InSightec Ltd. has obtained US Food and Drug Administration (FDA) approval for the expanded use of the company's ExAblate 2000 MR-guided Focused Ultrasound (MRgFUS) system.
The new labelling guidelines allow to treat up to 100% of the fibroid. The FDA previously restricted use of the minimally invasive devise to only treat up to half the fibroid tissue.
The change is for the treatment of uterine fibroids which cannot be surgically removed with a fiber optic device called a hysteroscope.
The expanded label for the device is expected to increase its market and the chances of obtaining insurance coverage for the treatment.
Although InSightec does not consider the ExAblate 2000 to be its main product, it is currently the company's primary source of revenue. The company's ExAblate device for pain palliation of bone metastases has so far only obtained marketing approval in Europe, and therefore generates less revenue than the ExAblate 2000.
Elbit Imaging Ltd. (Nasdaq: EMITF; TASE: EMIT) is one of teh owners of Insightec. Elbit Imaging president Shimon Yitzhaki said, "Treatment of half of uterine fibroids is in many cases effective in preventing side effects of the problem, including hemorrhaging, pain, and infertility. The alternative treatment is a hysterectomy. Today, there are doctors who believe that treating only half of the fibroids will result in a relapse, and they are liable to prefer the complete solution of a hysterectomy."
Yitzhaki added, "Insurers are also less interested in indemnifying a procedure that may have to be repeated. I believe that the moment that 100% of uterine fibroids are treatable, the opinion of caregivers and their financiers will change."
Yitzhaki predicted that this change would take six to twelve months.
Until now, insurance coverage has been the main barrier to the marketing of the ExAblate 2000 in the US, and the label change by the FDA ought to greatly boost sales.
Published by Globes [online], Israel business news - www.globes-online.com - on April 13, 2009
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