TEL AVIV, January 14 Elbit Imaging Ltd.(NASDAQ: EMITF) ("Elbit" "Company") that its subsidiary, InSightec Ltd.,announced today that Japan's Ministry of Health, Labor and Welfare (MHLW) hasapproved the company's ExAblate(R) MR-guided Focused Ultrasound (MRgFUS)system for the treatment of women with uterine fibroids.
ExAblate is currently the only noninvasive treatment for uterine fibroidsapproved for use in Japan.
InSightec Ltd. estimates that approximately 25% of Japanese women willdevelop symptomatic uterine fibroids, primarily during childbearing years.These benign tumors can significantly impair functionality and degradequality of life, resulting in significant work absences.
Using the ExAblate system, the physician uses the Magnetic ResonanceImaging (MRI) to visualize the patient's anatomy and then aims focusedultrasound waves at the targeted tissue to thermally ablate, or destroy it.The MRI allows the physician to monitor and continuously adjust the treatmentin real time. An additional benefit of using InSightec's ExAblate system isthat during the procedure to destroy the targeted tissue, patients requireonly limited conscious sedation as opposed to full sedation.
The ExAblate system received the CE Mark for uterine fibroids in October2002 and US Food and Drug Administration (FDA) approval in 2004. Over 5,500women around the world have chosen to undergo the non-invasive ExAblatetreatment for their symptomatic uterine fibroids over invasive surgery.
GE Healthcare is the approval holder and distributor of ExAblate in Japan.
Dr. Kobi Vortman, President and Chief Executive Officer of InSightec,said: "The approval was based on a growing body of evidence showing thatExAblate is a safe, effective, and durable treatment for this widespread,life-impacting condition. ExAblate is an outpatient procedure and patientsnormally return home the same day and to work within one to two days comparedto lengthy hospitalizations and recovery times associated with more invasiveprocedures such as hysterectomy, myomectomy or UAE."
Dudi Machluf, Chief Executive Officer (Co-CEO) of Elbit Imaging, said:"InSightec's technology is the first non-invasive treatment for uterinefibroids approved for use by Japan's Ministry of Health, Labor and Welfare(MHLW), an accomplishment which speaks for itself. In receiving thisapproval, InSightec made significant progress towards increasing its activityin Japan and receiving reimbursement. We expect that InSightec will leveragethe great potential capitalized in this in this market."
InSightec Ltd. is a privately held company owned by Elbit Imaging,General Electric, MediTech Advisors, LLC and employees. It was founded in1999 to develop the breakthrough MR guided Focused Ultrasound technology andtransform it into the next generation operating room. Headquartered nearHaifa, 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 goto: http://www.insightec.com/
About Elbit Imaging Ltd.
The Activities of Elbit Imaging Ltd. are divided into the followingprincipal fields: (i) Shopping and Entertainment Centers - Initiation,construction, operation, management and sale of shopping and entertainmentcenters and other mixed-use real property projects, predominantly in theretail sector, located in Central and Eastern Europe and in India; (ii)Hotels - Hotel ownership, operation, management and sale, primarily in majorEuropean cities; (iii) Image Guided Treatment - Investments in the researchand development, production and marketing of magnetic resonance imagingguided focused ultrasound treatment equipment; (vi) Residential Projects -Initiation, construction and sale of residential projects and other mixed-usereal projects, predominantly residential, located in Eastern Europe and inIndia; and (v) Other Activities - (a) The distribution and marketing offashion apparel and accessories in Israel; (b) venture capital investments;and (c) investments in hospitals, and farm and dairy plants in India, whichare in preliminary stages.
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SOURCE Elbit Imaging Ltd.