Israel's InSightec is working to convince the FDA that its focused ultrasound technology can improve the lives of patients with essential tremor, and, in a pilot study, ExAblate Neuro did just that.
In results published in The New England Journal of Medicine, InSightec's device improved symptoms and quality of life in 15 patients, as the device's incision-free ablation of thalmic tissues nearly halved average tremor scores. Much like the original ExAblate, already FDA-approved to treat uterine fibroids, InSightec's neuro version uses MRI-guided blasts of ultrasound energy to burn away targeted tissues, all without the need for surgery.
Now, InSightec is enrolling a larger, multicenter study of ExAblate Neuro designed to win FDA approval and start treating U.S. patients with essential tremor. The device won a CE mark in 2012 to treat Parkinson's disease-related tremors and neuropathic pain.
And while the FDA's final decision may be a long time away, ExAblate Neuro's positive results have neurologists excited about the future of ultrasound therapy. Jeffrey Elias, the study's lead researcher and a University of Virginia neurosurgery professor, told Bloomberg that the technology's targeted blasts could change the way physicians approach brain surgery.
"We took 1,000 beams, sent them through the skull non-invasively, focused them all to one specific spot about the size of a grain of rice deep in the middle of the brain and stopped most of the tremors," Elias said. "It didn't appear to damage any of the intervening brain, just the point of convergence."
InSightec believes the applications for its ExAblate platform will only grow exponentially, Marketing Director Lynn Golumbic said, and the company's goal is to change the way patients and physicians think about surgery, replacing risky procedures and long recovery times with painless, incision-free ablations.
The Tirat Carmel-headquartered company is owned by GE Healthcare ($GE), Elbit Imaging and MediTech Advisors.
Special Report: How did Israel become a hotbed for medical devices?