EDAP Announces First Patients Treated in Phase I/II Study Evaluating Focal One Robotic HIFU for the Treatment of Benign Prostatic Hyperplasia (BPH)
EDAP TMS SA (Nasdaq: EDAP) has announced the initiation of a Phase I/II study evaluating its Focal One® robotic high-intensity focused ultrasound (HIFU) technology for treating benign prostatic hyperplasia (BPH). The first patients have been treated in this study, which aims to explore a less invasive treatment option for BPH.
The study is designed in two parts: Part 1 will define optimal treatment parameters at two leading academic centers in France, while Part 2 will validate safety and efficacy across multiple centers. Dr. Harry Toledano, Head of Urology at Martigues Hospital, expressed enthusiasm about the potential of HIFU to improve BPH symptoms with minimal side effects.
EDAP's CEO, Ryan Rhodes, highlighted the significant need for less invasive BPH treatments and sees this as a logical expansion of their technology beyond prostate cancer applications. The company plans to initiate a BPH clinical study in the United States next year based on this foundational research.
EDAP TMS SA (Nasdaq: EDAP) ha annunciato l'avvio di uno studio di Fase I/II che valuta la sua tecnologia di ultrasuoni focalizzati ad alta intensità (HIFU) Focal One® per il trattamento iperplasia prostatica benigna (BPH). I primi pazienti sono stati trattati in questo studio, che mira a esplorare un'opzione di trattamento meno invasiva per la BPH.
Lo studio è suddiviso in due parti: La Parte 1 definirà i parametri ottimali di trattamento in due centri accademici di punta in Francia, mentre la Parte 2 convaliderà la sicurezza e l'efficacia in vari centri. Il Dr. Harry Toledano, Capo di Urologia presso l'Ospedale di Martigues, ha espresso entusiasmo riguardo al potenziale dell'HIFU di migliorare i sintomi della BPH con effetti collaterali minimi.
Il CEO di EDAP, Ryan Rhodes, ha evidenziato la significativa necessità di trattamenti BPH meno invasivi e vede questo come un'espansione logica della loro tecnologia oltre le applicazioni per il cancro alla prostata. La società prevede di avviare uno studio clinico sulla BPH negli Stati Uniti il prossimo anno sulla base di questa ricerca fondamentale.
EDAP TMS SA (Nasdaq: EDAP) ha anunciado el inicio de un estudio de Fase I/II para evaluar su tecnología de ultrasonido focalizado de alta intensidad (HIFU), Focal One®, para el tratamiento de hiperplasia prostática benigna (BPH). Los primeros pacientes han sido tratados en este estudio, que tiene como objetivo explorar una opción de tratamiento menos invasiva para la BPH.
El estudio está diseñado en dos partes: La Parte 1 definirá los parámetros óptimos de tratamiento en dos centros académicos líderes en Francia, mientras que la Parte 2 validará la seguridad y eficacia en múltiples centros. El Dr. Harry Toledano, Jefe de Urología en el Hospital de Martigues, expresó su entusiasmo por el potencial de HIFU para mejorar los síntomas de la BPH con efectos secundarios mínimos.
Ryan Rhodes, CEO de EDAP, destacó la necesidad significativa de tratamientos BPH menos invasivos y ve esto como una expansión lógica de su tecnología más allá de las aplicaciones para el cáncer de próstata. La compañía planea iniciar un estudio clínico sobre la BPH en los Estados Unidos el próximo año basado en esta investigación fundamental.
EDAP TMS SA (Nasdaq: EDAP)는 양성 전립선 비대증(BPH) 치료를 위한 Focal One® 로봇 고강도 집속 초음파(HIFU) 기술을 평가하는 1/2상 연구를 시작했다고 발표했습니다. 이 연구에서 첫 환자들이 치료를 받았으며, BPH에 대한 덜 침습적인 치료 옵션을 탐색하는 것을 목표로 하고 있습니다.
연구는 두 부분으로 설계되었습니다: 제1부에서는 프랑스의 두 개 선도 학술 센터에서 최적의 치료 매개변수를 정의하며, 제2부에서는 여러 센터에서 안전성과 효능을 검증합니다. 마르띠크 병원의 비뇨기과장인 해리 톨레다노 박사는 최소한의 부작용으로 BPH 증상을 개선할 HIFU의 잠재력에 대해 열정을 표현했습니다.
EDAP의 CEO인 라이언 로즈는 덜 침습적인 BPH 치료의 필요성이 크다고 강조하며, 이를 전립선암 치료를 넘어서는 기술의 논리적 확장으로 보고 있습니다. 이 회사는 다음 해에 미국에서 BPH 임상 연구를 시작할 계획입니다.
EDAP TMS SA (Nasdaq: EDAP) a annoncé le lancement d'une étude de Phase I/II évaluant sa technologie d'ultrasons focalisés à haute intensité (HIFU) Focal One® pour le traitement de l'hyperplasie prostatique bénigne (HPB). Les premiers patients ont été traités dans cette étude, qui vise à explorer une option de traitement moins invasive pour l'HPB.
L'étude est conçue en deux parties : la Partie 1 définira les paramètres de traitement optimaux dans deux centres académiques de premier plan en France, tandis que la Partie 2 validera la sécurité et l'efficacité dans plusieurs centres. Le Dr Harry Toledano, Responsable d'Urologie à l'Hôpital de Martigues, a exprimé son enthousiasme quant au potentiel du HIFU pour améliorer les symptômes de l'HPB avec des effets secondaires minimaux.
