2014

FDA Advisory Panel Recommends InSightec ExAblate System for Approval First Focused Ultrasound System Recommended for FDA Approval in U.S. with

Post-Approval Conditions



    GAITHERSBURG, Md., June 4 /PRNewswire-FirstCall/ -- InSightec Ltd., a
 majority owned subsidiary of Elbit Medical Imaging Ltd. (Nasdaq:   EMITF), today
 reported that the Obstetrics and Gynecology Devices Panel of the U.S. Food and
 Drug Administration (FDA) has recommended the Company's ExAblate(R) 2000
 System for the non-invasive treatment of uterine fibroids for approval, with
 post-approval conditions.  The ExAblate System is the first Magnetic Resonance
 guided Focused Ultrasound Surgery (MRgFUS) system to be reviewed by the panel
 and recommended for FDA approval.
     The ExAblate System is intended to provide a non-invasive alternative to
 current treatments for symptomatic uterine fibroids, which include
 hysterectomy, myomectomy, uterine artery embolization, and drug therapy.
 Uterine fibroids are the most common reason for surgery among women of
 reproductive age, after caesarean section.  Approximately 200,000 women in the
 United States currently undergo hysterectomy each year for the treatment of
 uterine fibroids.
     Dr. Jacob Vortman, President and Chief Executive Officer of InSightec,
 said, "We are pleased with the recommendation for approval and look forward to
 working closely with the FDA on the specific conditions for approval.  The
 ExAblate System is a breakthrough technology that has the potential to benefit
 millions of women around the world who are seeking a non-invasive alternative
 to surgery to deal with their uterine fibroid symptoms.  Although the concept
 of focused ultrasound has been researched for over 60 years, this is the first
 time an implementation of this technology has been recommended for FDA
 approval."
     The panel recommendation was based on the results of a multicenter,
 controlled clinical study that was performed at centers in the United States,
 Europe, and Israel, including Brigham and Women's Hospital, the Mayo Clinic,
 and Johns Hopkins Hospital in the US, St. Mary's Hospital in London, Charite
 Hospital in Berlin, and Sheba Medical Center and Hadassah Hospital in Israel.
 The primary endpoint of the study was to ensure improvement in uterine fibroid
 symptom severity, as measured using a patient treatment outcome questionnaire,
 and ensure safety of the device.
     "Upon approval, women will have a significant alternative for a very
 common, debilitating condition.  We are delighted to have participated in this
 ground-breaking study and hope that this will stimulate further research for
 fibroids," said Elizabeth A. Stewart, M.D., Brigham and Women's Hospital and
 co-principal investigator.
     Co-principal investigator Clare Tempany-Afdhal, M.D., Brigham and Women's
 Hospital stated, "The novel combination of Focused Ultrasound and Magnetic
 Resonance guidance provides a unique image-guided therapy that has the
 potential to be used for many other applications."
     Post-approval conditions recommended by the FDA panel were related to the
 development of training material and labeling.
     The ExAblate System attaches to a standard 1.5 Tesla MRI system used in
 many hospitals. During this outpatient procedure the patient lies inside the
 MRI scanner and highly focused ultrasound waves, which non-invasively ablate
 the uterine fibroid(s), are emitted into the body.  The device received the
 European CE mark in 2002 and is currently commercially available in Israel,
 Europe, and Japan.
 
     InSightec Ltd. is privately held company owned by Elbit Medical Imaging,
 General Electric, private investors, and employees. It was founded in 1999 to
 develop the promising MR guided Focused Ultrasound technology. Headquartered
 near Haifa, Israel, the company has over 80 employees and has invested more
 than $50 million in research, development, and clinical investigations. Its US
 headquarters are located in Dallas, Texas. ExAblate was awarded the 2004 grand
 prize of the IST (Information Society Technology) of the European Union for
 innovation and potential to serve mankind.  For more information, please go
 to: http://www.insightec.com .
     EMI is a subsidiary of Europe Israel (M.M.S.) Ltd. and focuses on four
 main fields of operations: Commercial and Entertainment Malls through its
 subsidiary Plaza Centers; the Hotel segment through its subsidiary Elscint
 Ltd.; image guided treatment through InSightec; and venture capital
 investments in the biotechnology and communication business.
     Any forward looking statements with respect to EMI's business, financial
 condition and results of operations included in this release are subject to
 risks and uncertainties that could cause actual results to differ materially
 from those contemplated in such forward looking statements, including, but not
 limited to, product demand, pricing, market acceptance, changing economic
 conditions, risks in product and technology development and the effect of
 EMI's accounting policies, as well as certain other risk factors which are
 detailed from time to time in EMI's filings with the Securities and Exchange
 Commission.
 
 

SOURCE InSightec Ltd.

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