EDAP Announces First Pancreatic Cancer Patient Treated with Proprietary HIFU Technology
EDAP TMS SA (NASDAQ: EDAP) has announced the successful treatment of the first patient in a phase I/II PULS Trial evaluating their proprietary High Intensity Focused Ultrasound (HIFU) technology for pancreatic tumors. The trial, sponsored by Centre Léon Bérard in Lyon, France, aims to assess both the tolerance and preliminary efficacy of intraoperative HIFU intervention on pancreatic lesions.
The first procedure was completed as planned, with the patient discharged without complications. This development represents a potential new treatment option for locally advanced pancreatic cancer patients, who currently have treatment options beyond chemotherapy and radiotherapy.
The trial's significance is highlighted by pancreatic cancer statistics: a five-year survival rate of just 11.5% across all stages (2012-2018 data), with 62,210 projected new cases and 49,830 projected deaths in the U.S. for 2022. Pancreatic cancer remains the third leading cause of cancer deaths, after lung and colorectal cancers.
EDAP TMS SA (NASDAQ: EDAP) ha annunciato il trattato con successo del primo paziente in una fase I/II del Trial PULS, che valuta la loro tecnologia proprietaria di Ultrasuoni Focalizzati ad Alta Intensità (HIFU) per i tumori pancreatici. Lo studio, sponsorizzato dal Centre Léon Bérard di Lione, Francia, mira a valutare sia la tolleranza che l'efficacia preliminare dell'intervento HIFU intraoperatorio sulle lesioni pancreatiche.
La prima procedura è stata completata come previsto, con il paziente dimesso senza complicazioni. Questo sviluppo rappresenta una potenziale nuova opzione terapeutica per i pazienti con cancro pancreatico localmente avanzato, che attualmente hanno opzioni terapeutiche oltre alla chemioterapia e alla radioterapia.
Il significato dello studio è evidenziato dalle statistiche sul cancro pancreatico: un tasso di sopravvivenza a cinque anni del solo 11,5% in tutte le fasi (dati 2012-2018), con 62.210 nuovi casi previsti e 49.830 decessi previsti negli Stati Uniti per il 2022. Il cancro pancreatico rimane la terza causa principale di morte per cancro, dopo il cancro ai polmoni e quello colorettale.
EDAP TMS SA (NASDAQ: EDAP) ha anunciado el tratamiento exitoso del primer paciente en una fase I/II del Estudio PULS que evalúa su tecnología propietaria de Ultrasonido Focalizado de Alta Intensidad (HIFU) para tumores pancreáticos. El ensayo, patrocinado por el Centre Léon Bérard en Lyon, Francia, tiene como objetivo evaluar tanto la tolerancia como la eficacia preliminar de la intervención HIFU intraoperatoria en lesiones pancreáticas.
El primer procedimiento se completó según lo previsto, con el paciente dado de alta sin complicaciones. Este desarrollo representa una nueva opción de tratamiento potencial para pacientes con cáncer de páncreas localmente avanzado, que actualmente tienen opciones de tratamiento más allá de la quimioterapia y la radioterapia.
La importancia del ensayo se destaca por las estadísticas del cáncer pancreático: una tasa de supervivencia a cinco años del solo 11,5% en todas las etapas (datos de 2012-2018), con 62,210 nuevos casos proyectados y 49,830 muertes proyectadas en EE. UU. para 2022. El cáncer de páncreas sigue siendo la tercera causa principal de muertes por cáncer, después del cáncer de pulmón y el cáncer colorrectal.
EDAP TMS SA (NASDAQ: EDAP)는 췌장 종양에 대한 독자적인 고강도 집중 초음파(HIFU) 기술을 평가하는 1/2상 PULS 시험에서 첫 번째 환자의 성공적인 치료를 발표했습니다. 이 시험은 프랑스 리옹의 센트르 레옹 베라르(Centre Léon Bérard)에서 후원하며, 췌장 병변에 대한 수술 중 HIFU 개입의 내성과 초기 효능을 평가하는 것을 목표로 하고 있습니다.
