EDAP Announces First HIFU Treatments Performed in New England
16 June 2016 - 10:30PM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today announced the first prostate ablation treatments
performed at Radiosurgery of New York and Eastern Massachusetts
Surgery Center, using the Company’s FDA-cleared Ablatherm Robotic
HIFU device deployed by HIFU USA Corp, a leading provider of mobile
technology solutions to urologists. Dr. Ron Israeli, Chief
Medical Officer of HIFU USA, Corp. performed the procedure at
Radiosurgery of New York, while the procedures at Eastern
Massachusetts Surgery Center were performed by Dr. Clifford Gluck
and Dr. James Lin both of Greater Boston Urology who are also
affiliated with
Beth Israel Deaconess Medical
Center.
The Ablatherm Robotic HIFU used in these procedures
is owned by HIFU USA, Corp., who mobilized the system to provide
HIFU access to select urologists and clinics across the New York
and New England regions.
Dr. Gluck commented, “We are thrilled to begin
treating patients with Ablatherm Robotic HIFU and to be the first
practice in all of New England to utilize HIFU for the ablation of
prostate tissue. As a minimally-invasive technique, HIFU has the
potential to significantly improve quality of life for a certain
subset of prostate cancer patients. This is especially important as
more men are being diagnosed earlier in life and may not be content
with the stress and uncertainty associated with active
surveillance. At Eastern Massachusetts Surgery Center, we are
committed to offering patients the most innovative therapeutic
options available. Ablatherm falls perfectly within this commitment
and we are excited to expand our use of the technology.”
Dr. Israeli added: “It is a privilege to perform
these initial prostate ablation treatments at Radiosurgery of New
York in midtown Manhattan. For certain men, HIFU has a range of
advantages over alternative therapies, and I look forward to
bringing the benefits of this innovative technology to appropriate
patients within my practice.”
He continued “We are pleased to add Ablatherm
Robotic HIFU to our technology portfolio and to have supported
these fine physicians with the procedures. Many of the physicians
we work with have expressed excitement at the opportunity to add
HIFU as another treatment option to their practice, providing them
with an intermediate option between active surveillance and radical
prostatectomy. We believe that Ablatherm optimally addresses
this substantial need and anticipate significant utilization, which
will result in us opening multiple Ablatherm Robotic HIFU centers
throughout the country in the immediate future.”
Marc Oczachowski, EDAP TMS Chief Executive Officer,
added: “We are happy to partner with HIFU USA, another leading
equipment mobilizer to expand the reach of the Ablatherm Robotic
HIFU device. We are also very pleased to see our HIFU technology
available to patients in New England, and we look forward to the
continued expansion of Ablatherm Robotic HIFU in the U.S.”
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 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.
About HIFU USA, Corp.HIFU USA
Corp. (www.hifumedusa.com) is a comprehensive, national
provider of HIFU services, providing access to the Ablatherm
Robotic HIFU device presently to physicians in the New York and New
England areas and soon throughout markets nationally. The
corporate headquarters for HIFU USA Corp. are located at 30 Hopper
Street in Westbury, NY.
Forward-Looking StatementsIn
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.
Contact:
Blandine Confort
Investor Relations / Legal Affairs
EDAP TMS SA
+33 4 72 15 31 72
bconfort@edap-tms.com
Investors:
Lee Roth
The Ruth Group
646-536-7012
lroth@theruthgroup.com
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