQ Prostate)
- Koelis 3D 생검 지도 및 DynaCAD 비뇨기과 데이터셋에 대한 확장된 기능
이 시스템은 간소화된 작업 흐름, 탑재된 비디오 라이브러리, 치료 스트리밍 및 녹화 기능을 도입했습니다. CEO인 라이언 로즈는 디자인 개선이 고객 피드백을 바탕으로 이루어졌으며, 최신 진단 영상 기법과 AI 알고리즘을 통합해 개인 맞춤형 절차에 대한 수요를 강조했다고 밝혔습니다. 시스템의 디지털 인터페이스는 원격 지도 및 협업 절차를 가능하게 하며, 클리블랜드 클리닉에서 오하이오에서 아부다비로 진행된 최초의 원격 대서양 횡단 Focal One 치료 성공 사례를 따릅니다.
EDAP TMS SA (Nasdaq : EDAP) a annoncé le lancement de son nouveau système robotisé HIFU Focal One i lors de la 120e réunion annuelle de l’American Urological Association à Las Vegas (26-29 avril 2025). Ce système amélioré offre une compatibilité étendue avec HIFUsion, comprenant :
- Intégration des scans PSMA PET
- Support de l’ExactVu Micro-Ultrasound
- Algorithmes pilotés par IA (Unfold AI et OnQ Prostate)
- Fonctionnalités étendues pour les cartes de biopsie 3D Koelis et les jeux de données DynaCAD Urology
Le système introduit des flux de travail simplifiés, des bibliothèques vidéo intégrées et permet le streaming ainsi que l’enregistrement des traitements. Le PDG Ryan Rhodes a souligné que les améliorations de conception reposaient sur les retours des clients, mettant en avant la demande d’intégrer les dernières modalités d’imagerie diagnostique et les algorithmes d’IA pour des procédures personnalisées. L’interface numérique du système permet la supervision à distance et les procédures collaboratives, suivant le succès du premier traitement Focal One transatlantique à distance réalisé par la Cleveland Clinic, de l’Ohio à Abu Dhabi.
EDAP TMS SA (Nasdaq: EDAP) kündigte die Einführung ihres neuen robotergestützten HIFU-Systems Focal One i auf der bevorstehenden 120. Jahrestagung der American Urological Association in Las Vegas (26.-29. April 2025) an. Das verbesserte System bietet erweiterte HIFUsion-Kompatibilität, darunter:
- Integration von PSMA-PET-Scans
- Unterstützung von ExactVu Micro-Ultrasound
- KI-gesteuerte Algorithmen (Unfold AI und OnQ Prostate)
- Erweiterte Funktionen für Koelis 3D-Biopsiekarten und DynaCAD Urology-Datensätze
Das System führt optimierte Arbeitsabläufe, integrierte Videobibliotheken ein und ermöglicht Streaming sowie Aufzeichnung von Behandlungen. CEO Ryan Rhodes betonte, dass die Designverbesserungen auf Kundenfeedback basieren und den Bedarf an der Integration neuester diagnostischer Bildgebungsmethoden und KI-Algorithmen für personalisierte Verfahren hervorheben. Die digitale Benutzeroberfläche des Systems ermöglicht Fernüberwachung und kollaborative Eingriffe, basierend auf dem erfolgreichen ersten transatlantischen Fern-Focal One-Einsatz der Cleveland Clinic von Ohio nach Abu Dhabi.
- Launch of advanced Focal One i system with expanded imaging compatibility and AI integration
- Successful demonstration of remote treatment capabilities (Ohio to Abu Dhabi)
- Enhanced workflow efficiency through streamlined procedures and video libraries
- System enables future expansion into remote collaborative procedures and new clinical indications
- None.
Insights
EDAP's Focal One i launch enhances their robotic HIFU platform with advanced imaging compatibility and remote capabilities, potentially strengthening their market position in minimally invasive prostate treatments.
The launch of EDAP's Focal One i represents a significant enhancement to their robotic HIFU (High-Intensity Focused Ultrasound) platform for prostate treatments. The system introduces expanded HIFUsion compatibility with advanced diagnostic tools including PSMA PET scans, ExactVu Micro-Ultrasound, and AI-driven algorithms like Unfold AI and OnQ Prostate. From a technical standpoint, this enhanced interoperability addresses a crucial need in precision medicine - the ability to incorporate multiple data sources for treatment planning.
