Functional Neuromodulation

About Functional Neuromodulation

Functional Neuromodulation Ltd. is a medical device company advancing deep brain stimulation (DBS) therapies to improve the lives of individuals with mild Alzheimer's disease. Founded in 2010 by Dr. Andres Lozano and Daniel O'Connell, the company is headquartered in Minneapolis, Minnesota. Dr. Lozano, a neurosurgeon at the University of Toronto, pioneered the concept of using DBS to treat memory disorders. O'Connell brought over two decades of experience in venture creation and investment with a focus on neurosciences.

The company's core technology, Deep Brain Stimulation of the Fornix (DBS-f), involves a surgically implanted medical device, similar to a cardiac pacemaker, that delivers mild electrical pulses to the fornix, a key pathway in the brain's memory circuit that is affected early in Alzheimer's disease. This is intended to drive neural activity and modulate the memory circuit. The technology is being evaluated through a series of clinical trials. The initial ADvance I study, a Phase II trial with 42 patients, was completed, and its results prompted the larger ADvance II pivotal study. The ADvance II trial is a randomized, double-blind, controlled study enrolling up to 210 patients across the U.S., Canada, and Germany to evaluate the safety and efficacy of the treatment.

Functional Neuromodulation operates through strategic partnerships, notably with Boston Scientific, which manufactures the Vercise™ DBS System used in the clinical trials. In January 2021, the U.S. FDA granted this system a Breakthrough Device designation for the treatment of mild probable Alzheimer's disease, a status that provides for priority review. The company has secured significant funding from investors including Genesys Capital, Foundation Medical Partners, and Boston Scientific to support its extensive clinical trials.