EDAP Announces Withdrawal of 510(k) Application for Focal One® to be Followed by New Submission to Conform to FDA Review Rul...
July 17 2017 - 4:46PM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today announced that the Company has withdrawn the
510(k) application for its Focal One device currently under review
by the FDA. Following advanced discussions with the agency, EDAP
plans to submit a new 510(k) file including new clinical data.
Marc Oczachowski, Chief Executive Officer of EDAP TMS,
commented: "As mentioned during our last quarterly call, a shift in
biopsy protocol has created difficulties in comparing biopsy data
under the current 510k application. We actively worked with some of
our key users in Europe to gather new and additional clinical data
on Focal One in order to provide them to the agency for review. It
is not possible to include this new clinical data in our current
file under review, and thus need to withdraw our current
application and submit a new 510(k) with the new set of clinical
data, which will be filed very soon."
Marc Oczachowski added: "We remain committed to having our HIFU
Focal One device FDA cleared as rapidly as possible. With the
exception of the new clinical data, the new application remains
unchanged."
Oczachowski concluded: "In our effort to continue to continue
making our HIFU technology and devices available in the U.S., we
will also submit a 510(k) filing to the FDA for the clearance of
our Ablatherm Fusion device in the near future, enabling American
patients to benefit from the latest innovations in prostate tissue
ablation with HIFU."
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® for high-intensity focused
ultrasound (HIFU) for prostate tissue ablation in the U.S. and for
treatment of localized prostate cancer in the rest of the world.
HIFU treatment is shown to be a minimally invasive and effective
option for prostatic tissue ablation 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 for
commercial distribution in Europe and some other countries
including Mexico and Canada, and has received 510(k) clearance by
the U.S. FDA. Ablatherm Fusion is not FDA cleared yet. The Company
also markets an innovative robot-assisted HIFU device, the Focal
One®, dedicated to focal therapy of prostate cancer. Focal One® is
CE marked but is not FDA cleared. The Company also develops its
HIFU technology for the potential treatment of certain other types
of tumors. EDAP TMS SA also produces and distributes medical
equipment (the Sonolith® lithotripters' range) for the treatment of
urinary tract stones using extra-corporeal shockwave lithotripsy
(ESWL) in most countries including Canada and the U.S. For more
information on the Company, please
visit http://www.edap-tms.com ,
and http://www.hifu-prostate.com.
Forward-Looking Statements
In addition to historical information, this press release may
contain forward-looking statements. Such statements 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 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.
Investor Contact
CG CAPITAL Rich Cockrell 877.889.1972
investorrelations@cg.capital
Company ContactBlandine ConfortInvestor Relations / Legal
Affairs EDAP TMS SA+33 4 72 15 31 50bconfort@edap-tms.com
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