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



    CHARLOTTE, NC, July 9 /CNW/ - USHIFU, LLC, a global leader in non
invasive high intensity focused ultrasound (HIFU) technology, is proud to
announce sponsorship of the Sonablate(R) International HIFU Registry (SIHR),
along with co-sponsors Misonix, Inc. (Nasdaq:   MSON) and Takai Hospital Supply
Co., Ltd., (THS). The SIHR is the first and only worldwide registry to gather
information about prostate cancer treatment using HIFU. It was established to
offer a single, secure, standardized repository of treatment information for
users of the Sonablate(R) technology.
    The SIHR is a truly independent database; it is stored in a secure online
environment by an independent IT company. The information gathered will be
reviewed and analyzed by independent, third-party statisticians. At no point
do the sponsoring organizations have access to the raw dataset. Registry
oversight will be provided by a steering committee consisting of senior
Sonablate(R) HIFU users from five different countries, including Mark
Emberton, M.D., London, England; Rowland Illing, M.D., London, England;
Stephen Scionti, M.D., Hilton Head, SC; Michael Marberger, M.D., Vienna,
Austria; and Prof. Toyoaki Uchida, Tokyo, Japan.
    "The Sonablate(R) International HIFU Registry was created to capture the
'real life' practice of prostate cancer treatment, which for the most part
fell outside the responsibility of clinical trials," said Dr. Illing of the
Clinical Effectiveness Unit at the Royal College of Surgeons of England.
"Sponsorship of this registry by the worldwide distribution partners of the
Sonablate(R) demonstrates their high level of confidence in the technology.
The SIHR will be an incredibly powerful tool for continuing medical education,
as it will allow the identification and dissemination of best practice. It
will also provide a comprehensive international dataset with which to assess
the determinants of outcome."
    Steve Puckett, Jr., CEO of USHIFU said, "We believe that setting up an
international database controlled and monitored by highly reputable physicians
will produce a data set that is credible and compelling to the broader
clinical community. It will capture the realistic outcomes achieved by
physicians in private practice in approved markets, which is highly valuable,
in addition to controlled protocol-driven data that is being collected in the
FDA clinical trials."
    Michael A. McManus, Jr., President and CEO of Misonix said, "The start of
this registry will provide information on the more than 6,000 patients that
have been treated with the Sonablate(R) 500 for prostate cancer around the
world outside of the U.S. It will also enable doctors who are presently
involved in clinics or who are treating patients on a regular basis to input
their data. The medical community and patients will benefit from the
availability of this information that will show the history and the successful
treatment record of prostate cancer procedures using the Sonablate(R) 500 for
a period of more than five years."
    David Quigley, President and CEO of THS said, "We are excited to let the
medical community know the consistent and excellent clinical results we are
experiencing around the world with the Sonablate 500. We think the Sonablate
registry will be a win-win scenario for patients and our users."

    About USHIFU, LLC

    USHIFU is a healthcare development company and medical device distributor
committed to creating a new standard for prostate cancer treatment with high
intensity focused ultrasound (HIFU) therapy. USHIFU works with hospitals and
medical centers in countries where HIFU is authorized for treating prostate
cancer, including Canada, Mexico, the Dominican Republic and the Bahamas, to
make 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.




For further information:

For further information: Amanda Willis of USHIFU, LLC, (704) 936-1823,
amandawillis@ushifu.com; Web Site: http://www.internationalhifu.com

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USHIFU

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MISONIX, INC.

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