• Immediate feedback of treatment

• Treatment through the intact skull

• Highly accurate thermal lesioning

• Single session procedure

• No ionizing radiation

Focused Ultrasound Transcranial Neurosurgery

MR guided Focused Ultrasound for Treatment of Essential Tremor, Tremor Dominant Parkinson’s Disease, Neuropathic Pain

Excellence backed by Experience

ExAblate Neuro integrates magnetic resonance imaging (MRI) and high intensity focused ultrasound to provide a non-invasive, image-guided personalized treatment of brain disorders through an intact skull using no ionizing radiation.

ExAblate Neuro uses intra-operative MRI for therapy planning, and continuous real-time MR thermal imaging feedback for monitoring safety and efficacy. The targeted tissue within the brain is ablated using high intensity ultrasound waves using a helmet-like, multi-channel high powered phased array transducer with over 1000 elements.

Brain tissue shifts or trauma do not occur during therapy. There is no bleeding risk and no risk of intracranial infection. In addition, target coverage is not limited by trajectory constraints(1).

ExAblate Neuro - Next Generation Neurosurgery

(1)Jeanmonod et al., Transcranial MRgFUS: noninvasive central lateral thalamotomy for chronic neuropathic pain. Neurosurg Focus Vol. 32 Jan. 2012(2)Moser et al., Measurement of targeting accuracy in focused ultrasound functional neurosurgery. Neur sosurg Focus Vol. 32 Jan. 2012

Illustration of how multiple high-intensity focused ultrasound waves converge on the precise targeted point in the brain.

Key features of ExAblate Neuro • Precise targeting accuracy(2)

• No mechanical brain tissue shifts

• No trajectory constraints

• No need for implants or no electrode placement

• Patients fully awake during treatment

• Lesion sculpting tailored to target anatomy

• 3D dose localization and verification

• Immediate intra-operative patient assessment

• Personalized image guided therapy

• Continuous thermal validation to ensure safety and effectiveness

• Closed loop feedback and control

MR display of real-time heat buildup at focus. Note: no heat build-up in surrounding tissue.

Closed loop feedback

and control

Target verification based on intra-operative stimulation

Treatment: Real–time thermometry

Thermal heat buildup precisely at focus

Outcome evaluationPatient feedback

Adjusting treatment parameters

Treatment planning and targeting

The closed loop feedback and control is key to ensuring safe and effective treatment. It enables physicians to know at any point during treatment what has been treated, the thermal effects, if changes are required and the immediate treatment outcome.

Essential TremorMedication-refractory patients suffering with Essential Tremor for tens of years underwent a unilateral VIM thalamotomy with ExAblate Neuro. After 3 months over 60% had an improvement in overall body score, 75% improvement in the treated side and over 92% improvement in disability. 80% reported an improvement between baseline and followup(3).

Clinical Results

(3)Jeff Elias, MD, PhD, presented at Focused Ultrasound Foundation Brain Workshop 3. www.fusfoundation.org/Event-Archive/brain-workshop-2011(4)Daniel Jeamonod, MD, PhD, presented at the Focused Ultrasound Foundation Symposium, Bethesda, MD, 2012 www.fusfoundation.org. page 23, 2-BR(5)Monteith et al. Potential intracranial applications of magnetic resonance-guided focused ultrasound surgery. J. Neurosurg. 118:215-221, Feb. 2013

Parkinson’s DiseasePatients suffering from Parkinson’s Disease underwent a thalamotomy with ExAblate Neuro. After 3 months they showed a 57.1% mean UPDRS improvement and a mean global symptom relief of 47.5%. Their spectral overactivities were reduced both in low and high frequencies, and their PTT lesions were clearly visible at 3 months follow up MR control.

The mean absolute targeting accuracy was 0.49 mm for the mediolateral, 0.4 mm for the anteposterior and 0.56 mm for the dorsoventral dimension(4).

Neuropathic PainPatients treated for neuropathic pain showed accurate targeting within 1 mm of the planned targets, high safety and a mean group pain relief profile across time, from 71% at 2 days after treatment to 49% at 3 months and 57% at 1 year after treatment. The visual analogue scale (VAS) improvement was similar at 3 months (42%) and at 1 year (41%)(1).

Post treatment MRI image showing bilateral thalamotomy with no damage to untargeted tissue*

Drawing tests by a patient with essential tremor before, immediately after and 3 months after treatment with ExAblate Neuro*

Post treatment MRI image showing unilateral thalamotomy with no damage to untargeted tissue*

3 months post-treatmentPre-treatment Immediately post-treatment

*Images courtesy of Jin Woo Chang, MD, PhD, Yonsei University College of Medicine, Seoul, Korea, Jeff Elias, MD, PhD, University of Virginia, Charlottesville, Virginia, USA, Daniel Jeanmonod, MD, PhD, SoniModul, Solothurn, Switzerland

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MRgFUS is a developing subspecialty of neurosurgery84.8% of the targeted coordinates lie within 1 mm, providing a mean targeting accuracy of the focused ultrasound treatment of 0.72 mm maximum. Such an accuracy requirement obeys clinical efficiency and safety criteria, and is globally compatible with the limitations of the target reconstruction procedure, primarily manual measurements on MR images, thickness of the MR slices (2 mm), lesion size (4x4x6 mm), and determination of the lesion center(2).

ExAblate Neuro patient table docked to the MR scanner

Physician testing fully-awake patient reaction during treatment. Patient lies in MRI with helmet-like transducer on head.

“Magnetic resonance-guided focused ultrasound surgery is a developing subspecialty of neurosurgery. Coupled with the continual improvement in MRI equipment, there is potential to treat deep targets within the brain for various CNS conditions. It is possible that several neurosurgical diseases currently treated routinely with open surgery will soon be referred to the MRgFUS suite for noninvasive, nonionizing brain surgery(5)”.

Corporate offices:InSightec Ltd. 5 Nachum Heth St., Tirat Carmel 39120, Israel | Tel: 972-4-8131313 | Fax: 972-4-8131322

info@insightec.com | www.insightec.comInSightec Ltd© 2013. All rights reserved PUB420000, Generic Name: MRgFUS Device name: ExAblate 4000

InSightec Ltd. Is a privately held company founded in 1999 and owned by Elbit Imaging, General Electric, MedTech Advisors, LLC and employees. InSightec is headquartered in Haifa, Israel, with US offices in Milwaukee, WI.

InSightec is the pioneer and global leader for MR-guided Focused Ultrasound (MRgFUS) therapies, which are at the forefront of a worldwide shift towards non-invasive surgery. Recipient of numerous prestigious awards, InSightec’s ExAblate system is currently operating in sites across the globe, with efficacy documented in hundreds of peer-reviewed publications and textbooks.

Thousands of patients have already benefitted from ExAblate’s safe, non-invasive MRgFUS treatments, while clinical tests for new applications are now underway.

ExAblate has been awarded many prizes for innovation and its potential to help mankind, including the Wall Street Journal Technology Award and the European Union’s IST Grand Prize. Business Week called it “one of 25 ideas for a changing world” and Time Magazine recently included it among the 50 best innovations.

Excellence backed by Experience