EDAP Granted European Market Clearance for Focal.One(R)
June 18 2013 - 8:01AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today that it received CE Mark (European
regulatory approval) for
Focal.One®, its new and
innovative robotic HIFU device fully dedicated to focal therapy of
prostate cancer. Focal.One was showcased as world premiere at the
European Urology Association Congress in Milan, Italy on March
15-19, 2013.
Marc Oczachowski, Chief Executive Officer of EDAP TMS,
commented, "This is a significant regulatory achievement and a key
milestone as we received EU market clearance for the first robotic
HIFU device dedicated to a focal targeted treatment
approach. This CE mark positions Focal.One for full
commercialization in Europe and in many other countries. It
confirms EDAP's expertise in managing R&D and regulatory
programs successfully. I wish to deeply congratulate the EDAP team
for their extraordinary efforts in bringing Focal.One to market in
a timely manner."
Mr. Oczachowski continued, "Utilizing a focal therapy approach
to target the cancer cells within the prostate gland for the
treatment of prostate cancer is gaining wider acceptance across the
international urological community. Combining into one unique HIFU
device the latest imaging modalities, such as MRI localization and
contrast-enhanced ultrasound control, with the ultimate dynamic
focusing HIFU technology, Focal.One will offer an optimal focal
therapy of prostate cancer while preserving patient quality of
life."
Focal.One is the first device fully dedicated to the focal
approach for prostate cancer therapy. It combines the three
essential components to efficiently perform a focal treatment: (i)
state-of-the-art imaging to localize tumors with the use of
magnetic resonance imaging (MRI) combined with real-time
ultrasound, (ii) utmost precision of HIFU treatment focused on
identified targeted cancer areas only and (iii) immediate feedback
on treatment efficacy utilizing Contrast-Enhanced Ultrasound
Imaging.
EDAP's unique and exclusive range of HIFU products, including
Ablatherm Integrated Imaging and Focal.One, has now the capacity to
offer a wide array of treatment options to patients with prostate
cancer.
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 as 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
EDAP TMS (NASDAQ:EDAP)
Historical Stock Chart
From Jun 2024 to Jul 2024
EDAP TMS (NASDAQ:EDAP)
Historical Stock Chart
From Jul 2023 to Jul 2024