Japan's MHLW approves InSightec's ExAblate MRgFUS system

- InSightec's ExAblate System Uses Magnetic Resonance-guided Focused Ultrasound to Perform Uterine Procedures Without Incisions

InSightec Ltd. announced today that Japan's Ministry of Health, Labor and Welfare (MHLW) has approved the company's ExAblate(R) MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with uterine fibroids.

"We are very pleased that the Japanese Ministry of Health has approved the ExAblate system and that women in Japan will now have access to a noninvasive treatment option for uterine fibroids," said Dr. Kobi Vortman, President and Chief Executive Officer of InSightec. "The approval was based on a growing body of evidence showing that ExAblate is a safe, effective, and durable treatment for this widespread, life-impacting condition. ExAblate is an outpatient procedure and patients normally return home the same day and to work within one to two days compared to lengthy hospitalizations and recovery times associated with more invasive procedures such as hysterectomy, myomectomy or UAE."

ExAblate is currently the only noninvasive treatment for uterine fibroids approved for use in Japan. Approximately 25% Japanese women will develop symptomatic uterine fibroids, primarily during childbearing years. These benign tumors can significantly impair functionality and degrade quality of life resulting in significant work absences.

Using the ExAblate system, the physician uses the Magnetic Resonance Imaging (MRI) to visualize the patient's anatomy and then aims focused ultrasound waves at the targeted tissue to thermally ablate, or destroy it. The MRI allows the physician to monitor and continuously adjust the treatment in real time. The patient is consciously sedated to alleviate pain and minimize motion.

A growing body of evidence supports the system's safety and efficacy, including the results of a study published in the August 2007 edition of Obstetrics and Gynecology. The study showed that ExAblate offered women sustained relief from uterine fibroid symptoms for up to two years, with a low incidence of side effects. The 359-patient Mayo Clinic-led collaborative study also showed that destroying as much of the fibroid as possible leads to the most durable symptom relief with 85% of the participants experiencing symptom improvement after one year. Studies conducted in Japan indicate similar results.

The ExAblate system received the CE Mark for uterine fibroids in October 2002 and US Food and Drug Administration (FDA) approval in 2004. Over 5,500 women around the world have chosen to undergo the non-invasive ExAblate treatment for their symptomatic uterine fibroids over invasive surgery.

GE Healthcare is the approval holder and distributor of ExAblate in Japan.