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 on
February
3, 2009
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 Forms F-3, file number 333-136811 and
333-147762.
PRESS
RELEASE – FOR IMMEDIATE RELEASE
|
Contact:
Blandine
Confort
Investor
Relations / Legal Affairs
EDAP
TMS SA
+33
4 72 15 31 72
bconfort@edap-tms.com
|
Investors:
R.J.
Pellegrino
The
Ruth Group
646-536-7009
rpellegrino@theruthgroup.com
|
EDAP Reports Record 2008 Fourth Quarter and
Full Year Preliminary Unaudited Revenues
Fourth Quarter 2008
Highlights:
|
·
|
Record
revenue of EUR 9.0 million, up 29%
year-over-year
|
|
·
|
Ablatherm-HIFU
RPP treatments increased 32%
year-over-year
|
|
·
|
Strong
EUR 15.0 million (USD 20.8 million) cash
position
|
|
·
|
Robust
backlog of Ablatherm-HIFU and lithotripsy devices entering
2009
|
LYON, France, February 3, 2009
– EDAP TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound,
announced today preliminary top-line financial revenues for the fourth
quarter and full year ended December 31, 2008.
For the
fourth quarter 2008, the Company reported record total revenue of approximately
EUR 9.0 million up 29% compared to the same period in 2007. Full year revenues
were approximately EUR 23.0 million, compared to EUR 22.2 million in the same
period last year. The Company has reported record revenue growth for the past
two consecutive years.
Marc
Oczachowski, EDAP’s Chief Executive Officer, commented, “We are pleased with
record revenue achieved during the fourth quarter. Our top line growth reflected
the positive trend we had anticipated for Ablatherm-HIFU sales as well as the
majority of our third quarter 2008 backlog successfully converting into revenue.
We continue to experience an increase in order flow, which is further supported
by our robust fourth quarter HIFU and lithotripsy backlog. We expect this
backlog to support our revenues into the first half of 2009.”
Mr.
Oczachowski continued, “Given the current economic uncertainty, we continue to
prudently manage our financial resources and preserve our strong cash position,
enabling us to move forward aggressively with our long-term growth
strategy.”
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,
http://www.hifu-planet.com
and http://www.pcaresearch.com.
Forward-Looking
Statements
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 FDA-approved or marketed in the United
States.
# #
#
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 :
February 3, 2009
EDAP TMS
S.A.
/S/ MARC
OCZACHOWSKI
MARC
OCZACHOWSKI
CHIEF
EXECUTIVE OFFICER