NeuroPace Files with FDA for Epilepsy Device

1072657_brainy_people NeuroPace, a company focused on implantable devices for the treatment of brain disorders, announced Thursday that it has filed a Premarket Approval application with the U.S. Food and Drug Administration for its investigational device for epilepsy patients. The device, called the RNS System, uses neurostimulation to “monitor and interrupt abnormal electrical activity in the brain before seizures occur.” If approved, the RNS system would be indicated for patients with medically refractory partial onset epilepsy. Partial onset epilepsy is a form of epilepsy that is difficult to treat with medication. In clinical trials involving a total of 191 patients, the device significantly reduced the frequency of disabling seizures.

An estimated 30 percent of epilepsy patients are not helped by medication. As we noted in December, studies have found that the side effects of anti-seizure medications may affect patients’ quality of life more than the seizures themselves. According to the Epilepsy Foundation, toxicity-related side effects such as sedation slurred speech, and unsteadiness can occur as drug levels build up in the body. Implantable devices offer a potential treatment alternative for patients who do not respond to epilepsy medication.

One company that already has an implantable anti-seizure device on the market is Cyberonics, developer of Vagus Nerve Stimulation (VNS) Therapy for patients with refractory epilepsy. The device is approved in the U.S. as an adjunct to drug therapy. VNS Therapy has been implanted in more than 50,000 patients worldwide, and may have applications to other disorders such as anxiety, migraines, and Alzheimer’s disease.

According to a June report by Frost & Sullivan, the emerging market for neurostimulation devices to treat epilepsy and other conditions is poised for growth. Don’t count the anti-seizure medication market out yet, though: A number of companies have epilepsy drugs in their pipelines, including NsGene. The biopharmaceutical company is developing an epilepsy treatment that may cross the blood-brain barrier. Desitin Pharmaceuticals offers a wide range of epileptic drugs recommended by the World Health Organization. MedGenesis Therapeutix is developing a targeted drug delivery system for patients with epilepsy and other central nervous system disorders.

Do you know of any other companies to watch in the epilepsy space?  Please post in comments.

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