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.
Mr. Klein commented, “The promise of HIFU, as a precise, yet non-invasive treatment for prostate disease, is a technology that has clearly come of age. Emerging methods of care ranging from active surveillance to focal therapy serve as compliments to existing prostate treatments and provide new treatment options for clinicians and offer a broader range of treatment choices for patients. I couldn’t be more excited to be joining US HIFU at this mission critical point in the development and adoption of this important technology.”
Mr. Klein has a strong background in oncology in addition to his medical device experience. He served as president and CEO of Xoft, Inc., a position he held from 2005 until the sale of Xoft to iCAD, Inc. in December 2010. Mr. Klein led the development, approval and commercialization of Xoft’s non-radioactive x-ray technology for radiation therapy for various cancers. He continues to serve on iCAD’s board of directors. In 2008, while with Xoft, Mr. Klein received R&D Magazine’s “Top 100 Award” which honors the 100 most technologically significant new products each year.
From 2000 to 2004, Mr. Klein served as chairman, president and CEO of R2 Technology, a company that produced computer-aided breast and lung cancer detection devices. R2 Technology was acquired by Hologic, Inc. He served as general manager of Varian Medical Systems’ oncology group from 1997 to 2000, where he managed businesses ranging from $25 million to $250 million. Mr. Klein served on the board of directors of Sanarus Medical, a breast biopsy and cryoablation company focused on the treatment of fibroadenomas.
US HIFU makes the Sonablate HIFU treatment available to patients with prostate cancer in locations where it is approved or authorized and commercially available, such as Canada, Mexico, Bermuda and the Bahamas. London-based UKHIFU, Ltd (UK HIFU), another of the company’s subsidiaries, distributes the Sonablate in Europe and Russia.
About USHIFU, LLC
USHIFU, LLC (US HIFU), a privately held healthcare company, is a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies. US HIFU is committed to treating prostate cancer using HIFU with the Sonablate® 500, a minimally invasive, outpatient procedure pioneered to control cancer and significantly improve patients’ quality of life. The company is engaged in ongoing research for technological advancements for the Sonablate® 500 system and/or other ultrasound applications.
The Sonablate® 500 is approved for investigational use within the U.S. and is being studied for the treatment of prostate cancer in clinical trials in the U.S. The FDA has made no decision as to the safety or efficacy of the Sonablate® 500 for the treatment of prostate cancer. Currently, the device is available for the treatment of prostate cancer outside the U.S. in more than 30 countries.
US HIFU was founded in 2004 and is headquartered in Charlotte, N.C. Additional information may be found at www.ushifu.com.
About Galen Partners
Galen Partners (Galen) is a leading healthcare growth equity, late stage venture capital firm based in Stamford, Connecticut. The firm focuses on growth equity investments in healthcare technology-enabled services, medical devices and specialty pharmaceutical companies. With nearly $1 billion under management raised through five funds, Galen has invested in more than 70 companies since 1990. The firm continues a tradition of strategic collaboration and partnership with its portfolio company management teams to build healthcare market leaders. Please visit Galen’s website at www.galen.com.
SOURCE USHIFU, LLC
