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EDAP TMS SA : UCI Health Medical Center Becomes First in the U.S. to Treat Patients Using EDAP's Breakthrough Focal One® HIFU Technology

UCI Health, one of the three US medical centers to acquire EDAP's Focal One device, is a recognized leader in prostate cancer diagnosis and treatment utilizing robot-assisted and minimally invasive technologies

LYON, France, February 5, 2019 -- EDAP TMS SA (EDAP) ("the Company"), the global leader in therapeutic ultrasound, today announced that UCI Health (UCI) has become the first medical center in the United States to treat prostate cancer patients with Focal One, the world's most advanced high intensity focused ultrasound (HIFU) technology. UCI is one of the three medical centers in the country to acquire Focal One, which provides urologists with one of the most precise tools on the market for the targeted, non-invasive ablation of prostate cancer tissue. The outpatient procedure preserves the prostate, enabling the patient to continue to live the best quality of life possible by lowering the incidences of troubling side effects, including impotence and incontinence associated with more invasive legacy treatments such as radical prostatectomy.

UCI is recognized for its expertise in robot-assisted and minimally invasive prostate cancer treatments and known for its dedication to the discovery of new medical breakthroughs to deliver the finest in evidence-based care. UCI's adoption of Focal One underscores its commitment to offering the latest in cutting-edge technology. 

"This recent advancement in prostate cancer treatment, Focal One HIFU, allows for incredibly accurate targeting in the removal of unhealthy prostate cancer tissue while sparing the healthy tissue and surrounding structure of the prostate. This procedure preserves the patient's quality of life and is an option for select prostate cancer patients," commented Edward M. Uchio, MD, Director of Urologic Oncology at UCI Health. Urologists interact with integrated 3D images on a large monitor while conducting the procedure.

 "Utilizing high resolution multiparametric prostate MRI fused with ultrasound images, and biopsy findings, a unique collaboration between radiology, pathology and urology, EDAP's HIFU technology enables the treatment of only the areas of the prostate harboring cancer seen on MRI while leaving normal tissue intact," commented Roozbeh Houshyar, MD, Director of Abdominal MRI at UCI Health. 

"Based on our thorough technology review and experience with numerous minimally invasive treatment devices, we were impressed with Focal One's outstanding imaging capabilities that clearly differentiate it from other devices on the market. We are excited to be among the first hospitals in the U.S. to offer this ground-breaking technology, and have already started treating patients-our first today-with the goal of offering the best possible medical outcomes to our prostate cancer patients," said Uchio.

"We are pleased to welcome UCI Health Medical Center to our rapidly growing roster of world-renowned U.S.  hospitals offering Focal One to their patients," said Marc Oczachowski, Chief Executive Officer of EDAP. "It confirms the growing interest in Focal One from many highly-regarded healthcare institutions across the U.S. This is also a testament to the clinical advantages of Focal One compared to surgery, radiotherapy, and even first-generation HIFU devices. We are seeing increased traction in the market and we continue to grow our pipeline of promising hospital prospects. We look forward to keeping the market informed of future sales developments." 

 About EDAP TMS SA

A recognized leader in the global therapeutic ultrasound market for almost 40 years, EDAP TMS develops, manufactures, promotes and distributes worldwide minimally invasive medical devices for urology using ultrasound technology. By combining the latest technologies in imaging and treatment modalities in its complete range of Robotic HIFU devices, EDAP TMS introduced the Focal One® in 2013 in Europe and in 2018 in the US as the answer to all requirements for ideal prostate tissue ablation as a complement to the existing FDA-cleared Ablatherm® Robotic HIFU and Ablatherm® Fusion. As a pioneer and key player in the field of extracorporeal shock wave lithotripsy (ESWL), EDAP TMS exclusively utilizes the latest generation of shock wave source in its Sonolith® range of ESWL systems. For more information on the Company, please visit http://www.edap-tms.com, and us.hifu-prostate.com.

About UCI Health Medical Center, Irvine

UCI Health comprises the clinical enterprise of the University of California, Irvine. Patients can access UCI Health at primary and specialty care offices across Orange County and at its main campus, UCI Medical Center in Orange, California. The 417-bed acute care hospital provides tertiary and quaternary care, ambulatory and specialty medical clinics, and behavioral health and rehabilitation services. UCI Medical Center features Orange County's only National Cancer Institute-designated comprehensive cancer center, high-risk perinatal/neonatal program and American College of Surgeons-verified Level I adult and Level II pediatric trauma center and regional burn center. UCI Health serves a region of nearly 4 million people in Orange County, western Riverside County and southeast Los Angeles County. For more information on UC Irvine, please visit http://www.ucihealth.org.

Forward-Looking Statements

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.

Company Contact
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 50
bconfort@edap-tms.com

Investor Contact
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.com