InSightec Image Guided Treatment Ltd. has obtained European CE Mark certification for its non-invasive Magnetic Resonance guided Focused Ultrasound ExAblate 2000 system for pain palliation of bone metastases.
The company said, “Bone is the third most common organ to which cancer metastasizes, after the lungs and liver. Almost all patients with metastatic prostate cancer have skeletal metastases and in breast cancer, bone is the second most common site of metastatic spread, affecting 90% of patients with progressive breast cancer. It is estimated 100,000 patients in Europe are diagnosed with bone metastases every year. Most cancer patients suffer from pain; controlling it and managing its symptoms are important treatment goals.”
The company added, “In clinical studies, which supported the CE mark certification, patients reported their pain levels using VAS (Visual Analog Score), a pain questionnaire used to monitor changes in pain levels and assess the efficacy of pain management. The majority of patients reported an immediate improvement in pain scores. Many also reported that they stopped using any analgesic pain relief.”
InSightec president and CEO Dr. Kobi Vortman said that ExAblate 2000 had been successfully used to for non-invasive treatment of uterine fibroids. “This second CE Mark represents a significant milestone in our quest to expand the potential applications of this non- invasive, innovative therapy for oncology applications.”
Elbit Medical Imaging Ltd. (Nasdaq: EMITF; TASE: EMIT) indirectly owns 52% of Insightec. Elbit Medical president Shimon Yizhaki said, “The CE approval for pain palliation of bone metastases represents the first oncology application approval which is a significant milestone in InSightec’s oncology roadmap and will significantly expand our market.”
Elbit Medical hopes to float InSightec this year, after many postponements.
Published by Globes [online], Israel business news - www.globes.co.il - on June 6, 2007
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