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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 2006 Results
January 23, 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 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 TMS S.A. UPDATES 2006 YEAR END REVENUE ESTIMATES, OUTLOOK
EDAP LEVERAGING POSITIONS IN EUROPE FOR HIFU; FINALIZING US MARKET STRATEGY
LYON, France, Jan. 23 /PRNewswire-FirstCall/ -- EDAP TMS S.A. (Nasdaq:
EDAP), the global leader in High Intensity Focused Ultrasound (HIFU) treatment
of prostate cancer announced estimated financial outcomes from its 2006 fiscal
year ended December 31. The company showed clear success in the planned
transition to its recurring revenue per procedure business.
For fiscal year 2006, total revenues are estimated at Euro 20 million ($26
million). For the full year, RPP revenues increased by approximately 60 percent
to more than Euro 2.8 million in response to market growth and the company's new
marketing and education initiatives launched in the second half. Service and
disposable revenue increased to more than Euro 2.2 million. Sales include
revenue from 8 Ablatherm and 37 ESWL devices during the period. At the end of
2006, cumulative Ablatherm treatments reached over 11,000 procedures,
approaching 3,000 in 2006, and the number of trained Ablatherm sites approached
130.
Cash at year end is estimated at Euro 10.9 million ($14.3 million), up from
Euro 10.5 million at September 30, 2006. Cash reflects increased spending on the
company's marketing programs offset by positive cash from equipment sales and
financing of units dedicated to the company's growing RPP business. The company
enters the 2007 first quarter with a strong machine backlog in the UDS division
plus an RPP treatment backlog in the HIFU division. With its strong cash
position, EDAP is now reinforcing its marketing and sales strategy, including
the addition of five senior sales professionals and a targeted marketing
spending of approximately Euro 2.4 million ($3.1 million), to expand its growth
activity in key markets.
"The results of 2006 reflect the successful shift in company strategy to
focus on developing the RPP program in key European markets, which creates a
predictable and recurring base of treatment revenue and more rapid adoption of
Ablatherm-HIFU," said Marc Oczachowski, Chief Operating Officer. "We are clearly
achieving success in Europe while rolling out our aggressive sales and
educational programs fully dedicated to establishing a strong 'HIFU Community.'
We see growing interest and demand for Ablatherm-HIFU from both physicians and
patients. We expect to strongly grow the number of patients for HIFU in the near
future. EDAP is dedicating significant resources, as planned, in marketing and
PR programs, e-learning and developing close contacts with supportive patient
advocacy groups to broadly discuss the benefits of Ablatherm-HIFU. This,
together with strong published data, will position Ablatherm-HIFU as a standard
of care for prostate cancer. EDAP is the undisputed leader in prostate cancer
HIFU by treatments, clinical success and medical credibility. We will continue
to advance this position aggressively."
The company also announces the recent launch of an additional Ablatherm-HIFU
treatment site in Wiesbaden, Germany, under the RPP program. Germany remains the
global leading market for HIFU with EDAP the clear driving force in HIFU therapy
for clinical sites in this key country. Dr. Von Kellenbach, Head of the Urology
Department, commented: "HIFU is establishing itself as a serious method in
prostate cancer treatment and expands our possibilities. We appreciate the
careful way EDAP goes about introducing new centers to HIFU treatment and were
convinced by the professional management. Personally we believe in giving
patients a solid option besides radical prostatectomy and radiation including
brachytherapy." The company is also organizing its first "HIFU tours" starting
next month in Germany covering major cities with a peer-to-peer HIFU education
program to accelerate further Ablatherm site growth.
In the United States, the approval process is currently being reviewed
following the decision of the Company's prior US partner to discontinue
Ablatherm FDA trials. EDAP is finalizing with its panel of experts a clear
pathway to approval, including an update of the trial protocol. The company also
expects the release of the first-ever long-term clinical data, supporting the
efficacy of HIFU for localized prostate cancer treatment and confirming
Ablatherm-HIFU as a solid therapeutic option.
Hugues De Bantel, Chief Executive Officer, commented: "At this stage, EDAP
is in the process of selecting the best option to address the US market,
including self-sponsoring the study for a direct launch as well as contracting
with new partners."
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 Halliburton Investor Relations
at (972) 458-8000, 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.
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.
CONTACT: EDAP TMS S.A. Halliburton Investor Relations
Blandine Confort Matt Kreps
+33 4 78 26 40 46 972 458 8000
SOURCE EDAP TMS S.A.
-0- 01/23/2007
/CONTACT: Blandine Confort, of EDAP TMS S.A., +33-4-78-26-40-46; or, Matt
Kreps, of Halliburton Investor Relations, for EDAP TMS S.A., +1-972-458-8000/
/Web site: http://www.edap-tms.com
http://www.hifu-planet.com /
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 : January 23, 2007
EDAP TMS S.A.
/S/ HUGUES DE BANTEL
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HUGUES DE BANTEL
CHIEF EXECUTIVE OFFICER