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ABC News NIGHTLINE Features HIFU with Sonablate(R) 500 as Non Invasive Treatment Option for Prostate Cancer
Date:6/27/2008

Segment fails to mention ongoing FDA-approved HIFU clinical trials in the United States and abundant clinical data on HIFU outcomes and experience

CHARLOTTE, N.C., June 27 /PRNewswire/ -- USHIFU, LLC, the exclusive distributor of the minimally invasive Sonablate(R) 500 for prostate cancer treatment in North and South America, announced that the June 16, 2008 edition of ABC News NIGHTLINE featured a segment on high intensity focused ultrasound (HIFU) for treating prostate cancer outside of the United States using the Sonablate(R) 500.

According to the segment, men diagnosed with prostate cancer have the ability to travel outside of the United States to receive HIFU, a non invasive, outpatient procedure for prostate cancer.

The segment failed to mention that the Sonablate(R) 500 HIFU treatment is currently involved in two different 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.

Dr. Herbert Lepor, Chairman of Urology at NYU School of Medicine and medical monitor for the trials said, "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 add to the international data already available and will further help define the appropriate role of the Sonablate(R) 500 device in the treatment of prostate cancer," Lepor added.

If patients meet the enrollment criteria they may qualify to enroll in the U.S. HIFU clinical trials. For more information about the clinical trials eligibility criteria call USHIFU at 1-877-874-4389.

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SOURCE USHIFU, LLC
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