Development of the VitalFlow® magnetic facial nerve stimulator as an emergency treatment for stroke

Abstract

Magnetic stimulation of the facial nerve has been shown to dilate cerebral arteries and increase cerebral blood flow. We began proof-of-concept testing of a magnetic stimulator as an early clinical treatment for stroke in 2010. In 2014 we founded Nervive, Inc., to develop a commercial clinical device we called the VitalFlow stimulator, which is currently undergoing clinical trials under FDA oversight for a PMA approval. The VitalFlow story is presented as a case study in moving discovery from bench to market, and how regulatory and funding considerations influence the R&D process.