EDAP TMS S.A. Announces a Letter of Intent With HealthTronics on Ablatherm(R) In the U.S.A.
16 December 2003 - 8:00AM
PR Newswire (US)
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/
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