Israel's InSightec is taking its uterine-fibroid-treating technology to Canada, winning local approval for the surgery-free ExAblate system as it works to expand indications around the globe.
ExAblate uses a focused stream of ultrasound energy to destroy fibroids from outside the body, pairing ablation technology with MRI monitoring to guide treatment and keep track of procedure outcomes. The device won FDA approval back in 2004, and Health Canada's blessing comes a month after the Chinese Food and Drug Administration signed off on the technology, giving InSightec a presence in some of the world's largest markets.
"Health Canada's approval is another vote of confidence in ExAblate's high safety profile and excellent outcomes," CEO Kobi Vortman said in a statement. "It once again highlights InSightec's firm commitment to expand clinical indications in gynecology as well as in oncology and neurosurgery."
InSightec scored a victory for its oncology ambitions in October when the FDA approved the device to treat pain from bone metastases, and now the company is focused on ExAblate Neuro, which uses the same ultrasound technology to ablate thalmic tissues and treat essential tremor.
Last month, in results published in The New England Journal of Medicine, ExAblate Neuro nearly halved average tremor scores in a study of 15 patients, improving symptoms and self-reported quality of life. Now InSightec is enrolling a multicenter trial of the device designed to win FDA approval, following its 2012 CE mark to treat Parkinson's disease-related tremors and neuropathic pain.
The Tirat Carmel-headquartered company is largely bankrolled by GE Healthcare ($GE), and the global giant ponied up $27.6 million of InSightec's $30.9 million Series C in December. Elbit Imaging and MediTech Advisors also own stakes in InSightec.
- read the announcement
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