Cortechs.ai and EDAP Announce World’s First OnQ™ Prostate-Assisted Focal One® Robotic HIFU Procedure at UCSF Prostate Cancer Center
Cortechs.ai and EDAP TMS (NASDAQ: EDAP) announced the world's first successful OnQ Prostate-assisted Focal One® Robotic HIFU procedure at the UCSF Prostate Cancer Center. The procedure, performed on January 28th, 2025, marks the first clinical application of OnQ Prostate's RSI technology in focal therapy.
OnQ Prostate, the only FDA-cleared solution for RSI-MRI, provides detailed tissue microstructure information to help urologists identify suitable candidates for focal therapy and target specific lesions. The technology integrates with focal therapy systems for real-time precision targeting during procedures.
Dr. Matthew R. Cooperberg, who performed the procedure, noted that OnQ Prostate clearly delineated tumor anatomy and helped map out a complex treatment plan. The technology aims to improve and standardize prostate MRI interpretation across various contexts in prostate cancer treatment.
Cortechs.ai e EDAP TMS (NASDAQ: EDAP) hanno annunciato il primo intervento di successo al mondo utilizzando il sistema OnQ Prostate-assisted Focal One® Robotic HIFU presso il UCSF Prostate Cancer Center. L'intervento, eseguito il 28 gennaio 2025, segna la prima applicazione clinica della tecnologia RSI di OnQ Prostate nella terapia focalizzata.
OnQ Prostate, l'unica soluzione approvata dalla FDA per RSI-MRI, fornisce informazioni dettagliate sulla microstruttura tissutale per aiutare gli urologi a identificare candidati idonei per la terapia focalizzata e a mirare a lesioni specifiche. La tecnologia si integra con i sistemi di terapia focalizzata per un targeting preciso in tempo reale durante le procedure.
Il Dr. Matthew R. Cooperberg, che ha eseguito l'intervento, ha sottolineato che OnQ Prostate ha chiaramente delineato l'anatomia del tumore e ha aiutato a mappare un complesso piano di trattamento. La tecnologia mira a migliorare e standardizzare l'interpretazione della MRI prostatica in vari contesti nel trattamento del cancro alla prostata.
Cortechs.ai y EDAP TMS (NASDAQ: EDAP) anunciaron el primer procedimiento exitoso en el mundo utilizando el sistema OnQ Prostate-assisted Focal One® Robotic HIFU en el UCSF Prostate Cancer Center. El procedimiento, realizado el 28 de enero de 2025, marca la primera aplicación clínica de la tecnología RSI de OnQ Prostate en la terapia focal.
OnQ Prostate, la única solución aprobada por la FDA para RSI-MRI, proporciona información detallada sobre la microestructura del tejido para ayudar a los urólogos a identificar candidatos adecuados para la terapia focal y dirigir lesiones específicas. La tecnología se integra con sistemas de terapia focal para una localización de precisión en tiempo real durante los procedimientos.
El Dr. Matthew R. Cooperberg, quien realizó el procedimiento, destacó que OnQ Prostate delineó claramente la anatomía del tumor y ayudó a mapear un complejo plan de tratamiento. La tecnología tiene como objetivo mejorar y estandarizar la interpretación de la resonancia magnética prostática en varios contextos en el tratamiento del cáncer de próstata.
Cortechs.ai와 EDAP TMS (NASDAQ: EDAP)가 UCSF 전립선암 센터에서 전 세계 최초의 성공적인 OnQ 전립선 보조 Focal One® 로봇 HIFU 시술을 발표했습니다. 2025년 1월 28일에 시행된 이 시술은 초점 치료에서 OnQ 전립선의 RSI 기술의 첫 번째 임상 적용 사례입니다.
OnQ 전립선은 RSI-MRI에 대해 FDA 승인을 받은 유일한 솔루션으로, 세부적인 조직 미세 구조 정보를 제공하여 비뇨기과 의사들이 초점 치료에 적합한 후보자를 찾고 특정 병변을 목표로 삼는 데 도움을 줍니다. 이 기술은 시술 중 실시간 정확한 목표 지정을 위해 초점 치료 시스템과 통합됩니다.
