EDAP Announces First HIFU Treatments Performed in New England

LYON, France, June 16, 2016 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the first prostate ablation treatments performed at Radiosurgery of New York and Eastern Massachusetts Surgery Center, using the Company’s FDA-cleared Ablatherm Robotic HIFU device deployed by HIFU USA Corp, a leading provider of mobile technology solutions to urologists. Dr. Ron Israeli, Chief Medical Officer of HIFU USA, Corp. performed the procedure at Radiosurgery of New York, while the procedures at Eastern Massachusetts Surgery Center were performed by Dr. Clifford Gluck and Dr. James Lin both of Greater Boston Urology who are also affiliated with Beth Israel Deaconess Medical Center.

The Ablatherm Robotic HIFU used in these procedures is owned by HIFU USA, Corp., who mobilized the system to provide HIFU access to select urologists and clinics across the New York and New England regions.

Dr. Gluck commented, “We are thrilled to begin treating patients with Ablatherm Robotic HIFU and to be the first practice in all of New England to utilize HIFU for the ablation of prostate tissue. As a minimally-invasive technique, HIFU has the potential to significantly improve quality of life for a certain subset of prostate cancer patients. This is especially important as more men are being diagnosed earlier in life and may not be content with the stress and uncertainty associated with active surveillance. At Eastern Massachusetts Surgery Center, we are committed to offering patients the most innovative therapeutic options available. Ablatherm falls perfectly within this commitment and we are excited to expand our use of the technology.”

Dr. Israeli added: “It is a privilege to perform these initial prostate ablation treatments at Radiosurgery of New York in midtown Manhattan. For certain men, HIFU has a range of advantages over alternative therapies, and I look forward to bringing the benefits of this innovative technology to appropriate patients within my practice.”

He continued “We are pleased to add Ablatherm Robotic HIFU to our technology portfolio and to have supported these fine physicians with the procedures. Many of the physicians we work with have expressed excitement at the opportunity to add HIFU as another treatment option to their practice, providing them with an intermediate option between active surveillance and radical prostatectomy. We believe that Ablatherm optimally addresses this substantial need and anticipate significant utilization, which will result in us opening multiple Ablatherm Robotic HIFU centers throughout the country in the immediate future.”

Marc Oczachowski, EDAP TMS Chief Executive Officer, added: “We are happy to partner with HIFU USA, another leading equipment mobilizer to expand the reach of the Ablatherm Robotic HIFU device. We are also very pleased to see our HIFU technology available to patients in New England, and we look forward to the continued expansion of Ablatherm Robotic HIFU in the U.S.”

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 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 is approved for commercial distribution in Europe and 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 HIFU USA, Corp.
HIFU USA Corp. (www.hifumedusa.com) is a comprehensive, national provider of HIFU services, providing access to the Ablatherm Robotic HIFU device presently to physicians in the New York and New England areas and soon throughout markets nationally. The corporate headquarters for HIFU USA Corp. are located at 30 Hopper Street in Westbury, NY.

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 bconfort@edap-tms.com Investors: Lee Roth The Ruth Group 646-536-7012 lroth@theruthgroup.com