EDAP TMS SA, the global leader in therapeutic ultrasound, announced that the French regulatory organization AFSSAPS has authorized a phase-I clinical study to evaluate High Intensity Focused Ultrasound (HIFU) technology in patients with metastatic liver cancer. HIFU has the potential to assist with liver ablations and reduce bleeding during surgery.
Over the next six months, 20 patients are expected to receive treatment with a HIFU-based device designed to help destroy hepatic metastasis, or liver cancer tumours, while preserving surrounding tissues and organs. The objective is to expand the number of patients eligible for surgery and extend the survival rate. The device was jointly developed by EDAP in collaboration with Centre Leon Berard (a national Lyon, France-based cancer center) and INSERM 556 Unit with the financial support from CLARA and OSEO, organizations respectively dedicated to supporting innovative cancer treatment initiatives and technological innovation.
Marc Oczachowski, EDAP chief executive officer, commented, "As a result of this successful cooperation among academic, clinical and industrial players, patients with liver cancer now have the potential to benefit from EDAP's HIFU technology. While EDAP maintains a focus on expanding our Ablatherm-HIFU business for patients with prostate cancer, our collaborators have clearly recognized the broader potential of our technology and the progress made by our R&D team in jointly developing a HIFU device to address liver cancer. Our collaboration in this early clinical study confirms EDAP's continuous leadership and expertise in HIFU and represents a preliminary step towards our long-term goal of positioning HIFU technology as a solution to improve existing treatment options across multiple pathologies."
EDAP TMS SA develops and markets Ablatherm, the most advanced and clinically proven choice for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Approved in Europe as a treatment for prostate cancer, Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently undergoing evaluation in a multicenter US phase-II/III clinical trial under an Investigational Device Exemption granted by the FDA, the ENLIGHT US clinical study. The company also is developing this technology for the potential treatment of certain other types of tumours. EDAP TMS SA also produces and commercializes medical equipment for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL).