Functional Neuromodulation

Functional Neuromodulation has initiated a pivotal randomized, double-blind controlled study ("ADvance II") to assess the safety and efficacy of deep brain stimulation of the fornix (DBS-f) for patients with mild Alzheimer’s disease. The company received FDA Breakthrough Device Designation for its Vercise DBS system targeting this indication. The trial aims to recruit up to 210 patients across major academic centers in the US, Canada, and Germany[4]. "Functional Neuromodulation has secured breakthrough device designation from the US Center for Devices and Radiological Health...for Vercise deep brain stimulation system to treat Alzheimer’s disease...initiated ADvance II pivotal study..."[4] Early results from prior studies have shown that DBS-f may enhance activity in critical memory circuits affected by Alzheimer's; however, definitive efficacy data are pending completion of ongoing trials[4].