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Devices Neurology

 News Release - September 21, 2011

ExAblate(R) Neuro has Been Used to treat 30 Patients with Chronic Neurological Disorders Such as Essential Tremor, Neuropathic Pain and Parkinson's Disease

Clinical trials being conducted at the University of Virginia broadcast on WWTV radio

TIRAT CARMEL, Israel, September 21, 2011 -- (Healthcare Sales & Marketing Network) -- InSightec Ltd., the global leader in MR guided Focused Ultrasound (MRgFUS) technology, announced today that its investigational ExAblateŽ Neuro system has been used in clinical studies to treat 30 patients suffering from chronic neurological disorders. The clinical trials are being conducted by functional neurosurgeons, neurologists and neuroradiologists in Switzerland, and the US to evaluate the safety and initial efficacy of the system for treating Essential Tremor, Neuropathic Pain and Parkinson's Disease. The system is limited to investigational use only.

Neurological disorders affect millions of people worldwide and may cause significant loss of functionality, suffering, and medication dependency, negatively affecting the quality of life of patients and their caretakers. For patients who do not respond to drug treatments, procedures include deep brain stimulation, radiofrequency ablation, radiosurgery which are either invasive or involve ionizing radiation. These are associated with recognized risks: either high doses of ionizing radiation or high risk of complications and side effects.

ExAblateŽ Neuro, pioneered by InSightec, is the first clinical system to use MR guided focused ultrasound through an intact skull, combining focused ultrasound and real time MR guidance and control, to treat tissue deep in the brain without incisions or cutting or ionizing radiation.

"The concept of using focused ultrasound for non-invasive treatment of brain disorders has been recognized for many years, however, vast technical barriers had to be overcome to enable this modality to become a reality. We have invested tremendous technological and clinical efforts to be able to reach this point and are very encouraged by the clinical results so far", said Eyal Zadicario, VP of R&D and Director of the Neuro program at InSightec.

"ExAblate Neuro has demonstrated the ability to ablate targets deep in the brain with high precision. The initial results have been encouraging. This gives us hope that this treatment alternative could in the future become a significant addition to the physicians' armamentarium in treating functional brain diseases." he continued.

The intra-operative image guidance built into ExAblate Neuro is designed to allow precision control and accurate delivery to the planned target with continuous real time feedback throughout the treatment.

Ongoing clinical research will evaluate the ability of this technology to reduce the risk of complications and side-effects. It may provide a treatment option for those individuals where surgery is currently not an option, or refuse an intervention of the brain.

Click here to view a story about the clinical trials being conducted at the University of Virginia aired on WVTF radio on Sept 20.

InSightec is planning to expand its Neuro research platform with additional clinical trials for brain tumors, stroke and targeted drug delivery to the brain.

About InSightec

InSightec Ltd. is a privately-held company owned by Elbit Imaging, General Electric, MediTech Advisors, LLC 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. Its U.S. headquarters are located in Dallas, Texas. For more information, please go to:

About ExAblateŽ

ExAblate is an Image Guided, Non-invasive, Robotic Acoustic Surgery platform. The ExAblate platform is the first to use the MR guided focused ultrasound technology that combines MRI - to visualize the body anatomy, plan the treatment and monitor treatment outcome in real time - and high intensity focused ultrasound to thermally ablate tumors inside the body non-invasively. MR thermometry, provided uniquely by the system, allows the physician to control and adjust the treatment in real time to ensure that the targeted tissue is treated and surrounding non targeted tissue is spared. The ExAblate system received the European CE mark for uterine fibroids in 2002, for pain palliation of bone metastases in June 2007 and for adenomyosis in June 2010. It was approved by the U.S. Food and Drug Administration in 2004 for symptomatic uterine fibroids. Over 8,000 patients have been treated worldwide with ExAblate systems.

Source: InSightec

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