Jan. 8, 2025 - EDAP TMS SA, a supplier of robotic energy-based therapies, has 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 11.5% based on data from 2012-2018. The National Cancer Institute’s projected new cases in the U.S. for 2022 is 62,210 and its projected number of annual deaths is 49,830. Pancreatic cancer still has the lowest rate of early detection and remains the most difficult cancer to treat versus all other major types of cancer. Despite the 5.5% improvement of relative 5-year survival rate compared to a decade ago, pancreatic cancer has become the third leading cause of cancer deaths trailing only lung and colorectal cancers.1
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1 Source: https://seenamagowitzfoundation.org/pancreatic-cancer-statistics/
April 16, 2025 
