Experimental Procedure Performed as Part of a Large U.S. Clinical Trial

TIRAT CARMEL, Israel, July 21 /PRNewswire/ — InSightec Ltd. announced
today that the first U.S. patient has been treated in the company’s pivotal
trial to evaluate the safety and effectiveness of the non-invasive,
radiation-free ExAblate(R) Magnetic Resonance-guided Focused Ultrasound
(MRgFUS) system as a pain relieving treatment for patients with bone
metastases who have failed an initial round of palliative radiation.

The ExAblate system was approved to treat women suffering from
symptomatic uterine fibroids in 2004. Over 4,000 women have already
undergone treatment with ExAblate worldwide.

“Pain from tumors that have spread to the bone is the most common kind
of pain for cancer patients,” said Dr. Kobi Vortman, InSightec’s president
and CEO. “Many patients are too weak to withstand invasive procedures to
quell their pain if it persists or recurs after palliative radiation. We
look forward to advancing the trial in hopes that ExAblate may provide a
non-invasive, ionized radiation-free means to improve the quality of life
of late-stage cancer patients.”

Bone is the third most common tissue to which cancer spreads, after the
lungs and liver. Almost all patients with metastatic prostate cancer have
skeletal metastases and in breast cancer, bone is the second most common
site of metastatic spread, affecting 90% of patients with progressive
breast cancer. Most cancer patients suffer from pain; controlling it and
managing its symptoms are important treatment goals.

Using the ExAblate system, the physician uses the Magnetic Resonance
Imaging (MRI) to visualize the patient’s anatomy and then aims focused
ultrasound waves at the targeted tissue to thermally ablate, or destroy it.
The MRI allows the physician to monitor and continuously adjust the
treatment in real time. The patient is consciously sedated to alleviate
pain and minimize motion. Due to the high acoustic absorption and low
thermal conductivity of the bone cortex, it is possible to use a low level
of energy and still achieve a localized heating effect while minimizing
damage to adjacent tissue.

InSightec hopes to enroll patients with bone metastases who have failed
palliative radiation therapy into the study, which is being conducted at 15
sites across the U.S. including Brigham & Women’s Hospital in Boston, Fox
Chase Cancer Center in Philadelphia, Methodist Hospital in Houston, Texas,
University of California, San Diego Medical Center and Weill Cornell
Medical College in New York.

The company is in the process of obtaining Institutional Review Board
(IRB) approval from the remaining sites, including Memorial Sloan Kettering
Cancer Center, Mount Sinai in Toronto, the Lahey Clinic in Burlington,
Mass. and the Mayo Clinic in Rochester, Minn.

The ExAblate 2000 system received the European CE Mark certification
for pain palliation of bone metastases in June. In clinical studies, which
supported the CE mark, the majority of patients reported pain relief within
days of treatment.

For more information on the study, please visit:
http://clinicaltrials.gov/ct2/show/NCT00656305?term=insightec&rank=2

SOURCE InSightec Ltd

Image: Newscom

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Experimental Procedure Performed as Part of a Large U.S. Clinical Trial

TIRAT CARMEL, Israel, July 21 /PRNewswire/ — InSightec Ltd. announced
today that the first U.S. patient has been treated in the company’s pivotal
trial to evaluate the safety and effectiveness of the non-invasive,
radiation-free ExAblate(R) Magnetic Resonance-guided Focused Ultrasound
(MRgFUS) system as a pain relieving treatment for patients with bone
metastases who have failed an initial round of palliative radiation.

Click here to read more.

Image: Newscom

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