FDA APPROVES NEW NON-INVASIVE‚ NON-IONIZING RADIATION THERAPY TO TREAT PAIN FROM BONE METASTASES
TIRAT CARMEL, Israel (October 22, 2012) – 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® 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.
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