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 issued on
30 October 2002 regarding
HIFU Developments
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.....
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 :
EDAP TMS S.A.
S/PHILIPPE CHAUVEAU
PHILIPPE CHAUVEAU
CHAIRMAN AND CHIEF EXECUTIVE OFFICER
EDAP TMS S.A.
ANNOUNCES SEVERAL HIFU DEVELOPMENTS
-- Update on FDA Discussions and Trials in the USA --
-- Ablatherm Approval in Korea and First Ablatherm Sale in Asia --
Vaulx-en-Velin, France, October 30, 2002-- EDAP TMS S.A. (Nasdaq: EDAP), a global leader in the development, marketing and distribution of a portfolio of minimally-invasive medical devices for the treatment of urological diseases, today announced that it plans to expand the number of U.S. patients treated with localized prostate cancer after failed radiotherapy under its already approved investigational device exemption ("IDE") study. Concurrent to the treatment of U.S. patients in this study, the Company intends on also treating failed radiotherapy patients in Europe in order to gain further validation of the results seen in the U.S.
Additionally,
the Company announced that it has just received formal guidance from the FDA
on its proposed IDE to test its HIFU therapy, the Ablatherm, as a primary
treatment for localized prostate cancer. The FDA has guided the Company to
perform a randomized study versus brachytherapy. It is the Company's intent
to comply with this guidance, but currently this study for the primary treatment
of localized prostate cancer in the U.S. is on hold pending the identification
of a U.S. partner.
As part of its worldwide strategy for HIFU, the Company reinforces its intent
to launch Ablatherm in the U.S. In order to do this in the most effective
manner; the Company will begin, sooner than originally planned, to identify
an American company for the joint development and marketing of the Ablatherm
in the U.S. market. The Company reconfirms that its HIFU division's worldwide
marketing and distribution plan, which does not include U.S. market revenue
in the next several years, has sufficient cash on hand and substantial revenue
growth potential worldwide to reach positive cash flow and profitability.
Finally, as an indication of the worldwide acceptance of the HIFU technology EDAP announced that, on October 22, 2002, the Company received official approval for Ablatherm in South Korea and completed the first sale of an Ablatherm in Asia to the prestigious National Kidney and Transplant Institute ("NKTI") in Manilla, headed by the renowned Dr. Enrique T. Ona.
EDAP TMS S.A.
is the global leader in the development, production, marketing and distribution
of a portfolio of minimally invasive medical devices primarily for the treatment
of urological diseases. The Company currently produces and markets devices
for the minimally invasive treatment of localized prostate cancer, using High
Intensity Focused Ultrasound (HIFU) and the treatment of urinary tract stones
using Extra-corporeal Shockwave Lithotripsy (ESWL). The Company also produces
and markets in Japan and Italy devices for the non-surgical treatment of benign
Prostate Hyperplasia (BPH) using Microwave Thermotherapy (TUMT). The Company
is also developing HIFU for the treatment of certain other types of tumors.
For more information, in the U.S., contact EDAP Technomed Inc., the Company's
U.S. subsidiary located in Atlanta, GA, by phone at (770) 446-9950.