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FDA Approves Label Change for Non-Invasive Fibroid Treatment
Date:4/7/2009

nd decrease the rates of miscarriage," Dr. Brown added. This trial tests the premise in women who have not been eligible for minimally invasive treatment.

The Fertility Enhancement study is being conducted at the Mayo Clinic in Rochester, Minnesota; Duke University in Durham, North Carolina; Willowbend Health and Wellness in Plano, Texas; and Focused Ultrasound Northwest in Renton, Washington. For more information on the study please visit http://www.clinicaltrials.gov/

To date, InSightec has reported 54 pregnancies, 22 deliveries with 11 ongoing pregnancies with women who previously underwent the ExAblate procedure.

About ExAblate(R) 2000

ExAblate is the first system to use the MR guided focused ultrasound technology that combines MRI - to visualize the body anatomy, plan the treatment and monitor treatment outcome in real time - and high intensity focused ultrasound to thermally ablate tumors inside the body non-invasively. MR thermometry, provided uniquely by the system, allows the physician to control and adjust the treatment in real time to ensure that the targeted tumor is fully treated and surrounding tissue is spared. The ExAblate system was approved by the U.S. Food and Drug Administration in 2004 as a treatment for symptomatic uterine fibroids. Over 4,500 women have been treated worldwide to date. ExAblate(R) 2000 received the European CE Mark certification for pain palliation of bone metastases in June 2007.

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 th
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