News & Media
EDAP TMS SA, today announced that the U.S. Food and Drug Administration (FDA) Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will review the Pre-Market Approval ("PMA") application for EDAP's Ablatherm-HIFU device for the treatment of localized prostate cancer on July 30, 2014.
EDAP TMS, announced that HIFU for the primary treatment and salvage therapy of localized prostate cancer are recommended by the European Urology Association in its 2014 Guidelines released in April at the EAU's Annual Congress held inStockholm.
Reimbursement of HIFU for Prostate Cancer - Apr 21, 2014
Reimbursement of HIFU for Prostate Cancer in France
EDAP TMS, announced today that it has completed its response to questions from the FDA regarding the Company's Ablatherm-HIFU Pre-Market Approval ("PMA") application, closing this step within the U.S. Food and Drug Administration ("FDA") review process.
EDAP TMS announced today the installation of its Focal One device at the ESKULAP Private Hospital in Bydgoszcz, Poland.
Arnaud MONTEBOURG en visite à EDAP TMS - Oct 2, 2013
Arnaud MONTEBOURG, Ministre du redressement productif se rendra à la société EDAP TMS vendredi 4 octobre.
EDAP to Raise $12 Million in Registered Direct Offering - May 21, 2013
EDAP TMS SA , announced that it has entered into definitive agreements with certain institutional investors for a registered direct placement of $12 million of ordinary shares in the form of American Depositary Shares ("ADSs") at a price of $4.00 per share, with warrants attached.
EDAP's Ablatherm-HIFU Demonstrates Long Term Efficacy, Durability and Reproducibility With Prospective Fourteen -Year Study - May 20, 2013
Third Long Term Study Published in 2013 Validates Ablatherm-HIFU as First Line Treatment of Prostate Cancer
- Four Scientific Sessions Highlighted HIFU for Treatment of Prostate Cancer
- HIFU Featured in Plenary Lecture and Two Moderated Posters at Engineering and Urology Society Meeting
- Significant Interest in both HIFU and ESWL Technologies at EDAP Booth
EDAP Reports Fourth Quarter 2012 and Full Year Results Highlights - Apr 2, 2013
EDAP Reports Fourth Quarter 2012 and Full Year Results Highlights Record fourth quarter 2012 revenue of EUR 9.5 million (USD 12.3 million), up 25.3% year-over-year Record full year revenue of EUR 26.1 million (USD 33.6 million), up 16.9% year-over-year Record lithotripsy sales in 2012 PMA for Ablatherm®-HIFU for treatment of low risk, localized prostate cancer accepted by the FDA for filing on March 26, 2013
EDAP TMS Receives U.S. FDA Filing Acceptance of Pre-Market Approval Application - Mar 28, 2013
Ablatherm® HIFU PMA Application Proceeds to Substantive Review EDAP TMS announced today that the U.S. Food and Drug Administration has provided a positive Filing Review Notification on the Company's Pre-Market Approval (PMA) application for its Ablatherm Integrated Imaging HIFU (High Intensity Focused Ultrasound) device for the treatment of low-risk, localized prostate cancer. The FDA conducted a filing review of EDAP's PMA, and found it to contain all of the information needed to proceed with the substantive review, in which the FDA will evaluate the safety and effectiveness of Ablatherm Integrated Imaging HIFU device, as well as EDAP's engineering, manufacturing and quality systems.
EDAP Introduces Focal.One(R): A New Robotic HIFU Device for Focal Therapy of Prostate Cance - Mar 14, 2013
Focal.One World Premiere at European Association of Urology Annual Congress. EDAP TMS SA, the global leader in therapeutic ultrasound, announced today the launch of Focal.One®, its new and innovative robotic HIFU device fully dedicated to focal therapy of prostate cancer. Focal.One® will be showcased for the first time at the European Association of Urology (EAU) 28th Annual Congress to be held in Milan, Italy on March 15-19, 2013 (booth # D41).
Munich Study Concludes 15 Year Outcome Data May Warrant Closing of Investigational Phase for HIFU
EDAP TMS SA, the global leader in therapeutic ultrasound, announced today new long term data demonstrating high rates of both cancer-specific survival, and freedom from salvage therapy for patients treated with high-intensity focused ultrasound (HIFU) therapy.