시술을 수행한 Matthew R. Cooperberg 박사는 OnQ 전립선이 종양의 해부학을 명확히 구분하고 복잡한 치료 계획을 작성하는 데 도움을 주었다고 언급했습니다. 이 기술은 전립선암 치료의 다양한 맥락에서 전립선 MRI 해석을 개선하고 표준화하는 것을 목표로 합니다.
Cortechs.ai et EDAP TMS (NASDAQ: EDAP) ont annoncé la première procédure réussie au monde utilisant la technologie OnQ Prostate-assisted Focal One® Robotic HIFU au UCSF Prostate Cancer Center. La procédure, réalisée le 28 janvier 2025, marque la première application clinique de la technologie RSI d'OnQ Prostate dans la thérapie focale.
OnQ Prostate, la seule solution approuvée par la FDA pour RSI-MRI, fournit des informations détaillées sur la microstructure des tissus pour aider les urologues à identifier les candidats appropriés pour la thérapie focale et à cibler des lésions spécifiques. La technologie s'intègre aux systèmes de thérapie focale pour un ciblage précis en temps réel lors des procédures.
Le Dr. Matthew R. Cooperberg, qui a réalisé la procédure, a noté qu'OnQ Prostate a clairement délimité l'anatomie de la tumeur et a aidé à élaborer un plan de traitement complexe. La technologie vise à améliorer et à standardiser l'interprétation de l'IRM prostatique dans divers contextes de traitement du cancer de la prostate.
Cortechs.ai und EDAP TMS (NASDAQ: EDAP) haben die weltweit erste erfolgreiche OnQ Prostate-assisted Focal One® Robotic HIFU-Prozedur am UCSF Prostate Cancer Center angekündigt. Der Eingriff, der am 28. Januar 2025 durchgeführt wurde, markiert die erste klinische Anwendung der RSI-Technologie von OnQ Prostate in der fokalen Therapie.
OnQ Prostate, die einzige von der FDA zugelassene Lösung für RSI-MRI, bietet detaillierte Informationen über die Mikrostuktur des Gewebes, um Urologen zu helfen, geeignete Kandidaten für die fokale Therapie zu identifizieren und spezifische Läsionen gezielt anzugehen. Die Technologie integriert sich mit fokalen Therapiesystemen für eine präzise Echtzeitansprache während der Eingriffe.
Dr. Matthew R. Cooperberg, der den Eingriff durchgeführt hat, bemerkte, dass OnQ Prostate die Tumoranatomie klar abgrenzte und dabei half, einen komplexen Behandlungsplan zu skizzieren. Die Technologie hat zum Ziel, die Interpretation von ProstatamrIs in verschiedenen Kontexten der Behandlung von Prostatakrebs zu verbessern und zu standardisieren.
- First successful integration of OnQ Prostate with Focal One Robotic HIFU system
- FDA clearance for OnQ Prostate's RSI technology
- Enhanced precision in lesion targeting and treatment planning
- Expansion of EDAP's Focal One capabilities
- None.
Insights
The successful integration of OnQ Prostate's RSI technology with EDAP's Focal One® platform represents a significant competitive advantage in the $8.3 billion prostate cancer treatment market. This breakthrough delivers three important benefits:
- Enhanced precision through RSI-MRI technology, the only FDA-cleared solution of its kind, creating a substantial barrier to entry for competitors
- Improved patient selection capabilities, potentially expanding the addressable market for focal therapy
- Seamless real-time integration, streamlining workflow and potentially reducing procedure times
The partnership with Cortechs.ai strategically positions EDAP at the forefront of precision focal therapy, addressing a critical market need for minimally invasive treatments with reduced side effects. The successful implementation at a prestigious institution like UCSF provides strong validation and could accelerate adoption among other leading medical centers.
The technology integration creates a compelling value proposition: better patient outcomes through precise lesion targeting, potentially lower complication rates and improved standardization of prostate MRI interpretation. This could drive increased utilization of Focal One® systems and generate higher procedure volumes, positively impacting EDAP's recurring revenue streams.
Looking ahead, this advancement could accelerate EDAP's market penetration in the growing focal therapy segment, particularly as healthcare providers increasingly seek minimally invasive treatment options. The exclusive FDA clearance for RSI-MRI technology provides a sustainable competitive advantage and potential pricing power in contract negotiations with healthcare providers.
