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

Progress Accelerates as U.S. FDA Approves Expansion, New Sites Join Study and U.S. NIH Provides Funding

June 12, 2013

Toronto, Ontario – Functional Neuromodulation Ltd.'s ADvance Study has implanted 20 mild Alzheimer's patients with deep brain stimulation (DBS) systems, and the U.S. Food and Drug Administration has approved expansion of the study from 20 to 30 U.S. patients in combination with 20 subjects approved in Canada.   

 The U.S. National Institutes of Health is providing support for the trial.  The National Institute on Aging, part of NIH, awarded a grant to Dr. Constantine Lyketsos, of Johns Hopkins Bayview Medical Center, Baltimore, and Dr. Andres Lozano, of the University of Toronto.  The NIA/NIH grant is expected to total more than $2 million over the next five years.

In addition, Banner Sun Health Research Institute in Sun City, Ariz. and Brown University affiliated Butler and Rhode Island Hospitals in Providence have partnered to join the study, bringing the total to seven centers participating in the study.  ADvance is evaluating the safety and potential clinical benefit of stimulating the fornix, a major inflow and output pathway in the brain's memory circuit, for patients with mild Alzheimer's. 

"We are halfway to our goal of enrolling 40 patients in the U.S. and Canada. The study investigators have been very diligent in enrolling appropriate patients with early Alzheimer's disease," said Todd Langevin, President and COO of Functional Neuromodulation.  "We expect our progress to accelerate as we now have active teams of Alzheimer's and neurosurgical experts in place and recruiting at seven leading research centers in North America."   

"Alzheimer's is a growing public health concern, and with the recent disappointments in drug research, we urgently need new ideas," said Stephen Salloway, MD, a principal investigator for the study and director of the Memory and Aging Program at Butler Hospital. "DBS has helped transform the treatment of Parkinson's disease and we hope that stimulation of memory circuits can have a similar benefit in treating Alzheimer's disease."

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)1. In Europe, Canada and Australia, 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 HDE2 . 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 http://fxneuromod.com

Contact:

info@fxneuromod.com  

  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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