EDAP Reports Superior Outcomes of Focal Ablatherm-HIFU Compared to Robotic Radical Prostatectomy
19 December 2016 - 11:30PM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today announced the publication of results comparing
Ablatherm Focal HIFU with Robotic Radical Prostatectomy. The
results of the study have been electronically published in the
prestigious peer-reviewed medical Journal of Endourology; the study
will subsequently appear in a print edition.
This matched pair analysis of HIFU hemiablation vs robotic
assisted laparoscopic prostatectomy was conducted by Professor
Roland van Velthoven, Head of the Urology Department at the
Institut Bordet Oncology Center in Brussels, Belgium. In this
study, 55 patients with unilateral localized prostate cancer were
treated using Ablatherm-HIFU and their outcomes were compared 1:1
with patients, having similar clinical criteria but underwent
robotic assisted laparoscopic prostatectomy. The matched pair
analysis concluded that HIFU was comparable to robotic-assisted
radical prostatectomy in the management of prostate cancer and
showed HIFU to have significantly better functional outcomes.
Prof. van Velthoven commented: "Clinical outcomes from this
comparative study are extremely encouraging as they confirm the
efficacy of HIFU focal in the treatment of localized prostate
cancer, reporting similar results to radical prostatectomy in terms
of cancer control at 5 years. More importantly, the study proves
focal HIFU superiority in terms of side effects with
significantly higher continence and potency preservation rates
at both 1 month and 2 years after the procedure. Focal HIFU is the
ideal minimally invasive approach for patients with low risk
prostate cancer seeking treatment of their disease while preserving
their quality of life".
Marc Oczachowski, EDAP TMS Chief Executive Officer, added: "We
are very enthusiastic about the published results from this study.
Once again, the data confirms HIFU as a viable option in the focal
ablation of prostatic tissue. It offers patients a non-invasive
alternative to current radical treatments. The need for our HIFU
treatment is now more evident following the recent
publications of the ProtecT study in the New England Journal
of Medicine and the Ablatherm-HIFU hemiablation study in the
European Urology journal."
Link to abstract: https://www.ncbi.nlm.nih.gov/pubmed/27799004
(epub ahead of print in Journal of Endourology).
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:
CG CAPITAL
877.889.1972
investorrelations@cg.capital www.cg.capital
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