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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6 K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
EDAP TMS S.A. Files
Press release on U.S. Clinical Study
April 4, 2007
EDAP TMS S.A.
Parc Activite La Poudrette Lamartine
4/6 Rue du Dauphine
69120 Vaulx-en-Velin - France
Indicate by check mark whether the registrant files or will file annual reports
under cover Form 20-F or Form 40-F.
Form 20-F [X] Form 40-F [ ]
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes [ ] No [X]
This report on Form 6-K with respect to the Company's 2006 annual results, is
hereby incorporated by reference in the registration statement of EDAP TMS S.A.
on Form F-3, file number 333-136811.
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EDAP TO RESUME US CLINICAL STUDY OF ABLATHERM-HIFU
Company Restarts US Trials for Localized Prostate Cancer HIFU
Management Shifts Reflect Dual European Acceleration, US Launch Strategy
LYON, France, April 3 /PRNewswire/ -- EDAP TMS S.A. (Nasdaq: EDAP), the
global leader in High Intensity Focused Ultrasound (HIFU) treatment of
prostate cancer and the international leader in the development, production,
and distribution of a wide portfolio of minimally invasive medical devices
primarily for the treatment of urological diseases, announced the transfer of
US clinical study responsibilities and conclusion of its management succession
plan announced December 2006. EDAP now has full rights to future US market
sales and profit following its elimination of the prior partnership
arrangement. Ablatherm-HIFU must complete an already begun FDA clinical study
and receive FDA clearance in order to be marketed in the US.
"We have completed a full review of the FDA program in the US over the
past three months and have made the decisions necessary to move forward with
this important clinical program," said Hugues de Bantel, in charge of the US
FDA programs for EDAP. "The IDE has been fully transferred to EDAP with
clinical screening and patient enrollment proceeding immediately at centers
including Duke, Georgetown, the Cleveland Clinic, Thomas Jefferson and
Vanderbilt among many others. We are evaluating numerous requests from
additional highly qualified medical centers to join the study. We are
examining patient awareness options to speed up study subject enrollment. Our
study centers are very enthusiastic about the Ablatherm trial as are our FDA
support team including M Squared Associates, Inc., as the clinical study
management and regulatory support group and Hogan and Hartson, as the group
supporting FDA communications and submissions. In the process of this review,
we spoke with numerous medical device and clinical study organizations, all of
whom agreed that the clinical study protocol defines a very well designed
study. Clearly Ablatherm's proven history and global leadership position are
attracting strong interest from potential partners in this clinical study."
The company intends to begin treatments at participating clinical centers
by the end of April. Patients interested in learning more about participating
in the trial can locate centers and examine the inclusion criteria online at
http://www.edap-tms.com .
Management Succession Plan Complete
Reflecting the full approval and broad support of Ablatherm-HIFU in Europe
where the company primarily markets its products today, the company promoted
former Chief Operating Officer Marc Oczachowski to the role of CEO with focus
on European growth and making Ablatherm-HIFU a new standard of care in
treatment of localized prostate cancer. Outgoing CEO Hugues de Bantel joins
the Company Board of Directors with active leadership responsibilities for the
US FDA program and securing additional reimbursement approvals for the
company's global leading Ablatherm-HIFU device.
Philippe Chauveau, Chairman of EDAP, stated, "This succession clearly
confirms the evolution of EDAP to a full marketing and growth business rapidly
advancing HIFU therapy in the field of prostate cancer from its position as
the unparalleled leader in both technology and clinical outcomes. This
structure focuses the company on its strategy to accelerate European HIFU
growth through successful execution of its education and Revenue-Per-Procedure
programs. Additionally, the company will now have dedicated resources focused
exclusively on reimbursement and approval programs, especially relating to the
United States where EDAP owns full rights to this important global market.
EDAP is the only company capable of making HIFU a new standard of care in
localized prostate cancer on both continents, and we intend to do so."
"EDAP and Ablatherm-HIFU are the undisputed leaders in clinical success
for localized prostate cancer HIFU with the only clinical outcomes that rival
traditional therapies with proven long term repeatability and sustainability,"
said Oczachowski. "In Europe, EDAP is the clear leader based on our clinical
results showing the best efficiency of treatment, repeatability of outcomes
and consistent successful use of HIFU for localized prostate cancer. We are
now moving to build a strong US focus to secure approval based on our clinical
excellence; then take the same leadership role based on Ablatherm-HIFU's cost
efficiency to the hospital and quality of care to the patient desiring
effective treatment from his urologist with low side effects."
About EDAP TMS S.A.
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 http://www.edap-tms.com and
http://www.hifu-planet.com.
To sign up for alerts please visit:
http://www.b2i.us/irpass.asp?BzID=1053&to=ea&s=0
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 S.A.
-0- 04/03/2007
/CONTACT: Blandine Confort of EDAP TMS S.A., +33-4-78-26-40-46; or Matt
Kreps of Magnolia Investor Relations, +1-972-801-4900, for EDAP TMS S.A./
/Web site: http://www.edap-tms.com
http://www.clinicaltrials.gov
http://www.hifu-planet.com
http://www.b2i.us/irpass.asp?BzID=1053&to=ea&s=0 /
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
Date: April 4, 2007
EDAP TMS S.A.
/s/ MARC OCZACHOWSKI
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MARC OCZACHOWSKI
CHIEF EXECUTIVE OFFICER