Resources are finally starting to flow, as investors recognize these new technologies are a smart future bet. Last fall, Cyberonics of Houston, Texas, made an initial €2 ($2.6)-million investment in Cerbomed, and ElectroCore of Basking Ridge, New Jersey, landed $40 million to develop its handheld vagus nerve stimulation (VNS) device from investors that include the Merck Global Healthcare Innovation Fund. Most recently, SetPoint Medical, of Valencia, California, became the first company to be selected for backing by GlaxoSmithKline's Action Potential fund. Famm says this is only the starting point—his division is sponsoring an upcoming summit in December where leaders in the field will chart a course for future research and is also providing support to academic laboratories engaged in early-stage neuromodulation research. “This is exploratory work to establish a spectrum of diseases that we have reason to believe are amenable to neural-axis intervention,” he says. “What we're seeing today are the first steps away from directly targeting the CNS and the spinal cord—but I think we're only scratching the surface.”
The first implantable VNS device for epilepsy was approved by the European Commission in 1994, and three years later by the US Food & Drug Administration (FDA). This device, manufactured by Cyberonics, consists of a surgically implanted pulse generator connected to an electrode wrapped around the vagus nerve near the base of the neck. Over 100,000 patients have been implanted so far. As an alternative, Los Angeles–based NeuroSigma has drawn on research from Christopher DiGeorgio at the University of California at Los Angeles (UCLA), demonstrating that epileptic patients can gain similar benefits from stimulation of the trigeminal nerve, a critical component of the facial sensory system. Because the trigeminal lies close to the skin, unlike the more deeply buried vagus, it can be stimulated transcutaneously through a patch worn on the forehead. Short-term treatment data from a randomized control trial using NeuroSigma's external trigeminal nerve stimulation device was positive enough to warrant going ahead with a larger pivotal trial (Neurology 80, 786–791, 2013). NeuroSigma's eTNS system is already commercially available in the EU and Canada. Cerbomed of Erlangen, Germany, is working toward the same end with NEMOS—a wearable device that selectively targets a small branch of the vagus nerve within the outer ear. As patients have no way of knowing whether VNS will treat their epilepsy until they undergo surgery, such externally worn devices could offer a valuable first-line alternative that allows patients to then decide whether to proceed with an implant.
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