Landmark HIFI Study Publication Demonstrates Positive Outcomes with Focal One® Robotic HIFU Versus Surgery in the Management of Prostate Cancer
EDAP TMS SA (Nasdaq: EDAP) announced the publication of the HIFI study results in European Urology, comparing Focal One® Robotic HIFU to radical prostatectomy (RP) for localized prostate cancer treatment. The landmark study, involving 3,328 patients across 46 centers, demonstrated that Focal One Robotic HIFU is non-inferior to surgery for Salvage Treatment-free Survival at 30 months.
Key findings show that the HIFU arm achieved 90% adjusted STFS compared to 86% in the RP arm. HIFU patients experienced significantly better outcomes in urinary continence (29% vs 44% deterioration) and erectile function. These superior functional results were achieved despite HIFU patients being approximately 9.6 years older than RP patients (median age 74.7 vs 65.1 years).
EDAP TMS SA (Nasdaq: EDAP) ha annunciato la pubblicazione dei risultati dello studio HIFI nella rivista European Urology, che confronta il Focal One® Robotic HIFU con la prostatectomia radicale (RP) per il trattamento del cancro alla prostata localizzato. Lo studio, considerato fondamentale, ha coinvolto 3.328 pazienti in 46 centri e ha dimostrato che Focal One Robotic HIFU non è inferiore alla chirurgia per la sopravvivenza senza trattamento Salvage a 30 mesi.
I principali risultati mostrano che il braccio HIFU ha raggiunto il 90% di STFS aggiustato rispetto all'86% nel braccio RP. I pazienti HIFU hanno mostrato risultati significativamente migliori in termini di continenza urinaria (29% vs 44% di deterioramento) e funzione erettile. Questi risultati funzionali superiori sono stati ottenuti nonostante i pazienti HIFU fossero circa 9,6 anni più anziani rispetto ai pazienti RP (età media 74,7 vs 65,1 anni).
EDAP TMS SA (Nasdaq: EDAP) anunció la publicación de los resultados del estudio HIFI en European Urology, que compara el Focal One® Robotic HIFU con la prostatectomía radical (RP) para el tratamiento del cáncer de próstata localizado. Este estudio pionero, que involucró a 3,328 pacientes en 46 centros, demostró que Focal One Robotic HIFU no es inferior a la cirugía en términos de Supervivencia Libre de Tratamiento Salvage a los 30 meses.
Los hallazgos clave muestran que el brazo HIFU logró un 90% de STFS ajustado en comparación con el 86% en el brazo RP. Los pacientes HIFU experimentaron resultados significativamente mejores en continencia urinaria (29% vs 44% de deterioro) y función eréctil. Estos resultados funcionales superiores se lograron a pesar de que los pacientes HIFU eran aproximadamente 9.6 años mayores que los pacientes RP (edad media de 74.7 vs 65.1 años).
EDAP TMS SA (Nasdaq: EDAP)는 Focal One® Robotic HIFU와 국소 전립선암 치료를 위한 근치적 전립선 절제술(RP)의 결과를 비교한 HIFI 연구 결과가 European Urology에 발표되었음을 알렸습니다. 3,328명의 환자가 46개 센터에서 참여한 이 획기적인 연구는 Focal One Robotic HIFU가 30개월 동안의 치료 없이 생존(Salvage Treatment-free Survival)에서 수술과 비슷한 수준임을 입증했습니다.
주요 발견에 따르면 HIFU 그룹은 조정된 STFS에서 90%를 달성한 반면 RP 그룹에서는 86%였습니다. HIFU 환자들은 요실금(29% 대 44% 악화) 및 발기 기능에서 유의미하게 더 나은 결과를 경험했습니다. 이러한 우수한 기능적 결과는 HIFU 환자가 RP 환자보다 약 9.6세 많은 것에도 불구하고 달성되었습니다(중간 연령 74.7세 대 65.1세).
