InSightec Launches ExAblate(R) One and ExAblate(R) OR Systems at CIRSE 2010

TIRAT CARMEL, Israel, September 29, 2010 /PRNewswire/ -- InSightec Ltd., the global leader in MR guided Focused Ultrasound technology (MRgFUS) announced today that it will be launching ExAblate(R) One for the treatment of uterine fibroids, adenomyosis and research options in women's health and the ExAblate(R) OR system as the Operating Room of the future at the upcoming Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2010 meeting.

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The ExAblate(R) family of systems employs Focused Ultrasound to non-invasively heat and destroy targeted tissue under MR guidance. The MRI system, the most advanced imaging modality available today, identifies and targets tumors, while providing real time temperature monitoring of the treated tissue.

With experience in treating over 6000 patients at more than 80 centers around the world, the ExAblate family of systems offers a proven and mature platform for commercially approved treatments as well as research options for a wide range of clinical indications.

Innovative ExAblate(R) One expands treatment choices for women suffering from uterine fibroids and adenomyosis. Recent advances in ExAblate(R) technology now enable the treatment of large and vascular fibroids as well as adenomyosis, broadening the patient base. The ability to treat greater fibroid volumes is expected to result in greater clinical efficacy. ExAblate(R) significantly improves adenomyosis symptoms, and in many cases can improve a patient's chances of overcoming infertility caused by the condition.

Patients treated for uterine fibroids or adenomyosis typically return to their normal routine within twenty four hours of the procedure, a major improvement over most fibroid treatment techniques. A growing number of women have become pregnant following the ExAblate treatment. Studies have shown that MRgFUS may even improve fertility in women suffering from infertility caused by uterine fibroids.(1)

Experience at sites around the world has shown that ExAblate significantly increases patient interest in MRgFUS treatment and facility traffic. A leading site in Tokyo, Japan reported that the number of patients treated for uterine fibroids increased by 550% in one year.(2)

The ExAblate treatment has also been proven as a cost-effective alternative to current treatments, meeting acceptable criteria for optimal cost-effectiveness in fibroid treatment.(3)

"MR guided Focused Ultrasound (MRgFUS) use in the treatment of uterine fibroids has been an accepted and viable option for increasing numbers of women for several years now. However, with the enhancements offered by ExAblate(R) One we are able to offer even more women the option of treatment with an effective, dedicated women's health platform with predictable results." Said Professor Wladyslaw M Gedroyc, MD, Head of Radiology, St. Mary's Hospital, London, UK. "In addition to the benefits to patients, such as preservation of the uterus and improved chances of fertility, we have also seen a significant reduction in treatment time."

The ExAblate(R) OR platform is a Non-invasive Image Guided and Controlled Acoustic Operating Room. The system incorporates interchangeable cradles for each application that are interfaced with a single common table. ExAblate(R) OR offers both commercially approved and research treatment options for a multitude of clinical indications such as: uterine fibroids and adenomyosis, breast cancer, prostate cancer, pain palliation of bone metastases and various other indications.

ExAblate(R) One and ExAblate(R) OR are compatible with both GE Healthcare's Signa and Discovery MRI product lines and have a newly designed patient bed with ergonomic advantage for patients, streamlined user interface and improved usability for physicians.

"Our vision has been to provide a dedicated ExAblate system which truly offers expanded non-invasive treatment choice and has a proven safety profile. Since the market introduction of the ExAblate(R) 2000 in 2004, clinicians and researchers have continued to strive to further improve and enhance the system based on innovation and accumulating clinical data and knowledge, "said Dr. Kobi Vortman, President and CEO of InSightec. "We are the only MR guided Focused Ultrasound technology provider to offer such a proven and mature image guided and controlled acoustic surgery platform".

The new ExAblate(R) One and ExAblate(R) OR patient bed will be featured at the InSightec booth # 44 at CIRSE (2-6, October 2010, Valencia, Spain). InSightec will also be hosting a satellite symposium at CIRSE, on October 3rd at which leading researchers will discuss their work in various fields using the ExAblate system. To learn more about InSightec's planned activities at CIRSE please visit: http://www.insightec.com

1 Rabinovici J, David M, Fukunishi H, Morita Y, Gostout BS, Stewart EA, for the MRgFUS Study Group. Pregnancy Outcome After Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) for Conservative Treatment of Uterine Fibroids, Fertility & Sterility, 2008.

2 Yutaka Morita, Tetsuya Nakamura Introduction of ExAblate(R) 2000 Dramatically Increases Revenues of OB/GYN Department in One Year InSightec Clinical Report Vol. 2, No. 1

3 O'Sullivan AK, Thompson D, Chu P, Lee DW, Stewart EA, Weinstein MC. Cost-Effectiveness of Magnetic Resonance guided Focused Ultrasound for the Treatment of Uterine Fibroids, Int. J of Technology Assessment in Health Care, 2009, 25(1): 14-25

About ExAblate(R)

The ExAblate(R)One and OR systems are built on enhancements made through dedication to research and development and InSightec's unparalleled experience and innovation in partnering with physicians around the world on clinical research.

The ExAblate(R) 2000 received CE mark in 2002 and the Food and Drug administration (FDA) approval in 2004 for the treatment of uterine fibroids. The system received the European CE mark for pain palliation of bone metastases in June 2007 and for adenomyosis in June 2010. ExAblate 2000 has won numerous innovation awards and has been used to treat thousands of patients around the world.

About InSightec

InSightec Ltd. is a privately-held company owned by Elbit Imaging, General Electric, MediTech Advisors, LLC and employees. It was founded in 1999 to develop the breakthrough MR guided Focused Ultrasound technology and transform it into the next generation operating room. Headquartered near Haifa, Israel, the company has over 160 employees and has invested more than $130 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas. For more information, please go to: http://www.insightec.com/

Note to editors:

ExAblate(R) One received a CE mark for adenomyosis treatment in June 2010. It is not approved by the FDA.

    Media Contact:

    For further information please contact:

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    Email: [email protected]
    Phone: +44(0)20-7632-3800

SOURCE InSightec Ltd

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