US HIFU Announces That 18 Recurrent Prostate Cancer Clinical Trial Sites Are Open For Enrollment

CHARLOTTE, N.C., Nov. 9, 2010 /PRNewswire/ -- USHIFU LLC (US HIFU), a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies and manufacturer of the Sonablate^® 500 (Sonablate) and Sonatherm^® 600 medical devices, is pleased to announce that 18 clinical trial sites involved in the recurrent prostate cancer trial have been initiated and opened. The recurrent prostate cancer trial, or STAR trial, is a multi-center clinical study of HIFU with the Sonablate device (Sonablate HIFU) for the treatment of locally recurrent prostate cancer following failed radiation therapy.

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"It is gratifying to have nearly completed the opening of all 20 trial sites, particularly with some of the most prestigious institutions in North America," said US HIFU's CEO Steve Puckett, Jr. "I believe I represent the sentiment of all of our sites that we are moving as quickly as possible toward trial completion in eager anticipation of bringing HIFU to prostate cancer patients in this country. This has been our top priority since founding the company in 2004."

The following list represents the majority of the current clinical trial sites. In addition, two well-known and–respected facilities are located in Southeast Texas and Southern Wisconsin; visit www.clinicaltrials.gov (search term fsi003) for the most recent and comprehensive listing:    

A partial list of criteria for inclusion in the recurrent trial, which is now in the pivotal phase, includes:

• Men with biopsy-confirmed, organ-confined recurrent prostate cancer
• Ages 40-85
• Treated with external beam radiation therapy (EBRT) two or more years prior

For more information on the STAR trial, including a full list of inclusion criteria, please call (877) 874-4389 or visit www.ushifu.com (click on clinical information) or www.clinicaltrials.gov (search term fsi003).  

About USHIFU LLC

USHIFU LLC (US HIFU), a privately held healthcare company, is a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies. US HIFU manufactures the Sonablate^® 500 medical device and is focused currently on treating primary and recurrent prostate cancer using Sonablate^® HIFU. The company is engaged in ongoing research for technological advancements for the Sonablate^® system or other ultrasound applications. US HIFU was founded in 2004 and is headquartered in Charlotte, N.C. Additional information can be found at www.ushifu.com.

About the Sonablate^® 500

The Sonablate^® 500 is a minimally invasive medical device that utilizes ultrasound energy to destroy tissue within the body. It was developed by Focus Surgery, Inc. Takai Hospital Supply Ltd. distributes the Sonablate^® 500 in Southeast Asia. The Sonablate^® 500 is not approved for use in the U.S. The Sonablate^® 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^® 500 for the treatment of prostate cancer. HIFU for prostate cancer with the Sonablate^® 500 is approved or authorized and commercially available in more than 30 countries outside the U.S.  

SOURCE USHIFU, LLC

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