23 Patients With Organ Confined Low Risk Prostate Cancer Have Been Treated in Clinical Trials Using the ExAblate(R) Non-Invasive Prostate Cancer System

By Insightec Ltd, PRNE
Tuesday, July 12, 2011

TIRAT CARMEL, Israel, July 13, 2011 -

Initial Results
are Encouraging,
Spurring Hope for a Treatment
Option W
ith a Lower
of Complications

InSightec Ltd., the global leader in MR-guided focused
ultrasound technology and the only company to receive FDA approval
for its ExAblate® system for treating uterine fibroids,
announced today that 23 patients with organ confined low risk
prostate cancer have already been treated with its
ExAblate® system in clinical trials, showing promising
initial results.

The goal of the trials is to demonstrate the feasibility of
using the ExAblate® MR-guided Focused Ultrasound
(MRgFUS) system in endorectal prostate treatments and to assess the
safety and preliminary effectiveness of the treatment. The trials
were approved by local ethic committees.

The treatment varies from focal treatment to near whole gland
ablation depending on the clinical decision of the investigators.
Out of 24 treatments in 23 patients, 5 were near total gland
ablation preserving potent patients’ urinary sphincter and
neurovascular bundles and 18 were focal treatments. None of the
treatments (whole gland or focal) triggered Severe Adverse Events
during or after treatment and none required post treatment
intervention, demonstrating a good safety profile.

Prostate cancer is one of the most commonly diagnosed cancers
among men. Approximately 900,000 new cases are diagnosed annually
in the world. Treatment options include prostatectomy (surgical
removal of the prostate gland), radiation therapy, brachytherapy
(implantation of radioactive seeds), and cryotherapy. However,
current treatment options are associated with a relatively high
level of adverse events among them impotence and incontinence which
significantly impair the quality of life of prostate cancer

“We are extremely pleased with the initial results and with the
rate of patient recruitment for these trials,” says Dr. Kobi
, President and CEO of InSightec. “One of our goals with the
ExAblate® prostate cancer program is to demonstrate that
an effective treatment does not have to be accompanied by serious
adverse events such as impotence and incontinence. We are very
encouraged by these early results that give hope that it may be
possible in the future to offer prostate cancer patients a
treatment option with a lower rate of complications compared to the
currently available options.”

Clinical trials are on-going at 4 sites: Sapienza University of
Rome, Italy, The National Cancer Centre Singapore, The NN Petrov
Institute of Oncology, St. Petersburg, Russia, and the Jaslok
Hospital and Research Center, Mumbai, India. InSightec will shortly
be expanding the prostate clinical trials to additional leading

Some of my patients express concern regarding the
preservation of their sexual function and continence and I have
informed them of the MRgFUS treatment as an investigational option
for low risk prostate cancer patients”, says Associate Professor
Christopher Cheng, Head & Senior Consultant, Department of
Urology Singapore General Hospital, Singapore. “So far, 9 patients
enrolled in the trial at our center with good initial results and
we hope that in time this promising technique will become a
standard option for low risk prostate cancer patients.”

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 120 employees and has invested more than $170 million in
research, development, and clinical investigations. Its U.S.
headquarters are located in Dallas, Texas. For more information,
please go to: href="www.insightec.com/">www.insightec.com/

About ExAblate®

ExAblate® is an Image Guided, Non-invasive, Robotic
Acoustic Surgery system. The ExAblate® system is the
first 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 treated and surrounding
non targeted 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 8,000 patients
have been treated worldwide to date with excellent results.
ExAblate® 2000 received the European CE Mark for pain palliation of
bone metastases in June 2007 and for Adenomyosis in June

Media Contact:

Hadas Hochman
Email: info@insightec.com


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