EDAP Announces Interim Results from Phase 3 Study Evaluating Robotic HIFU for the Treatment of Deep Infiltrating Endometriosis
EDAP TMS SA (Nasdaq: EDAP) announced interim results from its Phase 3 study evaluating robotic High-Intensity Focused Ultrasound (HIFU) therapy for deep infiltrating endometriosis. The study, involving 60 patients, aimed to assess acute pelvic pain levels. Key findings include:
1. Robotic HIFU therapy maintained an excellent safety profile, confirming results from earlier studies.
2. The primary endpoint of reduced acute pelvic pain in the HIFU arm compared to the Sham arm was not met at three months.
3. Both arms showed significant reduction in pelvic pain scores from baseline.
4. HIFU-treated patients experienced higher volume reductions in endometriosis nodules compared to the Sham arm.
5. The study continues, with Sham arm patients electing HIFU therapy after pain returned to baseline.
EDAP TMS SA (Nasdaq: EDAP) ha annunciato i risultati preliminari del suo studio di Fase 3 che valuta la terapia con ultrasuoni focalizzati ad alta intensità (HIFU) robotica per l'endometriosi infiltrante profonda. Lo studio, che ha coinvolto 60 pazienti, mirava a valutare i livelli di dolore pelvico acuto. I risultati principali includono:
1. La terapia HIFU robotica ha mantenuto un eccellente profilo di sicurezza, confermando i risultati di studi precedenti.
2. L'obiettivo primario di ridurre il dolore pelvico acuto nel gruppo HIFU rispetto al gruppo Sham non è stato raggiunto a tre mesi.
3. Entrambi i gruppi hanno mostrato una significativa riduzione dei punteggi di dolore pelvico rispetto al basale.
4. I pazienti trattati con HIFU hanno riportato una maggiore riduzione del volume dei noduli endometriosici rispetto al gruppo Sham.
5. Lo studio continua, con i pazienti del gruppo Sham che scelgono la terapia HIFU dopo che il dolore è tornato ai livelli basali.
EDAP TMS SA (Nasdaq: EDAP) anunció resultados interinos de su estudio de Fase 3 que evalúa la terapia robótica con ultrasonido focalizado de alta intensidad (HIFU) para la endometriosis profunda infiltrante. El estudio, que involucró a 60 pacientes, buscaba evaluar los niveles de dolor pélvico agudo. Los hallazgos clave incluyen:
1. La terapia HIFU robótica mantuvo un excelente perfil de seguridad, confirmando resultados de estudios anteriores.
2. El objetivo primario de reducir el dolor pélvico agudo en el grupo HIFU en comparación con el grupo Sham no se cumplió a los tres meses.
3. Ambos grupos mostraron una reducción significativa en las puntuaciones de dolor pélvico desde el nivel basal.
4. Los pacientes tratados con HIFU experimentaron mayores reducciones en el volumen de los nódulos de endometriosis en comparación con el grupo Sham.
5. El estudio continúa, con los pacientes del grupo Sham eligiendo la terapia HIFU después de que el dolor regresara a los niveles basales.
EDAP TMS SA (Nasdaq: EDAP)는 심부 침윤성 자궁내막증을 위한 로봇 고강도 집속 초음파(HIFU) 요법에 대한 3상 연구의 중간 결과를 발표했습니다. 이 연구는 60명의 환자를 대상으로 하였으며, 급성 골반 통증 수준을 평가하는 것을 목표로 하였습니다. 주요 발견 사항은 다음과 같습니다:
1. 로봇 HIFU 요법은 훌륭한 안전성 프로필을 유지하였으며, 이전 연구 결과를 확인하였습니다.
2. HIFU 그룹과 Sham 그룹의 급성 골반 통증 감소라는 주요 목표는 3개월 시점에서 달성되지 않았습니다.
3. 두 그룹 모두 기준선에서 골반 통증 점수가 유의하게 감소하였습니다.
4. HIFU 치료를 받은 환자들은 Sham 그룹에 비해 자궁내막증 결절의 용적 감소가 더 컸습니다.
5. 연구는 계속 진행 중이며, Sham 그룹의 환자들은 통증이 기준선으로 돌아간 후 HIFU 치료를 선택하고 있습니다.
