EDAP Updates on FDA Advisory Committee Meeting on Ablatherm-HIFU for the Treatment of Prostate Cancer
July 30 2014 - 6:11PM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today announced that the U.S. Food and Drug
Administration's (FDA) Gastroenterology and Urology Devices Panel
(GUDP) voted 3 yes, 5 no with 1 abstention on the question of
safety, 9 no on the question of efficacy, and 8 no with 1
abstention for the risk/benefit ratio for the use of its
Ablatherm-HIFU device for the treatment of low-risk, localized
prostate cancer.
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "We
are disappointed by the Committee's recommendation regarding
Ablatherm-HIFU for the treatment of low-risk, localized prostate
cancer and we appreciate the dialogue during today's meeting.
We look forward to subsequent discussion with the FDA. We will
continue to work diligently with the FDA as it carefully completes
its final review for Ablatherm-HIFU's PMA."
Prostate cancer is the most prevalent form of cancer in men with
approximately 233,000 new cases diagnosed in the United States and
approximately 380,000 in Europe each year.
The FDA is not bound by the GUDP's recommendation but will
consider the committee's guidance in reviewing the Pre-Market
Approval (PMA) application for Ablatherm-HIFU.
Documents presented at the advisory committee meeting, which
includes EDAP's executive summary and presentation, will be
available online and can be accessed from the investor relations
page of the Company's corporate website at www.edap-tms.com.
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. In
February 2013, the Company introduced a new innovative HIFU device,
the Focal One® dedicated to focal therapy of prostate cancer. Focal
One® is CE marked but is not FDA approved. 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 may
contain forward-looking statements.. Such statements00 are based on
management's current expectations and are subject to a number of
risks and uncertainties, including matters not yet known to us or
not currently considered material by us, and there can be no
assurance that anticipated events will occur or that the objectives
set out will actually be achieved. Important factors that could
cause actual results to differ materially from the results
anticipated in the forward-looking statements include, among others
the uncertainties of the U.S. FDA approval process, the clinical
status and market acceptance of our HIFU devices and the
continued market potential for our lithotripsy device.,. Factors
that may cause such a difference also may 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/Media:
David Burke/Aaron Estrada
The Ruth Group
646-536-7009/7028
dburke@theruthgroup.com
aestrada@theruthgroup.com
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