California medical device maker NeuroPace is finally getting a date with the FDA to review its premarket application for a neuromodulation implant for patients with epilepsy.
NeuroPace filed its application in July 2010 for its RNS System, hoping to win indication as an adjunct therapy for reducing seizures in patients aged 18 and older.
The application specifically targets patients with medically refractory partial onset epilepsy originating from one or two locations in the brain, a common form of epilepsy that is difficult to treat with medication. according to NeuroPace.
The Mountain View, Calif.-based firm last year announced that it drummed up $49.1 million of a hoped-for $61.9 million round, according to a filing, the 1st and only report filed with the SEC. A slew of names linked to venture capital firms were listed on the filing, from the likes of Kleiner Perkins Caufield & Byers, New Enterprise Associates, Angel Medical Systems, Cutlass Capital and Domain Associates.
The FDA’s Neurological Devices Panel will meet on February 22, 2013, to discuss and make recommendations on NeuroPace’s PMA, according to an FDA notice. More information will be made available no later than 2 business days before the meeting, the agency noted.