EDAP TMS SA (Nasdaq: EDAP) a annoncé des résultats intermédiaires de son étude de Phase 3 évaluant la thérapie par ultrasons focalisés de haute intensité (HIFU) robotique pour l'endométriose profonde infiltrante. L'étude, impliquant 60 patients, visait à évaluer les niveaux de douleur pelvique aiguë. Les résultats clés incluent :
1. La thérapie HIFU robotique a maintenu un excellent profil de sécurité, confirmant les résultats des études antérieures.
2. L'objectif principal de réduction de la douleur pelvique aiguë dans le groupe HIFU par rapport au groupe Sham n'a pas été atteint à trois mois.
3. Les deux groupes ont montré une réduction significative des scores de douleur pelvique par rapport à la ligne de base.
4. Les patients traités par HIFU ont connu des réductions de volume plus importantes des nodules d'endométriose par rapport au groupe Sham.
5. L'étude se poursuit, les patients du groupe Sham choisissant la thérapie HIFU après que la douleur soit revenue aux niveaux de base.
EDAP TMS SA (Nasdaq: EDAP) gab interim Ergebnisse seiner Phase-3-Studie zur Bewertung der robotergestützten hochintensiven fokussierten Ultraschalltherapie (HIFU) bei tief infiltrierender Endometriose bekannt. Die Studie, an der 60 Patienten teilnahmen, hatte das Ziel, akute Beckenschmerzniveaus zu bewerten. Zu den wichtigsten Ergebnissen gehören:
1. Die robotergestützte HIFU-Therapie wies ein ausgezeichnetes Sicherheitsprofil auf und bestätigte die Ergebnisse früherer Studien.
2. Der primäre Endpunkt der Reduzierung akuter Beckenschmerzen in der HIFU-Gruppe im Vergleich zur Sham-Gruppe wurde nach drei Monaten nicht erreicht.
3. Beide Gruppen wiesen eine signifikante Reduktion der Beckenschmerzpunkte im Vergleich zum Ausgangswert auf.
4. Die mit HIFU behandelten Patienten zeigten größere Volumenreduktionen der Endometriose-Knötchen im Vergleich zur Sham-Gruppe.
5. Die Studie läuft weiter, wobei Patienten der Sham-Gruppe sich für die HIFU-Therapie entscheiden, nachdem die Schmerzen auf das Ausgangsniveau zurückgekehrt sind.
- Robotic HIFU therapy maintained an excellent safety profile in patients with deep infiltrating endometriosis
- HIFU-treated patients experienced higher volume reductions in endometriosis nodules compared to the Sham arm
- Both arms showed significant reduction in pelvic pain scores from baseline
- Patients from the Sham treatment arm are electing to receive HIFU therapy, indicating potential confidence in the treatment
- The primary endpoint of reduced acute pelvic pain in the HIFU treatment arm compared to the Sham treatment arm was not met at three months
- The three-month post-procedure follow-up period was likely too short to show clinically meaningful differences in pain scores between the two arms
From a clinical perspective, the interim results of the Phase 3 study offer mixed signals regarding the effectiveness of robotic High-Intensity Focused Ultrasound (HIFU) for deep infiltrating endometriosis. While the study continues to affirm the excellent safety profile of HIFU, the primary endpoint of reduced acute pelvic pain compared to the Sham treatment arm was not met after three months. This suggests that the follow-up period may not be sufficient to observe a significant therapeutic benefit in pain reduction.
Interestingly, patients receiving HIFU did exhibit higher volume reductions in endometriosis nodules as measured by MRI, indicating a potential therapeutic effect on the physical manifestation of the disease. This aligns with findings from earlier phase studies, suggesting that the benefits of HIFU may become more pronounced over a longer term. Importantly, several patients from the Sham treatment arm opting for HIFU after their pain returned to baseline further reinforces the perceived efficacy and safety of the treatment.
For retail investors, it's important to understand that clinical trials often have complex and multi-phase timelines. The current interim results indicate a promising but not yet definitive therapeutic benefit, which could translate into long-term gains if further studies confirm the efficacy of HIFU in reducing endometriosis-related pain.
From a financial viewpoint, the interim results of the Phase 3 study have mixed implications for EDAP TMS SA. The confirmation of HIFU's safety profile is positive, ensuring that the treatment remains a viable option within the regulatory environment. However, the inability to meet the primary endpoint of significantly reduced acute pelvic pain as compared to the Sham arm could dampen investor enthusiasm in the short term.
