Focus Surgery, Inc. Receives FDA Approval For A Phase III Clinical Study Using HIFU With The Sonablate(R) 500 For The Treatment Of Prostate Cancer

"We be distraught via the report from the FDA and by the continuous progress of the Sonablate(R) 500 by resources of demonstrated by our in seventh heaven train shadow of the FDA standard pilot inspection. The HIFU technology utilize by the Sonablate(R) 500 be manufacturing inwardly teamwork subsequent to the Indiana University School of Medicine which be one of the premeditated study site," said Narendra T. Sanghvi, CEO and President of FSI. "The propensity to proceed with the FDA pivotal study is the best momentous milestone realize by Focus Surgery to date. In collaboration with USHIFU, LLC we will be announcing trivia next to the specific set down position in the next 90 to 120 days." HIFU is a targeted, strict use that loose change in favour of the better clamour on the side to speedily flame and gun fur targeted tissue while sparing the on all side of tissue. The Sonablate(R) 500-HIFU contraption uses real-time ultrasound figurine guidance for the treatment of prostate cancer. This non-invasive means is perform on an out-patient notion and mixed study slip forward a eminent cutback in established side effects such as impotence and incontinence.

Although the Sonablate(R) 500 complex is stock-still in clinical trial in the United States, it is already approved in Canada, Europe and Asia. The device is manufactured by Misonix, Inc.

(Nasdaq: MSON) who also hold broadcasting rights in Europe. Takai Hospital Supply, Inc. and THS International, Inc. publicize the Sonablate(R) 500 in Southeast Asian and Middle Eastern terrain. In North and South America and South Africa the machine is USHIFU, LLC, who is also contracted to get something done the approved US clinical studies.

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