InSightec Announces Enrollment of African American Women in FDA PostMarketing Study

ExAblate(R) 2000 to Treat African-American Women with Uterine Fibroids

Jun 22, 2005, 01:00 ET from Insightec Ltd.

    HAIFA, Israel, June 22 /PRNewswire/ -- InSightec announced today that
 five sites in the US are enrolling African American women in a post-marketing
 study to evaluate the efficacy of its ExAblate 2000 in treating uterine
 fibroids. This study is an element of the FDA's commercial approval for
 ExAblate in October 2004.
     Uterine fibroids are benign tumors that develop in the uterus. They can
 be as small as a pea or as large as a grapefruit and often cause heavy and
 extensive menstrual bleeding, pain or discomfort in the pelvis, pressure on
 the lower abdomen, and frequent urination, among other symptoms.
     According to the U.S. National Institutes of Health, at least 25 percent
 of women, or thirteen million women in U.S., aged 25-50, suffer from uterine
 fibroids and African-American women are three to five times more likely to
 develop the tumors than their Caucasian counterparts. This study is to
 confirm the efficacy of the ExAblate treatment in African American women as
 they tend to have more severe uterine fibroids.
     The study is open to African-American women who have symptomatic uterine
 fibroids, have completed their families and are not contraindicated for
 magnetic resonance imaging (MRI). Additional inclusion/exclusion criteria
 apply. The study includes a 36-month follow-up to evaluate long-term efficacy
 of the treatment.
     About the ExAblate(R) 2000 procedure
     ExAblate is the first system to use the breakthrough MRgFUS technology
 which combines MRI -- to visualize tissues in the body, plan the treatment
 and monitor in real time treatment outcome -- and high intensity ultrasound
 to thermally ablate tissue. MR thermal feedback, provided uniquely by the
 system, allows the physician to control and adjust the treatment to ensure
 that the targeted tumor is fully treated and other tissue is avoided. The
 ExAblate 2000 is only compatible with GE Healthcare's Signa MR systems.
     The five major medical centers in the United States that will be
 conducting this follow- study for the non-invasive treatment of uterine
 fibroids among African American women are:
     - Beverly Tower Wilshire Advanced Imaging Center - Radnet in
       Beverly Hills, CA
     - North Texas Uterine Fibroid Institute in Dallas, TX
     - University MRI in Boca Raton, FL
     - The Lahey Clinic in Burlington, MA
     - Brigham and Women's Hospital in Boston, MA
     - Virtua Health in Voorhees, NJ
     For more information about the trial and the facilities performing the
 procedure, please visit or call +1-(866)-EXABLATE or the
 local sites.
     About InSightec
     InSightec Image Guided Treatment Ltd. is a privately held company owned
 by Elbit Medical Imaging (EMI), General Electric, private investors 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 100
 employees and has invested more than $80 million in research, development,
 and clinical investigations. Its U.S. headquarters are located in Dallas,
 Texas. For more information, please go to:
     Contact Information
     Tel: +972-4-813-1329
     For media inquiries, contact:
     Fern Lazar
     Lazar Partners, Ltd.
     Tel: +1-212-867-1762
     For more information about uterine fibroids, please visit

SOURCE Insightec Ltd.