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US HIFU Names New Chief Executive Officer
Date:1/6/2012

CHARLOTTE, N.C., Jan. 6, 2012 /PRNewswire/ -- USHIFU, LLC (US HIFU), a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies, appointed Michael Klein as the company's new chief executive officer and member of the board of directors. Mr. Klein brings more than 30 years of experience in oncology and the medical device industry to US HIFU, most recently as president of the radiation oncology division of Roper Industries, Inc., a publicly traded, diversified manufacturer of engineered products. US HIFU is backed by an investor syndicate led by Galen Partners, a leading healthcare growth equity and late stage venture capital firm.

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US HIFU manufactures and distributes the Sonablate® 500 (Sonablate) medical device, designed to treat prostate cancer with HIFU energy. The prostate cancer procedure, known as Sonablate HIFU, is approved in more than 30 countries outside the United States and is currently under investigation in the US within an FDA approved IDE. Mr. Klein was selected for the role based, in part, on his significant experience overseeing clinical trials and interacting with the FDA. Specifically, Mr. Klein oversaw the clinical trial and PMA process for R2's computer-aided detection technology that received approval for both breast and lung cancer detection. During his tenure as CEO, the technology was cleared for US commercialization, achieved CPT-1 code approval and ramped to $55 million in annual revenue. This experience will be invaluable as Mr. Klein leads US HIFU through the final stages of the clinical trial in preparation for data submission to the FDA. In addition, he will oversee the company's other operations, including market development for the Sonablate outside of the United States and the Sonatherm™ 600, US HIFU's first 510(k)-cleared medical device.
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