February 09, 2012

FDA CLEARS EXABLATE FERTILITY ENHANCEMENT STUDY IN WOMEN WITH UTERINE FIBROIDS

TIRAT CARMEL, Israel, May 28 /PRNewswire/ --

- Study Will Compare Birth Rates of Women who Underwent Non-Invasive MRgFUS to Those who had Invasive Fibroid Surgery

InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) cleared the company to conduct a clinical trial to evaluate the efficacy and safety of the ExAblate(R) 2000 system utilizing MR-guided Focused Ultrasound Surgery (MRgFUS) for the enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids who are diagnosed with unexplained infertility.

Twenty U.S. and international sites will enroll a total of 650 women with uterine fibroids who are diagnosed with unexplained infertility. Half the women will undergo treatment with the ExAblate system, while the other half will have their fibroids surgically removed.

The study will measure the safety of each procedure, including pregnancy and delivery-related complications. The main efficacy goal of the trial will be to measure which procedure leads to a higher percentage of healthy live births resulting from pregnancies three to 15 months after treatment. Researchers will also examine the cost of treatment and any additional clinically required medical encounters and/or medications outside the study visits.

"While the link between uterine fibroids and infertility isn't fully understood, many women with uterine fibroids and infertility give birth to healthy babies after having their fibroids surgically removed," said Elizabeth A. Stewart, MD, a reproductive endocrinologist and Professor of Obstetrics and Gynecology at Mayo Clinic in Rochester, Minnesota. "The non-invasive ExAblate system precisely targets fibroid tissue without causing damage to the surrounding healthy areas, suggesting that it may be a safe approach for women with fibroids who want to preserve their fertility."

Accumulating clinical evidence shows that women have been able to conceive and successfully deliver babies after undergoing ExAblate treatment for their uterine fibroids. To date, 17 women delivered healthy infants at term without complications and with an average of seven and a half pounds birth weight. Ten women delivered vaginally and seven delivered by caesarean section. No treatment-related adverse events were reported in those earlier cases.

"As women have children later in their lives, the number of women having pregnancies and uterine fibroids is significant and growing," said Haywood L. Brown, MD, Professor of Obstetrics and Gynecology and chair of the Department of Obstetrics and Gynecology at Duke University Medical Center. "An evidence-based review concluded that if fibroids distort the uterine cavity, there is evidence in favor of removing them to increase pregnancy rates and decrease the rate of miscarriage. Unfortunately, since fibroids that have grown on the wall of the uterus need to be removed by myomectomy, a major abdominal procedure, the morbidity of the intervention may outweigh the benefits of removing the fibroids."

According to Gautam Chaudhuri, MD, Professor of Obstetrics and Gynecology and Chair of the Department of Obstetrics and Gynecology at the University of California, Los Angeles (UCLA) Medical Center, "In a small number of cases, a myomectomy will later require a hysterectomy. In less grave instances, myomectomy carries a risk of post operative adhesions, which may impair a woman's fertility and take time away from trying to become pregnant while she undergoes the procedure and lets her uterus heal. A non-invasive treatment could be a great benefit to women whose fertility issues may be caused by fibroids."

"We're pleased that the FDA has cleared us to start this important study that could potentially impact thousands of women who are struggling to conceive," said Dr. Kobi Vortman, President and Chief Executive Officer of InSightec. "We remain highly committed to moving the treatment paradigm away from invasive surgeries. To date, over 4,000 women around the world have chosen to undergo the non-invasive ExAblate treatment for their symptomatic uterine fibroids over invasive surgery. Should this trial confirm our expectations, more women will be able to choose a non-invasive treatment."

In October 2007, the European designated Notified Body changed the CE Mark to enable European women with uterine fibroids who may want to become pregnant to consider MRgFUS as a treatment option with their physicians. This change was made based on accumulating data from studies demonstrating that women safely gave birth after undergoing MRgFUS treatment. The ExAblate system received the CE Mark for uterine fibroids in October 2002 and the FDA approved the system as a treatment for symptomatic uterine fibroids in 2004 for patients who had finished their family planning.

About Uterine Fibroids

Uterine fibroids are benign growths in the uterus that affect more than 30% of women of childbearing age. Symptomatic women suffer from extensive and prolonged menstrual bleeding, anaemia, pain, pressure and often infertility. Existing treatment options include hysterectomy, myomectomy and uterine artery embolization that are invasive and minimally invasive, involving hospitalization and several weeks of recovery time. ExAblate is an outpatient procedure and patients return home the same day and to work within one to two days.

About ExAblate

ExAblate is the first system to use the breakthrough MRgFUS technology that combines MRI - to visualize the body anatomy, plan the treatment and monitor treatment outcome in real time - and high intensity focused ultrasound to thermally ablate tumors inside the body non-invasively. MR thermometry, 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. Approved by the U.S. Food and Drug Administration in 2004 as a treatment for symptomatic uterine fibroids, 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, the Red Herring 100 Europe 2007 Award and currently one of the World Economic Forum Technology Pioneer 2008.

About InSightec

InSightec Ltd. is a privately held company owned by Elbit Imaging (EI), 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 160 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/

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SOURCE InSightec Ltd