FDA OKs expanded label for InSightec's noninvasive ultrasound fibroid device

InSightec CEO Kobi Vortman

The FDA has signed off on Israeli devicemaker InSightec's ultrasound technology to treat women with uterine fibroids who want to conceive, a win for the company as it pushes for new indications of its product and reels in funding to spur R&D.

The Haifa-based company's ExAblate device now includes a label that clears it for use in women with symptomatic uterine fibroids who want to keep their uterus intact and still have the option of becoming pregnant, InSightec said in a statement. The FDA based its expanded approval on clinical data from 118 pregnancies that occurred after women were treated with the device.

A broadened label for ExAblate represents a "major milestone" for InSightec, CEO Kobi Vortman said in a statement, as the company runs clinical trials to show the device's ability to treat many different diseases and conditions. The product combines magnetic resonance imaging with ultrasound ablation--also known as MRgFUS--to noninvasively clear problematic tissue, treating everything from uterine fibroids to Parkinson's and neuropathic pain.

InSightec already markets the product in the EU for a variety of indications, and also has an FDA signoff for ExAblate to treat uterine fibroids and for pain management of bone metastases when radiation is not an option. The company also plans to expand the system into essential tremor, completing enrollment last year of a U.S. pivotal trial to test ExAblate in patients with the nervous system disorder.

InSightec's ExAblate system

Meanwhile, the GE ($GE)-backed company is roping in new funds to support its R&D pursuits. In December, InSightec closed a $59 million Series D round led by major investors in the U.S. and Asia. The company has already spent upward of $200 million on research and development, and additional cash could go a long way in helping InSightec broaden ExAblate's reach.

"We view this change of labeling as a significant one, because it makes MRgFUS treatment for uterine fibroids accessible to many more women in the US, including women who desire fertility-sparing options for their symptomatic uterine fibroids," Vortman said. "Insightec will continue to invest in developing our technology, in order to treat a wider range of clinical indications."

- read the statement

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