NeuroPace, a medical device manufacturer based in California, is set to meet with an FDA panel for review of its neuromodulation implant. The neuromodulation implant is designed for the treatment of epilepsy. The company first filed a premarket approval application with the FDA for the device in July of 2010.
In its 2010 PMA, the company aimed for approval of the device in patients 18 and older. The PMA sought approval of the device as an adjunct therapy for minimizing seizures. In particular, the application targeted patients with refractory partial onset epilepsy that originated from one or more parts of the brain. This form of epilepsy is resistant to pharmacological interventions.
According to a report filed with the SEC, NeuroPace received $49.1 million of a desired $61.9 million in its latest round of financing. Several prominent venture capital firms were included in the filing submitted to the SEC. This includes VC firms like New Enterprise Associates, Cutlass Capital, Domain Associations, Angel Medical Systems and Kleiner Perkins Caufield & Byers.
The Neurological Devices Panel at the FDA is set to meet on February 22nd, 2013. The panel meeting will discuss recommendations on the company’s PMA. According to a notice by the FDA, more information on the panel meeting will be available by the 20th of February at the latest.
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