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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6 K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
EDAP TMS S.A. Files
EDAP TMS S.A. Closes Private Placement
August 3, 2006
EDAP TMS S.A.
Parc Activite La Poudrette Lamartine
4/6 Rue du Dauphine
69120 Vaulx-en-Velin - France
Indicate by check mark whether the registrant files or will file annual reports
under cover Form 20-F or Form 40-F.
Form 20-F [X] Form 40-F [ ]
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes [ ] No [X]
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EDAP TMS S.A. CLOSES PRIVATE PLACEMENT
PROCEEDS TO ENHANCE MARKETING TO ACCELERATE ABLATHERM-HIFU
RPP BUSINESS IN EUROPE
LYON, France, Aug. 3 /PRNewswire-FirstCall/ -- EDAP TMS S.A. (Nasdaq: EDAP)
the global leader in High Intensity Focused Ultrasound (HIFU) treatment of
prostate cancer announced the closing of its private placement of 961,676
ordinary shares in the form of American Depositary Shares, resulting in net
proceeds of approximately $6.5 million. These funds are intended to fund
additional marketing efforts to accelerate the adoption of Ablatherm(R)- HIFU in
key European markets.
For the last 12 months, the company has transitioned its Ablatherm-HIFU
business from equipment sales to an already successful and growing revenue per
procedure (RPP) model, where the company provides Ablatherm-HIFU equipment to
participating hospitals and clinics and is paid a fee based on the number of
treatments performed. Under the RPP approach, hospitals and clinics are not
required to invest capital up-front to purchase the equipment, which provides a
significant advantage in promoting acceptance of Ablatherm-HIFU, especially when
combined with training programs that enable specialists to become proficient in
the use of the Ablatherm-HIFU in just 10-15 treatment sessions. The company will
continue to offer equipment sales and receive the accompanying maintenance and
disposable revenues when sites prefer a purchase option.
The company intends to use proceeds from the private placement to provide
additional marketing and sales resources to accelerate acceptance of RPP sites
primarily in European markets. The company's marketing strategy will target both
physicians and patients over the next 30 months, by increasing its web presence,
providing support material and resources to third-party patient referral
sources, hosting symposia and conversion workshops for medical staff and
continuing its clinical activity to support the credibility of HIFU treatment.
The company will also engage local public relations and marketing support in key
countries to assist in creating additional patient activity around new and
existing centers. Many of these measures have already been tested through local
marketing campaigns launched at certain new Ablatherm- HIFU centers, which have
proven successful. Proceeds will also support the hiring of additional sales
staff in key European markets, who will aim to accelerate the launch of new
Ablatherm-HIFU centers offering treatment for patients with localized prostate
cancer not pursuing surgery.
The run rate of RPP treatments has now exceeded 1,000 treatments per year.
In 2005, EDAP launched 30 new Ablatherm-HIFU treatment centers, and has launched
an additional 21 centers in the first 6 months of 2006. The company has already
observed that some centers using the Ablatherm-HIFU medical device are on the
way to treating 20% of their localized prostate cancer cases after completion of
their launch phase, typically the first year of operation.
The company also provided an update on its operations. EDAP continues to see
strong RPP growth in the second quarter as the company added more Ablatherm-HIFU
providers in key European markets. Cash at the end of the second quarter stood
at approximately euro 6.6 million. Proceeds from the private placement are
expected to increase cash balances by approximately euro 5.0 million to fund the
dedicated marketing and sales programs.
"We see significant opportunity today in the European marketplace as
noninvasive techniques to treat prostate cancer are growing in demand," said
Hugues de Bantel, CEO of EDAP. "EDAP has clearly achieved a strong medical
consensus supporting HIFU for nonsurgical cases and external beam radiation
failures as of this year's EAU Congress. We are now able to credibly roll out
major marketing campaigns in key countries with the support of the urology
community, with the aim of accelerating our growth rates. This capital increase
will supplement our existing cash position to enable EDAP to more aggressively
engage in sales and marketing efforts in key countries where we see substantial
growth opportunity. We believe the already strong trend lines in growth for the
RPP business combined with these enhanced sales and marketing efforts directed
at physicians and patients will help bring HIFU further into the mainstream of
prostate cancer therapy in Europe. We plan to both launch additional sites and
employ marketing programs at our existing sites to help make patients aware of
the unique and beneficial therapy available at these centers."
"We believe the Ablatherm-HIFU is a strong complement to the urologist's
practice," said de Bantel. "Presently urologists are treating about half their
cases of localized prostate cancer with surgery, while the other half are often
referred to radiation or other therapies. Ablatherm-HIFU allows the urologist to
offer a new option to these nonsurgical patients by providing a treatment that
rivals other therapies, but offers significantly lower side effects and reduced
recovery times. We are seeing clear evidence of adoption in centers using the
Ablatherm-HIFU, as well as growing adoption in the broader market. We believe
that we are well positioned to more aggressively approach the market to both
launch new centers and attract patients to our existing centers. Patients who
learn of the benefits of HIFU therapy often schedule appointments to consult
with a practicing urologist to discuss treatment options. We intend to
accelerate this trend."
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 United States absent registration or an
applicable exemption from registration requirements. As part of the private
placement, the company has agreed to file a resale registration statement on
Form F-3 with the Securities and Exchange Commission within 30 days following
the closing for purpose of registering for resale the American Depositary Shares
evidencing the ordinary shares sold in the offering.
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).
For more information on the Company, contact Halliburton Investor Relations
at (972) 458-8000, the Corporate Investor Relations Dept at +33 (0)4 78 26 40 46
or see the Company's Web sites at http://www.edap-tms.com and
http://www.hifu-planet.com .
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.
Hugues de Bantel - Philippe Chauveau
Blandine Confort
+33 4 78 26 40 46
Halliburton Investor Relations
Matt Kreps - Geralyn DeBusk
972 458 8000
SOURCE EDAP TMS S.A.
-0- 08/03/2006
/CONTACT: Hugues de Bantel, Philippe Chauveau, or Blandine Confort, all
of EDAP TMS S.A., +33-4-78-26-40-46; or Matt Kreps or Geralyn DeBusk, both of
Halliburton Investor Relations, +1-972-458-8000, for EDAP TMS S.A./
/Web site: http://www.edap-tms.com
http://www.hifu-planet.com /
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
Date : August 3, 2006
EDAP TMS S.A.
/S/HUGUES DE BANTEL
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HUGUES DE BANTEL
CHIEF EXECUTIVE OFFICER