EDAP Announces Scientific Presentation at 2024 AAGL Global Congress Comparing Focal One HIFU Versus Surgery for the Treatment of Deep Infiltrating Endometriosis
EDAP TMS SA presented clinical data comparing Focal One HIFU versus surgery for treating deep infiltrating endometriosis at the 2024 AAGL Global Congress. The retrospective multicenter study analyzed 120 patients across two cohorts: 60 patients treated with HIFU and 60 with surgery. Results showed that HIFU therapy demonstrated significant advantages over surgical intervention, including fewer moderate and severe post-operative complications, shorter operating time, and reduced hospital stay. The company's ongoing Phase 3 trial shows promising progress, with over 85% of Sham treatment patients opting for HIFU therapy after symptoms returned.
EDAP TMS SA ha presentato dati clinici che confrontano Focal One HIFU con la chirurgia per il trattamento dell'endometriosi infiltrante profonda durante il Congresso Globale AAGL 2024. Lo studio retrospettivo multicentrico ha analizzato 120 pazienti suddivisi in due coorti: 60 pazienti trattati con HIFU e 60 con chirurgia. I risultati hanno mostrato che la terapia HIFU ha dimostrato vantaggi significativi rispetto all'intervento chirurgico, inclusi meno complicanze post-operatorie moderate e gravi, tempi di operazione più brevi e una degenza ospedaliera ridotta. Lo studio di Fase 3 in corso dell'azienda mostra progressi promettenti, con oltre l'85% dei pazienti trattati con il trattamento Sham che optano per la terapia HIFU dopo il ritorno dei sintomi.
EDAP TMS SA presentó datos clínicos que comparan Focal One HIFU con cirugía para tratar la endometriosis infiltrante profunda en el Congreso Global AAGL 2024. El estudio multicéntrico retrospectivo analizó a 120 pacientes divididos en dos cohortes: 60 pacientes tratados con HIFU y 60 con cirugía. Los resultados mostraron que la terapia HIFU demostró ventajas significativas sobre la intervención quirúrgica, incluyendo menos complicaciones postoperatorias moderadas y graves, un tiempo de operación más corto y una estancia hospitalaria reducida. El ensayo de Fase 3 en curso de la compañía muestra un progreso prometedor, con más del 85% de los pacientes del tratamiento Sham eligiendo la terapia HIFU tras la reaparición de los síntomas.
EDAP TMS SA는 2024 AAGL 글로벌 학회에서 심부 침윤성 자궁내막증 치료를 위한 Focal One HIFU와 수술을 비교한 임상 데이터를 발표했습니다. 이 환자군은 HIFU로 치료받은 60명과 수술로 치료받은 60명 등 총 120명으로 구성된 다기관 후향적 연구였습니다. 결과적으로 HIFU 치료가 수술에 비해 상당한 이점을 보여주었습니다, 이는 중등도 및 심각한 수술 후 합병증이 적고, 수술 시간이 짧으며, 병원에 있는 기간이 줄어드는 것을 포함합니다. 회사의 진행 중인 3상 시험은 85% 이상의 위약 치료를 받은 환자들이 증상이 재발한 후 HIFU 치료를 선택하고 있어 유망한 진행 상황을 보여줍니다.
EDAP TMS SA a présenté des données cliniques comparant Focal One HIFU à la chirurgie pour traiter l'endométriose infiltrante profonde lors du Congrès Mondial AAGL 2024. L'étude rétrospective multicentrique a analysé 120 patients répartis en deux cohortes : 60 patients traités par HIFU et 60 par chirurgie. Les résultats ont montré que la thérapie HIFU présentait des avantages significatifs par rapport à l'intervention chirurgicale, notamment moins de complications post-opératoires modérées et sévères, un temps d'opération plus court et une durée d'hospitalisation réduite. L'essai de Phase 3 en cours de la société montre des progrès prometteurs, avec plus de 85 % des patients du traitement fictif optant pour la thérapie HIFU après le retour des symptômes.
