Healthcare Industry News:  INSIGHTEC 

Devices FDA

 News Release - March 1, 2007

FDA Approves use of InSightec's ExAblate(R) 2000 With GE Healthcare's 3 Tesla Magnetic Resonance Imaging System

Non-invasive Magnetic Resonance-guided Focused Ultrasound Uterine Fibroid Treatment Now Compatible With Both 1.5 Tesla and 3 Tesla Systems

HAIFA, Israel, March 1 (HSMN NewsFeed) -- INSIGHTEC Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved use of the company's ExAblateŽ 2000 incisionless surgery system for uterine fibroids with GE Healthcare's 3 Tesla Magnetic Resonance Imaging systems, based on studies conducted at University of California at San Diego (UCSD), Weill Cornell Medical Center and KNI Imaging. ExAblate 2000, which combines Magnetic Resonance Imaging with focused ultrasound waves (MRgFUS) to non-invasively destroy tumors, was previously approved for use with the 1.5 Tesla magnet in 2004.

"This new approval allows physicians the freedom to use ExAblate with either a 1.5 Tesla or 3 Tesla MRI scanner, allowing busy MRI centers greater flexibility in scheduling use of their systems and allowing women greater access to this non-invasive procedure to destroy their symptomatic uterine fibroids," said William G. Bradley, Jr., M.D., Ph.D., F.A.C.R., Chairman of the University of California at San Diego's Department of Radiology and a Professor of Radiology at UCSD School of Medicine. "The 3 Tesla system also provides a higher level of anatomical detail."

ExAblate 2000 is the only MRgFUS system approved by the FDA as a non-invasive, outpatient procedure to treat symptomatic uterine fibroids and over 2,500 women with the condition have been treated worldwide.

The company has begun clinical trials to study the technology's use in many oncology-based indications including breast, bone, liver and brain tumors.

About ExAblate 2000

The ExAblate 2000 is the first U.S. Food and Drug Administration (FDA) approved 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. Real time MR thermal feedback, provided uniquely by the system, allows the physician to control and adjust the treatment 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, and Advanced Imaging's 2005 Solutions of the Year.

Uterine fibroids are benign growths in the uterus appearing in up to 70% of women of childbearing age. Symptomatic women suffer from extensive and prolonged menstrual bleeding, anemia, pain, pressure and often infertility. Existing treatment options include hysterectomy, myomectomy which are invasive, involving hospitalization and several weeks of recovery time and uterine artery embolization that is minimally invasive requiring hospitalization and one to two weeks recovery. ExAblate is an outpatient procedure and patients return home the same day and to work within one to two days.

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/


Source: InSightec

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