Insightec said this week it submitted an application for pre-market approval to the Japanese Pharmaceuticals and Medical Devices Agency seeking an indication for its Exablate Neuro to treat advanced Parkinson’s Disease in patients suffering from mobility, rigidity or dyskinesia.
The Israel-based company’s Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous magnetic resonance imaging; the procedure can be performed non-invasively through an intact skull.
“Insightec is committed to supporting research that extends the applications and potential of focused ultrasound, to improve the lives of people living with Parkinson’s disease with a much less invasive approach than conventional surgery,” CEO Dr. Maurice Ferré said in a press release.
The Exablate Neuro is currently approved in Japan to treat medication-refractory essential tumor, with a total of seven medical institutions in the country performing procedures with the device on a routine basis, Insightec said.
In January, Insightec said that it closed a $150 million Series E private equity round of financing with plans to use funds to support marketing, commercialization and further development of its Exablate Neuro platform.