EDAP TMS SA (Nasdaq: EDAP) a annoncé la publication des résultats de l'étude HIFI dans European Urology, comparant le Focal One® Robotic HIFU à la prostatectomie radicale (RP) pour le traitement du cancer de la prostate localisé. Cette étude marquante, qui a impliqué 3 328 patients dans 46 centres, a démontré que Focal One Robotic HIFU n'est pas inférieur à la chirurgie en matière de survie sans traitement Salvage à 30 mois.
Les résultats clés montrent que le groupe HIFU a atteint 90% de STFS ajustés contre 86% dans le groupe RP. Les patients HIFU ont connu des résultats fonctionnels significativement meilleurs en matière de continence urinaire (29% contre 44% de détérioration) et de fonction érectile. Ces résultats fonctionnels supérieurs ont été obtenus malgré le fait que les patients HIFU étaient en moyenne environ 9,6 ans plus âgés que les patients RP (âge médian de 74,7 ans contre 65,1 ans).
EDAP TMS SA (Nasdaq: EDAP) gab die Veröffentlichung der Ergebnisse der HIFI-Studie in European Urology bekannt, die Focal One® Robotic HIFU mit der radikalen Prostatektomie (RP) zur Behandlung des lokalisierten Prostatakarzinoms vergleicht. Die wegweisende Studie, an der 3.328 Patienten in 46 Zentren teilnahmen, zeigte, dass Focal One Robotic HIFU in Bezug auf die Behandlung-freie Überlebenszeit (Salvage Treatment-free Survival) nach 30 Monaten nicht inferior zur Chirurgie ist.
Die wichtigsten Ergebnisse zeigen, dass die HIFU-Gruppe eine angepasste STFS von 90% erreichte, während die RP-Gruppe 86% erreichte. HIFU-Patienten wiesen signifikant bessere Ergebnisse bei der Harninkontinenz (29% vs. 44% Verschlechterung) und der erektilen Funktion auf. Diese überlegenen funktionalen Ergebnisse wurden erzielt, obwohl HIFU-Patienten im Durchschnitt etwa 9,6 Jahre älter waren als RP-Patienten (Medianalter 74,7 vs. 65,1 Jahre).
- HIFU demonstrated higher Salvage Treatment-free Survival (90%) compared to radical prostatectomy (86%)
- Better urinary continence outcomes with HIFU (29% deterioration) vs RP (44% deterioration)
- Significantly better preservation of erectile function in HIFU patients
- Study results expected to drive further adoption of Focal One as first-line treatment
- None.
Insights
This landmark HIFI study publication represents a significant milestone in prostate cancer treatment, demonstrating that Focal One® Robotic HIFU is non-inferior to radical prostatectomy with superior quality-of-life outcomes. The study's impressive scale (N=3,328) and rigorous methodology provide compelling evidence that could reshape treatment guidelines.
Key clinical outcomes show HIFU's 90% salvage treatment-free survival rate versus 86% for radical prostatectomy at 30 months. Notably, HIFU patients experienced significantly better outcomes in important quality-of-life metrics: 29% versus 44% stress urinary incontinence rates and markedly better preservation of erectile function. These results are particularly impressive considering the HIFU group was nearly 10 years older on average.
The publication in European Urology, the highest-impact urological journal, adds substantial credibility and will likely accelerate clinical adoption of HIFU as a first-line treatment option for localized prostate cancer.
This publication represents a significant commercial catalyst for EDAP TMS. With a market cap of
- Accelerated hospital adoption rates
- Improved insurance coverage
- Enhanced competitive positioning against traditional surgical approaches
The publication timing in European Urology maximizes visibility within the medical community, potentially catalyzing near-term sales growth. Given that 90% of HIFU procedures in the study utilized Focal One, this validates EDAP's technology leadership in the space.
