EDAP HIFU Advancements Highlighted at International Symposium on Therapeutic Ultrasound

LYON, France, March 22, 2016 -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that its advancements in High Intensity Focused Ultrasound (HIFU) were highlighted at the International Symposium on Therapeutic Ultrasound (ISTU 2016), which took place from March 14-17, 2016, in Tel Aviv, Israel. At ISTU 2016, HIFU experts from EDAP and the Company’s long-time academic partner, INSERM, presented their most recent advances in the development of therapeutic focused ultrasound.

EDAP, together with INSERM, a French public research laboratory, made high-level technical presentations on HIFU technology advancements in targeting cancer. Among the initiatives highlighted were promising clinical evaluations of HIFU in the treatment of liver metastasis, performed in cooperation with Centre Leon Berard, a Lyon-based hospital dedicated to cancer treatment and research, being conducted through EDAP’s work as part of the HECAM consortium.

The treatment of prostate cancer using the focal HIFU approach was also detailed, including improvements in imaging techniques in the diagnosis of tumors, the guidance of HIFU treatment and the assessment of its efficacy, as embodied by EDAP’s Focal One device.

“As a world leader in HIFU technology, it is imperative that we continue exploring its potential use beyond our core urology market. With our partners at INSERM, we are proud to share the results of our research with the international scientific community at ISTU, one of the preeminent global congresses on the use of therapeutic ultrasound,” said Marc Oczachowski, Chief Executive Officer of EDAP.

“We look forward to continuing our efforts aimed at identifying new potential applications for our HIFU technology, both independently and in conjunction with INSERM. We believe that such research initiatives could significantly broaden our addressable markets and maintain our leadership position in the HIFU space.”

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.

About ISTU
The International Society for Therapeutic Ultrasound (ISTU) is a non-profit organization founded in 2001 to increase and diffuse knowledge of therapeutic ultrasound to the scientific and medical community, and to facilitate the translation of therapeutic ultrasound techniques into the clinical arena for the benefit of patients worldwide.

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.

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]