The U.S. Food and Drug Administration (FDA) has approved Insightec’s system for treating advanced Parkinson Disease (PD) patients suffering from rigidity, mobility and dyskinesia symptoms. This is a significant expansion of Insightec’s system clinical indication, which until now was approved for treating PD patients experiencing essential tremor. Last month Insightec signed a merger agreement with a SPAC in order to list on Nasdaq with a company valuation of $2 billion. The new clinical indication extends the potential market for the company’s system. Currently, one million patients in the United States are coping with PD.
The system developed by Insightec is a minimally invasive surgery (MIS) technique, used for treating symptoms such as essential tremor and benign tumors in the uterus using focused ultrasound waves. Within the new clinical indication, Insightec’s system may be used as an incisionless method of performing a process called Pallidotomy, which is used to ablate a brain area called globus pallidus. Until now, the only method of performing Pallidotomy was to place a tiny electrical electrode in the globus pallidus, which is then heated and destroy a small area of brain cells. Using Insightec’s device, this process could be performed incisionlessly, by externally focusing the ultrasound waves to the target area. In many cases, this process reduces the severity of the patient’s symptoms.
Founded in 1999, Insightec developed the Exablate platform which provides non-invasive treatments for a variety of oncology and gynecology indications. Exablate Neuro uses focused ultrasound waves to target and ablate tissue deep in the brain with no surgical incisions or implants. The treatment is done under MRI guidance for real-time treatment monitoring.
In May 2017, Insightec received FDA Approval for Exablate Neuro fo the treatment of essential tremor. Following the approval Insightec has decided to initiate a pivotal study of the Exablate Neuro for treating dyskinesia symptoms or motor fluctuations of advanced Parkinson’s disease patients who have not responded to medication.
Parkinson’s disease afflicts millions of people worldwide, including approximately one million in the United States alone with 60,000 additional diagnoses each year. Treatment with the Exablate Neuro is intended to improve motor function and reduce dyskinesia, one debilitating symptom that presents as uncontrolled, involuntary movement of the arms and/or legs.