- HIFI Study is the largest (N = 3,328) prospective, comparative, multi-center clinical study ever conducted comparing prostate cancer treatments
- Positive study results are expected to drive further adoption of Focal One as a first line treatment option for the management of localized prostate cancer
- Study shows Focal One Robotic HIFU is non-inferior to surgery, meeting primary endpoint of non-inferiority for Salvage Treatment-free Survival (STFS) after High Intensity Focused Ultrasounds (HIFU) compared to Radical Prostatectomy (RP) at 30 months
- Study shows that patients receiving HIFU had better outcomes with respect to urinary continence and erectile function compared to patients receiving RP
LYON, France, December 4, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced the publication of the full results from the HIFI study in the prestigious, peer-reviewed journal, European Urology, which has the highest impact factor amongst scientific journals focused in urology. The study evaluated HIFU versus radical prostatectomy (RP) as a first line treatment of localized prostate cancer. The paper is entitled “Whole-gland or Subtotal High-intensity Focused Ultrasound Versus Radical Prostatectomy: The Prospective, Noninferiority, Nonrandomized, HIFI Trial” and is authored by Dr. Guillaume Ploussard from Department of Urology, UROSUD, Clinique La Croix du Sud, France. A link to the publication can be found here.
“The publication of the HIFI study in European Urology will importantly serve to increase awareness amongst the global urology and patient community on how robotic HIFU technology is rapidly changing the treatment paradigm for patients with localized, early-stage prostate cancer,” said Professor Pascal Rischmann, Principal Investigator of the HIFI trial and senior author of the publication. “It is clear that a growing number of men with localized prostate cancer are seeking less invasive, tissue-sparing treatment options that will help preserve their sexual function and urinary continence. The data from the HIFI Study not only underscores HIFU’s excellent oncologic control, but also highlights its significantly better functional outcomes when compared to radical prostatectomy.”
“We are pleased to announce the publication of the HIFI study results in the prestigious medical journal, European Urology,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “As the single largest and most rigorous clinical study ever conducted comparing oncologic and functional outcomes between Focal One robotic HIFU and radical prostatectomy, the publication of this data highlights the substantial clinical benefits of Focal One as an important, first line treatment option for the management of localized prostate cancer. We believe the publication of such important, positive results will provide additional momentum to growing Focal One adoption, while further advancing treatment decision guidelines.”
HIFI is the first prospective, multi-center, non-inferiority comparative study evaluating HIFU and RP in the management of localized prostate cancer. This seven-year study (April 2015 - March 2022) enrolled a total of 3,328 patients from 46 treatment centers: 1,967 consecutive patients were treated with EDAP’s robotic HIFU technologies, where Focal One was used for
Clinical Data Highlights:
- At 30 months, the adjusted STFS was higher in the HIFU arm (
90% ) compared with RP arm (86% ) - The propensity score-adjusted result is similar to the univariate result (HR=0.71 [
95% CI, 0.52-0.97], p=0.008). After adjustment on different variables (Age, BMI, ASA score, Grade Group, prostate volume, PSA): the risk of salvage treatment is lower in the HIFU arm compared to RP. This result remains true when analyzing the subgroup with intermediate risk (HR=0.66 [95% CI, 0.50-0.86], p=0.001). - International Continence Society (ICS) score, a measure of stress urinary incontinence was significantly less deteriorated for HIFU (
29% ) vs, RP (44% ) (RR=0.66 [95% CI, 0.59-0.74], p<0.001) for all ages combined. - International Index of Erectile Function-5 (IIEF-5), a well validated measurement of erectile function, decreased significantly less after HIFU than after RP with a drop in difference in medians from -9 (-10;-7.7) to -3.0 (-3.9; -2.1) between both groups, for all ages included.
- Post-procedural benefits of HIFU on both erectile function and urinary continence were demonstrated despite patients in the HIFU-treated group being an average of 9.6 years older (median age was 74.7 years for HIFU vs 65.1 years for RP, p<0.001)
About European Urology
European Urology is the official journal of the European Association of Urology (EAU). European Urology publishes peer-reviewed original articles and topical reviews on a wide range of urological problems. Topics such as oncology, impotence, infertility, pediatrics, lithiasis and endourology, as well as recent advances in techniques, instrumentation, surgery and pediatric urology provide readers with a complete guide to international developments in urology. Published monthly, European Urology is an important journal for all clinicians and researchers in this field. The 2023 Impact Factor of European Urology is 25.3, the highest impact factor of all urology-focused scientific journals.
About EDAP TMS SA
A recognized leader in the 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 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.
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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