Ryan Rhodes, PDG d'EDAP, a souligné le besoin significatif de traitements BPH moins invasifs et voit cela comme une extension logique de leur technologie au-delà des applications pour le cancer de la prostate. L'entreprise prévoit de lancer une étude clinique sur l'HPB aux États-Unis l'année prochaine, fondée sur cette recherche fondamentale.
EDAP TMS SA (Nasdaq: EDAP) hat den Beginn einer Phase I/II-Studie angekündigt, die ihre Focal One® robotergestützte Hochintensitätsfokussierte Ultraschall (HIFU) Technologie zur Behandlung von benigner Prostatahyperplasie (BPH) evaluiert. Die ersten Patienten wurden in dieser Studie behandelt, die darauf abzielt, eine weniger invasive Behandlungsoption für BPH zu erkunden.
Die Studie ist in zwei Teile gegliedert: Teil 1 wird die optimalen Behandlungsparameter an zwei führenden akademischen Zentren in Frankreich definieren, während Teil 2 die Sicherheit und Wirksamkeit an mehreren Zentren validieren wird. Dr. Harry Toledano, Leiter der Urologie am Krankenhaus Martigues, äußerte sich begeistert über das Potenzial von HIFU zur Verbesserung der BPH-Symptome mit minimalen Nebenwirkungen.
Ryan Rhodes, CEO von EDAP, hob den erheblichen Bedarf an weniger invasiven BPH-Behandlungen hervor und sieht dies als logische Erweiterung ihrer Technologie über die Anwendungen in der Prostatakrebsbehandlung hinaus. Das Unternehmen plant, im nächsten Jahr auf dieser grundlegenden Forschung basierend eine klinische Studie zu BPH in den Vereinigten Staaten zu starten.
- Initiation of Phase I/II study for Focal One robotic HIFU in BPH treatment
- Potential expansion of EDAP's technology beyond prostate cancer applications
- Planned BPH clinical study in the United States next year
- None.
Insights
This announcement marks a significant milestone for EDAP TMS SA as they initiate a Phase I/II study for their Focal One® robotic HIFU technology in treating BPH. The study's potential impact on BPH treatment is substantial, given the prevalence of the condition and the need for less invasive options.
Key points to consider:
- The study aims to offer a minimally invasive alternative for BPH treatment, potentially preserving urethral integrity.
- It represents an expansion of EDAP's technology beyond prostate cancer, opening up a larger market opportunity.
- The two-part study design allows for optimization of treatment parameters before broader validation.
- Positive outcomes could position EDAP as a leader in BPH treatment technology.
For investors, this development could significantly impact EDAP's market position and future revenue streams. However, it's important to note that clinical trials are time-consuming and outcomes are uncertain. The company's ability to execute this study successfully and potentially expand into the U.S. market will be important factors to watch.
The application of Focal One® robotic HIFU for BPH treatment is a promising development in urology. BPH affects a large population of aging men and current treatments often involve trade-offs between efficacy and side effects. The potential for HIFU to offer targeted treatment with minimal collateral damage could be a game-changer.
From a clinical perspective, several aspects are noteworthy:
- The technology's precision may allow for symptom improvement while minimizing side effects.
- The non-invasive nature of HIFU could lead to quicker recovery times for patients.
- The study's design, starting with parameter optimization, is a prudent approach to ensure safety and efficacy.
If successful, this treatment could fill a significant gap between medication and more invasive surgical options for BPH. However, long-term outcomes and comparative effectiveness against established treatments will be critical in determining its place in BPH management protocols.
LYON, France, October 1, 2024 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the first patients have been treated in a Phase I/II study evaluating the Company’s proprietary Focal One® robotic high-intensity focused ultrasound (HIFU) technology for the treatment of benign prostatic hyperplasia (BPH).
“We’ve been offering targeted HIFU ablation to prostate cancer patients for more than 15 years,” said Harry Toledano, MD, Head of the Urology Department of Martigues Hospital in Martigues, France. “Based on this large experience and the follow-up of hundreds of prostate cancer patients with their functional outcomes, we believe that the HIFU energy precisely delivered by Focal One has the potential to improve BPH symptoms with minimal side effects allowing a quick return to normal activities for a significant number of patients. We are enthusiastic to co-lead the first phase of this important clinical trial with our colleagues from Edouard Herriot Hospital – Lyon University and are looking forward to offering a new option to our BPH patients.”
“We are excited to initiate this important clinical study evaluating Focal One robotic HIFU for the treatment of BPH, a condition which impacts millions of men each year,” said Ryan Rhodes, Chief Executive Officer of EDAP TMS. “While there are other treatment options available for treating BPH, there remains a significant need for much less invasive treatment approaches that can preserve and protect the integrity of the urethra and other critical structures. We believe Focal One is ideally positioned to deliver this type of treatment solution, and this clinical approach in addressing BPH represents a logical next step in expanding our technology beyond the application in prostate cancer. We also believe this study will serve as a foundation for initiating a BPH clinical study in the United States next year.”
The Phase I/II study is a company-sponsored, prospective, multicenter clinical trial designed as a two-part study. Part 1 of the Phase I/II study will take place at two leading academic prostate treatment centers in France with a recognized expertise in the treatment of BPH as well as in the use of Focal One HIFU technology. Part 1 is designed to define the optimal treatment parameters to effectively treat BPH and its related symptoms with minimal side effects. Part 2 of the study will expand patient enrollment across a larger number of treatment centers in order to validate the safety and efficacy of the parameters as defined in Part 1 of the study.
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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