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 radiation.
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.
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.
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