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
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
