Focal One's precision means qualifying prostate cancer patients can forego prostate removal surgery and avoid life-altering side effects including incontinence and impotence

LYON, France - April 1, 2019 - EDAP TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound, today announced that the University of Chicago Medicine became the first medical center in the Midwest to offer focal therapy to men with localized prostate cancer, using Focal One, the only advanced robotic ultrasound technology available to target and ablate diseased prostate tissue.

Focal One HIFU (high intensity focused ultrasound) makes it possible for doctors to deliver a non-invasive precision treatment to the prostate-without removing it-reducing the likelihood of negative side effects like incontinence and impotence commonly related to surgical treatments.

UChicago Medicine is the fifth medical center in the U.S. to acquire Focal One since the new system for prostate tissue ablation received 510(k) clearance from the FDA in June 2018.

"Focal One specifically targets the diseased tissue and allows the patient to retain his prostate and his quality of life," said Arieh Shalhav, MD, Fritz and Mary Lee Duda Family Chair, Chief, Section of Urologic Surgery, Professor of Surgery and the Comprehensive Cancer Research Center Director of Robotic Surgery at the University of Chicago.  "Within a 90-minute procedure, we can pinpoint and destroy diseased tissue with minimal collateral damage. It bridges the gap between active surveillance and whole gland therapy."

"We are honored to add the University of Chicago Medicine to the growing roster of prestigious U.S. medical institutions utilizing Focal One," said Marc Oczachowski, Chief Executive Officer of EDAP.  "UChicago Medicine raises the standard for hospitals across the Midwest, bringing in the latest noninvasive robotic technology to treat prostate disease. Men with localized prostate disease who wish to maintain their quality of life post-treatment can now seek HIFU treatment with Focal One at UChicago Medicine."

About UChicago Medicine

The University of Chicago Medicine, with a history dating to 1927, is a not-for-profit academic medical health system based on the campus of the University of Chicago in Hyde Park, and with hospitals, outpatient clinics and physician practices throughout Chicago and its suburbs. UChicago Medicine unites five organizations to fulfill its tripartite mission of medical education, research and patient care: Pritzker School of Medicine, Biological Sciences Division, Medical Center, Community Health and Hospital Division, and UChicago Medicine Physicians.

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 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.

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.

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

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

Source: EDAP TMS S.A.