EDAP Highlights
EDAP's presence at BAUS focused on increasing physician awareness and further clarifying the unique capabilities of the Company's full product suite as well as the advantages of HIFU as a safe and proven treatment option for localized prostate cancer. During focused demonstrations of the Ablatherm-HIFU device, physicians had the opportunity to assess the technology and robotized approach while discussing the device's clinical superiority in terms of efficacy, safety and long-term data.
During this event, EDAP held its Ablatherm-HIFU United Kingdom user meeting for urologists which was attended by physician representatives from all 16 U.K. Ablatherm centers. This gathering was a success as it validated the full commitment and enthusiasm for Ablatherm-HIFU and its positive treatment outcomes. Representatives from all U.K. Ablatherm centers strongly adhered to the newly and officially introduced @-REGISTRY program ("Ablatherm Treatment"-Registry), a centralized database that collects follow-up data on patients who have undergone Ablatherm-HIFU treatment. Response to the launch of the program by U.K. users was very positive due to the @-REGISTRY's ability to compile results on previously treated patients as well as prospectively collected data. @-REGISTRY together with future publications, many of which are expected to result from this program, should help to further establish Ablatherm-HIFU as a proven treatment for prostate cancer, conforming NICE recommendations.
Dr. John Rewcastle, EDAP's Medical Director, commented, "The @-REGISTRY program will assist U.K. urologists who have embraced Ablatherm-HIFU and the follow up process with their patients. Outcomes from multiple studies have already demonstrated the reproducibility of Ablatherm-HIFU. As such, I expect the U.K. experience to produce a similar level of efficacy and morbidity. Enabling data collection and real time analysis with the @-REGISTRY will facilitate the presentation and publication process."
Marc Oczachowski, EDAP's Chief Executive Officer, said, "The BAUS Annual Meeting, and particularly our Ablatherm-HIFU users meeting, was a great success confirming the strong commitment to our HIFU technology offered to U.K. patients. Our @-REGISTRY extensive clinical database is the ideal tool to address the treatment and funding of U.K. prostate cancer patients conforming NICE guidelines."
"In addition to Ablatherm-HIFU, EDAP highlighted its newly designed Sonolith-I-sys lithotripter, which has gained traction among urologists as one of most advanced lithotripsy device on the market, fully meeting physician needs."
About EDAP TMS SA
EDAP TMS SA 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. Approved in Europe as a treatment for prostate cancer, Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently undergoing evaluation in a multicenter U.S. Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA. The Company also is developing this technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the company, please visit http://www.edap-tms.com and http://www.hifu-planet.com or http://www.urotoday.com/HIFU.
CONTACT: EDAP TMS SA
Investor Relations / Legal Affairs
Blandine Confort
+33 4 72 15 31 72
bconfort@edap-tms.com
The Ruth Group
Investors:
R.J. Pellegrino
646-536-7009
rpellegrino@theruthgroup.com
General news
EDAP TMS symposium success in Washington D.C. The 3rd International Symposium on Focal Therapy and Imaging of Prostate and Kidney Cancer held in Washington D.C last week (February 24-27 2010) was a success for EDAP TMS with a highlight on Ablatherm® HIFU during a dedicated session. The pionneers of focal prostate cancer treatment with Ablatherm® presented promising clinical results to the audience composed of international prostate cancer experts.
A Grenoble, on traite les calculs avec le Sonolith i-sys sans anesthésie France 3 Rhône-Alpes a consacré un reportage à l'unité de traitement des calculs urinaires du CHU de Grenoble dirigée par le Professeur Rambeaud et équipée avec le Sonolith® i-sys. Le CHU est pionnier dans le traitement des calculs urinaires sans aucune anesthésie rendu possible par la conception même du Sonolith® i-sys. Retrouvez le reportage en cliquant ici.
Journée de la prostate : vous avez le droit de savoir Aujourd'hui, 15 Septembre 2009, c'est la journée de la prostate organisée dans le cadre de la semaine Européenne de l'Urologie. Cette journée de la prostate a pour but de sensibiliser tout un chacun au cancer de la prostate, son dépistage et ses traitements. A cette occasion, nous mettons en ligne notre nouveau dossier de presse en Français.
First Ablatherm® HIFU sold in Bolivia EDAP TMS' first Ablatherm® HIFU system just got aquired by the Centro de Urologia Avanzada de la Clinica Incor Santa Cruz de la Sierra en Bolivia showing that the technology is penetrating more markets everyday.
Sonolith® i-sys receives FDA approval EDAP TMS' high-end lithotripter Sonolith® i-sys has just been granted FDA approval. The device is now cleared for routine ESWL treatment in the USA. Sonolith® i-sys obtained CE mark in 2007 and has widely been adopted in Europe since. As all lithotripters from the Sonolith® range, the Sonolith® i-sys uses the exclusive Electroconductive technology for the management of urinary tract stones.
