Focus Surgery, Inc. the developer
of the Sonablate(R) 500, announced today that the Food and Drug
Administration (FDA) granted the Sonablate(R) 500 a provisional
Investigational Device Exemption (IDE), which will allow the device to be
used in a multicenter clinical study to collect safety and efficacy data
for final FDA approval. The clinical study will use High Intensity Focused
Ultrasound (HIFU) for the treatment of low risk, localized (T1c/T2a)
prostate cancer with the Sonablate(R) 500. The study will enroll
approximately 466 subjects at 24 institutions.
"We are excited by the news from the FDA and by the continued progress
of the Sonablate(R) 500 as demonstrated by our successful completion of the
FDA approved pilot study. The HIFU technology utilized by the Sonablate(R)
500 was developed in collaboration with the Indiana University School of
Medicine which is one of the planned study sites," said Narendra T.
Sanghvi, CEO and President of FSI. "The ability to proceed with the FDA
pivotal study is the most significant milestone achieved by Focus Surgery
to date. In collaboration with USHIFU, LLC we will be announcing details on
the specific site locations in the next 90 to 120 days."
HIFU is a targeted, precise treatment that uses sound waves to rapidly
heat and kill targeted tissue while sparing the surrounding tissue. The
Sonablate(R) 500-HIFU device uses real-time ultrasound image guidance for
the treatment of prostate cancer. This non-invasive procedure is performed
on an out-patient basis and international studies suggest a substantial
reduction in common side effects such as impotence and incontinence.
Although the Sonablate(R) 500 system is still in clinical trials in the
United States, it is already approved in Canada, Europe and Asia. The
device is manufactured by Misonix, Inc. (Nasdaq: MSON) who also holds
distribution rights in Europe. Takai Hospital Supply, Inc. and THS
International, Inc. distribute the Sonablate(R) 500 in Southeast Asian and
Middle Eastern countries. In North and South America and South Africa the
distributor is USHIFU, LLC, who is also contracted to perform the approved
US clinical studies.
Currently, HIFU with the Sonablate(R) 500 is available at over 100
clinical centers for the treatment of prostate disease and it is
distributed within 18 countries worldwide. Additional information is
available at focus-surgery.
Focus Surgery, Inc.
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