Healthcare Industry News:  HIFU therapy 

Devices Oncology

 News Release - May 17, 2007

Ablatherm-HIFU Adoption Growing Across Europe

European Marketing and Education Strategy Validated

LYON, France, May 17 (HSMN NewsFeed) -- EDAP TMS S.A. (Nasdaq: EDAP ), the global leader in High Intensity Focused Ultrasound (HIFU) treatment of prostate cancer, updates shareholders on continued success of its marketing rollout across major European markets where EDAP is the top provider of HIFU for localized prostate cancer.

"EDAP's strong efforts as the HIFU market leader in Europe are paying off in center and treatment growth, especially in our Revenue Per Procedure business where we reported strong growth in our recent first quarter results per our commitment to regular updates on our progress," said Marc Oczachowski, CEO of EDAP. "Ablatherm-HIFU is well positioned and accepted by the medical community in major European markets. As the only HIFU provider with broad market access at more than 150 centers and more than 12,500 treatments performed to date showing the high repeatability of our outcomes, EDAP is creating a new standard of care in localized prostate cancer with the Ablatherm-HIFU."

EDAP operates across Europe and other markets where Ablatherm-HIFU is approved. It is currently in the midst of a major marketing and education program directed to the largest European medical markets on a local and regional level. Ablatherm-HIFU uses focused ultrasound to destroy prostate tissue without radiation or incision. The therapy generally requires one session of an average of two hours and a minimum of recuperative time. Ablatherm-HIFU is proven effective comparable to other standard nonsurgical treatments of localized prostate cancer, but often with lower side effects. The highly robotized procedure offers clear statistically predictive outcomes without any impasse to future care if it should be required. Ablatherm is also the HIFU system with proven dedicated protocols for treatment of recurrent prostate cancer following failed radiation therapy. Ablatherm-HIFU is currently in clinical trials in the US for future FDA approval.


EDAP is the clear leading provider of HIFU therapy in Germany, the largest and most advanced HIFU market in Europe. EDAP is driving marketing and education programs for both doctors and patients in Germany including attendance at urology congresses, organization of specific Ablatherm-HIFU symposiums and the company's first of its kind HIFU-Tour. Patient inquiries on EDAP's web site doubled in the last two months and treatments at existing sites are rising in response to these outreach programs.

In addition to ongoing strong launches of new mobile Revenue Per Procedure (RPP) centers, EDAP also launched its newest fixed RPP center at Krankenhaus Nordwest in Frankfurt. The center initially started services on a mobile RPP basis in January 2004. Due to growing patient loads and consistent outcomes the center advanced to a fixed RPP installation with a multiyear contract providing guaranteed baseline levels of utilization.

Professor Becht of Nordwest stated: "After three years of positive experience with Ablatherm-HIFU on a mobile basis for scheduling and organization we are very comfortable with the method. Krankenhaus Nordwest has now decided to install an Ablatherm on a fixed RPP basis. The reasons are very good experiences using strict inclusion criteria of over age 65, PSA less than 10, and Gleason 6 or less among those with localized prostate cancer, risk concerns for complications, or those where surgery is not applicable. The fixed Ablatherm equipment opens up the opportunity to offer HIFU to our patients without waiting time and makes our daily operating organization more efficient to increase patient satisfaction."


EDAP's new centers in France during the first quarter include one of the largest Urology departments in France, at Hospital Foch, Paris. Pr. Botto, from Hospital Foch, commented: "I am very pleased to add Ablatherm-HIFU to our portfolio of therapies offered to our patients with localized prostate cancer who seek the best standards of care available to preserve their quality of life. Ablatherm-HIFU reports the top outcomes available on HIFU in peer reviewed literature, including multi-center studies, and the lowest occurrence of side effects."

EDAP also opened its first fixed RPP site in France for private clinics at Clinique du Parc Rambot, Aix-en-Provence, and at Clinique de la Chataigneraie, at Clermont Ferrand.

Pierre Reboul, Director for France, commented, "We're clearly moving into the private sector as we see a growing interest in response to patients demanding therapy, a major step forward for EDAP. With no reimbursement in France yet, the outstanding results and recognized benefits compelled private clinics to add the Ablatherm to their treatment offering. As of today, we have 39 trained Ablatherm user sites, among which more than 26 are offering treatment on a shared or mobile basis. Today in France, half of prostate treatments are performed in private clinics. We are now seeing patients are ready to pay to preserve their quality of life after they learn of the tremendous outcomes available with Ablatherm-HIFU."

