EDAP Announces Positive Results from the FARP Randomized Controlled Trial Presented at the American Urological Association (AUA) Annual Meeting
EDAP TMS announced positive final results from the Focal Ablation Versus Radical Prostatectomy (FARP) randomized controlled trial at the 120th AUA Annual Meeting. The study compared ultrasound energy-based focal ablation against Robotic Prostatectomy for prostate cancer treatment.
Key findings from the 213-patient trial:
- Focal Ablation showed a treatment failure rate of 5.6% vs 7.9% for Radical Prostatectomy
- 25% of Radical Prostatectomy patients switched to Focal Ablation
- Both groups showed similar patient characteristics in age, PSA levels, and tumor metrics
The study achieved its primary endpoint, demonstrating that Focal One Robotic HIFU treatment is non-inferior to radical surgery at the 36-month follow-up. This breakthrough validates focal ablation's role in prostate cancer management, with results showing better treatment success rates compared to traditional surgery.
EDAP TMS ha annunciato risultati positivi definitivi dallo studio controllato randomizzato Focal Ablation Versus Radical Prostatectomy (FARP) presentato al 120° Congresso Annuale AUA. Lo studio ha confrontato l'ablazione focale basata su energia a ultrasuoni con la prostatectomia robotica per il trattamento del cancro alla prostata.
Principali risultati del trial con 213 pazienti:
- L'ablazione focale ha mostrato un tasso di insuccesso del trattamento del 5,6% contro il 7,9% della prostatectomia radicale
- Il 25% dei pazienti sottoposti a prostatectomia radicale è passato all'ablazione focale
- Entrambi i gruppi hanno presentato caratteristiche simili in termini di età, livelli di PSA e parametri tumorali
Lo studio ha raggiunto il suo endpoint primario, dimostrando che il trattamento Focal One Robotic HIFU non è inferiore alla chirurgia radicale a 36 mesi di follow-up. Questa scoperta conferma il ruolo dell'ablazione focale nella gestione del cancro alla prostata, con risultati che evidenziano tassi di successo superiori rispetto alla chirurgia tradizionale.
EDAP TMS anunció resultados finales positivos del ensayo controlado aleatorizado Focal Ablation Versus Radical Prostatectomy (FARP) en la 120ª Reunión Anual de la AUA. El estudio comparó la ablación focal basada en energía ultrasónica con la prostatectomía robótica para el tratamiento del cáncer de próstata.
Hallazgos clave del ensayo con 213 pacientes:
- La ablación focal mostró una tasa de fracaso del tratamiento del 5,6% frente al 7,9% de la prostatectomía radical
- El 25% de los pacientes de prostatectomía radical cambiaron a ablación focal
- Ambos grupos presentaron características similares en edad, niveles de PSA y métricas tumorales
El estudio alcanzó su objetivo principal, demostrando que el tratamiento Focal One Robotic HIFU no es inferior a la cirugía radical a los 36 meses de seguimiento. Este avance valida el papel de la ablación focal en el manejo del cáncer de próstata, con resultados que muestran mejores tasas de éxito en el tratamiento comparado con la cirugía tradicional.
EDAP TMS는 제120회 AUA 연례회의에서 Focal Ablation Versus Radical Prostatectomy (FARP) 무작위 대조 시험의 긍정적인 최종 결과를 발표했습니다. 이 연구는 전립선암 치료를 위해 초음파 에너지 기반의 국소 절제술과 로봇 전립선 절제술을 비교했습니다.
213명의 환자를 대상으로 한 주요 결과:
- 국소 절제술의 치료 실패율은 5.6%였고, 근치적 전립선 절제술은 7.9%였습니다
- 근치적 전립선 절제술 환자의 25%가 국소 절제술로 전환했습니다
- 두 그룹 모두 연령, PSA 수치 및 종양 지표에서 유사한 환자 특성을 보였습니다
이 연구는 36개월 추적 관찰에서 Focal One Robotic HIFU 치료가 근치 수술에 비해 비열등함을 입증하며 1차 목표를 달성했습니다. 이 획기적인 결과는 전립선암 관리에서 국소 절제술의 역할을 확인하며, 전통적 수술에 비해 더 나은 치료 성공률을 보여줍니다.
