ExAblate(R) Receives European CE Mark for Treatment of Adenomyosis

By Insightec Ltd, PRNE
Tuesday, June 22, 2010

Non-Invasive Procedure Now Available Where Options Were Limited; InSightec Innovation Continues to Expand Treatment Choice in Women's Health

TIRAT CARMEL, Israel, June 23, 2010 - InSightec Ltd. announced today that its ExAblate(R) system has received
an expanded CE Mark certification for "ablation of soft tissue for treatment
of benign tumors, including uterine fibroids and adenomyosis" using Magnetic
Resonance guided Focused Ultrasound (MRgFUS) technology. The certification
was granted on the basis of clinical evidence showing that focused ultrasound
is safe and effective in treating symptomatic adenomyosis, which included
published data of patients with the condition. The certification body KEMA
Quality agreed that treatment with InSightec's system resulted in
statistically significant improvement in subjective symptoms, and significant
volume reduction of the treated mass.

Adenomyosis is a benign gynecologic growth characterised by the presence
of ectopic endometrial glands and stroma in the myometrium and hyperplasia
(excessive cell reproduction) of adjacent smooth muscles. It manifests with
uterine myoma-mimicking symptoms such as heavy menstrual bleeding, pain, and
diffuse uterine enlargement. Women with this condition are unlikely to
conceive.

"Patients who suffer from Adenomyosis and want to preserve their uterus
have had few viable options in the past," said Dr. Jaron Rabinovici,
Vice-Chair, Department of Obstetrics and Gynecology, Sheba Medical Center.
"Adenomyosis may have a grave impact on a woman's health and quality of life
and until recently hysterectomy was the only accepted treatment involving
adverse effects and hospitalization. Another treatment option is medication,
which offered only temporary relief of symptoms and had its own set of side
effects.

"The availability of this procedure is a welcome development for women
living with this condition, because it means they now have a treatment choice
that is non-invasive, safe and effective. More importantly, women who
underwent this non-invasive option for adenomyosis conceived and delivered
subsequently healthy children."

"ExAblate(R) has been used to treat uterine fibroids non-invasively with
great success since 2004, and this expanded CE Mark represents a significant
milestone in our commitment to continually broaden the applications of this
non-invasive, innovative therapy in addressing women's health " said Dr. Kobi
Vortman
, President and CEO of InSightec. "This procedure is done on an
outpatient basis, patients can return to work the next day, and complications
are rare. The clinical and economic advantages of ExAblate(R) allow for
enhanced access to treatment - and improved quality of life - for more
women."

While fibroids and adenomyosis are both non-cancerous tumours of the
uterus, fibroids grow out from the uterine wall, and adenomyosis originates
from swelling of the uterine wall as a result of the penetration of
endometrial tissue. While a fibroid is distinct from the uterine wall and can
be removed, adenomyoma cannot be removed without actually removing the
involved uterine muscle. Clear-cut surgical excision of the whole adenomyosis
lesion is difficult because of its ambiguous boundary.

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
$130 million in research, development, and clinical investigations. Its U.S.
headquarters are located in Dallas, Texas. For more information, please go
to: www.insightec.com/

About ExAblate(R)

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 6,000 women have been treated
worldwide to date. ExAblate(R) 2000 received the European CE Mark for pain
palliation of bone metastases in June 2007.

For further information please contact:

    InSightec Ltd.
    P.O. Box 2059
    Tirat Carmel 39120, Israel
    Tel: +972-4-813-1313
    Fax: +972-4-813-1322
    Email: info@insightec.com

    Media contact
    Waggener Edstrom Worldwide-London
    Dr Jane Brearley
    Healthcare Practice EMEA
    T +44(0)20-7632-3897
    jbrearley@waggeneredstrom.com

InSightec Ltd., P.O. Box 2059, Tirat Carmel 39120, Israel, Tel: +972-4-813-1313, Fax: +972-4-813-1322, Email: info at insightec.com, Media contact: Waggener Edstrom Worldwide-London, Dr Jane Brearley, Healthcare Practice EMEA, T +44(0)20-7632-3897, jbrearley at waggeneredstrom.com

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