EDAP Signs Exclusive Agreement with Theraclion to Distribute Echopulse® HIFU Product in France
09 Outubro 2017 - 8:31AM
EDAP to Market Echotherapy for ablation of breast fibroadenomas
and benign thyroid nodules
LYON, France, October 9, 2017 -- EDAP TMS SA
(Nasdaq:EDAP), the global leader in therapeutic ultrasound, today
announced the signature of an Agreement with French HIFU Company
Theraclion, to exclusively distribute the Echopulse® system in
France. Echopulse is using EDAP's proprietary HIFU technology to
address breast fibroadenomas and benign thyroid nodules.
The long-lasting relationship between EDAP and
Theraclion is now expanding towards product commercialization. The
companies have worked closely for years, EDAP previously licensed
patents to Theraclion and will now provide significant expertise
with successful market penetration through various business models
in France.
Pierre Reboul, France Business Unit Director of
EDAP, commented: "We are very excited about this exclusive
agreement. During the past years, we built EDAP's business in
France as a unique global Urology company by adding other systems
such as Holmium lasers to complement our HIFU and ESWL
technologies, addressing most urology pathologies. We are pleased
to see EDAP TMS France evolve to offer various HIFU platforms
addressing multiple indications using different approaches."
David Caumartin, Chief Executive Officer of
Theraclion, added: "In France, EDAP has developed a mature sales
and logistics organization utilizing business models which enable
rapid market penetration where access to reimbursement is slow.
Offering a pay-per-use with a mobile solution will be very
beneficial in a market like France. The demand for such a model is
high and this partnership allows us to continue focusing our direct
distribution efforts in key markets such as Germany and Asia."
Marc Oczachowski, Chief Executive Officer of
EDAP TMS, concluded: "Our Sales and Marketing team in France has
done a tremendous job in the last few years generating major
revenue growth in urology while developing a unique set of
offerings with Holmium, HIFU and ESWL products. We plan to continue
this growth momentum by expanding our portfolio with new HIFU
applications such as breast fibroadenomas and benign thyroid
nodules, confirming our HIFU leadership in France."
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.
About Theraclion
Theraclion is a French company specializing in
high-tech medical equipment using therapeutic ultrasound. Drawing
on leading-edge technologies, Theraclion has designed and
manufactured an innovative solution for echotherapy, the
Echopulse®, allowing non-invasive tumor treatment through
ultrasound-guided high-intensity focused ultrasound. Theraclion is
ISO 13485 certified and has received the CE mark for non-invasive
ablation of breast fibroadenomas and thyroid nodules. Based in
Malakoff, near Paris, France Theraclion has brought together a team
of 35 people, 50% of whom are dedicated to R&D and clinical
trials. For more information, please visit Theraclion's website:
www.theraclion.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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