EDAP Announces Significant Presence of Focal One® at the Upcoming 120th American Urological Association (AUA) Annual Meeting
EDAP TMS (Nasdaq: EDAP) announces its largest-ever presence at the upcoming 120th American Urological Association (AUA) Annual Meeting, showcasing their Focal One Robotic HIFU platform. The event will feature expert-led demonstrations, semi-live procedures, and hands-on simulations.
Key highlights include the presentation of final results from the FARP Study, the first randomized clinical trial comparing focal ablation versus radical prostatectomy for early-stage prostate cancer. Dr. Ruben Olivares from Cleveland Clinic will present on the first-ever remote transatlantic Focal One Robotic HIFU procedure.
Prior to AUA, EDAP will host its first Robotic Focal HIFU Masterclass at USC's Keck School of Medicine on April 24-25th, 2025, featuring lectures, simulations, and live procedures. The event has attracted over 80 urologists and includes a keynote lecture by Prof. Sebastien Crouzet sharing insights from 3,000 Focal One procedures.
EDAP TMS (Nasdaq: EDAP) annuncia la sua partecipazione più importante di sempre al prossimo 120° Congresso Annuale dell'American Urological Association (AUA), presentando la sua piattaforma robotica Focal One HIFU. L'evento includerà dimostrazioni guidate da esperti, procedure semi-live e simulazioni pratiche.
Tra i momenti salienti la presentazione dei risultati finali dello studio FARP, il primo trial clinico randomizzato che confronta l'ablazione focale con la prostatectomia radicale per il carcinoma prostatico in fase iniziale. Il dottor Ruben Olivares della Cleveland Clinic presenterà la prima procedura robotica Focal One HIFU transatlantica eseguita da remoto.
Prima dell'AUA, EDAP organizzerà il suo primo Masterclass sul Robotic Focal HIFU presso la Keck School of Medicine della USC il 24-25 aprile 2025, con lezioni, simulazioni e procedure dal vivo. L'evento ha attirato oltre 80 urologi e prevede una lezione magistrale del professor Sebastien Crouzet che condividerà le sue esperienze derivanti da 3.000 procedure Focal One.
EDAP TMS (Nasdaq: EDAP) anuncia su mayor participación hasta la fecha en la próxima 120ª Reunión Anual de la American Urological Association (AUA), presentando su plataforma robótica Focal One HIFU. El evento incluirá demostraciones dirigidas por expertos, procedimientos semi-en vivo y simulaciones prácticas.
Entre los aspectos destacados se encuentra la presentación de los resultados finales del Estudio FARP, el primer ensayo clínico aleatorizado que compara la ablación focal frente a la prostatectomía radical para el cáncer de próstata en etapa temprana. El Dr. Ruben Olivares de la Cleveland Clinic presentará el primer procedimiento robótico Focal One HIFU transatlántico realizado de forma remota.
Antes de la AUA, EDAP llevará a cabo su primer Masterclass de Robotic Focal HIFU en la Keck School of Medicine de la USC los días 24 y 25 de abril de 2025, con conferencias, simulaciones y procedimientos en vivo. El evento ha atraído a más de 80 urólogos e incluye una conferencia magistral del profesor Sebastien Crouzet, que compartirá experiencias basadas en 3,000 procedimientos Focal One.
EDAP TMS (나스닥: EDAP)는 다가오는 제120회 미국비뇨기과학회(AUA) 연례회의에서 역대 최대 규모로 Focal One 로봇 HIFU 플랫폼을 선보인다고 발표했습니다. 이번 행사에서는 전문가 주도 시연, 반실시간 시술, 실습 시뮬레이션이 진행됩니다.
주요 내용으로는 초기 전립선암을 대상으로 하는 집속적 절제술과 근치적 전립선 절제술을 비교한 최초의 무작위 임상시험인 FARP 연구 최종 결과 발표가 포함됩니다. 클리블랜드 클리닉의 루벤 올리바레스 박사가 최초의 원격 대서양 횡단 Focal One 로봇 HIFU 시술에 대해 발표할 예정입니다.
AUA 이전에 EDAP는 2025년 4월 24-25일 USC 켁 의과대학에서 첫 번째 로봇 집속 HIFU 마스터클래스를 개최하며, 강의, 시뮬레이션 및 실시간 시술이 포함됩니다. 이 행사에는 80명 이상의 비뇨기과 전문의가 참여하며, 3,000건의 Focal One 시술 경험을 공유하는 세바스티앙 크루제 교수의 기조 강연도 예정되어 있습니다.
EDAP TMS (Nasdaq : EDAP) annonce sa plus grande participation à ce jour au 120e Congrès annuel de l'American Urological Association (AUA), où elle présentera sa plateforme robotisée Focal One HIFU. L'événement comprendra des démonstrations animées par des experts, des procédures semi-en direct et des simulations pratiques.
