EDAP Reports on Recent, Active Urology Congress and Clinical Activity

  • Multiple abstracts on whole prostate gland and focal HIFU presented at World Congress of Endourology and Lithotripsy
  • Two HIFU studies presented at Société Internationale d'Urologie
  • Company highlights Technology as exhibiting sponsor at Five Major American Urological Association Section Meetings

LYON, France, Nov. 3, 2015 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today provided an update on its participation at recent U.S. and international urology meetings.

At the World Congress of Endourology and Lithotripsy (WCE), held October 1-4, 2015 in London, EDAP's HIFU technology was the subject of abstracts presented by renowned urology groups from Italy, France, Germany and Belgium. These abstracts, which were presented to attending urology specialists, focused on several topics including the use of MRI (a non-invasive imaging modality) to be used as a follow-up tool following non-invasive HIFU, long-term results and efficacy of HIFU for the treatment of prostate cancer, outcomes from focal HIFU for prostate cancer and incorporating focal therapies into the a contemporary high volume cancer center. The respective presentations were:

  • MP4-15: Robotic HIFU: Evaluation with D-CD-MR Imaging
  • MP33-19: Robotic HIFU: Focus on early complications after 6 years' experience
  • MP33-20: HIFU hemiablation for prostate cancer in 50 men: results from a prospective cohort with a median follow-up of 3.3 years
  • MP37-1: From diagnostic to focal prostate cancer treatment at a high volume prostate cancer center: concept of a workflow

Additionally, two studies of EDAP's HIFU technology were presented by a prominent German HIFU group at the 35th Congress of the Société Internationale d'Urologie (SIU) in Melbourne, Australia October 15-18, 2015. One presentation demonstrated the ability of transurethral resection of the prostate (TURP) to reduce the already low side effect rate of HIFU, while the second demonstrated the oncologic efficacy of HIFU for patients with prostate cancer considered to be high risk. The presentations were:

  • MP-09.10: Therapeutic efficacy and PSA nadir in high risk PCa patients after HIFU treatment combined with TURP
  • MP-09.04: Morbidity profile of Immediate or delayed HIFU after TURP

Additionally, the Company is participating as an exhibiting sponsor at five sectional meetings of the American Urology Association (AUA), including:

  • Joint Annual Meeting of the Mid-Atlantic and New England Sections of the AUA October 22-24, 2015
  • Western Section AUA 91st Annual Meeting October 25-29, 2015
  • 67th Northeastern Section AUA Annual Meeting October 29-31, 2015
  • South Central Section of the AUA 94th Annual Meeting October 28-31, 2015
  • North Central Section of the AUA 89th Annual Meeting November 10-14, 2015

At these meetings, EDAP is exhibiting and discussing its unique technology features and actively supporting the American Urology Community in its scientific meetings.

Marc Oczachowski, EDAP's Chief Executive Officer, commented: "Presentations at prominent international meetings such as WCE and SIU further reinforce the value of HIFU in the market and its long-term therapeutic benefits. The value of HIFU has never been more apparent: the treatment is non-invasive, can be applied in a patient-tailored way to avoid side effects yet treat the known disease and be followed with minimally invasive imaging modalities."

Mr. Oczachowski continued, "Importantly, our continued presence at these congresses, both in the U.S. and internationally, provides an important opportunity to solidify relationships with thought leaders in the urology community and other key industry constituents. These activities are crucial to our business development objectives and are expected to play a significant role in our ongoing global expansion as we build upon our leadership position in both HIFU and lithotripsy."


EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer outside the U.S. 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. EDAP TMS has submitted a 510(K) notice for Ablatherm 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 uncertainties of the U.S. FDA clearance process, 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. Ablatherm-HIFU is not FDA-cleared or marketed in the United States.

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