EDAP TMS SA präsentierte klinische Daten, die Focal One HIFU mit der Chirurgie zur Behandlung der tief infiltrierenden Endometriose beim 2024 AAGL Global Congress vergleichen. Die retrospektive multizentrische Studie analysierte 120 Patienten in zwei Kohorten: 60 Patienten, die mit HIFU behandelt wurden, und 60 mit einer Operation. Die Ergebnisse zeigten, dass die HIFU-Therapie signifikante Vorteile gegenüber dem chirurgischen Eingriff aufwies, darunter weniger moderate und schwere postoperative Komplikationen, kürzere Operationszeiten und reduzierte Krankenhausaufenthalte. Die laufende Phase-3-Studie des Unternehmens zeigt vielversprechende Fortschritte, da über 85% der Patienten, die mit der Behandlung Sham behandelt wurden, nach dem Wiederauftreten von Symptomen sich für die HIFU-Therapie entscheiden.
- HIFU treatment demonstrated fewer post-operative complications compared to surgery
- Shorter operating time and reduced hospital stay with HIFU treatment
- 85% of Sham treatment patients in Phase 3 trial chose HIFU therapy
- Study suggests HIFU as viable alternative to invasive surgery
- None.
Insights
The clinical data comparing Focal One HIFU to surgery for deep infiltrating endometriosis reveals significant therapeutic advantages. The retrospective multicenter study of 120 patients demonstrates that HIFU therapy resulted in fewer moderate and severe post-operative complications and shorter hospital stays compared to surgical intervention. This positions EDAP's technology as a potentially transformative treatment option in the
The ongoing Phase 3 trial shows strong validation with
- Treatment with robotic HIFU showed reduction in moderate and severe post-operative complications and reduced hospital stay compared to surgery
LYON, France, November 19, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced a moderated scientific presentation of clinical data comparing Focal One HIFU versus surgery for the treatment of deep infiltrating endometriosis at the 2024 AAGL Global Congress, which took place from November 16-19, 2024, in New Orleans, LA. The presentation was entitled, "Evaluation of rectal endometriosis treatment with high-intensity focused ultrasound versus surgery: a retrospective multicenter study", and was delivered by Professor Gil Dubernard, Head of Gynecology Department at Croix-Rousse University Hospital, Lyon, France, and Principal Investigator.
“The comparative results from these two cohorts demonstrate that, based on its much less invasive treatment approach, robotic HIFU therapy could offer meaningful advantages over surgical intervention both with respect to reducing post-procedure complications, duration of hospital stay and improving overall patient health,” said Professor Dubernard. “I look forward to seeing robotic HIFU technology continue to advance for the treatment of rectal endometriosis, which at present, has very few treatment alternatives other than highly invasive surgical procedures.”
The objective of the study was to compare the management of rectal endometriosis with HIFU and surgery in terms of treatment-related improvements in symptoms and morbidity. The trial was designed as a comparative, retrospective, multicenter study that reviewed treatment outcomes of 120 patients issued from 2 prospective databases. The first cohort comprised 60 consecutive patients from the ENDO-HIFU-R1 Phase 2 study who underwent a High-Intensity Focal Ultrasound (HIFU) treatment of the posterior deep infiltrating endometriosis at 4 different centers. The second cohort was comprised of 60 patients from a large surgical database who had complete surgical excision of their endometriosis lesions, including digestive involvement.
Highlighted Results
- Compared to surgery, patients treated with HIFU therapy for the management of deep infiltrating rectal endometriosis nodules showed encouraging data with respect to health improvement, reduced rate of complications, shorter operating time, and reduction in length of hospital stay.
- Moderate and severe postoperative complications were significantly less frequent after HIFU treatment compared to surgery.
- These findings suggest that HIFU treatment could be an alternative to surgery in select patients with rectal endometriosis.
As previously reported, the Company’s ongoing Phase 3 trial evaluating Focal One HIFU for the treatment of deep infiltrating endometriosis continues per protocol, with more than
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.
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 were the key findings of EDAP's HIFU vs surgery study for endometriosis treatment?
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