EDAP
TMS S.A. Closes $20 Million Placement to Fully Fund Its U.S. Clinical
Studies
Company
Now in Position to Roll-Out Its U.S. Strategy
LYON,
France, Nov. 5, 2007 (PRIME NEWSWIRE) -- EDAP TMS S.A. (Nasdaq:EDAP), the
global
leader in High Intensity Focused Ultrasound treatment of prostate cancer,
announces that it has closed its capital raise with selected U.S. based
qualified institutional buyers, pursuant to which the investors purchased
US $20
million in Unsecured Convertible Debentures, convertible into EDAP's ordinary
shares, to be delivered in the form of American Depository Receipts ("ADRs").
The Company expects this investment to fully fund EDAP's ongoing Phase
II/III
clinical studies of Ablatherm-HIFU at selected leading cancer treatment
centers
across the U.S. Eligibility criteria and center information can be found
online
at www.clinicaltrials.gov or at participating centers.
"We
are
extremely happy with this financing because it provides EDAP with all the
necessary funds to make HIFU a standard of care in the U.S., the most important
market in the world for treatment of prostate disease," said EDAP CEO Marc
Oczachowski. "Our European program, based on aggressive marketing and sales
activity, is well on track, supported by last year's PIPE, and we are
experiencing high growth in our Revenue-Per-Procedure business model, as
reported. We believe EDAP now has all the resources we need to complete
our
ongoing U.S. clinical trials, which will allow us to seek FDA approval
of
Ablatherm HIFU within our expected timeframe, conforming our approved study
protocol. In addition, we believe we have the right team in place to
successfully conclude these trials, with our new North American-based Medical
Director leading our group of investigators that are, without any doubt,
among
the best prostate cancer treatment centers in the U.S. and in the world.
Thanks
to this financing, we believe all of our strategic programs are now fully
funded
and well on track towards full success of Ablatherm HIFU as the real robotic
option to treat localized Prostate Cancer."
EDAP's
U.S.
Phase II/III clinical study of the Ablatherm-HIFU system in the treatment
of
localized prostate cancer has already successfully treated patients at
leading
U.S. cancer treatment centers nationwide, with additional centers slated
to join
in the months to come. HIFU has been approved for use in the European Union
and
other countries worldwide. Current peer-reviewed clinical studies documenting
efficacy and side effects using Ablatherm-HIFU over the past 10 years are
available from the company or online at www.hifu-planet.com and www.edap-tms.com
.
Dr.
John
Rewcastle, EDAP's Medical Director, commented: "The entire U.S. clinical
team is
very excited by the additional funding. We will now accelerate EDAP's FDA
approval program building upon the strong forward momentum created in the
past
few months. Sites have been selected, several of which have received their
local
ethics committee approval allowing them to treat patients, and the logistical
frame work to execute the trials is in place and is working well. In
mid-October, we held an investigators meeting in Chicago with over 35
participants representing some of the most prestigious medical centers
in the
U.S. The trial is already benefiting from the leadership of Dr. Cary Robertson,
from Duke University, who is now the principle investigator. We already
have
patients being treated on trial almost weekly in the U.S. and intend to
deploy
an education and recruitment program in the months ahead to raise awareness
of
the trial to quicken patient recruitment. The timing of this funding is
excellent as we expect several high profile sites to receive ethics approval
to
participate in the clinical trials by the end of the year. In addition,
centers
not in the study are continuously inquiring about the FDA program. I believe
this is reflective of the urologic community's optimism towards the role
of HIFU
as a prostate cancer treatment."
Eric
Soyer,
CFO, added: "The U.S. clinical study is now fully funded and can be carried
out
within the defined timeframe. The choice of this unsecured convertible
debt
instrument provided favorable terms without highly restrictive financial
covenants. We thank our lead placement agent Cowen and Company, LLC and
its team
for helping us succeed in this transaction. Management will now be able
to focus
on delivering operating results in established and developing markets,
now
including the U.S."
The
securities issued in connection with the private placement referenced herein
have not been registered under the Securities Act of 1933, as amended,
and may
not be offered or sold in the U.S. absent registration or an applicable
exemption from registration requirements.
This
press
release shall not constitute an offer to sell or a solicitation of an offer
to
buy, nor shall there be, absent any exemption therefrom, any sale of these
securities in any state or jurisdiction in which such an offer, solicitation
or
sale would be unlawful prior to registration or qualification under the
securities laws of any such state or jurisdiction.
About
EDAP
TMS S.A.
EDAP
TMS
S.A. develops and markets Ablatherm, the most advanced and clinically proven
choice for High Intensity Focused Ultrasound (HIFU) treatment of localized
prostate cancer. HIFU treatment is shown to be a minimally invasive and
effective treatment option with a low occurrence of side effects. Ablatherm-HIFU
is generally recommended for patients with localized prostate cancer (stages
T1-T2) who are not candidates for surgery or who prefer an alternative
option,
or for patients who failed radiotherapy treatment. The company is also
developing this technology for the potential treatment of certain other
types of
tumors. EDAP TMS S.A. also produces and commercializes medical equipment
for
treatment of urinary tract stones using Extra-corporeal Shockwave Lithotripsy
(ESWL).
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In
addition
to historical information, this press release contains 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 these 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. Ablatherm-HIFU treatment
is
in clinical trials but not yet FDA approved or marketed in the United
States.
CONTACT:
EDAP
TMS S.A.
Blandine
Confort
+33
4 78 26 40 46
Magnolia
Investor Relations
Matt
Kreps
469
362 5960