EDAP's Ablatherm-HIFU to be Showcased at 31st World Congress of Endourology
23 October 2013 - 12:00AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today that its high-intensity focused
ultrasound (HIFU) for the treatment of localized prostate cancer,
Ablatherm-HIFU, will be featured in multiple presentations
addressing minimally invasive prostate cancer therapies and the
successful evaluation of EDAP's device at the 31st World Congress
of Endourology (WCE). Top level technical presentations will be
made from key opinion leaders in urology, including Dr. Chaussy
Christian, Department of Urology, University of Regensburg, Dr.
Thuroff Stefan, Department of Urology, Klinikum Munchen Harlaching,
and Dr. Sebastian Crouzet, Urologist at Edouard Herriot Hospital in
Lyon, France. The WCE is scheduled to take place from October
22-26, 2013, in New Orleans, LA.
John Rewcastle, Ph.D., Medical Director of EDAP-TMS, commented,
"The World Congress of Endourology is a marquee event in the
urologic calendar. The clinical data to be presented evidence
further recognition and adoption of HIFU and is the foundation of
the increased interest. The presentations from Drs. Chaussy and
Thuroff show the durability of the excellent long-term outcomes
they published earlier this year. Importantly, they demonstrate
that cancer control was achieved with an acceptable morbidity
profile."
Marc Oczachowski, Chief Executive Officer of EDAP TMS, stated,
"We are excited that the World Congress of Endourology meeting this
year will have a significant focus on prostate cancer, and in
particular, the use of high intensity focused ultrasound as a
minimally invasive treatment option. Globally, people are becoming
more aware of the prevalence of prostate cancer and efforts to
identify the disease at an earlier stage are increasing.
"With the notable benefits of HIFU treatment, we believe demand
will continue to grow as patients seek a non-invasive curative
therapy that affords quality of life and is backed by solid
clinical evidence. We look forward to the poster presentations from
our colleagues which will demonstrate the successes we have
achieved with the use of Ablatherm-HIFU in the treatment of
localized prostate cancer."
Presentations and
Posters: |
Prostate Cancer Research |
|
Wednesday, October 23,
2013 |
Plenary
Session |
Prostate Cancer: Options and
Management for Advanced Disease |
Moderator: Christian Chaussy, M.D. |
Salvage Treatment Options:
HIFU |
Christian Chaussy, M.D. |
|
MP09-04 |
Classification and Endoscopic
Repair of Infravesical Obstruction After
HIFU |
Stefan Thueroff*, Munich, Germany, |
Christian Chaussy, Regensburg, Germany |
|
MP09-05 |
High Intensity Focused
Ultrasound in Incidental Prostate Cancer – a Non-Invasive Curative
Therapy |
Stefan Thueroff*, Derya Tilki, Munich,
Germany |
Christian Chaussy, Regensburg, Germany |
|
MP10-14 |
Complete HIFU in Localized
Prostate Cancer |
Christian Chaussy*, Regensburg,
Germany |
Derya Tilki, Stefan Thueroff, Muenchen,
Germany |
|
Thursday, October
24 |
Panel
Discussion |
Minimally Invasive Prostate
Cancer Therapies |
Moderator: Peter A. Pinto, M.D. |
Panel: Sebastien Crouzet, Ph.D.; Thomas
Polascik, M.D.; and Stephen |
Scionti, M.D. |
|
MP13-12 |
Start of Salvage Treatment
for Persistent Positive Biopsies after HIFU |
Rafael Sanchez-Salas*, Dominique |
Prapotnich, Paris, France, Fernando |
Secin, Buenos Aires, Argentina, Eric |
Barret, Francois Rozet, Marc Galiano, |
Annick Mombet, Nathalie Cathala, Xavier |
Cathelineau, Paris, France |
|
MP20-09 |
Evolution of Technology:
Short-Term Outcomes with Integrated Imaging
Ablatherm-HIFU |
Rafael Sanchez-Salas*, Dominique |
Prapotnich, Paris, France, Fernando |
Secin, Buenos Aires, Argentina, Eric |
Barret, Francois Rozet, Marc Galiano, |
Annick Mombet, Nathalie Cathala, Xavier |
Cathelineau, Paris, France |
|
Friday, October 25,
2013 |
MP25-20 |
Holmium Laser Enucleation of
the Prostate (HOLEP) Before High Intensity Focused Ultrasound
(HIFU) for the Prostate Cancer Treatment: Our
Experience |
Antonio Salvaggio*, Angelo Cafarelli, |
Donato Dente, Abano Terme (Padua), |
Italy, Emanuele Cappa, Chieti, Italy, |
Angelo Porreca, Abano Terme (Padua), |
Italy |
About Ablatherm-HIFU
Ablatherm-HIFU is an ultrasound guided HIFU device for the
treatment of organ-confined prostate cancer. The device consists of
a treatment module, a control table with a computer and a computer
screen, and a diagnostic ultrasound device connected to the
treatment module. After insertion of an endorectal probe, the
physician visualizes the prostate and defines the area to be
treated. The computer automatically calculates the optimum
treatment distribution of lesions. During the treatment, the
transducer automatically moves and fires at each predefined lesion
until the entire area has been treated, while controlling and
imaging the treatment in real time due to its integrated imaging
system. Cell destruction by HIFU is accomplished by a combination
of thermal and cavitation effects caused by focused application of
piezoelectric-generated high-intensity ultrasound. The procedure is
performed under general or spinal anesthesia.
Ablatherm-HIFU is cleared for distribution in the European
Union, South Korea, Canada, Australia, South Africa, New Zealand,
the Philippines, Taiwan, Mexico, Argentina, Brazil and Russia. As
of December 31, 2012, more than 32,000 prostate cancer treatments
successfully performed clinical outside the U.S. with
Ablatherm-HIFU and results have been published in 60 peer-reviewed
scientific publications.
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® 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, Ablatherm-HIFU is approved and
commercialized in Europe as a treatment for prostate cancer and is
currently under regulatory review in the U.S. following submission
of the Pre-Market Approval Application in February 2013 after the
completion of a multi-center U.S. Phase II/III clinical trial
under an Investigational Device Exemption (IDE) granted by the FDA.
The Company also develops its HIFU technology for the potential
treatment of certain other types of tumors. EDAP TMS SA also
produces and commercializes medical equipment (the Sonolith® range)
for treatment of urinary tract stones using extra-corporeal
shockwave lithotripsy (ESWL). For more information on the Company,
please visit http://www.edap-tms.com, and
http://www.hifu-planet.com.
Forward-Looking Statements
In addition to historical information, this press release
contains forward-looking statements that involve risks and
uncertainties. Such statements are based on management's current
expectations and are subject to a number of uncertainties,
including the uncertainties of the FDA PMA review process, our
ability to expand our U.S. operations and execute our growth
strategy and the market potential for our medical technologies, as
well asrisks 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 and in particular, in the sections "Cautionary
Statement on Forward-Looking Information" and "Risk Factors" in the
Company's Annual Report on Form 20-F. Ablatherm-HIFU treatment is
in clinical trials, but not FDA-approved or marketed in the United
States.
CONTACT: Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
bconfort@edap-tms.com
Investors:
Stephanie Carrington
The Ruth Group
646-536-7017
scarrington@theruthgroup.com
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