EDAP Announces filing of 510(k) Application for Ablatherm-Fusion® device
July 31 2017 - 7:31AM
LYON, France, July 31, 2017 -- EDAP TMS SA (Nasdaq:EDAP), the
global leader in therapeutic ultrasound, today announced that the
Company submitted a 510(k) application for its Ablatherm Fusion
device, enabling a more precise method for targeting of diagnosed
areas within the prostate.
Marc Oczachowski, Chief Executive Officer of EDAP TMS,
commented: "As recently mentioned, the next generation of Ablatherm
devices merge MRI, 3D biopsy maps, and ultrasound images by
integrating EDAP's proprietary software and fusion algorithm. This
innovative, state of the art option tremendously improves the
imaging and targeting capabilities of the Ablatherm while
maintaining its unique, proven tissue ablation efficacy."
Marc Oczachowski added: " Ablatherm Fusion is well positioned to
perfectly complement our already commercialized range of HIFU
devices and offerings. The submitted 510k file is straightforward
as it maintains same treatment parameters from the previously
approved current generation of Ablatherm devices."
About EDAP TMS SAEDAP 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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