InSightec Partners With American College of Radiology Imaging Network (ACRIN) to Study Using MR Guided Focused Ultrasound to Eliminate Breast Tumors

MR Guided-Focused Ultrasound to be Tested as Alternative to Lumpectomy

Nov 22, 2005, 00:00 ET from InSightec Ltd.

    HAIFA, Israel, November 22 /PRNewswire/ -- InSightec Ltd. announced today
 that it is partnering with the American College of Radiology Imaging Network
 (ACRIN) to enroll patients in a Phase II study assessing how effectively the
 ExAblate(R) 2000 technology can ablate, or destroy, cancerous breast tumors.
 If effective, this outpatient procedure could become a potential non-invasive
 treatment alternative to lumpectomies or surgical removal of breast tumors
 and the surrounding area of normal tissue.
     The ExAblate 2000 combines magnetic resonance imaging (MRI) with
 highly-focused ultrasound to non-invasively thermally ablate (destroy) tumors
 in the body. Currently, the technology is used to treat uterine fibroids, a
 benign but painful condition that affects approximately 25% of women.
     This Phase II trial is intended to demonstrate that ExAblate 2000 can
 effectively and non-invasively serve as the method for destruction of the
 localized tumor versus conventional lumpectomy. For this study, MR guided
 Focused Ultrasound (MRgFUS) will be used to treat the tumor plus a margin of
 normal tissue. A contrast MR will be performed 14-21 days later to assess the
 completeness of the treatment. Following this, a conventional lumpectomy will
 be performed and the cancerous growth will be excised for pathological
 evaluation, and the patient will receive the conventional standard of care
 therapy (radiation and/or chemotherapy). This study will use the pathology
 data to determine if ExAblate can destroy 95% of the tumor or more of the
 tumor volume. A secondary endpoint will be to evaluate the ability of
 contrast MR to identify those patients with residual tumor post MRgFUS
 treatment. The study will involve 200 patients at up to 10 sites worldwide.
     "We are very interested in exploring this new non-invasive technology for
 breast cancer, which is such a prevalent disease, " said Mitchell D. Schnall,
 MD, PhD, Matthew J. Wilson Associate Professor of Research Radiology,
 Associate Chair of Research, Department of Radiology at University of
 Pennsylvania, Deputy Chair of ACRIN, and one of the leading investigators in
 this trial. "The use of MRI can enable us to view residual untreated tumors,
 and enable us to possibly treat an even larger portion of the tumor
     "We are excited about the potential of ExAblate in the breast tumor
 setting. Our studies to date indicate that we can use focused ultrasound
 energy to destroy breast tumors, while minimizing the risk of damage to
 overlaying and surrounding tissue," said Kobi Vortman, PhD, President and
 Chief Executive Officer of InSightec. "ExAblate has already transformed
 medical practice by giving women with uterine fibroids options other than
 hysterectomies or surgical removal and we hope it will have the same effect
 in changing the treatment paradigm for early-stage breast cancer."
     Upon successful completion of this Phase II, the company plans to embark
 upon a Phase III trial which would involve no excision of the breast tumor,
 and represent a truly non-invasive alternative to current breast surgery.
     This non-invasive treatment would avoid the principal drawbacks of
 surgery including surgical trauma to healthy tissue, tissue scarring and
 complications such as blood clots, serious infection, excessive bleeding and
 potential cosmetic deformities of the affected breast.
     The ExAblate 2000 system will be exhibited at the Annual Meeting of the
 Radiology Society of North America, RSNA, November 27 to December 2, 2005 at
 theGE Healthcare booth, #7714 in the North Hall.
     Also at RSNA, ACRIN research will be featured along with other ACR
 highlights related to research, information, advocacy and education at the
 ACR booth (#3950 South Building, Hall A)
     About Breast Cancer
     In the United States, breast cancer is the leading form of cancer among
 women, and ranks second among cancer deaths in women, behind lung cancer.
 According to the Mayo Clinic, it is estimated that in the United States
 200,000 women are diagnosed with breast cancer annually and nearly 40,000
 women die annually of breast cancer. If the cancer is limited to a single
 tumor in one breast, the five-year relative survival rate is 97%. If the
 cancer has spread, or metastasized, to the regional lymph nodes, the
 five-year relative survival rate is 79%. If the cancer has metastasized to a
 distant site, the five-year relative survival rate is 16%. The desire to
 detect breast cancer prior to metastasis has resulted in the widespread use
 of mammographic screening. As a result, many patients are now diagnosed with
 small cancerous tumors, often less than two centimeters in size.
     Currently the most popular treatment of breast cancer is the surgical
 removal of the tumor plus a surrounding area of normal tissue, or lumpectomy,
 typically in combination with additional therapies such as radiation therapy
 or chemotherapy to prevent recurrence. A lumpectomy procedure may not be a
 treatment option if the tumor is deep within the patient's breast, if the
 patient has multiple tumors in the same breast that are spread far apart or
 if the tumor is too large. Often in situations where a lumpectomy procedure
 is not feasible, the chosen treatment is mastectomy, which entails the
 removal of patient's entire breast.
     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 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. Currently the ExAblate is approved for the treatment of symptomatic
 uterine fibroids.
     Uterine fibroids are benign growths in the uterus that affect
 approximately 13 million women of childbearing age in the U.S. Each year
 approximately 200,000 women have hysterectomies, to treat uterine fibroids.
 Unlike hysterectomy, myomectomy and UAE, this technology is completely
 non-invasive using MR-guided focused ultrasound to thermally ablate (destroy)
 tumors in the uterus. For women this means no hospital stay and only 2-3 days
 of recovery as opposed to the one week (UAE); two weeks (myomectomy); or six
 weeks (hysterectomy) usually associated with treatment of this condition. To
 date over 1200 women have been treated w/ the ExAblate for symptomatic
 uterine fibroids. Clinical trials are ongoing world wide on malignant and
 benign tumors in the bone, liver, breast and brain.
     About ACRIN
     ACRIN, in operation since March 1999, is a cooperative group that manages
 clinical trials for imaging technologies as they relate to cancer. ACRIN both
 funds and provides a complete infrastructure for multi-institutional clinical
 trials of imaging and related disciplines applied to cancer with support from
 the National Cancer Institute. It facilitates the development and
 implementation of trials, data acquisition and management, protocol design
 and biostatistical analysis, monitoring and quality assurance, financial
 management and reporting of trial results.
     About InSightec
     InSightec Ltd. is a privately held company owned by Elbit Medical Imaging
 (EMI), General Electric, private investors 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 120 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
     Contact Information
     InSightec Ltd.
     Tel: +972-4-813-1313
     For media inquiries, contact:
     Fern Lazar
     Lazar Partners, Ltd.
     Tel: +1-212-867-1762

SOURCE InSightec Ltd.