The system's streamlined workflows with guided, step-by-step procedures are designed to improve efficiency - a key consideration in surgical settings where time and precision are paramount. The onboard video libraries for sharing standard techniques and clinical best practices could facilitate training and standardization of procedures.
Perhaps most notably, the Focal One i's integrated ability to support remote proctoring and collaborative procedures builds upon Cleveland Clinic's achievement of conducting the first remote transatlantic Focal One treatment between Ohio and Abu Dhabi. This capability could potentially expand access to specialized care by allowing experts to participate in procedures remotely.
The announcement's timing at the American Urological Association Annual Meeting provides EDAP with visibility among their core customer base. The emphasis on features developed based on "Voice of Customer feedback" suggests EDAP is responding directly to user needs, which is typically a sound product development strategy. While the immediate market impact remains to be seen, these enhancements appear designed to strengthen EDAP's position in the minimally invasive prostate treatment space.
- Focal One i expands HIFUsion® patient-specific imaging compatibility to include PSMA PET, ExactVu™ Micro-Ultrasound, along with AI-driven and intelligent algorithms including Unfold AI™ and OnQ™ Prostate
- Focal One i extends HIFUsion capabilities to integrate Koelis® 3D biopsy maps and DynaCAD Urology datasets
- Focal One i system will enable future capabilities including treatment streaming and recording, remote collaborative procedures and expanded clinical indications
AUSTIN, Texas, April 24, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced the launch of the new Focal One i system at the upcoming 120th American Urological Association (AUA) Annual Meeting being held in Las Vegas, Nevada from April 26-29, 2025.
The Focal One i system incorporates important new features and enhanced capabilities including:
- Expanded HIFUsion compatibility including Prostate-Specific Membrane Antigen (PSMA) PET scans, ExactVu Micro-Ultrasound, Unfold AI® and OnQ Prostate®, as well as extended capabilities for Koelis 3D biopsy maps and DynaCAD Urology datasets
- Streamlined HIFUsion and treatment workflows with guided, step-by-step procedures designed to improve efficiency
- Onboard Video Libraries to facilitate sharing standard techniques and clinical best practices
- Integrated ability to stream and record Focal One i treatments as well as enabling remote proctoring and remote collaborative procedures
“The new features and design of the Focal One i system are based directly on the feedback from our customers, as well as anticipating the future needs of surgeons performing focal therapy. Voice of Customer feedback is clear that Focal One surgeons want to incorporate the latest diagnostic imaging modalities like PSMA PET and emerging AI- driven and intelligent algorithms to further personalize Focal One Robotic HIFU procedures,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “In addition, we believe Focal One’s digital interface and fully robotic HIFU energy delivery design is uniquely suited to enable remote proctoring and remote collaborative procedures. Cleveland Clinic’s successful achievement of the world’s first remote transatlantic Focal One Robotic HIFU treatment from Ohio to Abu Dhabi serves as the first step in continued innovations that will allow Focal One surgeon experts to connect remotely and share their expertise. We also believe the Focal One i will allow more efficient and effective training and mentoring of surgeons while further broadening patient access to expert care.”
AUA attendees are invited to visit the Focal One booth #1419 to experience a hands-on demonstration of the Focal One i system and explore the new features, system design, and future capabilities that demonstrate Focal One’s continued commitment to innovation and reinforce its global leadership in focal therapy.
About EDAP TMS SA
A recognized leader in robotic energy-based therapies, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics and precise non-invasive energy delivery, EDAP TMS introduced the Focal One® in Europe and in the U.S. as the leading prostate focal therapy controlled by urologists with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit https://focalone.com.
Forward-Looking Statements
In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy and distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics like the COVID 19 pandemic, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services.
Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com
Investor Contact
John Fraunces
LifeSci Advisors, LLC
(917) 355-2395
jfraunces@lifesciadvisors.com
FAQ
What new features does EDAP's Focal One i robotic HIFU system include?
When will EDAP launch the Focal One i system?
What significant achievement has been made with EDAP's Focal One system?
How does the new Focal One i system improve workflow efficiency?
