EDAP Announces FDA Clearance of its Ablatherm-Fusion® device
04 Ottobre 2017 - 2:15PM
LYON, France, October 4, 2017 -- EDAP TMS SA (Nasdaq:EDAP), the
global leader in therapeutic ultrasound, today announced FDA
approval of 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: "We are very pleased with the expedient
clearance of our Ablatherm-Fusion following our 510(k) application
on July 31; as anticipated the review process was straightforward.
This project confirms EDAP's ability to efficiently upgrade its
product offering to answer market demand."
Marc Oczachowski added: "This innovative next
generation of Ablatherm device merges MRI, 3D biopsy maps and
ultrasound images to facilitate the targeting of areas to be
ablated. This will improve Ablatherm's ability to perform efficient
Focal Ablation of prostate tissue. Our sales team will begin
marketing this upgrade to our current Ablatherm users and new users
immediately. "
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
FDA cleared. 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 CAPITALRich Cockrell877.889.1972
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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