- First Focal One® procedure utilizing Cortechs.ai’s advanced MRI-imaging technology, OnQ Prostate, successfully performed at the University of California, San Francisco Prostate Cancer Center
- OnQ Prostate’s Restriction Spectrum Imaging (RSI) technology improves lesion localization and targeting for urologists performing Focal One Robotic High Intensity Focused Ultrasound (HIFU) ablation
- Reflects EDAP’s continued commitment to innovation and further validates Focal One as the leading focal therapy platform controlled by urologists
San Diego, CA and Austin, Texas, February 6, 2025 - Cortechs.ai, an emerging leader in novel imaging solutions for prostate cancer care, and EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced the successful completion of the world’s first OnQ Prostate-assisted Focal One® Robotic HIFU procedure at the University of California, San Francisco (UCSF) Prostate Center. This milestone marks the first clinical application of OnQ Prostate’s patented RSI technology to guide focal therapy, demonstrating how advanced MR-imaging can improve lesion localization and targeting for urologists performing focal therapy.
As the only FDA-cleared solution for RSI-MRI, OnQ Prostate uniquely provides more detailed information about the tissue microstructure that can help urologists more confidently identify which patients are the best candidates for focal therapy and which lesions should be targeted. Additionally, OnQ Prostate integrates seamlessly into these focal therapy systems, allowing for real-time precision targeting during the procedure to maximize likelihood of successfully ablating the desired area.
“OnQ Prostate very clearly delineated the tumor anatomy in this case, and helped us map out a relatively complex treatment plan for our focal therapy patient” said Dr. Matthew R. Cooperberg, M.D., M.P.H, Professor of Urology at the University of California, San Francisco, who performed the Focal One procedure on Tuesday, January 28th, 2025. “I am quite optimistic that this technology will help improve and standardize prostate MRI interpretation in multiple contexts across the prostate cancer journey.”
“This milestone at UCSF underscores the critical role our advanced imaging plays in empowering urologists to deliver more precise, personalized treatment,” said Kyle Frye, CEO of Cortechs.ai. “We are committed to driving meaningful advancements in prostate cancer care, ensuring that both physicians and patients benefit from enhanced precision at every stage of the treatment journey.”
“We are pleased to be partnering with the Cortechs.ai team in the integration of OnQ Prostate with Focal One Robotic HIFU,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “This new clinical offering further demonstrates our ongoing commitment to expand the capabilities of Focal One to assist urologists in the delivery of a precise, patient-specific treatment to their prostate cancer patients.”
Focal therapy for prostate cancer is an emerging approach that aims to ablate clinically significant disease while preserving healthy tissue, reducing the side effects associated with whole-gland treatments. For urologists performing focal therapy, the ability to precisely localize lesions is critical to achieving successful oncologic control while minimizing damage to surrounding healthy tissue. OnQ Prostate enhances this process by enhancing lesion conspicuity, allowing for more informed patient-selection and treatment planning.
As focal therapy becomes increasingly integrated into prostate cancer care, Cortechs.ai remains at the forefront of developing solutions that support urologists in delivering more effective, evidence-based, and minimally invasive treatment strategies.
About Cortechs.ai
Cortechs.ai is a leader in AI applications in radiology, leveraging advanced technologies in medical imaging to enhance disease screening and early detection, empowering healthcare providers to deliver better outcomes for patients. The company develops and markets innovative medical device software that quantifies and tracks neurodegeneration and prostate cancer, helping clinicians detect and monitor clinically significant cases. Cortechs.ai’s industry-leading imaging solutions offer radiologists, oncologists, and urologists a streamlined, cost-effective way to assess prostate health, including detection and monitoring of cancer. The company also has FDA-cleared products for use in assessing neurological disorders such as Alzheimer’s disease, epilepsy, multiple sclerosis, brain trauma, tumors, and other brain abnormalities. For more information, please visit www.cortechs.ai and follow us on Twitter, LinkedIn, and Facebook.
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.
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.
Coretechs.ai contact:
Michi Sassa, Chief Financial Officer
msassa@cortechs.ai
+1 858 459 9700
EDAP TMS Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com
EDAP TMS Investor Contact
John Fraunces
LifeSci Advisors, LLC
(917) 355-2395
jfraunces@lifesciadvisors.com
FAQ
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