FDA Will Evaluate Submission Through an Expedited Review Process
TIRAT CARMEL, Israel, Jan. 24, 2012 /CNW/ - InSightec Ltd, the leader in
MR guided Focused Ultrasound therapy, announced that it has submitted a
premarket approval application (PMA) to the U.S. Food and Drug
Administration (FDA) for its ExAblate treatment of pain palliation of bone metastases. ExAblate uses MR guided focused ultrasound (MRgFUS) to treat the pain
caused by bone metastases non-invasively and without ionizing
Over sixty percent of cancer patients suffer from painful bone
metastases. Of these thirty percent will not respond to radiation
therapy. ExAblate was investigated as an option for these patients.
The PMA submission was based on a two arm randomized controlled trial comparing patients undergoing ExAblate's MR guided focused ultrasound for palliation of painful bone metastases with patients undergoing a sham, (no) treatment. Patients who had no
response to the sham treatment were later allowed to undergo an
ExAblate treatment. The FDA also granted an expedited review process
for the PMA submission.
"Today's announcement is a significant milestone: our second medical
indication submitted for FDA approval and the first PMA for oncology "
said Dr. Kobi Vortman, President and CEO of InSightec. "This represents
our continued commitment to bring MRgFUS into broad clinical use."
ExAblate combines high intensity focused ultrasound to thermally ablate
tumors and continuous MRI to visualize the anatomy, plan treatment and
monitor treatment outcomes in real time.
ExAblate is the only MRgFUS system with FDA approval, granted in 2004
for uterine fibroids. It also received European CE marking for uterine
fibroids, bone metastases, and adenomyosis. Clinical trials are ongoing
for brain disorders, including essential tremor and Parkinson's
disease, and prostate cancer.
InSightec Ltd. is privately held by Elbit Imaging, General Electric,
MediTech Advisors, 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 130 employees and has invested more than
$150 million in research, development, and clinical investigations.
ExAblate has won several awards for innovation and its potential to
help mankind including the Wall St. Journal Technology Innovation Award
and the European Union's IST grand prize. Time Magazine recently
included it among the 50 best inventions. ExAblate was presented at TEDMED 2011 in San Diego, Ca.
Websites: http://www.insightec.com; http://www.bone-pain-palliation.co.uk/
About Focused Ultrasound Foundation
The Focused Ultrasound Foundation is dedicated to improving the lives of millions of people with serious
medical disorders by accelerating the development and adoption of
focused ultrasound -- an amazing, early-stage, noninvasive therapeutic
technology that has the potential to revolutionize surgery, radiation
therapy and drug delivery and to transform the treatment of many
life-threatening and disabling conditions.
SOURCE InSightec Ltd
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