Ablatherm HIFU receives approval in Argentina EDAP TMS just obtained approval from the Minitry of Health in Argentina for Ablatherm HIFU for the minimally-invasive treatment of localized prostate cancer. After being approved in Brazil earlier this year, the approval in Argentina shows that Ablatherm HIFU is gaining acceptance in South America.
AURO publishes official guidelines regarding HIFU treatment In its latest recommendations, the AURO (Association of Italian Urologists) recommends Ablatherm® HIFU treatment as first-line treatment for localized prostate cancer. This publication coming a year after the publication of similar recommendations by the AFU (French Association of Urology) reinforces the growing place of HIFU in the treatment of prostate cancer.
Ablatherm® HIFU confirms success in South Africa
With 3 new treatment centers in Pretoria, Johannesburg and Durban, Ablatherm confirms its presence in South Africa. The country now counts 4 Ablatherm® HIFU treatment centers in major cities of the country.
Visit www.hifu-planet.com website to view the full list of Ablatherm® HIFU treatment centers.
EAU 2009 in Stockholm highlights HIFU 12.000 urologists attended this year's EAU congress in Stockholm which is a particularly successful edition for EDAP TMS. The EAU hosted the EDAP TMS sponsored HIFU symposium with 200 urologists attending from all over the world. Vincenzo Ficarra from University of Padua, Italy chaired the symposium around the theme of High Intensity Focused Ultrasound in the Modern Urology Practice.
Ablatherm® HIFU is now approved in Brazil Ablatherm® HIFU is now approved in Brazil adding new outlooks for the technology.
With the recent installation of Ablatherm® HIFU in Mexico, the expansion of HIFU is on its way in Latin America.
First Ablatherm® HIFU system is now treating in Mexico. The first Ablatherm® HIFU system was installed in Centro Médico Puerta de Hierro Hospital in Guadalajara this month and Dr. Jorge Gutierrez Aceves successfully performed the first treatments for localized prostate cancer. Mexico is the first country in Latin America to adopt Ablatherm® HIFU and the technology is now available in 26 countries worldwide.
3 Sonolith® i-sys systems are now in operation in Ecuador EDAP TMS installed 3 Sonolith® i-sys systems in Ecuador this January and the first treatments were performed successfully by the teams of highly trained physicans. The 3 Sonolith® i-sys are installed in Quito, the capital of Equator, Guayaquil, the largest city of the country and Cuenca, the capital of Azuay province. The national and local Equatorian media widely relayed the installation of these high-tech ESWL systems.
India treats its first prostate cancer patients with Ablatherm® HIFU
On January 21st, the first Indian patients from Muljibhai Patel Urological Hospital in Nadiad, successfully received Ablatherm® HIFU treatment. The Ablatherm® installed at MPUH is the first one installed in India and the technology is now available in more than 25 countries.
Ultrasound & Therapy Community website is launched EDAP TMS is proud to announce that launching of Ultrasound & Therapy Community website for Ablatherm® HIFU and Sonolith® users : "Continuous education and information network for EDAP TMS users". Designed to link Ablatherm® users via Internet, U&T Community website enables all users to have access to online training, videos, images and clinical publications all in one place.
Ablatherm® HIFU is now available in more than 200 centers. In September 2008, the 200th Ablatherm® HIFU treatment center started treating patients for localized prostate cancer.
2 new Ablatherm® HIFU treatment centers in the Netherlands. EDAP TMS is proud to announce the opening of 2 new Ablatherm® HIFU treatment centers in Zaandam and Roosendaal.
Ablatherm® is now operating in the Netherlands EDAP TMS is proud to announce that Ablatherm® is now available in a new country. Amphia Ziekenhuis in Breda (Netherlands) is the first hospital of the country equipped with Ablatherm®.
New HIFU planet website launched in Germany
EDAP TMS launched a dedicated patient website for German prostate cancer patients seeking information on prostate cancer treatment. Visit HIFU planet at http://www.hifu-planet.de/ . Patients will find all information on Ablatherm® treatment and treatment centers addresses.
HIFU planet website in Turkish EDAP TMS is proud to announce the launching of its patient website www.hifu-planet.com in Turkish. HIFU planet website is already available in English, French, German, Italian and Spanish and is dedicated to prostate cancer patients looking for information on Ablatherm® HIFU treatment. After only a few days of activity, 400 visits are recorded!
EDAP Highlights Minimally Invasive Robotic HIFU Technology At British Association of Urological Surgeons Annual Meeting Launches "@-REGISTRY" Database in the United Kingdom.
Prostate cancer, patient web site,
Enlight, USA Clinical Trial