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InSightec Announces Enrollment of African American Women in FDA PostMarketing Study

Posted on: Wednesday, 22 June 2005, 09:00 CDT

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 http://www.insightec.com/ 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: http://www.insightec.com/

Contact Information InSightec http://www.insightec.com/ Tel: +972-4-813-1329 Email: info@insightec.com For media inquiries, contact: Fern Lazar Lazar Partners, Ltd. Tel: +1-212-867-1762 Email: flazar@lazarpartners.com

For more information about uterine fibroids, please visit http://www.uterine-fibroids.org/

Insightec Ltd.

CONTACT: Contact Information: InSightec, http://www.insightec.com/, Tel:+972-4-813-1329, Email: info@insightec.com; For mediainquiries, contact: Fern Lazar, Lazar Partners, Ltd., Tel:+1-212-867-1762, Email: flazar@lazarpartners.com

Source: PRNewswire

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