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Thirty Patients Implanted in Functional Neuromodulation's ADvance Study of Deep Brain Stimulation for Alzheimer's Disease

Enrollment to be Completed First Quarter 2014

December 5, 2013

Toronto, Ontario –Functional Neuromodulation is pleased to report that 30 patients with  mild Alzheimer's  disease have been successfully implanted in the ongoing ADvance Study.   ADvance is evaluating the safety and potential clinical benefit of deep brain stimulation (DBS) of the fornix, a major inflow and output pathway in the brain's memory circuit, for patients with mild Alzheimer's.  This important enrollment milestone and positive safety reviews by the Data Safety Monitoring Board have triggered follow-on funding from existing investors Genesys Capital, Foundation Medical Partners and Medtronic.  The company expects study enrollment to be completed with at least 40 patients implanted by the end of the first quarter 2014.  

"Our investigators at seven leading North American research centers have done an excellent job of enrolling patients with early Alzheimer's disease and fulfilling the protocol," said Dan O'Connell, Co-Founder and CEO of Functional Neuromodulation.  "We expect to have top-line outcomes data in the second quarter of 2015, and we are hopeful that stimulation of memory circuits will ultimately prove to be effective for this challenging and devastating disease."

About ADvance

ADvance is a randomized double-blind controlled trial of patients age 45 to 85 with mild Alzheimer's disease.  The trial compares the effects of DBS turned on to those observed with the system turned off.  The patients will undergo regular physiological, psychological and cognitive assessments for 12 months at which time those patients in the DBS off group will have the system activated.  Brain imaging measures of changes in glucose metabolism and the size of key structures involved in memory will also be assessed at multiple time points.

Patients are still being recruited to participate in the study at the Banner Alzheimer's Institute in Phoenix, Ariz.; Banner Sun Health Research Institute in Sun City, Ariz.; Butler Hospital and Rhode Island Hospital in Providence, R.I.; Johns Hopkins Bayview Medical Center in Baltimore, Md.; Toronto Western Hospital in Toronto, Ont.; University of Florida Center for Movement Disorders and Neurorestoration in Gainesville, Fla; and the University of Pennsylvania in Philadelphia, Pa.

 ADvance is co-chaired by Andres Lozano, MD, PhD, R.R. Tasker Chair in Stereotactic and Functional Neurosurgery at the University Health Network and University of Toronto and Scientific Founder of the company; and Constantine Lyketsos, MD, MHS, Elizabeth Plank Althouse Professor, Johns Hopkins University, and Director, Johns Hopkins Memory and Alzheimer's Treatment Center.  The study is being supported through a grant from the National Institute on Aging, part of the National Institutes of Health, awarded to Dr. Lyketsos and Dr. Lozano.  The NIA/NIH grant is expected to total more than $2 million over the next five years.

About Deep Brain Stimulation

Deep brain stimulation (DBS) uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver mild electrical pulses to precisely targeted areas of the brain.  Medtronic, in collaboration with leading physicians around the world, pioneered DBS therapy, which was first approved in Europe in 1995 and in the United States in 1997.  The therapy is currently licensed in Canada and approved in other regions, including the European Union and the United States, for the treatment of the disabling symptoms of essential tremor, advanced Parkinson's disease and chronic intractable primary dystonia, for which approval in the United States is under a Humanitarian Device Exemption (HDE).  In Europe, Canada, Australia and Taiwan, DBS therapy is approved for the treatment of refractory epilepsy.  The therapy is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder in the European Union, Australia and in the United States under an HDE.  More than 100,000 people worldwide have received Medtronic DBS therapy.

About Functional Neuromodulation, Ltd.

Founded in Toronto, Ontario in 2010, Functional Neuromodulation is dedicated to advancing the application of DBS therapies to help improve the lives of people with Alzheimer's and other memory and cognitive disorders.  The Company has received funding from Genesys Capital, Foundation Medical Partners and Medtronic. For more information, visit www.fxneuromod.com

Humanitarian Device in the U.S.: The effectiveness of this device for the treatment of dystonia has not been demonstrated.

Humanitarian Device in the U.S.:  The effectiveness of this device for the treatment of obsessive-compulsive disorder has not been demonstrated.

 
  1. Humanitarian Device in the U.S.: The effectiveness of this device for the treatment of dystonia has not been demonstrated.
  2. Humanitarian Device in the U.S.:  The effectiveness of this device for the treatment of obsessive-compulsive disorder has not been demonstrated.

CAUTION — Investigational device. Limited by Federal law to investigational use.

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