첫 번째 절차는 계획대로 완료되었으며, 환자는 합병증 없이 퇴원했습니다. 이러한 발전은 화학요법과 방사선 요법 외에 치료 옵션이 없는 국소 진행 췌장암 환자들을 위한 잠재적인 새로운 치료 옵션을 나타냅니다.
이 시험의 중요성은 췌장암 통계에 의해 강조됩니다: 모든 단계에서 5년 생존율이 단 11.5%에 불과하며(2012-2018년 데이터 기준), 2022년 미국에서 62,210건의 신규 사례와 49,830건의 사망이 예상됩니다. 췌장암은 폐암과 대장암에 이어 암 관련 사망 원인 중 세 번째로 피융합니다.
EDAP TMS SA (NASDAQ: EDAP) a annoncé le traitement réussi du premier patient dans un essai PULS de phase I/II évaluant leur technologie propriétaire d'Ultrasons Focalisés à Haute Intensité (HIFU) pour les tumeurs du pancréas. L'essai, parrainé par le Centre Léon Bérard à Lyon, France, vise à évaluer à la fois la tolérance et l'efficacité préliminaire de l'intervention HIFU peropératoire sur les lésions pancréatiques.
La première procédure a été réalisée comme prévu, le patient ayant été évacué sans complications. Ce développement représente une nouvelle option potentielle de traitement pour les patients atteints de cancer du pancréas localement avancé, qui ont actuellement des options de traitement limitées au-delà de la chimiothérapie et de la radiothérapie.
L'importance de l'essai est soulignée par les statistiques du cancer du pancréas : un taux de survie à cinq ans de seulement 11,5 % tous stades confondus (données de 2012-2018), avec 62 210 nouveaux cas et 49 830 décès projetés aux États-Unis pour 2022. Le cancer du pancréas reste la troisième cause de décès par cancer, après les cancers du poumon et colorectal.
EDAP TMS SA (NASDAQ: EDAP) hat die erfolgreiche Behandlung des ersten Patienten in einer Phase I/II PULS-Studie angekündigt, die ihre proprietäre Technologie der Hochintensitäts-Fokussierten Ultraschall (HIFU) zur Behandlung von Bauchspeicheldrüsen-Tumoren evaluiert. Die Studie, die vom Centre Léon Bérard in Lyon, Frankreich, unterstützt wird, zielt darauf ab, sowohl die Verträglichkeit als auch die vorläufige Wirksamkeit des intraoperativen HIFU-Eingriffs bei Bauchspeicheldrüsen-Läsionen zu bewerten.
Der erste Eingriff wurde planmäßig durchgeführt, und der Patient wurde ohne Komplikationen entlassen. Diese Entwicklung stellt eine potenzielle neue Behandlungsoption für Patienten mit lokal fortgeschrittenem Bauchspeicheldrüsenkrebs dar, die derzeit über Chemotherapie und Strahlentherapie hinaus Optionen erhalten.
Die Bedeutung der Studie wird durch Statistiken zum Bauchspeicheldrüsenkrebs unterstrichen: eine fünfjährige Überlebensrate von nur 11,5 % über alle Stadien (Daten 2012-2018), mit 62.210 prognostizierten neuen Fällen und 49.830 prognostizierten Todesfällen in den USA für 2022. Bauchspeicheldrüsenkrebs bleibt die dritthäufigste Todesursache durch Krebs, nach Lungen- und Darmkrebs.
- Successfully completed first HIFU treatment for pancreatic cancer without complications
- Expansion into new therapeutic area with significant market potential (62,210 projected new cases in U.S.)
- Addresses significant unmet medical need in pancreatic cancer treatment
- Early-stage trial (Phase I/II) with uncertain outcomes
- Long path to potential commercialization due to clinical trial phases required
Insights
The initiation of EDAP's PULS Trial for pancreatic cancer represents a potentially groundbreaking development in oncology. Pancreatic cancer's <percent>11.5%</percent> five-year survival rate underscores the urgent need for innovative treatments. The HIFU technology's successful first patient treatment without complications is particularly noteworthy given the therapeutic options for locally advanced cases.
