US HIFU Adds Mark Carol, MD, As Chief Development Officer

CHARLOTTE, N.C., May 14, 2012  /PRNewswire/ -- USHIFU, LLC (US HIFU), a world leader in minimally invasive high intensity focused ultrasound (HIFU) technologies, announced today that Mark Carol, MD, has joined the new management team as chief development officer. With more than 25 years of clinical practice and medical device industry experience, Dr. Carol will focus on continued development of the company's breakthrough Sonablate® 500 System.

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"Dr. Carol brings extensive experience in radiation oncology to the company and is an innovative developer of therapeutic technologies for a wide range of applications," said Mike Klein, CEO for US HIFU. "We are pleased to have him join Dr. Mark Schoenberg, our chief medical officer, and the rest of the management team in developing this important treatment option. We believe a concentrated focus on gaining additional clinical data and optimizing HIFU technology holds significant promise to position this minimally invasive treatment as a new option in the spectrum of care, balancing effectiveness and quality of life."

After spending four years in clinical practice, Dr. Carol founded several medical device companies, including NOMOS, where he pioneered the development of technology related to stereotactic and holographic-guided surgery. He also conceptualized and implemented clinically the first commercial inverse treatment planning, intensity modulation radiation therapy (IMRT) and image guided radiation therapy systems. Dr. Carol has published extensively in the fields of radiation therapy and neurosurgery and holds more than a dozen patents in radiation therapy, neurosurgery and cardiology. He received his M.D. with distinction from the University of Rochester. He also completed a residency and fellowship in neurosurgery at the University of Maryland.

"I am excited about the future of this technology as we work to optimize the platform," said Dr. Carol. "Our ongoing development will focus on improving efficacy even further and minimizing the duration of the procedure. In addition, we look forward to enhancing the interface to allow a more straight-forward user experience."

In other news, US HIFU recently reported that the company's Sonablate System was used in a key study at the University College of London to deliver focal treatment for prostate cancer. The outcome of this initial study indicates HIFU may provide an alternative to traditional treatment with significantly fewer side effects, according to results published in the current issue of Lancet Oncology (DOI:10.1016/S1470- 2045(12)70121-3).

In addition, although still investigational in the United States, recent HIFU treatment guidelines have been issued by the National Institute for Health and Clinical Excellence (NICE), the independent organization responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health in the United Kingdom. NICE interventional procedure guidance 424, "Focal therapy using high-intensity focused ultrasound for localised prostate cancer," indicates current evidence on focal therapy using HIFU for localized prostate cancer raises no major safety concerns. The NICE guidelines also state that patients treated with targeted high-intensity ultrasound could avoid many of the risks of more extensive procedures that treat the whole prostate gland. For more information, visit http://guidance.nice.org.uk/ipg424 

"We are very encouraged by the results of the Lancet Oncology published study and the guidelines which demonstrate how HIFU can be used to further refine the boundaries of the emerging field of focal therapy," said Dr. Carol. "These events provide support for the initiation of a larger trial with additional sites to examine the role of focal therapy in the treatment of primary, organ-confined prostate cancer. We look forward to completing these clinical trials in the U.S. and elsewhere as we strive to provide state-of-the-art technology for the treatment of this wide-spread disease."

The majority of men treated for prostate cancer are treated with surgery or radiotherapy, which involve treating the whole prostate. Both cause damage to the surrounding non-cancerous tissue and can lead to substantial side effects such as urinary incontinence and impotence. The goal of focal therapy is to offer an alternative to men who value genito-urinary function and quality of life, allowing each patient and their physician to balance the risk and clinical benefit of individual treatment options.

HIFU is a therapy that destroys targeted tissue with rapid heat elevation. HIFU concentrates high frequency ultrasound waves (similar to a magnifying glass) into an area the size of a grain of rice. At that location, or focal point, the temperature rapidly rises to almost 90 degrees Celsius (195 degrees Fahrenheit). Tissue at the focal point, including cancerous tissue, is destroyed. HIFU uses non-ionizing energy, so the procedure can be repeated, if necessary. HIFU is being studied around the world to treat a wide variety of cancers and soft tissue diseases.

About USHIFU, LLC

USHIFU, LLC (US HIFU), a privately held, venture-backed 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. US HIFU is engaged in ongoing research for technological advancements for the Sonablate System and/or other ultrasound applications. The Sonablate is approved for investigational use within the U.S. and is being studied in a clinical trial as a possible treatment for recurrent prostate cancer in patients treated previously with radiation therapy. The FDA has made no decision as to the safety or efficacy of the Sonablate 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.

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