FDA Approves Label Change for Non-Invasive Fibroid Treatment

Label Allows Doctors to Use ExAblate(R) to Treat up to 100% of Uterine Fibroid
Volume; Label Change Based on Data Showing Greater Long-Term Symptom Reduction
Following More Complete Fibroid Treatment

TIRAT CARMEL, Israel, April 7 /PRNewswire/ -- InSightec Ltd. announced
today that the U.S. Food and Drug Administration (FDA) approved a label
change for the company's ExAblate(R) 2000 MR-guided Focused Ultrasound
(MRgFUS) system for the treatment of women with non-hysteroscopically
resectable uterine fibroids. Under the new labeling, the agency allows
physicians to treat up to 100% of the fibroid compared to its previous
restriction to only treat up to half the fibroid tissue.
"In allowing doctors to destroy the entire fibroid, we believe the FDA
has demonstrated further confidence in the safety and efficacy of the
non-invasive ExAblate system," said Haywood L. Brown, MD, Chair of Obstetrics
and Gynecology/Maternal-Fetal Medicine at Duke Medicine in Durham, North
Carolina.
The FDA label change was based on a growing body of evidence supporting
the system's safety and efficacy, including the results of a study published
in the August 2007 edition of Obstetrics and Gynecology demonstrating that
patients experience longer and improved symptom reduction as a greater volume
of the fibroid is destroyed.
"We're extremely pleased that the FDA approved this important label
change and believe this underscores the safety of our system, the only
non-invasive treatment for uterine fibroids available today," said Dr. Kobi
Vortman, President and Chief Executive Officer of InSightec. "We remain
committed to continuously expanding our treatment indications and
applications through research. An ongoing research study is evaluating the
potential of treating fibroids with the ExAblate system to enhance fertility
when other potential causes of women's infertility have been ruled out. The
study will compare birth rates of women who underwent ExAblate treatment to
those who had a surgical myomectomy."
"Evidence supports removing fibroids that distort the uterine cavity to
increase pregnancy rates and 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 than
$120 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/
Media Contact:
Hollister Hovey
Lazar Partners
+1-646-871-8482
hhovey@lazarpartners.com

SOURCE InSightec Ltd

Media Contact: Hollister Hovey, Lazar Partners, +1-646-871-8482,
hhovey@lazarpartners.com