from the December 2004 issue

FDA Approves InSightec System

The United States Food and Drug Administration has approved an InSightec ultrasound device, ExAblate, to treat uterine fibroids. These are clumps of tissue that can cause miscarriages, painful menstruation and related problems in women, explained InSightec.

The system uses ultrasound waves to break up the clumps and can provide an alternative to the removal of a uterus, or hysterectomy. But the FDA cautioned that the ExAblate 2000 System is not intended for women who want to get pregnant in the future.

About 80 percent of women suffer from uterine fibroids at some point in life, according to the National Institutes of Health. Symptoms include pain, bleeding and uterine swelling, accompanied by a heightened need to urinate. But many women have no symptoms. Up to 25% will eventually require a hysterectomy, while the ExAblate proffers a noninvasive alternative to many. Sometimes fibroids are treated with hormone therapy, but in that case the growths tend to recur, InSightec explains.

The ExAblate uses magnetic resonance imaging to pinpoint the non-cancerous tumors. Heat from carefully guided ultrasound waves then selectively kills the fibroid tissue, which is flushed from the body naturally. The company says its treatment is practically painless, and obviates the need for hospitalization, which sharply reduces healthcare costs. Patients lost an average of 1.2 working days compared with 19 in the case of women who underwent hysterectomy.

GE Healthcare, a unit of General Electric Co., said it was collaborating with InSightec to deliver the ExAblate system, which works with GE's Signa MR system. GE also owns 21% of InSightec, and the medical-technology venture capital fund MTA owns 7%. The rest of the company's shares are owned by its workers, management and founders.

InSightec says the FDA approval followed trials on 109 women in seven medical centers around the world. Significant improvement was reported in 71% of cases, it said.

InSightec president and chief operating officer Dr. Jacob Vortman said his company is investigating possible use of the device to treat breast, liver, bone and brain cancers. "Today's approval ... underscores the importance of imaging technologies not only as diagnostic tools, but also as therapeutic treatment," Vortman said.

Recently, InSightec completed a $21 million financing round from its existing shareholders. For the purpose of the investment the company was valued at $100 million.

Reprinted from the Israel High-Tech & Investment Report December 2004

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