EDAP Announces Filing of New 510(k) Application for Focal One® Device
September 11 2017 - 7:31AM
510(k) Includes New Clinical Data to Support EDAP's File
LYON, France, September 11, 2017 -- EDAP TMS SA (Nasdaq:EDAP),
the global leader in therapeutic ultrasound, today announced that
the Company submitted a new 510(k) application for its Focal One
device, including an updated clinical section for FDA review.
As reported on July 17, 2017, the Company decided to withdraw
its existing Focal One 510(k) application to allow the inclusion of
a new set of clinical data.Marc Oczachowski, Chief Executive
Officer of EDAP TMS, commented: "The new 510k review may be more
efficient as the updates only pertain to the clinical section which
includes new studies from active and academic Focal One centers in
Europe. Our regulatory and clinical teams have been working
diligently to gather the new set of data." Marc Oczachowski added:
"As the new 510(k) application differs mainly within the clinical
section, we will work closely with the agency to facilitate a
straightforward review."
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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