EDAP's Ablatherm-HIFU Demonstrates Long-Term Efficacy and Safety Over Fourteen-Year Period - Feb 8, 2013
Longest Retrospective Study of HIFU Patients to Date Published Confirms Benefits of Treatment
EDAP TMS Submits U.S. FDA Pre-Market Approval Application for Ablatherm(R)-HIFU for Treatment of Low Risk, Localized Prostate Cancer - Feb 1, 2013
EDAP TMS, the global leader in therapeutic ultrasound, announced today the submission of its Pre-Market Approval (PMA) application to theU.S. Food and Drug Administration (FDA) onJanuary 31, 2013 for the Company's Ablatherm-HIFU (High Intensity Focused Ultrasound) for treatment of low risk, localized prostate cancer.
Strengthens Sales Team In Line With Strategy to Focus on U.S. Urology Market
EDAP TMS SA announced today the appointment of Bill Brown as U.S. based Senior Sales Manager. Mr. Brown joins EDAP's U.S. team to enhance the market penetration of the Company's Sonolith i-move extracorporeal lithotripsy (ESWL) system, expand U.S. lithotripsy sales initiatives, and begin to prepare for potential U.S. Food and Drug Administration (FDA) approval of the Company's Ablatherm-HIFU (High Intensity Focused Ultrasound) device.
Strengthens Team for Final Stages of Ablatherm-HIFU Phase II/III Clinical Trial for Prostate Cancer
EDAP TMS SA today announced the retention of Greenleaf Health LLC, a full service regulatory consulting firm. Greenleaf Health will provide the Company with high-level strategic guidance regarding the final stages of its Ablatherm-HIFU (High Intensity Focused Ultrasound) ENLIGHT U.S. Phase II/III clinical trial for the indication of low risk, localized prostate cancer.
EDAP TMS SA, today provided an update regarding its Ablatherm-HIFU (High Intensity Focused Ultrasound) ENLIGHT U.S. clinical trial for the indication of low risk, localized prostate cancer. The trial is a multi-center U.S. Phase II/III clinical trial conducted under an Investigational Device Exemption (IDE) granted by the FDA. As previously announced, the last Ablatherm-HIFU patient was treated in June 2010. The two year anniversary of the last patient treated occurred on June 30, 2012, which marked the conclusion of the two year follow-up phase, and the Company confirms the completion of all two year follow-up visits.
Major shift in EDAP's strategy - May 16, 2012
Philippe Chauveau, EDAP's Chairman of the Board of Directors, said, "The Board has unanimously decided upon a major shift in EDAP's strategy and recommended, with immediate effect, that EDAP focus its efforts on the U.S. market where opportunities and priorities have been identified. This focus will involve immediate relocation to the U.S. of EDAP's CEO Marc Oczachowski."
Installation of a third Sonolith i-move lithotripter in the U.S - May 4, 2012
EDAP TMS SA announced today the installation of a third Sonolith i-move lithotripter in the U.S. The revolutionary lithotripter has been delivered to Allied Metro, a New York tri-state area partnership with more than 300 urologists.
Ablatherm® HIFU posters receive best poster awards at EAU 2012 in Paris - Feb 27, 2012
Among the 7 Ablatherm® HIFU poster presentations at EAU 2012 in Paris, 2 posters have been awarded "Best Posters" highlighting HIFU clinical data relevance.
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "This confirms the recognition and acceptance of HIFU as one of the hottest topic in modern urology. It validates the support from the international urology community for Ablatherm-HIFU's positioning as a complement to surgery in addressing prostate cancer and proven ability to bring minimally invasive treatment to patients and urologists."
First Sonolith i-move now in use in the United States - Jan 4, 2012
New York Methodist Hospital (NYM) is the very first American hospital to acquire and use the Sonolith® i-move, the latest generation of Electroconductive lithotripter by EDAP TMS. "With the added conveniences of a handheld ultrasound probe to locate the stones, and the ability to generate consistent shock waves, we can treat lithotripsy patients with more precision and accuracy than ever before," said Grunberger, Head of Urology Division at NYM.
