EDAP to Showcase New Data at 2012 American Urological Association Annual Meeting
2012年5月17日 - 10:41PM
EDAP TMS SA (Nasdaq:EDAP), a global leader in therapeutic
ultrasound, announced today that its Ablatherm® High Intensity
Focused Ultrasound (HIFU) will be featured in two presentations
supporting the technology's efficacy for the treatment of localized
prostate cancer, both as a primary care option and as a salvage
treatment. The data, as well as EDAP's extracorporeal shock wave
lithotripsy (ESWL) platform, the Sonolith® i-move, will be featured
at the American Urological Association (AUA) 2012 Annual Meeting,
held May 19-23 in Atlanta, GA.
EDAP is a pioneer of ESWL for the non-invasive treatment of
urinary stones. Its eighth-generation Sonolith i-move was
cleared by the FDA in August 2011 and has already been installed in
three locations in the U.S. It will be available for live
demonstration at AUA booth #2837.
Ablatherm-HIFU is approved in Europe and currently
investigational in the U.S. as a minimally invasive treatment for
localized prostate cancer. It uses ultrasound waves to heat
and ablate the targeted tumor tissue, while reducing the risk of
collateral tissue and nerve damage, compared to more invasive,
traditional therapies. The two-year follow-up phase for a
pivotal multicenter U.S. Phase II/III clinical trial (ENLIGHT) is
expected to be completed at the end of June 2012 and outcomes data
are expected to be submitted to the U.S. FDA in the fourth quarter
of 2012.
Scientific Session Highlights:
Date/Time: Sunday, May 20, 10:30 AM
Podium 382: Salvage HIFU after failed external
beam radiation: 6 years biochemical survival and morbidity of 982
patients from a multicenter database – Six year oncologic outcomes
of High Intensity Focused Ultrasound as salvage treatment of
localized prostate cancer recurrence following external beam
radiation therapy. Outcomes from 982 patients followed with
the @-Registry.
Date/Time: Tuesday, May 22, 1:00 PM
Poster 1813: Oncological outcomes of
high-intensity focused ultrasound for localized prostate cancer in
1098 consecutive patients –Outcomes of patients treated with High
Intensity Focused Ultrasound as a primary care option for localized
prostate cancer, and to determine factors influencing the
outcomes. Outcomes from 1098 patients.
Additionally, three posters highlighting HIFU will be presented
on Saturday, May 19, 2012, at the 27th Annual Meeting of the
Engineering and Urology Society, held in conjunction with
AUA. Dr. Christian Chaussy of the University Regensburg,
Germany and a member of the Company's Scientific Advisory Board,
and Dr. Thuroff of Harlaching Hospital, Munich, will present their
findings and be available to answer questions.
Poster 21: 15 Years transrectal High Intensity
Focused Ultrasound in Localized Prostate Cancer therapy: Impact of
neoadjuvant TURP before HIFU on Oncological Efficacy–Analysis of
the oncological efficacy of TURP before HIFU as therapy for
localized prostate cancer according to PSA Nadir.
Poster 40: 15 Years Transrectal High Intensity
Focused Ultrasound in Prostate Cancer Therapy: Development of Side
Effects –Analysis of overall side effects of combined TURP and HIFU
as therapy for localized prostate cancer, analysis of influence of
three therapeutic strategies using HIFU, and evaluation of the
relative influence of neoadjuvant TURP on side effects.
Poster 41: Treatment of Locally Advanced
Prostate Cancer with Transrectal High Intensity Focused Ultrasound
(HIFU) delays Androgen Deprivation Therapy (ADT) – Evaluation of
the efficacy of local TURP and HIFU treatment in patients with
locally advanced prostate cancer and the necessity of ADT.
About EDAP TMS SA
EDAP TMS SA 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. Approved in Europe as a treatment for prostate
cancer, Ablatherm-HIFU (High Intensity Focused Ultrasound) is
currently undergoing evaluation in a multi-center U.S. Phase II/III
clinical trial under an Investigational Device Exemption (IDE)
granted by the FDA, the ENLIGHT U.S. clinical study. The
Company also is developing this 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. These include statements regarding the
Company's growth and expansion plans, the conclusiveness of the
results of and success of its Ablatherm-HIFU clinical trials and
expectations regarding the IDE submission to and approval by the
FDA of the Ablatherm-HIFU device. Such statements are based
on management's current expectations and are subject to a number of
uncertainties, including the uncertainties of the regulatory
process, 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 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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