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Last updated on April 24, 2014 at 21:24 EDT

FDA Approves New Non-Invasive, Non-Ionizing Radiation Therapy to Treat Pain from Bone Metastases

October 22, 2012

TIRAT CARMEL, Israel, October 22, 2012 /PRNewswire/ –

InSightec Ltd, the leader in magnetic resonance imaging (MRI)-guided Focused
Ultrasound therapy, announced that the U.S. Food and Drug Administration (FDA) has
approved ExAblate(R) MRI-guided focused ultrasound as a therapy to treat pain from bone
metastases in patients who do not respond or cannot undergo radiation treatment for their
pain. This is the second FDA approval for ExAblate, which has been used widely since it
was approved in 2004 as a non-invasive, outpatient, therapy for uterine fibroids.

To view the Multimedia News Release, please click:

http://www.multivu.com/mnr/56632-insightec-fda-approves-exablate

Bone metastases occur when cancer cells break away from their primary site and spread
to other parts of the body.

“Pain is the most common and severe symptom of bone metastases, often causing
significant physical and emotional discomfort with a large impact on enjoyment of life,”
says Mark Hurwitz, M.D., principal investigator of the international, multi-center,
randomized study that formed the basis of InSightec’s Pre-Market Approval (PMA)
application with the FDA. “Pain palliation by ExAblate can dramatically improve the
quality of life for cancer patients with bone metastases. Results from the clinical study
showed that ExAblate therapy significantly reduces pain caused by bone metastases.
Patients also reported lasting improvement in well being and function, along with a
decrease in the need for medication.”

Dr. Hurwitz, who is currently Director of Thermal Oncology and Vice Chair of the
Radiation Oncology Department at Thomas Jefferson University in Philadelphia, led the
study during his previous tenure as Director of Regional Program Development for the
Department of Radiation Oncology at Brigham and Women’s Hospital and Associate Professor
of Radiation Oncology at Harvard Medical School.

According to the American Cancer Society, more than two-thirds of breast and prostate
cancers that metastasize spread to the bones and this also occurs in up to 30% of
metastatic lung, bladder and thyroid cancers. Up to thirty percent of patients with bone
metastases either do not respond to radiation therapy or will be unable to undergo
radiation for pain relief.

ExAblate combines therapeutic acoustic ultrasound waves and continuous guidance and
treatment monitoring with an MRI. Physicians use the MRI to plan and guide the therapy and
monitor treatment outcome. The focused ultrasound acoustic energy destroys the nerves
causing the pain, resulting in rapid reduction in pain.

“The recent FDA approval of ExAblate for pain palliation will offer new options for
cancer patients with crippling bone pain who are seeking pain-management options and are
no longer eligible for radiation treatment,” said Dr. Kobi Vortman, President and CEO of
InSightec. “This is the second FDA approval for the ExAblate technology and represents a
significant milestone in our quest to expand the applications for this innovative,
non-invasive therapy. It also demonstrates our continued commitment to bringing ExAblate
MRI-guided focused ultrasound into broad clinical use and improving our patients’ quality
of life.”

The second FDA approval for ExAblate was based on the results of an international,
multi-center, randomized clinical study comparing patients with painful bone metastases
undergoing palliative therapy with ExAblate to a similar group undergoing a placebo
therapy. Patients who underwent the ExAblate therapy reported clinically significant pain
relief and improvement of quality-of-life during follow-up three months after treatment.
Over 15 centers participated in the clinical trial including Fox Chase Cancer Canter,
Stanford University, UCSD, UVA, Moffitt, and Brigham and Women’s Hospital in the US as
well as University of Toronto, La Sapienza University in Rome, Sheba and Rambam Medical
Centers in Israel, Petrov Research Institute of Oncology and Rostov Medical University in
Russia.

ExAblate is the only FDA-approved MRI-guided focused ultrasound system for treating
uterine fibroids and bone metastases related pain management. It has also received
European CE marking for uterine fibroids, bone metastases, and adenomyosis. Twenty
hospitals in Europe and Asia-Pacific offer ExAblate as a palliative therapy for bone
metastases.

InSightec will be conducting a multi-center post-marketing study of 70 US patients who
suffer from painful bone metastases and will also be establishing a commercial registry to
collect data about patients undergoing ExAblate therapy for the palliation of painful bone
metastases.

About InSightec

InSightec [http://www.insightec.com ] Ltd. is privately held by Elbit Imaging, General
Electric, and MediTech Advisors. Founded in 1999 InSightec developed ExAblate to transform
MRI-guided Focused Ultrasound (MRgFUS) into a clinically viable technology. ExAblate has
won several awards for innovation and its potential to help mankind including The Wall
Street Journal Technology Innovation Awards and the European Union’s IST grand prize. TIME
magazine recently named Focused Ultrasound as “one of 50 best inventions.” For more
information about treatment centers and bone metastases please visit:
http://www.insightec.com [http://http//us.insightec.com ] and

http://www.bone-pain-palliation.co.uk

        Media contact:

        Lynn Golumbic
        +972-4-813-1368
        lynng@insightec.com

        Hollister Hovey
        +1-646-871-8482
        hhovey@lazarpartners.com


    Video: 

http://www.multivu.com/mnr/56632-insightec-fda-approves-exablate

SOURCE InSightec Ltd


Source: PR Newswire