Parmi les points forts, la présentation des résultats finaux de l'étude FARP, le premier essai clinique randomisé comparant l'ablation focale à la prostatectomie radicale pour le cancer de la prostate à un stade précoce. Le Dr Ruben Olivares de la Cleveland Clinic présentera la toute première procédure robotisée Focal One HIFU transatlantique réalisée à distance.
Avant l'AUA, EDAP organisera son premier Masterclass Robotic Focal HIFU à la Keck School of Medicine de l'USC les 24 et 25 avril 2025, avec des conférences, des simulations et des procédures en direct. L'événement a attiré plus de 80 urologues et comprend une conférence principale du Professeur Sebastien Crouzet, qui partagera son expérience issue de 3 000 procédures Focal One.
EDAP TMS (Nasdaq: EDAP) kündigt seine bisher größte Präsenz auf der bevorstehenden 120. Jahrestagung der American Urological Association (AUA) an und präsentiert dabei seine Focal One Robotic HIFU-Plattform. Die Veranstaltung umfasst von Experten geleitete Demonstrationen, semi-live Verfahren und praktische Simulationen.
Zu den Highlights zählt die Vorstellung der finalen Ergebnisse der FARP-Studie, der ersten randomisierten klinischen Studie, die fokale Ablation mit radikaler Prostatektomie bei Prostatakrebs im Frühstadium vergleicht. Dr. Ruben Olivares von der Cleveland Clinic wird das erste ferngesteuerte transatlantische Focal One Robotic HIFU-Verfahren präsentieren.
Vor der AUA veranstaltet EDAP am 24. und 25. April 2025 an der Keck School of Medicine der USC seinen ersten Robotic Focal HIFU Masterclass mit Vorträgen, Simulationen und Live-Verfahren. Die Veranstaltung hat über 80 Urologen angezogen und beinhaltet eine Keynote von Prof. Sebastien Crouzet, der Einblicke aus 3.000 Focal One Verfahren teilt.
- First-ever successful remote transatlantic robotic HIFU procedure demonstrates technological advancement
- Growing acceptance and utilization of Focal One platform in global urology community
- Completion of first randomized controlled trial (FARP Study) comparing focal therapy to standard treatment
- Strong registration numbers for Masterclass with 80+ urologists indicates growing market interest
- None.
Insights
EDAP's upcoming clinical trial results and remote surgery demonstration could validate Focal One's effectiveness against traditional prostate cancer treatments.
EDAP's announcement about their presence at the AUA Annual Meeting centers on the upcoming presentation of final results from the FARP Study - the first randomized controlled trial comparing focal ablation versus radical prostatectomy for early-stage prostate cancer. This represents a crucial milestone as level-1 evidence from randomized trials is the gold standard for changing clinical practice patterns. The FARP Study follows the already completed HIFI Study, which the article notes demonstrated "comparable cancer control and superior urinary and erectile function preservation" compared to surgery.
The technological capabilities of Focal One are being highlighted through a presentation on the first-ever remote transatlantic robotic HIFU procedure by Dr. Ruben Olivares from Cleveland Clinic. This remote surgery demonstration showcases the advanced robotic capabilities of the platform and potential for expanding access beyond major medical centers.
The company is reporting increased scientific interest in focal therapy for prostate cancer, with "a notable increase in the number of scientific presentations" at this year's AUA meeting. Their pre-conference Masterclass at USC has attracted over 80 urologists from around the world, suggesting growing clinical interest in the technology. The article mentions that Professor Sebastien Crouzet will be sharing "Lessons Learned from 3,000 Focal One Procedures," indicating substantial real-world experience with the technology.
If the FARP Study results are positive (which remains to be seen when presented), they could significantly influence treatment guidelines and accelerate adoption of focal therapy approaches for prostate cancer, potentially benefiting EDAP as the "global leader in robotic energy-based therapies."
Upcoming presentation of first randomized trial comparing focal therapy to radical prostatectomy represents potential watershed moment for prostate cancer treatment alternatives.
The upcoming presentation of the FARP Study results at AUA2025 represents a potential inflection point for focal therapy in prostate cancer management. As the first completed randomized controlled trial comparing focal ablation directly to radical prostatectomy, this study provides the level-1 evidence that has been missing from the focal therapy literature. The article indicates these are "final, three-year oncological results" - a meaningful follow-up period for initial cancer control assessment.
What makes this particularly significant is that focal therapy has traditionally been viewed as experimental by many in the urological community due to lack of randomized data, despite its theoretical advantages in preserving urinary and sexual function. The article notes that these results come "shortly after the publication of the HIFI Study," which was described as "the largest prospective comparative study already providing strong support" for Focal One's efficacy and functional preservation benefits.
The Masterclass at USC featuring experts from "highest-ranked institutions" and the presentation by Prof. Crouzet on "3,000 Focal One Procedures" indicates substantial clinical experience with this technology already exists. The high registration numbers (80+ urologists) suggest growing clinical interest in focal therapy approaches.
In the current prostate cancer treatment landscape, if the FARP Study demonstrates non-inferiority for cancer control with superior functional outcomes, it could legitimize focal therapy as a standard treatment option rather than an experimental approach. However, we must await the actual presentation of results before drawing conclusions about the comparative efficacy of HIFU versus radical prostatectomy.
