EDAP‘s Ablatherm® Robotic HIFU Positioned as Efficient Option for Unilateral Prostate Ablation in Breakthrough Multicenter...
October 11 2016 - 9:20AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today announced the results of a multicentric study
using Ablatherm Robotic HIFU which demonstrates promising oncologic
outcomes with low side effects. The results of the study have been
electronically published in the prestigious peer-reviewed medical
journal European Urology; the study will subsequently appear in a
print edition.
The prospective, independent, multi-institutional
study conducted by the French Urological Association (AFU) was
designed to evaluate HIFU hemiablation (treatment of the half of
the prostate where the tumor is located, sparing the rest of the
gland) as a primary treatment for localized, unilateral prostate
cancer. In the study, 111 patients received focal hemiablation
using EDAP’s Ablatherm® Robotic HIFU at 10 different clinical
institutions. Control biopsies were performed 1 year following
treatment, with 95% of subjects showing absence of clinically
significant cancer on the treated side. The study also showed very
low side effects with continence preserved in 97% of patients at 1
year and erectile function preserved in 78% of patients. There was
no significant decrease in Quality of Life score observed at 12
months, and the rate of radical treatment free survival at 2 years
was 89%, meaning that only 11% of patients underwent surgery or
radiotherapy.
Pascal Rischmann, Chairman of the Department of
Urology, kidney transplantation and Andrology, University Hospital
of Rangueil in Toulouse, France at the time of the study, and lead
author on the study said, “This study supported by the French
Association of Urology builds upon the interest in focal therapy
and demonstrates its role in the management of prostate cancer
based on quality of life preservation and efficacy. I have long
thought HIFU was an ideal ablation modality for focal therapy and
this is substantiated by the study results.”
Marc Oczachowski, Chief Executive Officer of EDAP
TMS, added: “This focal HIFU study and its promising clinical
outcomes confirms HIFU as a true alternative for select patients
diagnosed with prostate malignancy. When these patients wish to
avoid radical surgery or radiotherapy but feel uncomfortable just
“watching and waiting” for the development of their disease, HIFU
with a partial-ablation approach seems to be a good compromise
between these two extreme options. This is a real opportunity for
EDAP’s superior HIFU technology.”
Link to e-publication:
http://www.europeanurology.com/article/S0302-2838(16)30679-0/abstract/focal-high-intensity-focused-ultrasound-of-unilateral-localized-prostate-cancer-a-prospective-multicentric-hemiablation-study-of-111-patients
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. 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.
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
EDAP TMS (NASDAQ:EDAP)
Historical Stock Chart
From Aug 2024 to Sep 2024
EDAP TMS (NASDAQ:EDAP)
Historical Stock Chart
From Sep 2023 to Sep 2024