EDAP Appoints Vice-President of Global Medical, Regulatory and Quality Affairs in the U.S.
March 06 2017 - 8:31AM
EDAP Appoints Vice-President of Global
Medical, Regulatory and Quality Affairs in the U.S.
LYON, France, March 6, 2017 -- EDAP TMS SA
(Nasdaq: EDAP), the global leader in therapeutic ultrasound, today
announced the appointment of Noah J. Bartsch as Vice President of
Global Medical, Regulatory, and Quality Affairs. Mr. Bartsch
will be responsible for leading EDAP's Medical, Regulatory, and
Quality Affairs operations in the United States to expand and
execute the strategy to advance High-Intensity Focused Ultrasound
(HIFU) technology adoption and recognition. This will include
managing U.S. Food and Drug Administration (FDA) developments,
initiating reimbursement coverage for HIFU, and collaborating with
Key Opinion Leaders. He will also lead EDAP's clinical research and
regulatory submission strategies worldwide and will be based in
EDAP's U.S. headquarters in Austin, Texas. In this position, Mr.
Bartsch will become a member of the Global Executive Team for
EDAP.
Prior to joining EDAP, Mr. Bartsch was the
Global Vice President of Clinical, Regulatory, and Quality Affairs
at LDR (Nasdaq: LDRH) where he spent the last 10 years supporting
the growth of the French start-up orthopedic spine company into a
U.S. market leader. LDR was acquired in July 2016 for one billion
U.S. dollars. While at LDR, he worked extensively with the FDA,
leading the Premarket Approval (PMA) submission process and
obtaining approval of two PMAs for Class III indications. He
managed the related Investigational Device Exemption (IDE) studies
and led the clinical publication strategies that supported market
adoption and reimbursement coverage. He also achieved several U.S.
510(k) market clearances. His efforts in quality affairs
resulted in a mature quality system functioning globally while
maintaining compliance with regulations and quality standards
worldwide.
Noah Bartsch commented: "There is an opportunity
to advance the adoption and utility of HIFU in the United States,
along with the rest of the world, as patients and physicians demand
less invasive treatments that improve quality of life. EDAP's
technology is very promising and will require continued
collaboration with regulatory agencies, insurance providers, and
physician users. I am excited to join EDAP at this phase in the
company's history and to ultimately provide properly indicated
patients with additional treatment options."
Marc Oczachowski, EDAP Chief Executive Officer,
added: "We are extremely pleased to have Noah join EDAP's Global
Executive Team. With his impressive background and participation in
LDR's success, Noah will bring his extensive experience to our
clinical and regulatory global developments. Based in the U.S
headquarters in Austin, Texas, he will contribute strongly to our
U.S. expansion while ensuring continued quality excellence
worldwide."
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 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 is
approved for commercial distribution in Europe and other countries
including Mexico and Canada, and has received 510(k) clearance by
the U.S. FDA. 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 approved. 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-planet.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 Contact
Blandine Confort
Investor Relations / Legal Affairs EDAP TMS
SA
+33 4 72 15 31 50
bconfort@edap-tms.com
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