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First U.S. Patient Implanted in Functional Neuromodulation Study of Deep Brain Stimulation for Alzheimer's Disease

University of Pennsylvania Joins the ADvance Study

December 6, 2012

Toronto, Ontario – December 6, 2012 – The first U.S. patient to enroll in Functional Neuromodulation's ADvance Study was successfully implanted with a deep brain stimulation (DBS) system. ADvance will evaluate the safety and potential clinical benefit of DBS of the fornix (DBS-f), a major inflow and output pathway in the brain's memory circuit, for patients with mild Alzheimer's.

The ADvance Study is making rapid progress, with six implants conducted to date. The first U.S. implant was done at Johns Hopkins and five patients have been implanted at Toronto Western Hospital. The University of Pennsylvania has joined the study, bringing the total to five leading North American research centers participating in ADvance.

"In just two years, we have partnered with expert clinical researchers and assembled a lean team of seasoned professionals that have propelled the company through funding, regulatory requirements, study initiation and significant patient enrollment," said Todd Langevin, President and COO of Functional Neuromodulation.

"Given the urgent need for progress and the ongoing challenges in drug research for Alzheimer's, we are excited to assess a completely new circuitry-based approach that could offer hope," commented David Wolk, MD, Assistant Professor of Neurology and Assistant Director of the Penn Memory Center. "Pre-clinical testing has suggested that DBS may result in physiological changes that could alter disease progression. ADvance will help us to determine whether stimulation of the fornix can drive activity in the memory circuit to improve memory and lead to better clinical outcomes."

About ADvance

ADvance is a randomized double-blind controlled trial initially involving 20 people aged 55-80 with mild Alzheimer's disease. Patients are currently being recruited to participate in the study at the Banner Alzheimer's Institute in Phoenix, AZ, Johns Hopkins Bayview Medical Center, Toronto Western Hospital, University of Florida Center for Movement Disorders and Neurorestoration and the University of Pennsylvania. The trial will compare 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 off group will be eligible to 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.

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.

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 and Canada, 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 and in the United States under an HDE2.  More than 85,000 people worldwide have received DBS therapy.

About Functional Neuromodulation Ltd.

Founded in Toronto, Ontario in 2010, Functional Neuromodulation is dedicated to advancing the application of deep brain stimulation (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.

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.


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