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FDA Approves Exablate 2000 System As Non-Invasive Surgery For Uterine Fibroids-New outpatient procedure significantly reduces symptoms and improves quality of life for women with symptomatic uterine fibroids - -First FDA approval for Magnetic Resonance guided Focused Ultrasound System- Haifa, Israel– October 22, 2004 – InSightec today reported that the U.S. Food and Drug Administration (FDA) has awarded pre-market approval (PMA) to the company's ExAblate® 2000 system for non-invasive surgery for symptomatic uterine fibroids. Elbit Medical Imaging Ltd. (NASDAQ: EMITF) and General Electric (NYSE: GE) are significant shareholders in InSightec. According to the U.S. National Institutes of Health (NIH), at least 25 percent of women suffer from uterine fibroids. As many as 77 percent of women may actually have the condition, but may be unaware of it because they exhibit few or no symptoms. Symptoms of uterine fibroids include heavy bleeding or painful periods, bleeding between periods, pressure on the lower abdomen, frequent urination (resulting from fibroid pressure on the bladder), pain during sex and lower back pain. Until today, treatment options for uterine fibroids included invasive and minimally invasive procedures such as hysterectomy, myomectomy or uterine artery embolization (UAE). Hormonal therapy, the only non-invasive treatment available, offers only temporary relief of symptoms, and fibroids frequently grow back once therapy is terminated. “Many women with fibroids continue to suffer with their symptoms rather than undergo treatment out of concern for the side effects of existing therapies. ExAblate 2000 gives women an important new choice to help reduce the symptoms of uterine fibroids,” said Elizabeth A. Stewart, M.D., Brigham and Women’s Hospital and co-principal lead investigator. Dr. Jacob Vortman, Ph.D., President and Chief Executive Officer of InSightec, said, “Today’s approval marks an historic event for InSightec and underscores the importance of imaging technologies not only as diagnostic tools, but also as therapeutic treatment enablers for a growing range of diseases. By bringing together world experts in gynecology, ultrasound and magnetic resonance imaging, we have helped to commercialize the first non-invasive surgery for uterine fibroids that has the potential to provide significant relief of disease symptoms.” “InSightec is committed to using focused ultrasound
surgery and innovative MR imaging to advance the care of patients with
serious diseases, and we are exploring the potential application of
the ExAblate system in other diseases such as breast, liver, bone and
brain cancer.” About the ExAblate® 2000 System During this outpatient procedure the patient lies inside the MRI scanner. The MRI scanner provides three-dimensional images of the fibroid and surrounding tissue, enabling precise guidance of the ultrasound waves to the target tissue. Highly focused ultrasound waves are directed into the body, and at the focal point, the ultrasound waves raise the temperature of the tissue, leading to its destruction. The thermal imaging capabilities of the MRI scanner provide real-time feedback on the temperature achieved at the target tissue during treatment, helping to ensure therapy outcome control. "Our partnership with InSightec demonstrates our company’s commitment to partner and invest in innovative technologies that benefit both doctors and patients,” said Joe Hogan, president and CEO, GE Healthcare Technologies. “What’s most gratifying about GE’s contribution to the ExAblate 2000 system is knowing millions of women around the world afflicted with fibroids will now have another alternative to hysterectomy for their fibroid symptoms” The ExAblate is the first focused ultrasound thermal ablation system approved by the FDA and is also the first focused ultrasound surgery system using Magnetic Resonance (MR) guidance approved by the FDA, providing an alternative treatment option for women with uterine fibroids, the most common non-cancerous tumor in women of childbearing age. The device received the European CE mark and ISO 9001 and is commercially available in Israel, Europe, and Asia. The ExAblate System was awarded the 2004 European Information Society Technologies grand prize for innovation and potential to serve mankind. Around the world over 700 women have been treated with ExAblate 2000. Clare Tempany, M.D., Brigham and Women's Hospital, and co-principal investigator said, "ExAblate 2000 provides a major advance in image guided therapy, significantly increasing our ability to both identify the precise target and treatment location as well as directly monitor the treatment effect and outcome.” Other treatment modalities for uterine fibroids, including hysterectomy and myomectomy, are conducted as in-patient procedures usually requiring a hospital stay. Hysterectomy is the most common surgical procedure for uterine fibroids and the NIH estimates that more than 200,000 women undergo hysterectomy each year as a treatment for uterine fibroids. According to the Society of Interventional Radiology, hysterectomy requires a three- to four-day hospital stay and a recovery time of approximately six weeks; myomectomy also requires a hospital stay of several days and a recovery time of two to four weeks; and UAE requires a day of hospitalization and a week of recovery time. According to a RAND report, direct costs alone associated with treating uterine fibroids are more than $1 billion annually. As an outpatient procedure, ExAblate has the potential to be a more cost effective therapy compared with current invasive and minimally invasive treatment strategies. Pivotal Trial Results Availability of ExAblate 2000 for the Treatment
of Uterine Fibroids
About InSightec About EMI Any forward looking statements with respect to EMI’s business, financial condition and results of operations included in this release are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward- looking statements, including, but not limited to, product demand, pricing, market acceptance, changing economic conditions, risks in product and technology development and the effect of EMI’s accounting policies, as well as certain other risk factors which are detailed from time to time in EMI’s filings with the Securities and Exchange Commission. About GE Healthcare GE Healthcare is a $14 billion unit of General Electric Company (NYSE: GE) that is headquartered in the United Kingdom. Worldwide, GE Healthcare employs more than 42,500 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our Web site at http://www.gehealthcare.com/. October 22, 2004 |
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