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InSightec Resumes Clinical Trials for Non-Invasive Treatment of Brain Tumors
Date:9/25/2007

HAIFA, Israel, September 24 /PRNewswire/ -- InSightec Ltd. has begun the second stage of its FDA approved Phase I clinical trial for non-invasive treatment of brain tumors using MR guided Focused Ultrasound Surgery on the ExAblate(r) system.

The objectives of the study are to evaluate the safety of focused ultrasound delivered through an intact skull and to estimate the effect of the thermal ablation on the tumors. Patients with recurrent and inoperable glioblastomas or cerebral metastases are being recruited for this study.

ExAblate(r) uses high-intensity focused ultrasound waves to ablate (destroy) tissue in combination with Magnetic Resonance Imaging (MRI). The system provides visualization of the tumor and acoustic energy beam path as well as real time thermal feedback that allows the physician to monitor and control the treatment process.

Three patients with recurrent glioblastoma have already been treated at Brigham and Women's Hospital in Boston, evaluating the ability of the ExAblate system to safely reach a targeted tumor. Based on the safety profile submitted for review, the FDA recently approved the continuation of the trial.

"The ExAblate MRgFUS technology has significant potential as a non-invasive and non-ionizing tumor therapy, and offers an important potential alternative or adjunct to radiation therapy, and eventually, for brain surgery" says Ferenc Jolesz, MD Professor of Radiology, Brigham and Women's Hospital, Boston MA.

Dr. Peter Black, Professor of Neurosurgery at the Brigham and Women's Hospital and co-director of the study adds that "The challenge of brain tumor surgery is to achieve complete tumor removal or the greatest possible extent of tumor reduction without causing brain injury. This feasibility study will significantly advance our understanding of the potential of this technology for brain tumor treatment and if successful, prepare the way for a clinical efficacy study."

Further details of ExAblate technology and clinical experience can be found at http://www.insightec.com. Details about the clinical trial can also be found at Clinical Trials.gov (http://www.clinicaltrials.gov/ct/show/NCT00147056;jsessionid= DA645CDD9781968B8BF5161676409C8B?order=4)

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About ExAblate

The ExAblate(r) is the first system to use the breakthrough MRgFUS technology that combines MRI - to visualize tissues in the body, plan the treatment and monitor in real time treatment outcome - and high intensity focused ultrasound to thermally ablate uterine fibroid tissue. MR thermal feedback, provided uniquely by the system, allows the physician to control and adjust the treatment in real time to ensure that the targeted tumor is fully treated and surrounding tissue is spared. ExAblate received FDA approval for the treatment of symptomatic uterine fibroids in October 2004. ExAblate has been recognized for its innovation and potential to serve mankind and has been awarded the 2004 European Union's Information Society Technologies grand prize, The Wall Street Journal's 2004 Technology Innovation Awards, Advanced Imaging's 2005 Solutions of the Year and, the Red Herring 100 Europe 2007 Award.

About InSightec

InSightec Ltd. is a privately held company owned by Elbit Medical Imaging (EMI), 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 135 employees and has invested more than $100 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas. For more information, please go to: http://www.insightec.com/

Contact Information:

InSightec Ltd.

http://www.insightec.com/

Tel: +972-4-813-1313

Email: info@insightec.com

For media inquiries:

Fern Lazar

Lazar Partners, Ltd.

Tel: +1-212-867-1762

Email: flazar@lazarpartners.com

For medical inquiries:

Black, Peter Mclaren,M.D.,Ph.D.

Prof. of Neurosurgery

Department of Neurosurgery

Brigham and Women's Hospital

Harvard Medical School

75 Francis Street, Boston MA 02115

Tel: +1-617-732-6600

Fax: +1-617-734-8342

E-mail: pblack@partners.org

Ferenc A. Jolesz, MD.

B. Leonard Holman Professor of Radiology

Vice Chairman for Research

Director, Division of MRI and Image Guided Therapy Program

Department of Radiology

Brigham and Women's Hospital

Harvard Medical School

75 Francis Street, Boston MA 02115

Tel: +1-617-732-5961

Fax: +1-617-582-6033

E-mail: jolesz@bwh.harvard.edu

For media inquiries Brigham and Women's Hospital:

Jessica Podlaski

Media Relations Coordinator

Brigham and Women's Hospital

321 Columbus Avenue

Boston, MA 02116

Phone: +1-617-534-1603

Fax: +1-617-534-1610

Pager: +1-(617)-732-6660 #33916

E-mail:jpodlaski@partners.org


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SOURCE InSightec Ltd
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