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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