EDAP and Avenda Health Launch World’s First AI-Assisted Focal One® Robotic HIFU Procedures
EDAP TMS SA (Nasdaq: EDAP) and Avenda Health have launched the world's first AI-assisted Focal One® Robotic HIFU procedures for prostate cancer treatment. The collaboration integrates Avenda's FDA-cleared Unfold AI® technology with EDAP's Focal One robotic HIFU platform. Unfold AI creates 3D patient-specific cancer maps, enabling more precise tumor targeting and healthy tissue preservation.
The first AI-assisted procedures were successfully performed at UCLA School of Medicine. This integration aims to provide more tailored, patient-specific HIFU ablation for prostate cancer patients. The companies will present simulated procedures at the 2024 Joint Meeting of the Focal Therapy Society & Society of Urologic Robotic Surgeons in Washington, DC.
EDAP TMS SA (Nasdaq: EDAP) e Avenda Health hanno lanciato le prime procedure al mondo di HIFU robotico Focal One® assistite dall'IA per il trattamento del cancro alla prostata. La collaborazione integra la tecnologia Unfold AI® di Avenda, approvata dalla FDA, con la piattaforma HIFU robotica Focal One di EDAP. Unfold AI crea mappe tumorali 3D specifiche per il paziente, consentendo un targeting più preciso del tumore e la conservazione dei tessuti sani.
Le prime procedure assistite dall'IA sono state eseguite con successo presso la UCLA School of Medicine. Questa integrazione mira a fornire un ablazione HIFU più personalizzata e specifica per i pazienti affetti da cancro alla prostata. Le aziende presenteranno procedure simulate al Joint Meeting 2024 della Focal Therapy Society e della Society of Urologic Robotic Surgeons a Washington, DC.
EDAP TMS SA (Nasdaq: EDAP) y Avenda Health han lanzado los primeros procedimientos asistidos por IA en el mundo de HIFU robótico Focal One® para el tratamiento del cáncer de próstata. La colaboración integra la tecnología Unfold AI® de Avenda, aprobada por la FDA, con la plataforma HIFU robótica Focal One de EDAP. Unfold AI crea mapas tumorales en 3D específicos para el paciente, permitiendo una mayor precisión en la localización del tumor y la preservación del tejido sano.
Los primeros procedimientos asistidos por IA se llevaron a cabo con éxito en la UCLA School of Medicine. Esta integración busca proporcionar una ablación HIFU más adaptada y específica para los pacientes con cáncer de próstata. Las empresas presentarán procedimientos simulados en la Reunión Conjunta 2024 de la Focal Therapy Society y la Society of Urologic Robotic Surgeons en Washington, DC.
EDAP TMS SA (Nasdaq: EDAP)와 Avenda Health가 전 세계 최초의 인공지능(AI) 보조 Focal One® 로봇 HIFU 절차를 발병한 전립선 암 치료에 대한 프로세스를 시작했습니다. 이번 협력은 Avenda의 FDA 승인된 Unfold AI® 기술과 EDAP의 Focal One 로봇 HIFU 플랫폼을 결합합니다. Unfold AI는 환자 맞춤형 3D 암 지도를 생성합니다, 더 정확한 종양 타겟팅과 건강한 조직 보전을 가능하게 합니다.
AI 지원 절차는 UCLA 의과대학에서 성공적으로 수행되었습니다. 이 통합은 전립선암 환자에게 개별화되고 맞춤형 HIFU 절제술을 제공하는 것을 목표로 합니다. 두 회사는 워싱턴 DC에서 열리는 2024년 Focal Therapy Society 및 Society of Urologic Robotic Surgeons의 공동 회의에서 시뮬레이션된 절차를 발표할 것입니다.
EDAP TMS SA (Nasdaq: EDAP) et Avenda Health ont lancé les premiers procédés HIFU robotisés Focal One® assistés par IA au monde pour le traitement du cancer de la prostate. La collaboration intègre la technologie Unfold AI® d'Avenda, approuvée par la FDA, avec la plateforme HIFU robotisée Focal One d'EDAP. Unfold AI crée des cartes tumorales 3D spécifiques au patient, permettant un ciblage tumorale plus précis et la préservation des tissus sains.
