EDAP TMS S.A. and HealthTronics Surgical Services, Inc. Announce Finalization Of Agreement for Ablatherm(R) in the U.S.A.
March 01 2004 - 8:01AM
PR Newswire (US)
EDAP TMS S.A. and HealthTronics Surgical Services, Inc. Announce
Finalization Of Agreement for Ablatherm(R) in the U.S.A. Allows
HealthTronics to Pursue PMA Approval and Grants Distribution Rights
In the U.S.A. VAULX-EN-VELIN, France and MARIETTA, Ga., March 1
/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, and HealthTronics Surgical Services, Inc. , a leading
provider of minimally invasive surgical services for the urologic
and orthopaedic communities, today announced that the two companies
finalized a distribution agreement for Ablatherm in the United
States. The distribution agreement is based on a letter of intent
entered into by both companies in December 2003. The distribution
agreement grants 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 grants HealthTronics
exclusive distribution rights in the United States, when and if a
PMA is granted bythe FDA. The Ablatherm, which is currently being
utilized at 42 sites, has successfully treated more than 4,500
patients in Europe. The final agreement between the two companies
includes the issuance of warrants by EDAP TMS to HeathTronics in
consideration for providing services related to pursuing a PMA from
the FDA. The issuance of warrants was approved by the shareholders
of EDAP TMS at an extraordinary shareholder meeting held January
29, 2004. The warrants issued to HealthTronics vest at various
times based on certain milestones related to the PMA process and
based on certain lithotripsy purchase expectations. Philippe
Chauveau, Chairman and Chief Executive Officer of EDAP TMS S.A.
commented, "We are very excited to announce that we have finalized
our agreement with a U.S. partner for our HIFU technology. In
HealthTronics, we feel we have found a partner who will champion
HIFU in the United States and will work to bring this technology to
the people who will benefit the most from it, the hundreds of
thousands of men who are diagnosed each year with localized
prostate cancer." Argil J. Wheelock, M.D., Chairman and Chief
Executive Officer of HealthTronics Surgical Services, commented,
"Our partnership with EDAP offers us the opportunity to introduce a
very exciting new prostate cancer treatment modality to the United
States. After discussions with several well-known urologists in
Europe and observing several cases, I am convinced that HIFU has
great potential to play an important role in the treatment of
prostate cancer. In Europe, HIFU has been shown to be clinically
effective and very cost efficient. Several prominent urologists in
the United States have already expressed a strong interest in
participating in our FDA clinical trials. These factors, along with
our previous experience in getting products and treatments through
the FDA process, gives me confidence that we will be successful in
getting HIFU with the Ablatherm approved for use in the United
States. We believe that this agreement will benefit patients, third
party payers, urologists and our shareholders." About the
Companies: 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.edap-tms.com/.
HealthTronics Surgical Services, Inc. is one of the nation's
leading providers of non-invasive and minimally invasive surgical
services for certain urologic and orthopaedic conditions. The
Company provides technical and administrative services to
physicians, hospitals and ambulatory surgery centers using
extracorporeal shock wave devices. The two primary services offered
by HealthTronics are lithotripsy extracorporeal shock wave
treatment, which is a procedure for treating kidney stones in a
non-invasive manner, and Orthotripsy(r) extracorporeal shock wave
surgery, which is a procedure for treating orthopaedic soft tissue
disorders in a non-invasive manner. The Company has operations in
approximately 45 states in the United States. More information
about HealthTronics Surgical Services can be found at the Company's
web site, http://www.healthtronics.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.; HealthTronics Surgical Services, Inc. CONTACT: Philippe
Chauveau or Blandine Confort both of EDAP TMS S.A.,
+33-4-72-15-31-50, or Ian Vawter of EDAP Technomed Inc.,
+1-770-446-9950 Web site: http://www.edaptechnomed.com/
http://www.healthtronics.com/ http://www.edap-tms.com/
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