United Kingdom

EDAP is pursuing expansion in the United Kingdom through its growing relationships with top UK centers, patient groups and the urology community. The company engaged a specialized medical public relations agency to vigorously build awareness of Ablatherm-HIFU in the UK among patients, urologists and general practitioners. EDAP is organizing a Users' Group Meeting for UK Ablatherm Users and a HIFU Tour in the second part of the year. Already the company has 16 up-and-running Ablatherm-HIFU centers with multiple trained staff in all sites across the UK, including 12 centers using services on a mobile basis. With EDAP's strong efforts, now four private insurers are reimbursing the HIFU procedure in the UK at strong values ranging from 10,500 and 12,000 per treatment package. Centers now include EDAP's first fixed RPP center in the UK, the Capio Springfield Hospital in Chelmsford (Essex).

Mark Perry, UK Sales Manager, said: "We are very pleased with the progress in the UK where EDAP has a strong start and significant accomplishments are already paving the way toward our future successes. We still need to maintain strong focus on the education of patients and doctors, which we will do with the support of our agency. The dual offering of both lithotripsy and Ablatherm creates excellent opportunities to visit urologists on quality platforms, opening more doors for EDAP based on an established history of success and innovative new standards of care."


EDAP concluded its first Italian HIFU Tour in major cities May 15 presenting Ablatherm-HIFU in Aviano, Milano, Genoa, Firenze, Rome and other centers. As with the company's ongoing marketing programs, there is strong interest in Ablatherm-HIFU from its long-term clinical base, consistent proven methodologies and stable outcomes for both high efficacy and low side effects. The company is following this initial interest through the conversion process of awareness, education, commitment from the center, training and site launch. As in Germany, in the UK and in France, EDAP will engage a local PR resource to greatly increase awareness of Ablatherm-HIFU. The conversion process generally takes several months, from which the center launches initial service, then increases utilization toward higher levels.

EDAP also participated in the International Urology Meeting held in Sicily with strong attendance at the Ablatherm-HIFU presentations by Dr. Thuroff. The company's Italian business is growing strongly in line with expectations, and continued growth in the RPP lines is anticipated as the company's marketing efforts launch new centers. A number of centers are already training or scheduled for training in advance of opening new fixed and mobile RPP centers in Italy in the months ahead.


In other progress from around Europe, the company continues to advance in launching Ablatherm-HIFU at centers in other countries. Aker Hospital in Norway upgraded from an RPP unit to a purchased unit due to strong demand and good outcomes. The center had established Ablatherm-HIFU over the course of about 12 months, and is the largest prostate cancer center in Scandinavia. EDAP has successfully launched services in Turkey, a new market for the company with several procedures now completed at Turkish centers. The company also continues training new doctors from Spain where the company recently established services on the RPP basis.

"We are pleased with the progress from our dedicated marketing programs and the early signs of success ahead from our continued hard work. These results show it was clearly a good decision to implement the RPP strategy and our marketing growth programs. Growth in treatments, especially RPP sessions, is now the main metric to evaluate the success of EDAP. The per procedure business emphasis builds a higher recurring revenue base for steady growth and results as EDAP moves to profitability by the end of 2008. We will continue to launch new centers and train more users to fuel Ablatherm-HIFU's clear march toward standard of care that will, as anticipated, convert into performed treatments. EDAP's position as the HIFU leader for prostate cancer in Europe, with more than 96% of the European market being controlled by EDAP, is more than ever reinforced."


EDAP TMS S.A. develops and markets Ablatherm, the most advanced and clinically proven choice for High Intensity Focused Ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option 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. The company is also developing this technology for the potential treatment of certain other types of tumors. EDAP TMS S.A. also produces and commercializes medical equipment for treatment of urinary tract stones using Extra-corporeal Shockwave Lithotripsy (ESWL).

For more information on the Company, contact Magnolia Investor Relations at (972) 801-4900, the Corporate Investor Relations Dept at +33 (0)4 78 26 40 46 or see the Company's Web sites at and

In addition to historical information, this press release contains forward-looking statements that involve risks and uncertainties. These include statements regarding the Company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in these forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission. Ablatherm-HIFU treatment is in clinical trials but not yet FDA approved or marketed in the United States.

Source: EDAP TMS

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