BrainsGate is a medical device company that develops therapies for patients suffering from central nervous system diseases, with a focus on the treatment of acute ischemic stroke. The companys platform technology involves electrical stimulation of the sphenopalatine ganglion, a nerve center known to increase cerebral blood flow.
Building on its technology, BrainsGate has developed the Ischemic Stroke System (ISS), in which a miniature electrode is implanted in the roof of the mouth in a minimally invasive bedside procedure performed under local anesthesia and comparable to a dental treatment.
In 2008, BrainsGate completed ImPACT-1, a pilot clinical trial for acute ischemic stroke with promising results. In 2011, the company completed a 300-patient RCT pivotal trial that further substantiated the safety and efficacy of its treatment for acute ischemic stroke patients.
BrainsGate is currently running the ImpACT-24b, a multinational, randomized, double-blind, sham-controlled pivotal study to assess the safety and efficacy of its treatment for stroke patients in a 24-hour window.