EDAP Reports on Recent, Active Urology Congress and Clinical Activity
03 Noviembre 2015 - 7:30AM
- Multiple abstracts on whole prostate gland and focal HIFU
presented at World Congress of Endourology and Lithotripsy
- Two HIFU studies presented at Société Internationale
d'Urologie
- Company highlights Technology as exhibiting sponsor at Five
Major American Urological Association Section Meetings
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today provided an update on its participation at recent
U.S. and international urology meetings.
At the World Congress of Endourology and Lithotripsy (WCE), held
October 1-4, 2015 in London, EDAP's HIFU technology was the subject
of abstracts presented by renowned urology groups from Italy,
France, Germany and Belgium. These abstracts, which were presented
to attending urology specialists, focused on several topics
including the use of MRI (a non-invasive imaging modality) to be
used as a follow-up tool following non-invasive HIFU, long-term
results and efficacy of HIFU for the treatment of prostate cancer,
outcomes from focal HIFU for prostate cancer and incorporating
focal therapies into the a contemporary high volume cancer center.
The respective presentations were:
- MP4-15: Robotic HIFU: Evaluation with D-CD-MR Imaging
- MP33-19: Robotic HIFU: Focus on early complications after 6
years' experience
- MP33-20: HIFU hemiablation for prostate cancer in 50 men:
results from a prospective cohort with a median follow-up of 3.3
years
- MP37-1: From diagnostic to focal prostate cancer treatment at a
high volume prostate cancer center: concept of a workflow
Additionally, two studies of EDAP's HIFU technology were
presented by a prominent German HIFU group at the 35th Congress of
the Société Internationale d'Urologie (SIU) in Melbourne, Australia
October 15-18, 2015. One presentation demonstrated the ability of
transurethral resection of the prostate (TURP) to reduce the
already low side effect rate of HIFU, while the second demonstrated
the oncologic efficacy of HIFU for patients with prostate cancer
considered to be high risk. The presentations were:
- MP-09.10: Therapeutic efficacy and PSA nadir in high risk PCa
patients after HIFU treatment combined with TURP
- MP-09.04: Morbidity profile of Immediate or delayed HIFU after
TURP
Additionally, the Company is participating as an exhibiting
sponsor at five sectional meetings of the American Urology
Association (AUA), including:
- Joint Annual Meeting of the Mid-Atlantic and New England
Sections of the AUA October 22-24, 2015
- Western Section AUA 91st Annual Meeting October 25-29,
2015
- 67th Northeastern Section AUA Annual Meeting October 29-31,
2015
- South Central Section of the AUA 94th Annual Meeting October
28-31, 2015
- North Central Section of the AUA 89th Annual Meeting November
10-14, 2015
At these meetings, EDAP is exhibiting and discussing its unique
technology features and actively supporting the American Urology
Community in its scientific meetings.
Marc Oczachowski, EDAP's Chief Executive Officer, commented:
"Presentations at prominent international meetings such as WCE and
SIU further reinforce the value of HIFU in the market and its
long-term therapeutic benefits. The value of HIFU has never been
more apparent: the treatment is non-invasive, can be applied in a
patient-tailored way to avoid side effects yet treat the known
disease and be followed with minimally invasive imaging
modalities."
Mr. Oczachowski continued, "Importantly, our continued presence
at these congresses, both in the U.S. and internationally, provides
an important opportunity to solidify relationships with thought
leaders in the urology community and other key industry
constituents. These activities are crucial to our business
development objectives and are expected to play a significant role
in our ongoing global expansion as we build upon our leadership
position in both HIFU and lithotripsy."
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® for high-intensity focused
ultrasound (HIFU) treatment of localized prostate cancer outside
the U.S. 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. EDAP TMS has submitted a
510(K) notice for Ablatherm 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 uncertainties of the U.S. FDA clearance process, 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. Ablatherm-HIFU is not FDA-cleared or
marketed in the United States.
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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