EDAP TMS partnership received €2.4 million grant for the developpement of new imaging technology - Aug 25, 2011
The development partnership, comprised of EDAP TMS, Edouard Herriot Hospital, and SuperSonic Imagine, received the highly competitive grant from Fonds Unique Interministerial (FUI), a French government fund for advancing technical innovation with short and midterm market applications. Marc Oczachowski, CEO quoted: "We are proud that our partnership won this grant, as it is another strong recognition and validation of EDAP as the leading player in the development of HIFU. [...] It will strengthen Ablatherm-HIFU's position as the premier gold standard for the non-invasive treatment of prostate cancer in line with current and future therapeutic strategies."
Sonolith® i-move, the high-tech latest generation of Sonolith lithotripters just received FDA approval.
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "This FDA clearance is a major milestone for EDAP and its U.S. business. The Sonolith i-move lithotripter is a technologically advanced device with modularity and mobile capability. We believe our Sonolith i-move is attractively positioned to take market share in the U.S., the second largest lithotripsy market worldwide. Our established U.S. sales and marketing organization has clearly identified potential customers within this dynamic lithotripsy market."
Join EDAP TMS on Facebook now! - Jul 12, 2011
You can now access all the EDAP TMS fresh news on Facebook. Join us now! www.facebook.com/edaptmscompany
Sonolith i-sys receives approval in Taiwan - Jun 21, 2011
Taiwan health authorities granted Sonolith® i-sys approval on the market. With the recent approval of Sonolith® i-move in Japan, this new approval is a major step towards broad acceptation of our lithotripters in Asia.
Sonolith i-move receives approval in Japan - Jun 21, 2011
EDAP TMS' latest lithotripter, Sonolith® i-move, receives market approval from the Japanese Health Authorities. This approval is a milestone for Sonolith® i-move as Japan is the first lithotripter market worldwide. The full range of Sonolith® lithotripters is now available on the Japanese market enabling to cover the market needs with a high tech modular device (Sonolith® i-move) and a high-end device (Sonolith® i-sys).
Ablatherm now reimbursed in France under a special innovative therapies regimen - Feb 9, 2011
The French National Authority for Health (HAS - Haute Autorité de Santé) granted Ablatherm® HIFU treatment temporary reimbursement authorization under a special regimen for innovative therapies. More than 10 years after obtaining CE marking, the temporary reimbursement is a major step towards acceptation of HIFU as a standard treatment for prostate cancer.
First Ablatherm HIFU now treating prostate cancer patients in the Caribbean - Feb 8, 2011
CEDIMAT Center (Centro Diagnóstico, Medicina Avanzada y Telemedicina) in Santo Domingo, Dominican Republic is the first hospital of the Carribean to offer Ablatherm® HIFU treatment for prostate cancer. Dr. Octavio Cruz Piñeda has already performed 8 treatments with Stefan Thüroff, the most experiences Ablatherm® HIFU user with more than 2,000 patients treated. With the Ablatherm® HIFU treatment now available in the Caribbean, EDAP TMS reinforces the accessibility to Ablatherm® HIFU - minimally-invasive treatment for prostate cancer - in North America.
First Sonolith i-sys now in operation in South Africa - Jan 18, 2011
Pretoria Urology Hospital (PUH), the largest private urology hospital in South Africa, has installed and started treating patients with the first Sonolith i-sys lithotripter of the country. Only one year after the installation of the first Ablatherm HIFU device in South Africa in PUH, the installation of the first Sonolith i-sys is a major milestone in EDAP TMS' strategy to penetrate new markets.
Sonolith i-move receives Korean FDA approval - Dec 20, 2010
Less than one year after being launched in Europe, the Sonolith i-move, EDAP TMS' new modular lithotripter received Korean FDA (KFDA) approval. Korean is the second largest Asian market for lithotripsy behind Japan and this approval is an opportunity to gain market share and to reinforce our position as one of the leaders on the Korean market.
EDAP TMS receives 2010 Innovation Trophy for Sonolith i-move - Nov 23, 2010
The 2010 Rhône-Alpes Innovation Trophy ceremony awarded EDAP TMS the Product Innovation Trophy for its Sonolith® i-move, the revolutionnary lithotripter launched in 2010. This prize materializes our R&D efforts and our long tradition of innovation to bring safe, effective and minimally invasive treatment solutions for urological conditions.
