EDAP TMS SA : EDAP Announces Sales of Two Additional Focal One® Devices in Brazil

Hospital 9 de Julho and Hospital Moriah join growing roster of highly-regarded hospitals in Brazil offering Focal One

LYON, France, January 14, 2019 -- EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in therapeutic ultrasound, announced today that the Company has completed sales of two additional Focal One High Intensity Focused Ultrasound (HIFU) devices to two leading hospitals in Brazil: Hospital 9 de Julho and Hospital Moriah. With these sales, EDAP has now sold five Focal One HIFU devices into the Brazil market to date.

"We are very pleased to add two additional highly-regarded hospitals, Hospital 9 de Julho and Hospital Moriah, to the growing list of premier healthcare institutions in Brazil now offering Focal One to their patients," said Marc Oczachowski, Chief Executive Officer of EDAP. "Brazil is the fastest growing market in Latin America for robotic HIFU treatment of localized prostate cancer, and we believe our accelerating sales momentum, with five Focal One HIFU devices now sold in Brazil, speaks to the growing awareness of Focal One's clinical advantages versus existing prostate cancer treatment modalities and the desire of leading urologists to deliver superior outcomes to patients across the region. As both of these institutions are known to be on the cutting edge of prostate cancer treatment, these will be important reference hospitals that we believe will help raise awareness of Focal One and drive future sales."  

"Prostate cancer has historically been aggressively treated with radiotherapy or open prostatectomy that, in many cases, overtreats earlier stages of disease and carries life-altering side effects. In contrast, Focal One represents a targeted, less invasive and personalized approach that can produce improved outcomes for select patients depending on their stage of disease," said Dr. Rafael Coelho, onco-urologist and robotic surgeon at Hospital 9 de Julho. "As a leading center for the treatment of localized prostate cancer in Brazil, Hospital 9 de Julho seeks to leverage the latest innovations, and Focal One is the most advanced device on the market today for the highly targeted ablation of localized prostate cancer. We look forward to commencing patient treatments with Focal One imminently." 

"We are enthusiastic to be pioneers and amongst the few institutions in Brazil to offer Focal One to patients who seek an effective prostate cancer treatment while avoiding the drawbacks of radical treatment," said Pr. Miguel Srougi of Hospital Moriah. "Hospital Moriah is a leader in the field of robotic surgery across many disciplines, with a particular strength in urology, and is among the premier teaching hospitals in Brazil. We are delighted to be able to offer this advanced next-generation prostate cancer treatment option to our physicians and patients alike."         


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.

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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