EDAP TMS SA (Nasdaq: EDAP) has announced the treatment of the first patient in the Phase I/II PULS Trial, marking a significant step forward in the development of new treatment options for pancreatic cancer. The trial, sponsored by the Centre Léon Bérard in Lyon, France, is evaluating the use of High Intensity Focused Ultrasound (HIFU) technology for treating pancreatic tumors.
The PULS Trial is a multicenter study focusing on patients with locally advanced and unresectable pancreatic tumors. Phase I is designed to assess the tolerance of intraoperative HIFU intervention on pancreatic lesions, while Phase II will evaluate the preliminary efficacy of the HIFU intervention.
Rationale for HIFU Therapy
Professor Aurélien Dupré, MD, PhD, Surgical Oncologist at Centre Léon Bérard and Principal Investigator of the PULS Trial, emphasized the critical need for innovative treatments. "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."
The first procedure was completed as planned, and the patient was discharged without complications, indicating initial tolerance of the HIFU treatment.
Leadership Perspective
Ryan Rhodes, Chief Executive Officer of EDAP, stated, "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. 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."
Pancreatic Cancer: A Challenging Landscape
Pancreatic cancer remains one of the most difficult cancers to treat, with a five-year survival rate of only 11.5% across all stages (based on data from 2012-2018). The National Cancer Institute projects 62,210 new cases in the U.S. for 2022, with 49,830 annual deaths. Despite a slight improvement in survival rates compared to a decade ago (5.5%), it has become the third leading cause of cancer deaths, trailing only lung and colorectal cancers.
About EDAP TMS SA
EDAP TMS SA is a recognized leader in robotic energy-based therapies, developing minimally invasive medical devices using ultrasound technology. Their Focal One® device is used in Europe and the U.S. for prostate focal therapy. The HIFU technology for pancreatic tumors was developed in collaboration with LabTAU (Laboratory of Therapeutic Applications of Ultrasound).
About Centre Léon Bérard
The Centre Léon Bérard is a member of the Unicancer network, recognized as a regional, national, and international reference center for oncology. Based in Lyon, France, its mission encompasses care, research, and teaching to improve the quality and accessibility of cancer care. The DRCI (Clinical Research and Innovation Department) manages over 200 active clinical trials per year.