HIFU for liver metastases from colorectal cancer - Nov 5, 2010
6 patients have successfully been treated with EDAP TMS' new HIFU device for liver cancer in the framework of a preliminary trial at Léon-Bérard center in Lyon, France. The first results confirm the feasibility of this innovative perioperative approach. This first step is very encouraging for this new application of HIFU technology developed jointly with the Inserm (French National Institute of Medical Research). Next step of the evaluation program on human is already scheduled for early 2011.
HIFU PLANET website available in Spanish, Italian and Dutsch - Sep 29, 2010
A recent in-press publication in European Urology reported long-term clinical outcomes of 803 patients treated with Ablatherm® HIFU between 1993 and 2007. This study conducted by Dr. Sébastien Crouzet, the control of the disease was achieved with an 85% rate of negative biopsies and a biochemical disease free survival rate (Phoenix criteria) of 83% in low risk cancer patients. The durability of efficacy outcomes of robotic Ablatherm-HIFU in the treatment of localized prostate cancer is now established out to eight years.
HIFU PLANET website receives HonCode certification - Jul 16, 2010
HIFU Planet, our website dedicated to patient information on prostate cancer and AblathermÂ® HIFU treatment just received HONcode certification.You can visit the websites www.hifu-planet.co.uk and www.hifu-planet.fr . HONcode is the oldest and the most used ethical and trustworthy code for medical and health related information available on Internet. We are proud to bear this internationnally renowned certification and to provide reliable information for patients.
Fist Sonolith® i-sys lithotripter in operation in Japan - Jul 8, 2010
Now online: check out new HIFU PLANET website - Jun 8, 2010
Sonolith i-move receives CE marking - Apr 13, 2010
EDAP TMS nominated for European Inventor Award 2010 - Mar 29, 2010
EDAP TMS symposium success in Washington D.C. - Mar 4, 2010
Journée de la prostate : vous avez le droit de savoir - Sep 15, 2009
First Ablatherm® HIFU sold in Bolivia - Sep 11, 2009
Sonolith® i-sys receives FDA approval - Aug 24, 2009
Ablatherm HIFU receives approval in Argentina - Jun 3, 2009
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 BrazilÂ earlier this year, the approval in Argentina shows thatÂ Ablatherm HIFU is gaining acceptance in South America.Â
AURO publishes official guidelines regarding HIFU treatment - Apr 22, 2009
Â In its latest recommendations, the AURO (Association of Italian Urologists) recommends AblathermÂ® 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 - Apr 9, 2009
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 - Apr 2, 2009
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 - Feb 24, 2009
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. - Feb 12, 2009
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 - Dec 11, 2008
Ablatherm® HIFU is now available in more than 200 centers. - Nov 10, 2008
2 new Ablatherm® HIFU treatment centers in the Netherlands. - Oct 20, 2008
Ablatherm® is now operating in the Netherlands - Aug 26, 2008
New HIFU planet website launched in Germany - Jul 30, 2008
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 - Jul 30, 2008
EDAP Expands Ablatherm-HIFU Business in Germany - Jul 15, 2008
Two Additional Centers Continue to Drive Revenue Per Procedure Adoption.
EDAP Highlights - Jun 30, 2008
Minimally Invasive Robotic HIFU Technology At British Association of Urological Surgeons Annual Meeting Launches "@-REGISTRY" Database in the United Kingdom.
EDAP Reports Publication Highlighting - Jun 10, 2008
EDAP Reports Publication Highlighting Ablatherm's Safety and Efficacy in Prostate Cancer
The French Association of Urology Defines the Indications for HIFU as Standard of Care for Prostate Cancer
EDAP Reports Q1 2008 - May 15, 2008
EDAP Reports First Quarter 2008 Financial Results
MD Anderson Cancer Center - May 13, 2008
EDAP Adds Premiere M.D. Anderson Cancer Center for Phase II/III Ablatherm-HIFU Clinical Trial
EDAP Conf Call Q1-08 - May 5, 2008
EDAP Announces Webcast and Conference Call of First Quarter 2008 Results