The trial's two-phase structure is strategically designed - Phase I focusing on safety and tolerance while Phase II will evaluate efficacy. This methodical approach in a multicenter setting strengthens the study's potential validity. With 62,210 projected new cases and 49,830 annual deaths in the US alone, successful development could address a critical market gap where current treatments are largely ineffective.
The intraoperative HIFU intervention represents a novel approach that could potentially complement or provide an alternative to traditional chemotherapy and radiotherapy regimens. The fact that the first patient was discharged without complications provides an early positive signal for the technology's safety profile.
This clinical milestone holds significant market implications for EDAP, a small-cap company with a market capitalization of <money>$93.87M</money>. The pancreatic cancer treatment market represents a substantial opportunity, with current global market valuations in the billions. A successful HIFU application could position EDAP as a pioneer in this underserved segment.
The collaboration with Centre Léon Bérard, a prestigious French cancer center, adds credibility to the trial and potentially reduces development costs through shared resources. The strategic focus on inoperable locally advanced tumors targets a specific market niche with competition and high unmet needs.
While early-stage trials typically carry significant development risks, EDAP's established expertise in HIFU technology and existing commercialized products in other indications provide some risk mitigation. Investors should monitor patient enrollment rates and preliminary safety data as key indicators of the trial's progression.
AUSTIN, Texas, January 8, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the first patient has been treated in a phase I/II PULS Trial sponsored by the Centre Léon Bérard, Lyon, France, evaluating proprietary High Intensity Focused Ultrasound (HIFU) technology for the treatment of pancreatic tumors.
“The initiation of the PULS Trial represents a major milestone in efforts to develop a new and innovative approach for treating this devastating disease with such poor prognosis,” said Professor Aurélien Dupré, MD, PhD, Surgical Oncologist, Centre Léon Bérard, and Principal Investigator of the PULS Trial. “For patients diagnosed with locally advanced pancreatic cancer, the standard treatment is chemotherapy with or without radiotherapy. The low proportion of patients who can benefit from surgery and the scarcity of alternative therapies make the development of new treatments vital and urgent. HIFU has the potential to provide a solution for these patients. This first procedure was performed and completed as planned and the patient was discharged and sent home without complications.”
“We are proud to share this noteworthy achievement as part of our on-going commitment to innovation and improving the lives of patients across a diverse spectrum of disease states,” said Ryan Rhodes, Chief Executive Officer of EDAP. “This first treatment milestone is the result of a strong collaboration between our product and clinical development teams as well as our strategic research and clinical partnerships. This demonstrates our on-going technical and clinical leadership in applying focused ultrasound therapy in areas of significant unmet need.”
The PULS Trial is a phase I/II, multicenter study for patients with locally advanced and unresectable pancreatic tumors. The Phase I aims at evaluating the tolerance of intraoperative High Intensity Focused Ultrasound (HIFU) intervention on the pancreatic lesion. The phase II aims at evaluating the preliminary efficacy of the HIFU intervention.
The five-year survival rate across all stages of pancreatic cancer is
1 Source: https://seenamagowitzfoundation.org/pancreatic-cancer-statistics/
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 www.focalone.com.
HIFU technology addressing pancreatic tumors has been developed in cooperation with LabTAU (Laboratory of Therapeutic Applications of Ultrasound) a joint research unit under the academic authorities of Claude Bernard University Lyon 1, INSERM and Centre Léon Bérard.
About the Centre Léon Bérard
The Centre Léon Bérard is a member of the Unicancer network, which brings together 18 French cancer centers and one affiliated facility. It is recognized as a regional, national and international reference center for oncology. Based in Lyon, France's 2nd largest city, the CLB's mission is threefold: care, research and teaching, with the constant aim of improving the quality and accessibility of care for cancer patients. This care comprises patient diagnosis, treatment, care, rehabilitation, screening and prevention, as well as innovation (with teams dedicated to basic, translational and clinical research) and education. The DRCI (Clinical Research and Innovation Department) manages over 200 active clinical trials per year including ~25 trials sponsored by CLB. Actually, the CLB is the 3rd French Cancer Centre in terms of patient recruitment into clinical trials, and 2nd in terms of percentage of active patients included in clinical trials (
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
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