That said, the observed reduction in nodule size and the migration of patients from the Sham arm to the HIFU arm are promising signs that suggest long-term potential. If these interim findings are bolstered by future data showing sustained pain relief over a longer period, the market could react positively, leading to increased adoption and sales of HIFU therapy. Investors should keep an eye on subsequent updates and final results of the Phase 3 study, as they will be critical in determining the financial viability of HIFU for endometriosis treatment.
In summary, while there is a cautious note in the short term due to unmet primary endpoints, the long-term outlook remains optimistic pending further positive data and this could ultimately benefit EDAP's market position.
- Robotic HIFU therapy continues to maintain an excellent safety profile, confirming positive safety data from prior Phase 1 and 2 studies in patients with deep infiltrating endometriosis
- At three months post procedure, the study’s primary endpoint of reduced acute pelvic pain in the HIFU treatment arm compared to the Sham treatment arm was not met
- Significant improvements were observed across primary and secondary outcome measures (endometriosis and digestive symptoms) across the entire study population at three months
- The Phase 3 study continues as planned per protocol, with patients from the Sham treatment arm electing HIFU therapy
LYON, France, July 19, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced interim results from its Phase 3 study evaluating robotic High-Intensity Focused Ultrasound (HIFU) therapy for the treatment of deep infiltrating endometriosis. The Phase 3 study is a 60-patient comparative, randomized, double blind trial, with the primary objective of evaluating acute pelvic pain levels. All patients were initially followed for three months after either the HIFU treatment or the Sham treatment.
Interim results:
- Robotic HIFU therapy continues to maintain an excellent safety profile in patients with deep infiltrating endometriosis, confirming results from earlier Phase 1 and Phase 2 studies
- While both arms of the study showed significant reduction in pelvic pain scores at three months from baseline as measured by Visual Analog Scale (VAS), the primary endpoint of reduced acute pelvic pain in the HIFU treatment arm compared to the Sham treatment arm was not met; the Company and the Principal Investigator of the study believe the three-month post-procedure follow-up period was likely too short of a time period to show clinically meaningful differences in pain scores between the two arms of the study
- As measured by MRI, patients receiving robotic HIFU therapy experienced higher volume reductions in the endometriosis nodule as compared to patients in the Sham treatment arm
- The Phase 3 study continues per protocol, with several patients initially in the Sham treatment arm having elected and already received HIFU therapy after their pelvic pain returned to baseline levels
“The interim results from the ongoing Phase 3 study demonstrate that robotic HIFU therapy continues to maintain an excellent safety profile in patients with deep infiltrating endometriosis. Additionally, the reduction in the volume of the nodules observed in the HIFU arm confirms the therapeutic effect of the HIFU treatment,” said Professor Gil Dubernard, Head of Gynecology Department at Croix-Rousse Academic Hospital, Lyon, France, and Principal Investigator of the Study. “This data is consistent with the prior results from the Phase 2 study that was recently published in the Journal of Human Reproduction1 on the safety and the potential benefit of HIFU treatment for well-selected patients with deep infiltrating endometriosis.”
“Although this initial data shows similar levels of improvement in pelvic pain scores between the two arms, we believe that a therapeutic benefit favoring robotic HIFU is more likely to be confirmed over a longer period of time post-procedure, as suggested by the stabilization of pain scores at six and twelve months observed in the Phase 2 study,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “Moreover, the cumulative safety and efficacy data from the Phase 1, 2 and 3 studies, suggests that robotic HIFU is a safe, non-invasive treatment and has significant potential to reduce pain for women suffering from this debilitating condition. We are encouraged to see additional patients from the Sham treatment arm elect to be treated with HIFU therapy in accordance with the study protocol, and we look forward to providing another update on the program later this year.”
About Endometriosis
Endometriosis is a chronic, progressive disease affecting nearly 10
1 G Dubernard, E Maissiat, G Legendre, T Dennis, P Capmas, S Warembourg, P Descamps, F Chavrier, H Roman, H Fernandez, E Nguyen-Ba, B Merlot, P Rousset, C Lafon, Charles-André Philip, Evaluating the safety of high-intensity focused ultrasound treatment for rectal endometriosis: results from a French prospective multicentre study including 60 patients, Human Reproduction, 2024;, deae127, https://doi.org/10.1093/humrep/deae127
2 Source: https://drseckin.com/rectal-endometriosis/
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
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