Les premières procédures assistées par IA ont été réalisées avec succès à la UCLA School of Medicine. Cette intégration vise à offrir une ablation HIFU plus personnalisée et spécifique pour les patients atteints de cancer de la prostate. Les entreprises présenteront des procédures simulées lors de la réunion conjointe 2024 de la Focal Therapy Society et de la Society of Urologic Robotic Surgeons à Washington, DC.
EDAP TMS SA (Nasdaq: EDAP) und Avenda Health haben die weltweit ersten KI-unterstützten Focal One® Robotik-HIFU-Verfahren zur Behandlung von Prostatakrebs eingeführt. Die Zusammenarbeit integriert Avendas von der FDA zugelassene Unfold AI®-Technologie mit der Focal One-Roboter-HIFU-Plattform von EDAP. Unfold AI erstellt 3D-patientenspezifische Krebs-Karten, was eine präzisere Tumoransprache und den Erhalt gesunder Gewebe ermöglicht.
Die ersten KI-unterstützten Verfahren wurden erfolgreich an der UCLA School of Medicine durchgeführt. Diese Integration zielt darauf ab, maßgeschneiderte, patientenspezifische HIFU-Ablationen für Prostatakrebspatienten bereitzustellen. Die Unternehmen werden simulierte Verfahren bei der Joint Meeting 2024 der Focal Therapy Society und der Society of Urologic Robotic Surgeons in Washington, DC präsentieren.
- Launch of world's first AI-assisted Focal One® Robotic HIFU procedures for prostate cancer treatment
- Integration of FDA-cleared Unfold AI® technology with Focal One robotic HIFU platform
- Successful completion of first AI-assisted procedures at UCLA School of Medicine
- Potential for more precise tumor targeting and healthy tissue preservation
- Expansion of EDAP's technological capabilities in prostate cancer treatment
- None.
Insights
This collaboration between EDAP and Avenda Health marks a significant advancement in prostate cancer treatment. The integration of Avenda's Unfold AI with EDAP's Focal One robotic HIFU platform creates a powerful synergy that could revolutionize personalized cancer care. The FDA clearance of Unfold AI adds credibility and regulatory support to this innovative approach.
The ability to create 3D patient-specific cancer maps addresses a critical challenge in prostate cancer treatment: accurately identifying and targeting cancerous tissue while sparing healthy tissue. This precision could potentially lead to improved oncological outcomes and reduced side effects, addressing two major concerns in prostate cancer treatment.
However, it's important to note that while initial procedures have been successful, long-term data on efficacy and patient outcomes will be important to fully assess the impact of this technology combination.
As a urologist, I find the integration of AI into prostate cancer treatment planning extremely promising. The Unfold AI's ability to reveal invisible tumor extent could be a game-changer in ensuring complete tumor eradication. This addresses one of our biggest challenges: confidently identifying all cancerous tissue during treatment.
The combination with Focal One's robotic HIFU offers precise ablation control, potentially allowing for more aggressive treatment of the tumor while minimizing collateral damage to surrounding structures. This could significantly improve our ability to preserve urinary and sexual function post-treatment, a major quality-of-life concern for patients.
However, it's important to remember that the technology's effectiveness will ultimately depend on the urologist's skill in interpreting and applying the AI-generated data. Proper training and experience will be key to fully leveraging this advanced technology.
The integration of Avenda's Unfold AI with EDAP's Focal One represents a significant leap in the application of AI to cancer treatment. This multimodal AI decision support platform demonstrates the potential of AI to enhance human decision-making in complex medical scenarios.
The FDA clearance of Unfold AI is particularly noteworthy, as it validates the technology's safety and efficacy. This could accelerate adoption and integration into clinical practice. The ability to create detailed, patient-specific cancer maps could lead to more personalized and effective treatment plans.
However, it's important to consider the challenges of implementing AI in healthcare settings, including data privacy concerns, the need for continuous model updates and potential biases in AI algorithms. The success of this technology will depend on rigorous ongoing validation and the ability to seamlessly integrate into existing clinical workflows.