- Activities to include expert-led demonstrations, semi-live Focal One procedures and hands-on simulations
- Final results of randomized clinical trial (FARP Study) comparing ultrasound-based focal ablation versus radical prostatectomy as a first-line treatment for prostate cancer
- Presentation on the first ever remote transatlantic Focal One Robotic HIFU procedure will be given by Ruben Olivares, MD, Urologic Surgeon at the Cleveland Clinic, at the AUA session of the Engineering & Urology Society
- Notable increase in the number of scientific presentations on focal therapy and ablation in the management of prostate cancer
- Focal One Robotic HIFU Masterclass will be held at the Keck School of Medicine of the University of Southern California on April 24-25th, prior to AUA Annual Meeting
AUSTIN, Texas, April 22, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that Focal One will have its largest presence ever at the upcoming 120th American Urological Association (AUA) Annual Meeting.
“This year’s AUA meeting promises to be the most significant scientific meeting to date highlighting the growing acceptance and utilization of the Focal One Robotic HIFU platform by the global urology community,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “We will have our largest presence ever at this year’s meeting, enabling us to offer numerous hands-on Focal One simulations, live demonstrations by some of the leading experts in focal therapy, as well as featuring multiple semi-live procedures. Leading into the AUA, the first ever Focal One Robotic HIFU Masterclass will be held at the Keck School of Medicine of USC in Los Angeles, which will be led by world-renown expert faculty and will feature several live Focal One procedures, along with offering hands-on Focal One simulations for attendees.
“We also anticipate a growing number of presentations focused exclusively on robotic HIFU technology at this year’s AUA Annual Meeting, including the much-anticipated final results from the FARP study, which is the first randomized, controlled clinical trial designed to generate level-1 evidence evaluating focal therapy using ultrasound ablative energy versus robotic prostatectomy as a first-line treatment for early-stage prostate cancer. I am also pleased to note that Dr. Ruben Olivares will be making a presentation highlighting the first ever remote transatlantic Focal One Robotic HIFU procedure at the upcoming AUA Annual meeting. We are obviously excited about this event which underscores Focal One’s highly advanced technology and remote capabilities.”
Focal One Highlights at AUA2025
- Presentation of the final results from the first randomized control trial (“FARP Study”) ever completed that compares focal therapy to the standard of care treatment (robotic prostatectomy). The presentation is titled “Final, three-year oncological results of a randomized clinical trial FARP comparing focal ablation and radical prostatectomy in patients with unilateral clinically significant prostate cancer” and is scheduled to be presented in person by the lead investigator, Eduard Baco from Oslo University Hospital in Norway as part of a podium presentation session titled “Prostate Cancer: Localized: Ablative Therapy II” on Sunday, April 27, 2025, at 3:30 PM PT. This first much-anticipated level-1 evidence trial will be instrumental in providing the scientific argument in support of focal ablation with Focal One shortly after the publication of the HIFI Study, the largest prospective comparative study already providing strong support in favor of Focal One’s ability to provide comparable cancer control and superior urinary and erectile function preservation as compared to surgery.
- Ruben Olivares, MD, Urologic Surgeon at the Cleveland Clinic, will be presenting the successful experience of the very first remote transatlantic Focal One Robotic HIFU procedure in a presentation titled “Telesurgery for Focal Therapy: The First Transcontinental Clinical Application” on Monday, April 28, 2025, at 9:16 AM PT as part of the session of the Engineering & Urology Society (EUS). A link first announcing this procedure can be found here, as well as a link to the video of the procedure.
- EDAP to host the first ever Robotic Focal HIFU Masterclass at USC in Los Angeles on April 24-25th, two days ahead of the AUA Annual Meeting. In addition to the 10+ renowned faculty from some of the highest-ranked institutions in the United States and Europe, more than 80 urologists from the U.S. and around the world have registered for this unique and exciting event. The program will include lectures, hands-on Focal One simulations, and three live Focal One procedures. Sebastien Crouzet, MD, PhD, Professor and Associate Chief of Urology of Lyon University Hospital will be giving a Keynote Lecture titled “Lessons Learned from 3,000 Focal One Procedures”.
- Focal One activities at AUA are expected to be the largest in the company’s history with hands-on simulations, expert-led demonstrations, semi-live Focal One procedures, and breakout meetings with key scientific thought leaders.
- This year’s scientific program features a significant number of scientific presentations on focal therapy and ablation in this year’s official program, including multiple plenary sessions and podium presentations, pointing towards the growing utilization of robotic HIFU technology in the management of prostate cancer.
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 are the key findings of the FARP Study for EDAP's Focal One treatment vs. prostatectomy?
When and where will EDAP's first Robotic Focal HIFU Masterclass take place?
How many urologists have registered for EDAP's 2025 HIFU Masterclass?
What technological advancement has EDAP achieved with Focal One in 2025?