EDAP TMS a annoncé des résultats finaux positifs de l'essai contrôlé randomisé Focal Ablation Versus Radical Prostatectomy (FARP) lors de la 120e réunion annuelle de l'AUA. L'étude a comparé l'ablation focale basée sur l'énergie ultrasonore à la prostatectomie robotique pour le traitement du cancer de la prostate.
Principaux résultats de l'essai portant sur 213 patients :
- L'ablation focale a montré un taux d'échec du traitement de 5,6 % contre 7,9 % pour la prostatectomie radicale
- 25 % des patients ayant subi une prostatectomie radicale ont opté pour l'ablation focale
- Les deux groupes présentaient des caractéristiques similaires en termes d'âge, de taux de PSA et de paramètres tumoraux
L'étude a atteint son critère principal, démontrant que le traitement Focal One Robotic HIFU n'est pas inférieur à la chirurgie radicale au suivi de 36 mois. Cette avancée confirme le rôle de l'ablation focale dans la prise en charge du cancer de la prostate, avec des résultats montrant de meilleurs taux de réussite du traitement comparés à la chirurgie traditionnelle.
EDAP TMS gab positive Endergebnisse der randomisierten kontrollierten Studie Focal Ablation Versus Radical Prostatectomy (FARP) auf dem 120. AUA Jahreskongress bekannt. Die Studie verglich die fokale Ablation mittels Ultraschallenergie mit der robotergestützten Prostatektomie zur Behandlung von Prostatakrebs.
Wichtige Ergebnisse der Studie mit 213 Patienten:
- Die fokale Ablation zeigte eine Therapieversagensrate von 5,6% gegenüber 7,9% bei der radikalen Prostatektomie
- 25% der Patienten der radikalen Prostatektomie wechselten zur fokalen Ablation
- Beide Gruppen wiesen ähnliche Patienteneigenschaften hinsichtlich Alter, PSA-Werten und Tumormetriken auf
Die Studie erreichte ihren primären Endpunkt und zeigte, dass die Focal One Robotic HIFU-Behandlung nach 36 Monaten Nachbeobachtung der radikalen Operation nicht unterlegen ist. Dieser Durchbruch bestätigt die Rolle der fokalen Ablation im Management von Prostatakrebs, mit Ergebnissen, die bessere Behandlungserfolge im Vergleich zur traditionellen Chirurgie zeigen.
- FARP trial achieved primary endpoint, demonstrating non-inferior results for Focal Ablation compared to Radical Prostatectomy
- Lower treatment failure rate in Focal Ablation (5.6%) vs Radical Prostatectomy (7.9%)
- Study validates EDAP's Focal One Robotic HIFU as a leading treatment option for prostate cancer
- Large-scale clinical validation with 213 enrolled patients strengthens market position
- Results expected to accelerate adoption of Focal One Robotic HIFU technology
- 25% of patients (26/106) in Radical Prostatectomy arm refused surgery and crossed over, which could impact study interpretation
- Small statistical difference (2.3%) between treatment arms may not be compelling enough for widespread adoption
Insights
FARP trial validates EDAP's Focal One HIFU technology with Level 1 evidence showing non-inferior outcomes to radical prostatectomy for prostate cancer.
The FARP randomized controlled trial results represent a significant clinical milestone for prostate cancer treatment. This first-of-its-kind study comparing focal ablation to radical prostatectomy enrolled 213 patients and demonstrated that focal ablation achieved a treatment failure rate of only 5.6% compared to 7.9% with surgery. This not only shows non-inferiority but suggests potentially superior outcomes with the focal approach.
Critically, the trial specifically notes that EDAP's Focal One Robotic HIFU technology was used for "the vast majority" of patients in the focal ablation arm, directly validating their platform. The equivalent patient demographics across both trial arms (age, PSA, tumor characteristics) and rigorous intention-to-treat analysis further strengthen these findings.
The study also revealed that 25% of patients initially randomized to surgery crossed over to focal ablation, suggesting potential patient preference for less invasive options. This Level 1 evidence from a randomized controlled trial - the gold standard in clinical research - provides physicians with robust data supporting focal ablation as an effective alternative to surgical intervention, potentially transforming treatment pathways for selected prostate cancer patients.
