DELAND, Fla., May 13 /PRNewswire/ -- USHIFU, the clinical trial
management provider for Focus Surgery, Inc. (Indianapolis, IN), is pleased
to announce conditional written approval pending minor changes to the
protocol from the FDA to begin a pivotal trial for the treatment of
recurrent prostate cancer with the Sonablate(R) 500 in men who have failed
external beam radiation therapy.
Dr. Herbert Lepor, Chairman of Urology at NYU School of Medicine and
medical monitor for the trial said, "It is my pleasure to serve as the
medical monitor for the prostate cancer clinical trial program evaluating
the safety and effectiveness of the Sonablate(R) 500 HIFU device."
"I have personally reviewed the preliminary data and observed the
Sonablate(R) 500 in action and I am impressed with this advanced technology
for ablating the prostate. These rigorous clinical trials will help define
the appropriate role of the Sonablate(R) 500 device in the treatment of
prostate cancer," Lepor added.
This trial will be conducted at various sites across the U.S. and is
expected to enroll approximately 202 subjects and 10 clinical centers. This
clinical trial is based on results from the feasibility trial completed in
October 2007 which enrolled 11 subjects from two clinical research sites
within the U.S. Ten of the eleven subjects had failed external beam
radiation therapy prior to participating in the clinical trial. The results
of this feasibility trial provided a basis for the pivotal study.
Additional studies are still needed to satisfy the safety and effectiveness
standards, including long term outcomes, set by the FDA for marketing
approval.
The Sonablate(R) 500 is not approved for use in the U.S. The
Sonablate(R) 500 remains investigational in the U.S. and is being studied
for the treatment of prostate cancer in clinical trials in the U.S. FDA has
made no decision as to the safety or efficacy of the Sonablate(R) 500 for
the treatment of prostate cancer.
The Sonablate(R) 500 was developed by Focus Surgery, Inc. and is
manufactured by Misonix, Inc. (Nasdaq: MSON) who also holds distribution
rights in Europe. Takai Hospital Supply Ltd. and THS International
distribute the Sonablate(R) 500 in Southeast Asia and the Middle East.
SOURCE USHIFU
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Related links:
http://www.internationalhifu.com
CONTACT:
Amanda Willis of USHIFU, +1-704-936-1823,
amandawillis@ushifu.com
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