EDAP's Long Term Academic HIFU Partner INSERM LabTAU Designated Center of Excellence by the Focused Ultrasound Foundation
LYON, France, March 8, 2017 -- EDAP TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound, today announced that the prestigious Focused Ultrasound Foundation, based in Charlottesville, VA, designated long-term academic French partner INSERM LabTAU a Center of Excellence.
EDAP and INSERM Laboratory of Therapeutic Applications of Ultrasound (LabTAU), in conjunction with the University Hospital Edouard Herriot in Lyon, have been collaborating closely for the past 27 years in the development and use of therapeutic ultrasound in the treatment of kidney stones and localized prostate cancer. These strategic interfaces resulted in the successful marketing of Sonolith®, Ablatherm® Robotic-HIFU and Focal One® worldwide. So far, more than 45,000 prostate cancer patients have been treated using our HIFU technology. EDAP and INSERM LabTAU are currently pursuing on-going development projects using HIFU for therapeutic applications beyond prostate cancer.
Dr. Cyril Lafon, Ph.D., Director of LabTAU, commented: "INSERM LabTAU and EDAP privileged partnership is a valuable example of a fruitful and successful cooperation between academic scientists and a medical device company. Our expertise and advancements are complementary thus accelerating the availability of such non-invasive technology as HIFU to patients."
"LabTAU at INSERM is a pioneering site for research and development in focused ultrasound. They have a long history of establishing how focused ultrasound interacts with tissue, and they use that information to develop innovative clinical applications," says Foundation Chairman Neal F. Kassell, MD. "Their laboratory research has resulted in a number of commercially available products -- including those used for the first focused ultrasound treatment for patients with prostate cancer."
Marc Oczachowski, EDAP TMS Chief Executive Officer, concluded: "We are very enthusiastic and proud of the nomination of our privileged partner INSERM LabTAU as Center of Excellence by the prestigious Focused Ultrasound Foundation. It is a recognition of INSERM's highly qualified research work on therapeutic ultrasound. The designation validates our successful collaboration in developing HIFU and ensuring that our co-advancements benefit patients. We at EDAP remain dedicated to making HIFU a standard of care in the treatment of particular types of tumors."
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) for prostate tissue ablation in the U.S. and for treatment of localized prostate cancer in the rest of the world. HIFU treatment is shown to be a minimally invasive and effective option for prostatic tissue ablation with a low occurrence of side effects. Ablatherm 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. Ablatherm is approved for commercial distribution in Europe and other countries including Mexico and Canada, and has received 510(k) clearance by the U.S. FDA. The Company also markets an innovative robot-assisted HIFU device, the Focal One®, dedicated to focal therapy of prostate cancer. Focal One® is CE marked but is not FDA approved. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and distributes medical equipment (the Sonolith® lithotripters' range) for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL) in most countries including Canada and the U.S. For more information on the Company, please visit http://www.edap-tms.com
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About INSERM LabTAU
The laboratory LabTAU for Laboratory of Therapeutic Applications of Ultrasound (Claude Bernard Lyon 1 University and INSERM Unit 1032), under the direction of Cyril Lafon, is specialized in the development of non-invasive or minimally invasive therapeutic applications of image-guided ultrasound, by combining experimental and theoretical research for which very few teams, even international, possess the required know-how. Since January 1, 2005, the laboratory has produced 198 publications in referred journals and 190 communications, including 22 invited communications. Technological or methodological expertise of the team and its partners covers the entire range of investigations from the bench to the bedside. The research on ultrasound therapy conducted in LabTAU is widely regarded as being at the forefront of worldwide developments in this field leading to international activity by means of several actions: reception of foreign researchers, European actions, bilateral collaboration contracts, thesis co-supervision. For more information on INSERM LabTAU, please visit: http://labtau.univ-lyon1.fr/
About The Focused Ultrasound Foundation
The Focused Ultrasound Foundation (FUSF) is a non-profit organization based in Charlottesville, Virginia, United States, dedicated to accelerating the development and adoption of focused ultrasound. Its main areas of involvement and support are research, collaboration, education and advocacy. In 2009, the Foundation created the Centers of Excellence program which brings together the best people and technical resources at luminary sites to showcase the technology and serve as hubs for collaboration. For more information on the Foundation, please visit https://www.fusfoundation.org
In addition to historical information, this press release may contain forward-looking statements. 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 device. Factors that may cause such a difference also may 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.
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