EDAP's Focal One technology validated in landmark trial showing equivalent cancer control to surgery, likely accelerating market adoption and revenue growth.
The positive FARP trial results represent a potential inflection point for EDAP TMS's commercial trajectory. Obtaining Level 1 evidence demonstrating non-inferiority against the current standard of care (radical prostatectomy) provides the company with powerful clinical validation that addresses a critical barrier to wider technology adoption and reimbursement.
For medical device companies, robust clinical evidence is often the decisive factor in gaining market acceptance. EDAP now possesses compelling data from both the FARP trial and the previously published HIFI study, creating what CEO Ryan Rhodes describes as "instrumental in further accelerating adoption of Focal One Robotic HIFU."
The prostate cancer treatment landscape represents a substantial market opportunity, with over 288,000 new cases diagnosed annually in the US alone. These results significantly strengthen EDAP's competitive position by validating their core technology in the highest standard of clinical research. With treatment failure rates of 5.6% vs 7.9% favoring focal ablation, EDAP now has compelling evidence to drive physician adoption of its Focal One platform, potentially accelerating revenue growth in this important therapeutic area.
- Final 3-year outcome of Focal Ablation versus Radical Prostatectomy (FARP) Randomized Controlled Trial (RCT) presented at 120th AUA Annual Meeting on Sunday, April 27, 2025.
- Study achieved its primary endpoint and demonstrated that the rate of treatment failure in the Focal Ablation (FA) group is non-inferior to that in the Radical Prostatectomy (RP) group at the final 36-month follow-up.
AUSTIN, Texas, April 29, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, announced the positive final results of the Focal Ablation Versus Radical Prostatectomy (FARP) Study, the first randomized controlled trial completed comparing ultrasound energy-based focal ablation versus Robotic Prostatectomy. The study achieved its primary endpoint and demonstrated that the rate of treatment failure in the Focal Ablation (FA) group is non-inferior to that in the Radical Prostatectomy (RP) group at the final 36-month follow-up.
“The purpose of this study was to generate scientific Level 1 evidence comparing focal therapy for the treatment of clinically-significant localized prostate cancer versus robotic prostatectomy,” said Eduard Baco, MD, PhD, Associate Professor at the Department of Cancer Surgery at the Oslo University Hospital and Principal Investigator of the FARP Study. “Our final 3-year results met the primary endpoint of showing non-inferiority between the two arms of the trial, with the results showing a significantly lower rate of treatment failure in the focal ablation arm compared to the robotic prostatectomy arm. The findings from this randomized controlled trial provide significant additional evidence that support the use of focal ablation with ultrasound energy for the management of organ-localized prostate cancer, in particular HIFU.”
FARP Trial Results
- A total of 213 patients were enrolled in the study; 107 were randomized to FA and 106 to RP.
25% (26/106) of the patients in the RP arm refused surgery and crossed-over to the FA arm.- The two arms were equivalent in terms of mean age (64 vs. 66 years, p=0.3), PSA (8.6 vs. 8.5 ng/ml, p=0.9), index tumor diameter on MRI (14.5 vs. 15.5 mm, p=0.2), prostate volume (41.3 vs. 41.7 ml, p=0.9) and Gleason Grade Group on biopsy.
- All included patients were evaluated following an intention-to-treat (ITT) analysis.
- The proportion of treatment failure was
5.6% in the FA arm (6/107;95% CI [3 – 13]) vs7.9% in the RP arm (8/101,95% CI [5 - 15]), resulting in a statistical difference of2.3% (95% CI [-4.9 – 9.9]) in favor of Focal Ablation.
“The positive results from the FARP randomized controlled trial further validate the role of robotic focal ablation with ultrasound energy in the management of prostate cancer,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “Focal One Robotic HIFU was used for the vast majority of the patients treated with focal ablation in this study. This demonstrates Focal One’s leadership position in the rapidly growing treatment category of focal therapy for prostate cancer. We anticipate that the positive data from the FARP trial, once published, combined with the recent publication of the HIFI Study, the largest prospective, comparative study ever conducted demonstrating Focal One’s ability to provide comparable cancer control and superior urinary and erectile function preservation as compared to surgery, will be instrumental in further accelerating adoption of Focal One Robotic HIFU.”
A link to the FARP Study abstract can be found here.
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
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