- First Unfold AI®-Assisted Focal One procedures successfully performed at the UCLA School of Medicine
- FDA-cleared Unfold AI enables urologists to provide tailored, patient-specific Robotic HIFU ablation for prostate cancer patients
- EDAP and Avenda Health to present Unfold AI-Assisted Focal One simulated procedures at the 2024 Joint Meeting of the Focal Therapy Society & Society of Urologic Robotic Surgeons in Washington, DC September 19-21, 2024
LYON, France, September 19, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, and Avenda Health (“Avenda”), a leading AI healthcare company, today announced a collaboration agreement for the purpose of offering personalized prostate cancer care, utilizing Avenda’s groundbreaking AI technology, Unfold AI, to launch the world’s first AI-assisted Focal One robotic high-intensity focused ultrasound (HIFU) procedures.
Avenda Health’s Unfold AI is a multimodal AI decision support platform cleared by the U.S. Food and Drug Administration (FDA) that brings “superhuman” abilities to cancer surgeons and oncologists to power the future of cancer care. Unfold AI builds 3D patient-specific cancer maps that reveal invisible tumor extent and enables physicians to avoid leaving cancerous tissue behind while sparing healthy surrounding tissue. By leveraging Unfold AI’s planning with the Focal One robotic HIFU platform, EDAP and Avenda believe that urologists can provide a more tailored, patient-specific HIFU ablation procedure for their prostate cancer patients.
“Incorporating AI technology into the diagnostics and treatment planning for patients with prostate cancer enables urologists to more accurately pinpoint the presence of tumor cells,” said Wayne G. Brisbane, M.D., Assistant Professor of Urology at The University of California Los Angeles David Geffen School of Medicine. “Having performed the first Focal One procedures utilizing data from Unfold AI, the seamless integration of these two technologies can precisely guide the ablation for optimized oncologic control without damaging healthy surrounding structures, hence minimizing the risk of side effects.”
“We are pleased to enter into this collaboration with the Focal One team” said Shyam Natarajan, Ph.D., Chief Executive Officer of Avenda Health. “Unfold AI is a highly complementary technology that when combined with Focal One robotic HIFU, will enable urologists to map cancer effectively so that the entire tumor can be confidently eradicated. This exciting collaboration with Focal One represents a unique opportunity for Avenda to introduce our groundbreaking AI-technology to a broad community of leaders in the field of prostate cancer to further improve outcomes.”
“We are excited to announce this unique and important collaboration with the highly talented team at Avenda Health during Prostate Cancer Awareness Month and congratulate Dr. Brisbane on successfully completing the first Unfold-AI assisted Focal One procedures,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “The combination of Avenda’s Unfold AI patient-specific cancer map with Focal One’s proprietary HIFUsion® software significantly augments a surgeon’s ability to combine existing diagnostic information and deep-learning algorithms to assist the urologist in creating a personalized precise treatment plan. AI-assisted procedures therefore represent an important and strategic next step in the evolution of the Focal One platform that will help us remain at the forefront of delivering the most advanced treatment solutions for patients with prostate cancer.”
About Avenda Health
Avenda Health is creating a more personalized future of prostate cancer care. Using deep learning, Avenda Health software maps a patient’s cancer in 3D, giving physicians precise information and the confidence to make care decisions. Dedicated to bringing this cutting-edge technology to all practices and physicians treating prostate cancer patients, Avenda Health aims to improve outcomes, preserve quality of life, and create a new standard of cancer care.
About EDAP TMS SA
A recognized leader in the global therapeutic ultrasound market, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for various pathologies using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One® in Europe and in the U.S. as an answer to all requirements for ideal prostate tissue ablation. With the addition of the ExactVu™ Micro-Ultrasound device, EDAP TMS is now the only company offering a complete solution from diagnostics to focal treatment of Prostate Cancer. EDAP TMS also produces and distributes other medical equipment including the Sonolith® i-move lithotripter and lasers for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.com, us.hifu-prostate.com and www.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.
Other factors that may cause such a difference may also include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F.
Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.
EDAP 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
Avenda Health Media Contact
Alaina Chiappone
achiappone@ampublicrelations.com
FAQ
What is the significance of EDAP's collaboration with Avenda Health for prostate cancer treatment?
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