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EXABLATE RECEIVES EXTENDED CE MARK CERTIFICATION FOR BENIGN AND CANCEROUS BONE TUMORS

July 1, 2013
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Tirat Carmel, Israel (July 1, 2013) -- INSIGHTEC Ltd, the leader in MRI guided Focused Ultrasound therapy, has announced that its ExAblate® systems have received an extended European CE Mark for the local treatment of cancerous and benign primary and secondary bone tumors, including but not limited to multiple myeloma, bone metastases, osteoid osteoma as well as facet joint back pain. The CE mark applies to the ExAblate 2000 and 2100 as well as the ExAblate 2100 Conformal Bone System. The CE mark was based on additional published clinical evidence.

 

ExAblate combines therapeutic acoustic ultrasound waves and continuous guidance and treatment monitoring with an MRI. Physicians use the MRI images to plan and guide the therapy and monitor treatment outcome. The focused ultrasound energy could be used to ablate the tumor or destroys the nerves transmitting or causing the pain, resulting in rapid reduction in pain. ExAblate 2000 received the CE mark for pain palliation of painful bone metastases in 2007 and ExAblate 2000 and 2100 received FDA approval for this indication in 2012.

 

"The extended CE mark which now includes the conformal bone system and new indications such as osteoid osteoma, facet joint denervation and other bone tumors ablation is another major milestone in our quest to extend this non-invasive innovative therapy to additional patient populations," said Dr. Kobi Vortman, CEO and founder of INSIGHTEC. "The clinical results have been very encouraging and show that focused ultrasound can both alleviate patient's pain and ablate tumors, providing patients with improved quality of life".

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