EDAP Expands Ablatherm-HIFU Into China by Entering Exclusive Distribution Agreement
26 August 2010 - 10:00PM
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic
ultrasound, announced today that it will expand into the rapidly
growing Chinese healthcare market with its Albatherm HIFU device
for the treatment of prostate cancer. Ablatherm HIFU will be
distributed throughout China by Shaw Han Biomedical Co. Ltd.
This exclusive distribution agreement underscores EDAP's
global expansion strategy for HIFU in what is the fastest growing
medical device market. With the largest population in the
world, China represents a significant market for prostate cancer
treatment as cancer detection rates rise, awareness of treatment
options increases and the expanding aging population garners
greater access to healthcare. It is an opportune time to
commence the regulatory and marketing process in China for EDAP's
robotized, quality-of-life preserving device.
Marc Oczachowski, Chief Executive Officer of EDAP TMS,
commented, "This partnership affords a significant market
opportunity for EDAP to tap into the rapidly growing medical device
market in China. We undertook extensive due diligence to
identify the optimal distribution partner to address the large,
dynamic and complex Chinese market. This exclusive agreement will
involve a two-stage process. Initially, Shaw Han will be
responsible for processing the marketing clearance application with
China's State Food and Drug Administration (SFDA) for
Ablatherm-HIFU for localized prostate cancer treatment.
Following receipt of SFDA clearance, Shaw Han will lead the
promotion, marketing, and distribution of the device in China for
four years post approval. As part of the agreement, Shaw Han has
committed to purchase a minimum number of Ablatherm HIFU units
during the period covered by the two-stage process."
EDAP's distribution partnership with Shaw Han will officially be
announced at the Asian Congress of Urology (ACU) to be held in
Taiwan on August 27-28, 2010. Together with its partner, EDAP
will showcase its state-of-the-art HIFU and lithotripsy
technologies at the ACU.
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 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