EDAP TMS (NASDAQ:EDAP)
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EDAP TMS S.A. Announces a Letter of Intent With HealthTronics on Ablatherm(R) In
the U.S.A.
- Agreement to Allow Right to Pursue PMA Approval and Grants Distribution Rights
-
VAULX-EN-VELIN, France, Dec. 15 /PRNewswire-FirstCall/ -- EDAP TMS S.A. , 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 has entered into a letter of intent with HealthTronics
Surgical Services, Inc. ("HealthTronics") . This letter of intent outlines terms
that would grant HealthTronics the right to begin clinical trials with the
Ablatherm, a medical device that utilizes High Intensity Focused Ultrasound
("HIFU") to provide minimally invasive treatment of prostate cancer, to obtain
Pre-Market Approval ("PMA") from the Food and Drug Administration ("FDA") and
would grant HealthTronics exclusive distribution rights in the United States,
when and if, a PMA is granted by the FDA. The letter of intent is subject to
the negotiation and execution of definitive agreements between EDAP TMS and
HealthTronics.
The final agreement between the two companies will include the issuance of
warrants by EDAP TMS S.A. to HeathTronics in consideration for providing
services related to pursuing a PMA from the FDA. Certain aspects of the
proposed transaction will require the approval of the shareholders of EDAP TMS
at an extraordinary shareholder meeting prior to the execution of a final
agreement. The Board of Directors anticipates calling such a meeting to be held
at the end of January 2004. Shareholders of EDAP TMS S.A. will receive details
of the resolutions to be voted on as soon as the Board has finalized the meeting
and record dates.
Philippe Chauveau, Chairman and Chief Executive Officer of EDAP TMS S.A.
commented, "We are pleased to announce that we are moving forward with a
partnership in the United States for our HIFU technology. We look forward to
discussing this partnership with our shareholders as we progress towards the
shareholders meeting at the end of January, 2004." Argil J. Wheelock, M.D.,
Chairman and Chief Executive Officer of HealthTronics Surgical Services, Inc.
commented, "We are very pleased to have reached preliminary terms with EDAP and
look forward to finalizing a definitive agreement and moving forward with the
project."
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.
For additional information on the Company, please see the Company's web site at:
http://www.edaptechnomed.com/.
This press release contains, in addition to historical information,
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 the 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.
CONTACT: Philippe Chauveau / Blandine Confort
33.4.72.15.31.50
Ian Vawter - EDAP Technomed Inc.
1.770.446.9950
DATASOURCE: EDAP TMS S.A.
CONTACT: Philippe Chauveau or Blandine Confort, +33-4-72-15-31-50, or
Ian Vawter of EDAP Technomed Inc., +1-770-446-9950
Web site: http://www.edaptechnomed.com/