KOREAN MINISTRY OF FOOD AND DRUG SAFETY APPROVES INSIGHTEC’S EXABLATE NEURO
INSIGHTEC, the leader in MR guided Focused Ultrasound (MRgFUS) therapy announces today that the Korean Ministry of Food and Drug Safety (MFDS) has approved its Exablate Neuro system to treat movement, pain and behavioral disorders. INSIGHTEC’s Exablate Neuro platform is transforming medicine by presenting a non-invasive treatment alternative that combines two technologies: Focused Ultrasound, which is used to lesion the targeted tissue deep in the brain, and Magnetic Resonance Imaging (MRI), which is used to guide the ultrasound waves to the specific target tissue and provide real-time feedback on treatment progress and outcome. The result of the above integration is a breakthrough therapy platform that enables outpatient procedures.
This regulatory approval allows Korean patients suffering from neurological disorders which cause significant disability access to a new, non-invasive treatment option that does not require open surgery. Previous treatment options for patients who do not respond to drugs include deep brain stimulation, radiofrequency ablation and radiosurgery which are highly invasive and/or involve risks such as ionizing radiation, infection, bleeding and collateral brain tissue damage.
Dr. Kobi Vortman, CEO and Founder of INSIGHTEC said, “This regulatory approval is an important milestone, because it makes MRgFUS treatment accessible to many patients with neurological disorders in Korea. INSIGHTEC will continue to invest in developing our technology for a wider range of clinical indications.”
“This is a major breakthrough in the treatment of neurological disorders,” said Dr. Jin Woo Chang, Professor and Chairman of the Department of Neurosurgery as well as the Director of the Brain Research Institute at Yonsei University College of Medicine in Seoul, Korea. “Neurosurgeons can now offer patients a treatment that is not only non-invasive but can effectively treat their debilitating symptoms,” he emphasized.
INSIGHTEC’s Exablate Neuro system was CE marked for the treatment of essential tremor, tremor dominant Parkinson’s disease and neuropathic pain in 2012 and is currently under FDA review for the treatment of essential tremor.