Sonablate(R) International HIFU Registry is the First Worldwide HIFU Clinical Registry for Prostate Cancer ... (e the non invasive therapyavailable. USH...)

Sonablate(R) International HIFU Registry is the First Worldwide HIFU Clinical Registry for Prostate Cancer Treatments

Date:7/9/2008

e the non invasive therapy available. USHIFU is also funding FDA-approved clinical trials in the United States to gather data important for analysis of the technology by the FDA. The first is a pivotal trial for the treatment of primary organ confined prostate cancer that will enroll 466 participants at 24 different centers. A second pivotal trial will begin for the treatment of recurrent prostate cancer in men who have failed external beam radiation therapy. This single arm study will enroll 202 participants at 10 different sites.

About the Sonablate(R) 500

The Sonablate(R) 500 is a non invasive medical device that utilizes ultrasound energy to destroy tissue within the body. It was developed by FSI 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.

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.

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