EDAP Announces Presentations and Live Demonstrations of Ablatherm® Robotic HIFU at 2016 American Urology Association Annual Meeting, May 6-10, 2016

Company to Participate in Two Plenary Sessions and Five Poster Sessions

Ablatherm Treatments Performed During “L.A. Live” Pre-AUA Symposium at USC

LYON, France, May 04, 2016 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that it will demonstrate the capabilities of the Ablatherm Robotic HIFU and other urology devices including its Sonolith i-move and i-dust laser in booth #4107 at the 111th American Urology Association Annual Meeting, the global urology community’s largest annual event, to be held May 6-10, 2016 in San Diego, CA. Experts will conduct live demonstrations of ablation and lithotripsy techniques throughout the meeting.

Marc Oczachowski, EDAP's Chief Executive Officer, commented, “We are particularly excited with the forthcoming 2016 AUA meeting as this year’s congress will be the first that EDAP is showcasing Ablatherm Robotic HIFU as a commercially available product in the U.S. In addition to the plenary sessions and poster presentations on the use of our HIFU technology for prostate ablation, we expect significant activity at our booth where we will demonstrate Ablatherm Robotic HIFU through a series of ‘Meet the Experts’ sessions. We will have a significant presence at this year’s meeting, with dedicated marketing actions and a broad clinical program to increase HIFU awareness, which we believe will be instrumental in building upon the sales momentum that Ablatherm Robotic HIFU has enjoyed since its U.S. launch in the fourth quarter of 2015.”

The company’s HIFU technology will be presented during two late-breaking plenary sessions:

  • “High-intensity Focused Ultrasound - Hope or Hype?” on Friday, May 6 from 11:50 am to 1:00 pm PDT during plenary session II in Room 6A
  • “Hemiablation HIFU for Unilateral Localized Prostate Cancer: a Prospective Multicenter Trial” on Monday, May 9, from 11:40 am to 12:00 pm PDT during the Plenary I-Monday session in Hall A

In addition, five posters during the “Prostate Cancer: Localized: Ablative Therapy” session on Friday, May 6 from 3:30 pm to 5:30 pm PDT in Room 30 ABC will report outcomes achieved with Ablatherm HIFU:

  • MP18-06 / Salvage External beam radiation therapy (EBRT) for local recurrence after High Intensity Focused Ultrasound (HIFU) failure versus Salvage HIFU for local recurrence after EBRT failure: A Matched Pair Comparison
  • MP18-10 / Oncologic outcomes after hemiablation therapy for localized prostate
  • MP18-15 / Efficacy of high intensity focused ultrasound (HIFU) as a primary monotherapy for low risk localized prostate cancer: outcomes from the enlight trial
  • MP18-17 / Comparisons of Oncological and Functional Outcomes among Radical Retropubic Prostatectomy, High Dose Rate Brachytherapy, Cryoablation and High-intensity Focused Ultrasound for Localized Prostate Cancer: A Prospective, Controlled, Nonrandomized Trial
  • MP18-19 / Local Radical Tumor Ablation through Combined Transurethral Resection and Transrectal High Intensity Focused Ultrasound: A valid therapy to treat High Risk Prostate Cancer?

Prior to the start of AUA, the USC Institute of Urology team, led by Dr. Inderbir Gill, MD, conducted a HIFU live surgery course titled, “High Intensity Focused Ultrasound (HIFU) hands-on and simulation training course” on May 3. This will be the first such training course in the U.S., and will take place during a bonus day event at the USC Institute of Urology’s “L.A. Live” International ROBOTIC & OPEN Live Surgery Symposium held May 4-5 at the University of Southern California in Los Angeles, CA.

Mr. Oczachowski added, “We are honored that Keck Medicine of USC, the first Ablatherm site in the U.S., and Dr. Gill, one of the world’s top urologists, will be using Ablatherm for the country’s first live training course on HIFU. “L.A. Live” is a perfect opportunity for us to introduce the benefits of Ablatherm Robotic HIFU to a large number of prominent urologists and robotic surgeons leading into AUA. The exposure that we expect to gain from these two events will significantly strengthen our U.S. sales and marketing efforts as we continue working to maximize Ablatherm’s footprint in the U.S.”

Further information on the plenary sessions, poster presentations and booth activities is available on EDAP’s website in the Company’s AUA 2016 Scientific Program.

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