InSightec Resumes Clinical Trials for Non-Invasive Treatment of Brain Tumors

September 25, 2007
Haifa, ISRAEL (September 25, 2007). 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 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 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 www.insightec.com. Details about the clinical trial can also be found at ClinicalTrials.gov

About ExAblate
The ExAblate 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: (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: 617-732-6600
Fax: 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: 617 732 5961
Fax: 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: (617) 534-1603
Fax: (617) 534-1610
Pager: (617) 732-6660 #33916
E-mail:jpodlaski@partners.org