Healthcare Industry News:  ultrasound 

Devices Distribution

 News Release - January 30, 2012

EDAP Regains Ablatherm(R)-HIFU Distribution Rights in Canada and Caribbean

Leverages Growing U.S. Awareness and Demand for Minimally Invasive Prostate Cancer Treatment to Drive Off-Shore Market Potential

LYON, France, Jan. 30, 2012 -- (Healthcare Sales & Marketing Network) -- EDAP TMS SA (Nasdaq:EDAP ), a global leader in therapeutic ultrasound, announced today that it has regained the distribution rights for its Ablatherm(R)-HIFU treatment in Canada and the Caribbean. In 2005, EDAP entered the North American market with an exclusive sales agreement with Maple Leaf HIFU, which has expired. The Company plans to leverage its growing presence among U.S. urologists to expand the off-shore potential of this non-invasive attractive HIFU treatment option for prostate cancer patients that is not yet available in the U.S.

EDAP will now, effective immediately, be in direct control of leveraging the strong market potential across North America as the demand for minimally invasive treatment of prostate cancer and the preservation of patients' quality of life continues to grow. American urologists and patients will now benefit from direct access to our HIFU technology through EDAP's surging U.S. presence. This is a timely development as the Company receives more and more requests for this treatment, which is not yet available in the U.S.

EDAP has an increasing presence among U.S. urologists through its sales and marketing network developed to promote its FDA approved Sonolith range of lithotripters. Based on these relationships, EDAP has become aware of the opportunity to leverage these relationships to offer treatment options to urologists and patients.

Marc Oczachowski, Chief Executive Officer of EDAP TMS, commented, "We are most excited to leverage this opportunity to provide patients in the U.S. with access to our Ablatherm-HIFU technology through convenient offshore locations. We now have a well-organized and active US based EDAP Technomed subsidiary in charge of sales and marketing geographically close to North American markets allowing us to seize all opportunities and requests for Ablatherm-HIFU."

Marc Oczachowski continued, "We are at the end of our follow-up phase in our FDA approval process for the Ablatherm-HIFU. We plan to submit our file to the FDA by the end of 2012 and expect a response from the agency in the early days of 2013. Retrieving the rights to all of North America is a huge opportunity for EDAP to start building the US market in both answering patients and urologists needs with an off-shore solution and in establishing its network of partners, users and customers in the US. We are laying the foundation in advance of the anticipated approval for our Ablatherm-HIFU."

About EDAP TMS SA

EDAP TMS SA develops and markets Ablatherm(R), 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 multi-center U.S. Phase II/III clinical trial under an Investigational Device Exemption (IDE) granted by the FDA, the ENLIGHT U.S. clinical study. 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 (the Sonolith(R) range) 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.


Source: EDAP TMS

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