DELAND, Fla., May 13 /PRNewswire/ -- USHIFU, LLC, 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, LLC|
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