INSIGHTEC SUBMITS PRE MARKET APPLICATION (PMA) FOR FDA APPROVAL OF EXABLATE FOR TREATMENT OF PAINFUL BONE METASTASES
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.