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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
INDIANAPOLIS, Aug. 9 /PRNewswire/ -- Focus Surgery, Inc. the developer of the Sonablate® 500, announced today that the Food and Drug Administration (FDA) granted the Sonablate® 500 a provisional Investigational Device Exemption (IDE), which will allow the device to be used in a multi-center 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® 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® 500 as demonstrated by our successful completion of the FDA approved pilot study. The HIFU technology utilized by the Sonablate® 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® 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® 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® 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 U.S. clinical studies.
Currently, HIFU with the Sonablate® 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
http://www.focus-surgery.com.
To be eligible for this study, you must meet the following criteria:
- Have organ confined recurrent prostate cancer stage T1 or
T2
- Be between 40 and 80 years of age
- Have a Gleason score of less than or equal to 7
- Have a PSA level between 0.5ng/ml and 10ng/ml
- Have had no previous treatment for prostate cancer
- Have a recent prostate biopsy that is positive for cancer cells.
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