EDAP Reports Publication of Long-Term Clinical Results for Largest Cohort of Ablatherm-HIFU Patients
September 08 2010 - 9:46AM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, today reported favorable clinical outcomes for patients
treated with Ablatherm-HIFU. A total of 803 patients with localized
prostate cancer, treated with Ablatherm-HIFU from 1993 until 2007,
were reported in a study carried out by Dr. Sébastien Crouzet,
Urologist at Edouard Herriot Hospital, Lyon, France. The analysis
has been published electronically by the medical journal European
Urology, the official scientific publication of the European
Association of Urology, and will appear in an upcoming print
edition of European Urology. These results were recently presented
by Dr. Crouzet at the World Congress of Endourology in Chicago.
This French multi-centric study reports the largest series of
patients who have been followed for the longest amount of time. The
durability of efficacy outcomes of robotic Ablatherm-HIFU in the
treatment of localized prostate cancer is now established out to
eight years. Clinical results obtained using Ablatherm-HIFU were
favorable. For a representative number of patients with a minimum
of two year follow-up and a maximum of 15 years, the cancer
specific survival rate and the freedom from metastatic disease rate
were 99% and 97%, respectively, at eight years. In this study, the
local control of the disease was achieved with an 85% rate of
negative biopsies and a biochemical disease free survival rate
(Phoenix criteria) of 83% in low risk cancer patients.
These results build upon those already published in 2006 from a
cohort of 297 patients treated with Ablatherm-HIFU at Edouard
Herriot Hospital in Lyon, France. The data clearly demonstrates
efficacy and stability of Ablatherm-HIFU approach in the treatment
of localized prostate cancer.
Dr. Sébastien Crouzet commented, "Ablatherm-HIFU long term
results compiled in this study were very positive in terms of
efficacy. The clinical outcomes clearly demonstrate stability and
efficacy over time using this robotic non-operator dependant
approach. Based on these positive findings, Ablatherm-HIFU should
be offered to a younger and wider patient population suffering from
localized prostate cancer, as it would preserve their quality of
life by avoiding risk, such as incontinence and impotence."
Marc Oczachowski, EDAP's Chief Executive Officer, added, "This
publication demonstrating Ablatherm-HIFU efficacy and great
stability over a long term period represents a major milestone in
the HIFU acceptance process as it further validates Ablatherm-HIFU
role as a standard of care for the treatment of localized prostate
cancer. This further validation will be a key element in helping
EDAP market HIFU, create awareness among patients, drive adoption
among the clinical community and increase recognition by healthcare
authorities."
About EDAP TMS SA
EDAP TMS SA develops and markets Ablatherm, the most advanced
and clinically proven choice for high-intensity focused ultrasound
(HIFU) treatment of localized prostate cancer. HIFU treatment is
shown to be a minimally invasive and effective treatment option
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. Approved in Europe as a treatment for prostate cancer,
Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently
undergoing evaluation in a multicenter U.S. Phase II/III clinical
trial under an Investigational Device Exemption granted by the FDA,
the ENLIGHT U.S. clinical study. The Company also is developing
this technology for the potential treatment of certain other types
of tumors. EDAP TMS SA also produces and commercializes medical
equipment for treatment of urinary tract stones using
extra-corporeal shockwave lithotripsy (ESWL). For more information
on the Company, please visit http://www.edap-tms.com,
http://www.hifu-planet.com.
CONTACT: EDAP TMS SA
Investor Relations / Legal Affairs
Blandine Confort
+33 4 72 15 31 72
bconfort@edap-tms.com
The Ruth Group
Investors:
Stephanie Carrington
646-536-7017
scarrington@theruthgroup.com
EDAP TMS (NASDAQ:EDAP)
Historical Stock Chart
From Jun 2024 to Jul 2024
EDAP TMS (NASDAQ:EDAP)
Historical Stock Chart
From Jul 2023 to Jul 2024