EDAP’s Ablatherm® Robotic HIFU Deployed by HIFU Solution

LYON, France, April 18, 2016 -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the first prostate ablation treatments performed in Orlando, Florida, using the Company’s FDA-cleared Ablatherm Robotic HIFU.

This Ablatherm Robotic HIFU is owned by HIFU Solution, LLC who has mobilized the device to offer access to the technology to physicians and clinics in its network throughout the United States.

Dr. P. Narayan MD, HIFU Solution Medical Director, commented: “It is with great pleasure and pride that our company, in conjunction with Urologists and surgery centers of Orlando, was able to bring mobile HIFU to the state of Florida, utilizing the state of the art Ablatherm treatment device from EDAP. We will be offering this service to many others in the urology community, in Florida and around the country, who wish to make use of this superior procedure.”

Marc Oczachowski, EDAP TMS Chief Executive Officer, added: “The new HIFU Solution mobile operation is a significant step toward increasing the availability of treatment for patients in need. We look forward to working closely with their team as we continue to expand Ablatherm Robotic HIFU’s footprint in the U.S. urology market.”

HIFU Solution combines compassionate, highly qualified and experienced physicians and professionals with pioneering, noninvasive HIFU technology for the diagnosis and treatment of prostate cancer to provide unparalleled patient care. The company aims to provide patients and their families with answers about the diagnosis and treatment options, and a clear path forward. HIFU Solution is comprised of a network of twenty-six qualified physicians placed in ten states. With five centers established on the East Coast, HIFU Solution plans to launch five more centers in the Midwest and Western parts of the country. For more information on the company please visit http://www.hifusolution.com. 

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-HIFU 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-HIFU is approved for commercial distribution in Europe and some 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, and http://www.hifu-planet.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.

Contact:
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
[email protected]

Investors:
Lee Roth
The Ruth Group
646-536-7012
[email protected]