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EDAP TMS SA : EDAP announces Installation of First Focal One HIFU device in South Korea

  • Successful HIFU Treatments Performed in Seoul National University Bundang Hospital

LYON, France, September 20, 2018 -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the installation of the first Focal One device in South Korea, at the renowned Seoul National University Bundang Hospital ("SNUBH").

Dr. Hakmin Lee, Urologist in SNUBH commented: "We are very happy to adopt the first "Focal One" device in our institution and we also believe that Korean patients will significantly benefit from the upcoming HIFU procedures. From our initial experiences, the Focal One device showed extraordinary performance which was definitely beyond our expectations. We are very excited to provide the new technology to Korean patients using our new device."

Jean-François Bachelard, Asia Business Unit Director commented: "We are delighted to start the first Focal One treatments in Seoul National University Hospital, one of the biggest Urology centers in Korea. This prominent clinical site is set to become our HIFU reference center in South Korea to promote prostate cancer treatment using our HIFU technology."

Marc Oczachowski, Chief Executive Officer of EDAP TMS, concluded: "We are thrilled to have the first Korean Focal One installation in such a renowned center of excellence as the Seoul National University Bundang Hospital. After Korean FDA clearance of Focal One in 2016, this installation and first cases performed successfully are a clear and strong milestone in the EDAP HIFU expansion program in South Korea, one of the most important medical device markets in Asia. We look forward to continuing HIFU development with our EDAP local team in South Korea as well as in key Asian markets, where we already benefit from a strong and established position with our ESWL technologies".

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 Seoul National University Bundang Hospital (SNUBH)

SNUBH has been consistently ranked first in the category of quality measurements of general hospitals for thirteen consecutive years and Korea Brand Power Index. In 2012, SNUBH was given the title of "1st Class in all categories" of quality measurements based on outcomes, patient safety, and customer satisfaction, the recognition from the Health Insurance Review and Assessment Service, which is a subsidiary of the National Insurance Company of Korea. Our 1,360-bed medical center, located at the Southern suburb of Seoul, offers sophisticated cutting edge diagnostic and therapeutic care in virtually every specialty and subspecialty of medicine and surgery. Our nine multidisciplinary specialty care centers, comprising of SNUBH medical staff from all different lines of specialties provide comprehensive one stop medical care to the patients with various medical conditions and different medical needs. Bringing cutting edge technology and traditional humanity together, the quality of our medical care has been consistently proved to be of the highest class in this country, based on all of the quality measurement criteria.  For more information on Seoul National University Hospital, please visit http://www.snubh.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

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