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.
"HIFU offers non invasive treatment option for men who are looking for a therapy that will not completely disrupt their lives. A story on a prominent news program, such as ABC, NIGHTLINE increases awareness of the procedure and encourages people to conduct personal research to see if HIFU is a treatment option they should consider," said Steve Puckett, Jr., USHIFU Chief Executive Officer.
In the program, NIGHTLINE followed HIFU patient Richard Brightmire, as he traveled to Cancun, Mexico to have HIFU in February. According to the story, Brightmire chose HIFU because he wanted to preserve his quality of life and he was not satisfied with the other treatment options that were presented to him.
Four months after his procedure, Brightmire's PSA is zero and he has maintained his quality of life. "I'm doing fine since the HIFU procedure. Everything is back to normal," Brightmire said.
"I think that NIGHTLINE stressed sexual preservation as the main reason for going with HIFU. It's my belief that sexual preservation is only one of several important aspects," Brightmire continued. "For me, I went with the procedure because of the results outside the U.S. that show it to be non-invasive and show a lower risk of long-term hospitalization, and a lower risk of incontinence as well as impotence especially compared to surgery and other treatments available today."
USHIFU recognizes that, as the segment mentions, not all physicians are advocates of new prostate cancer therapies, "We understand that there is a very high bar of scrutiny for new prostate cancer treatment modalities, as there should be," Puckett said. "We highly encourage physicians to evaluate the technology for themselves and explore the international clinical outcomes that exist."
"In the program I found it particularly interesting that Dr. Patrick Walsh, of John Hopkins University was referenced as an expert with regards to HIFU. To my knowledge he has never seen or used our technology. We extend an invitation for him, as well as any other physician, to come see HIFU firsthand and learn," Puckett added.
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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